Hutchison China MediTech Limited ("Chi-Med") is a China-based globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products.

Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets and distributes prescription drugs and consumer health products in China.

Chi-Med is listed on the London Stock Exchange’s AIM market (AIM: HCM). It is majority owned by CK Hutchison Holdings Limited (SEHK: 0001), a leading international conglomerate committed to innovation and technology with over a quarter of a million employees in more than 50 countries and annual sales of over US$50 billion.

http://www.chi-med.com/eng/global/home.php

2012 Interim Report - ended 30th June 2012

http://www.chi-med.com/eng/irinfo/reports/2012ir.pdf

Chi-Med operating profits up 97%
StockMarketWire.com
Operating profits at Hutchison China MediTech jumped by 97% to $7.2m in the six months to the end of June.

Revenues were up 25% at $102.9m and there was a net profit attributable to Chi-Med equity holders of $2.5m compared with a loss of $0.7m a year ago.

Chief executive Christian Hogg said: "This has been another good half year.

"Revenues on continuing operations are up 25%, sustaining our top-line growth, operating profit almost doubled and net profitattributable to Chi-Med equity holders is $2.5 million, compared to a loss in the same period last year. Our outlook is promising.

"We are one of the leading innovators in the China pharmaceutical industry, having invested almost $130 million in drug research and development in the field of oncology and immunology over the past eleven years.

"We believe the fruits of this investment are set to emerge over the coming few years, and are set to transform the group."

Drifted down back end of Aug, recovering well in Sept.

..Hutchison China Meditech director tops up stake

Sharecast – 55 minutes ago

......
LONDON (ShareCast) - Michael Howell, an Independent Non-Executive Director at Hutchison China Meditech, a research and development company majority-owned by Chi-Med, purchased 31,800 shares at 435.00p each on Tuesday.

The £138,330 transaction, which takes Howell's interest in the company to 153,600 shares, comes six weeks after the firm unveiled a strong first half.

During the six months ended June 30th, Hutchison saw pre-tax profits almost doubled to $6.5m on revenues of $109.2m, and said it was well-positioned to take advantage of the enormous Chinese market.

The firm said profits had been spurred on by the rapid expansion of domestic consumer spending power in China.

The AIM 100-listed company has seen a 25% increase in its share price over the past year, equal to 85p.

Towards the end of August the company announced Panmure Gordon as its new financial advisor after its old one, Lazard, stopped its nominated advisory services.

Phase I trial with EGFR inhibitor theliatinib
RNS
RNS Number : 9475P
Hutchison China Meditech Limited
01 November 2012









Hutchison China MediTech Limited ("Chi-Med")
(AIM: HCM)


Hutchison MediPharma Limited initiates Phase I clinical study
with its novel EGFR inhibitor Theliatinib


London: Thursday, 1 November 2012: Chi-Med announced that Hutchison MediPharma Limited ("HMP"), its majority owned R&D company, initiated the first-in-human Phase I clinical trial of Theliatinib (HMPL-309). This is the fourth oncology compound from the internal discovery programmes of HMP to enter into clinical development in China. Theliatinib is a novel, orally active small molecule inhibitor targeting the wild type epidermal growth factor receptor ("EGFR") or resistant EGFR tumours. The first patient was dosed on 30 October 2012.

The primary objectives of the Phase I study are to evaluate its safety and tolerability in patients with advanced solid tumours and to determine its maximum tolerated dose. This study will also evaluate its preliminary efficacy against non-small cell lung cancer ("NSCLC"), determine the pharmacokinetics of Theliatinib under single dose and repeat doses and explore the relationship between the Theliatinib's activity and certain biomarkers.

In pre-clinical studies, Theliatinib demonstrated strong anti-tumour activity against EGFR wild type tumours at doses that are expected to be well tolerated. Theliatinib was also found to have good pharmacokinetic properties and a favourable safety profile. These studies also exhibited good tissue distribution and stronger anti-tumour activity in EGFR wild type and EGFR resistant tumours, compared with first generation small molecule EGFR inhibitors. "If these attributes are also demonstrated in clinical studies, we believe that Theliatinib could become an important therapy in this area," said Christian Hogg, Chief Executive Officer of Chi-Med.

Ends

Enquiries

Hutchison initiates phase 1 on Theliatinib trial
Thu 01 Nov 2012

HCM - Hutchison China Meditech Ltd



LONDON (SHARECAST) - Pharmaceutical company Hutchison China MediTech (Chi-MEd) has announced that through its majority-owned research and development company it has initiated the first-in-human phase 1 clinical trial of its Theliatinib (HMPL-309) product.

The firm said the main aim of the study is to evaluate its safety and tolerability in patients with advanced solid tumours and to determine its maximum tolerated dose.

The trial is the fourth oncology compound from the internal discovery programmes the R&D company to enter into clinical development in China.

Theliatinib is an orally active product which targets the wild type epidermal growth factor receptor (EGFR) or resistant EGFR tumours.

Phase 1 will also evaluate its preliminary efficacy against non-small cell lung cancer (NSCLC), determine the way the body responds to Theliatinib under single dose and repeat doses and explore the relationship between the Theliatinib's activity and certain biomarkers.

"In pre-clinical studies, Theliatinib demonstrated strong anti-tumour activity against EGFR wild type tumours at doses that are expected to be well tolerated," the company said.

"These studies also exhibited good tissue distribution and stronger anti-tumour activity in EGFR wild type and EGFR resistant tumours, compared with first generation small molecule EGFR inhibitors. If these attributes are also demonstrated in clinical studies, we believe that Theliatinib could become an important therapy in this area."

http://www.edisoninvestmentresearch.co.uk/researchreports/HutchisonChinaMediTechQV051112.pdf

Hutchison China Meditech is focused primarily on China and it has three divisions- healthcare division, drug development and consumer products. Drugs are supplied over the counter or by prescription and one of Chi-Meds products is on China's essential list of medicines, of which there are only about 370. As the Chinese become more affluent , more and more people are signing up for medical insurance, while the government is increasing its investment in national health care. In the last four years there has been a 53% surge in spending to $58.7 billion , which works out an average of $142 per person. so the potential for further growth in spending is substantial within the sector.

Chi-Med and Nestle? Health Science Joint Venture
RNS
RNS Number : 1484S
Hutchison China Meditech Limited
28 November 2012











Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





Chi-Med and Nestlé Health Science establish Joint Venture

'Nutrition Science Partners' intends to:


· Research and develop a pipeline of innovative gastrointestinal botanical medicines and nutritional products through access to best-in-class Traditional Chinese Medicine library and discovery platform
· Progress HMPL-004, the lead candidate, through Phase III trials for ulcerative colitis and Crohn's disease


London: Wednesday, 28 November 2012: Nestlé Health Science SA, a fully-owned subsidiary of Nestlé SA, and Chi-Med, today announce that they have agreed to form a 50/50 joint venture to be named Nutrition Science Partners Limited ("NSP").

The purpose of NSP is to research, develop, manufacture and market worldwide novel medicines and nutritional products derived from botanical plant origins. NSP will focus on gastrointestinal indications ("GI"), and may in the future expand into the metabolic disease and brain health areas.

Luis Cantarell, President and CEO of Nestlé Health Science said: "This JV provides Nestlé Health Science with an opportunity to develop and commercialise truly innovative and scientifically validated botanical based nutrition solutions for personalised healthcare in gastrointestinal health. Whilst Nestlé Health Science will bring unique competencies in nutritional sciences, diagnostics and commercial capabilities, Chi-Med will provide their best-in-class Traditional Chinese Medicine library and discovery platform, which will be the basis of NSP's future GI pipeline. The lead candidate HMPL-004 addresses key unmet GI needs for IBD patients."

Christian Hogg, CEO of Chi-Med, said: "Chi-Med has invested for many years in developing novel medicines for the global market derived from proven botanical sources. We are today a leading company in the world in this field. We are now joined in this important endeavour by Nestlé Health Science, and are confident that by harnessing the resources of our two groups, we will succeed in bringing a stream of novel botanical medicines and nutritional products to market and in-so-doing build significant value for patients and for our shareholders."

Nestlé Health Science will make an initial capital investment in return for its 50% shareholding in NSP; while Chi-Med will provide exclusive rights to its extensive botanical library and well-established botanical R&D platform, in the field of gastrointestinal disease. Such botanical library contains over 1,500 purified natural products and over 50,000 extracts/fractions derived from more than 1,200 different medicinal plants.

NSP will also progress HMPL-004, a novel, oral therapy for Inflammatory Bowel Disease ("IBD") developed by Hutchison MediPharma Limited ("HMP") and derived from a botanical extract, through Phase III registration trials for ulcerative colitis and Crohn's disease. The clinical efficacy and safety of HMPL-004 in the treatment of IBD has already been demonstrated in over 400 patients, including successful Phase IIb trials completed by HMP in North America and Europe. The Phase III program for HMPL-004 is scheduled to start in early 2013. It will be conducted primarily in the US and Europe and is expected, in total, to enrol over 2,700 patients suffering from ulcerative colitis and Crohn's disease.

NSP will be governed by its Board. Luis Cantarell will be the Chairman, and Christian Hogg will be both a Director and the first General Manager of NSP.

NSP will be funded primarily through the initial Nestle Health Science capital investment and further milestone payments linked to success of clinical and commercial activities.

This transaction is subject to regulatory approval.



Ends

Hutchison China Meditech: UBS raises target price from 470p to 520p and reiterates its buy recommendation.

http://www.edisoninvestmentresearch.co.uk/researchreports/HutchisonChinaMediTechQV291112.pdf

Whats new - Major deal with Nestle, phase lll trials due to start, FDA looking favourably at botanical medicines.

The surge in HCM's shareprice inthe first quarter of last year signalled that the market had started to understand how important the company's access to the Chinese medical market could be in years to come.Nestle seems to have recognised the importance of HCM's research into plant-derived medicines by forming a joint venture (JV) with the company. The jv will allow the company's main product, HMPL-004, a treatment for gastroin-testinal problems, to go into phase lll clinicaltrials, with the potential commercialisation around the world to follow. The trials start early this year and will involve more than 2,700patients.

Upgrades to follow earnings and portfolio developments - Analysts believe the company will grow sales at a compound clip of some 12.3% a year out to 2014 and thus outpace its target markets. This progress will be partly driven by positive newsflow from Chi-Meds oncology portfolio and its volitnib cancer treatment. Its UK division should also perform well, with operating profits predicted to increase by as much as $2 million. Other areas to watch include the £230 million caps joint venture formed with food giant Nestle last November to develop and market medicines and nutritional products.
Chi-meds financial statements already look healthy. In the first half of the year its unaudited revenues increased 25% year-on-year to $102.9 million,while its operating profit jumped almost 100% to $7.2 million, the firm also has $26.5 million in net cash on the balance sheet.

Just read the headline in IC that Biotech is back and that it could pay investors to give the sector some serious attention. The sector is waking up due to large pharma companies are closing down and outsourcing more of the research and development and concentrating on the eventual product instead. So another way of playing the trend is to asses where the greatest amount of biotech investment will be over the next few years. In this case it is China that sweeps the boardas the government is commited to spending over $300bn on bioscience research in its latest five year plan.
The easiest way to access the market is via london listed companies such as Hutchinson China Meditech (HCM)

Notice of Results
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RNS Number : 0263Y
Hutchison China Meditech Limited
18 February 2013











Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





Notice of Announcement of 2012 Final Results





London: Monday, 18 February 2013: Chi-Med will be announcing its final results for the year ended 31 December 2012 on Tuesday, 26 March 2013. An analyst presentation will be held at 9:00 am on the same day at Citigate Dewe Rogerson, 3 London Wall Buildings, London, EC2M 5SY.

Final Results



Consolidated Group Results


Revenue from continuing operations up 18% to $195.4 million (2011: $165.0m).
Operating profit up 65% to $8.9 million (2011: $5.4m) - China Healthcare and Drug R&D gains partially offset by Consumer Products Division restructuring costs.
Net profit attributable to Chi-Med equity holders up 412% to $3.6million (2011: $0.7m).
Cash and cash equivalents and unutilised bank loan facilities of $85.9 million. Net cash $23.9 million.


China Healthcare Division - Increasingly significant source of profit and cash for the Group

Sales of subsidiaries and jointly controlled entities ("JCE") up 29% to $350.5million (2011: $271.0m). Organic expansion of own brands (up 15% to $300.0m) with prescription drug sales remaining the key driver. Growth of over-the-counter ("OTC") drug distribution business (up 351% to $50.5m).
Net profit attributable to Chi-Med equity holders up 11% to $15.5 million (2011: $14.0m).
Positive impact expected in 2013 as OTC raw material prices continue to normalise.
http://www.moneyam.com/action/news/showArticle?id=4561569

Hutchison China Meditech - Full year results interview.

Click here to listen

Hutchison China MediTech Ltd (HCM:LSE) set a new 52-week high during today's trading session when it reached 470.00. Over this period, the share price is up 11.07%.

Been waiting ages gf, must break out soon.


As of Mar 22, 2013, the consensus forecast amongst 3 polled investment analysts covering Hutchison China MediTech Limited advises that the company will outperform the market. This has been the consensus forecast since the sentiment of investment analysts deteriorated on Feb 22, 2012. The previous consensus forecast advised investors to purchase equity in Hutchison China MediTech Limited.

Yep flagged it up on Chart Attack.

Thanks gf.

Chi-Med operating profits up 65%
StockMarketWire.com
Hutchison China MediTech's operating profits rose by 65% in the year to the end of December and the company expects strong progress in 2013.

Revenue from continuing operations increased by 18% to $195.4m and operating profit rose to $8.9m from $5.4m) with China healthcare and drug R&D gains being partly offset by consumer products division restructuring costs.

Net profit attributable to Chi-Med equity holders jumped by 412% to $3.6m.

Chief executive Christian Hogg said: "2012 has been a great year for Chi-Med. In particular, our Drug R&D operation and its potential have been transformed through our 50-50 joint venture with Nestlé Health Science, which followed our 2011 deal with AstraZeneca, and by the rapidly expanding programme of discovery, clinical trial proof-of-concept data and licensing dialogue. The significant value of its pipeline of compounds is becoming increasingly clear.

"Our China healthcare division has shown continued solid growth, especially in its prescription drug and OTC drug distribution businesses, and its profitability will benefit in 2013 from an expected fall in OTC raw material costs, which has to date held back its profit growth rate, and from clarification on our property values.

We have also cut out the loss-making operations from our consumer products division, creating a clear growth path for this division in China.

"We have a clear and well established growth platform, with our business now focused on the continued powerful growth of the China pharmaceutical sector and with a Drug R&D business with considerable potential in global markets as well as China.

"The drug R&D division is now beginning to demonstrate that its innovations are of considerable worth and consequently we expect other partnership deals in 2013. We expect to create substantial shareholder value in 2013-2014 and the years beyond."

A speculative buy in this weeks IC

Data Presentations at AACR

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RNS Number : 7466B

Hutchison China Meditech Limited

08 April 2013




















Hutchison China MediTech Limited ("Chi-Med")
(AIM: HCM)



Presentations of Fruquintinib Phase I Clinical Data and Volitinib Preclinical Data

at the 2013 AACR Annual Meeting



London: Monday, 8 April 2013: Chi-Med today announces that data from the recently completed Phase I clinical trial of Fruquintinib (HMPL-013) and from preclinical studies of Volitinib (HMPL-504), two of the novel small molecule targeted anti-cancer drugs of Hutchison MediPharma Limited ("HMP"), its majority owned R&D company, are being presented at the 2013 American Association for Cancer Research ("AACR") Annual Meeting held in Washington, DC, USA from 6 to 10 April 2013. Presentations on Volitinib are prepared jointly with HMP's collaboration partner AstraZeneca PLC.

AACR is the world's first and largest professional organisation dedicated to advancing cancer research and its mission to prevent and cure cancer. AACR membership includes more than 34,000 laboratory, translational and clinical researchers; population scientists; other health care professionals; and cancer advocates residing in more than 90 countries. AACR marshals the full spectrum of expertise of the cancer community to accelerate progress in the prevention, biology, diagnosis and treatment of cancer by annually convening more than 20 conferences and educational workshops, the largest of which is the AACR Annual Meeting with more than 17,000 attendees.

One presentation will report on the final results of the Fruquintinib Phase I study, which demonstrated favourable clinical safety profile, pharmacokinetic properties and preliminary clinical efficacy. Additionally, three presentations relating to the pharmacokinetics and efficacy of Volitinib in preclinical models are being presented.

The presentations are as follows:

· Phase I study of safety and pharmacokinetics of Fruquintinib, a selective inhibitor of VEGF receptor -1, -2, and -3 tyrosine kinases in patients with advanced solid tumours

· Preclinical disposition and pharmacokinetics of Volitinib, a novel selective c-Met inhibitor

· Synergistic effect of c-Met inhibitor Volitinib in combination with EGFR inhibitor Gefitinib on EGFR-TKI resistant NSCLC model HCC827C4R harbouring acquired Met gene amplification

· Volitinib (HMPL-504), a novel, selective and potent c-Met inhibitor, is efficacious in primary tumour models of c-Met-driven gastric cancer

Further information about the 2013 AACR Annual Meeting and the abstracts is available on AACR's website at http://www.aacr.org/home/scientists/meetings--workshops/aacr-annual-meeting-2013/program.aspx.

Hutchison China MediTech Ltd (HCM:LSE) set a new 52-week high during today's trading session when it reached 498.00. Over this period, the share price is up 27.56%.

Nutrition Science Partners JV Approved
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RNS Number : 2116C
Hutchison China Meditech Limited
12 April 2013









Hutchison China MediTech Limited ("Chi-Med")
(AIM: HCM)




Nestlé Health Science and Chi-Med complete regulatory approvals for the establishment of Nutrition Science Partners Joint Venture


London: Friday, 12 April 2013: Nestlé Health Science SA, a fully-owned subsidiary of Nestlé SA, and Chi-Med, today announce that all regulatory approvals required for the establishment of the 50/50 joint venture Nutrition Science Partners Limited ("NSP") have been received.



The purpose of NSP is to research, develop, manufacture and market worldwide novel medicines and nutritional products derived from botanical plant origins. NSP will focus on gastrointestinal indications and may in the future expand into the metabolic disease and brain health areas.



Ends

Global Phase III UC trial initiated with HPML-004

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RNS Number : 0816D

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24 April 2013




















Hutchison China MediTech Limited ("Chi-Med")
(AIM: HCM)





Nutrition Science Partners announces initiation and treatment of the first Ulcerative Colitis patient in the global NATRUL Phase III trial for the novel botanical oral drug HMPL-004



London: Wednesday, 24 April 2013:Nutrition Science Partners, a 50/50 joint venture between Chi-Med and Nestlé Health Science, today announces that the first patient has been enrolled and has begun treatment in the first global Phase III study of HMPL-004, NATRUL-3, in patients with mild-to-moderate ulcerative colitis ("UC").



HMPL-004 is a proprietary, novel, botanical oral drug in late stage development for the treatment of inflammatory bowel disease ("IBD"). It has undergone multiple clinical trials in North America, Europe and Asia, which showed efficacy in the induction of clinical response, remission, and mucosal healing; as well as a clean safety profile.



The Phase III registration trial programme to be named NATRUL is designed to evaluate the efficacy and safety of HMPL-004 in patients with mild-to-moderate UC. It consists of three separate randomised double-blind, multi-centre, placebo-controlled Phase III studies of HMPL-004.




NATRUL-3:

The primary endpoint of this study is to evaluate 8-week treatments of 1,800 mg/day and 2,400 mg/day dosages of HMPL-004 compared with placebo in patients with active UC who have an inadequate response to their current treatment with Mesalamine. Secondary endpoints of this study include clinical response and mucosal healing. The NATRUL-3 study is expected to take approximately 24 months to complete.


NATRUL-4:

This study is designed to evaluate HMPL-004 as a 52-week maintenance therapy. Subjects who have completed NATRUL-3 will be eligible to enter NATRUL-4 directly.


NATRUL-5:

This study is a second UC induction study to fulfil regulatory requirements.


A separate Crohn's disease programme will be triggered by satisfactory NATRUL-3 clinical data analysis. All HMPL-004 studies beyond NATRUL-3 will be announced separately upon treatment of their first patient.

The current standard of care for IBD starts with 5-aminosalicyclic acids (5-ASAs) which can induce and maintain clinical response and remission in an average of approximately 50% of IBD patients. For the 5-ASA non-responding patients with moderate-to-severe active diseases, various forms of corticosteroids and immunosuppressant drugs and anti-TNF agents such as biologics are prescribed. These agents, though effective, are associated with many side effects, sometimes serious, and are not often suitable for prolonged usage. There remain clear unmet medical needs for novel agents which can induce and maintain remission among 5-ASA non-responding or intolerant patients, and the need for safer agents without the side effects of corticosteroids and immune suppressors.

Dr. William Sandborn, Professor of Clinical Medicine at the University of California San Diego and Director of the IBD Center and Chief of the Division of Gastroenterology for the UC San Diego Health System, said: "At the moment there are limited alternatives available for UC patients with mild to moderate disease who are seeking a safe and effective therapy. As a natural oral product with promising efficacy and an excellent safety profile, I expect patients and physicians alike to be enthusiastic at its potential if this trial is successful."

Christian Hogg, Chi-Med CEO said: "This is the first of what we expect to be many landmark events that will be achieved by our joint venture, Nutrition Science Partners, as it begins to invest in developing truly innovative and scientifically validated botanical based solutions for personalised healthcare. We are very pleased to start this global registration trial to help address IBD, a disease that is estimated to affect approximately 1.4 million in the US alone."



Ends

Hutchison China Medi: UBS ups target price from 520p to 590p keeping its buy recommendation.

A buy in this weeks IC - The company's deal with Nestle will allow it to progress its main HPML-004 gastro-intestinal product into phase iii trials. That Huchinson can get to this point is no mean achievement as a phase iii trial for such a product might involve up to 3000 patients and cost tens of millions. This puts Huchinson in a different league when it comes to biotech companies in the UK, with the aim company the most significant player outside of the big four pharma giants of AstraZeneca, GlaxoSmithKline, Shire and BTG. It has an enormous and rapidly developing market on its doorstep.

Hutchison China MediTech Ltd (HCM:LSE) set a new 52-week high during today's trading session when it reached 560.00. Over this period, the share price is up 25.14%.

Hutchison China MediTech Ltd (HCM:LSE) set a new 52-week high during today's trading session when it reached 599.50. Over this period, the share price is up 29.94%.

Financial calendar


Closure of Register of Members 09 May 2013 to 10 May 2013

Annual General Meeting 10 May 2013

As of May 03, 2013, the consensus forecast amongst 3 polled investment analysts covering Hutchison China MediTech Limited advises that the company will outperform the market. This has been the consensus forecast since the sentiment of investment analysts deteriorated on Feb 22, 2012. The previous consensus forecast advised investors to purchase equity in Hutchison China MediTech Limited.

Trading statement due Friday 10 May.

Notice of Results

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RNS Number : 5845H

Hutchison China Meditech Limited

24 June 2013














Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





Notice of Announcement of 2013 Interim Results





London: Monday, 24 June 2013: Chi-Med will be announcing its interim results for the six months ended 30 June 2013 on Tuesday, 30 July 2013. An analyst presentation will be held at 9:00am on the same day at Citigate Dewe Rogerson, 3 London Wall Buildings, London, EC2M 5SY.







Ends

Volitinib Phase I triggers US$5 million milestone

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Hutchison China Meditech Limited

25 June 2013






Hutchison China MediTech Limited ("Chi-Med")
(AIM: HCM)

Initiation of Volitinib China Phase I study triggers US$5 million milestone payment;
Australia Phase I study to report in late 2013





London: Tuesday, 25 June 2013: Chi-Med today announces that Hutchison MediPharma Limited ("HMP"), its majority owned R&D company, has initiated the Phase I clinical trial of Volitinib (HMPL-504) in China, which entitles HMP to receive a cash milestone payment of US$5 million pursuant to the global licensing, co-development and commercialisation agreement entered into between AstraZeneca PLC and HMP in December 2011.



The primary objectives of the Phase I study of Volitinib in China are to evaluate its safety and tolerability in patients in China with advanced cancer and to determine its maximum tolerated dose. The study will also evaluate Volitinib's preliminary efficacy against various tumours, including lung cancer and gastric cancer, both being major unmet medical needs in China. The c-Met gene amplification status and protein expression levels will be evaluated to help inform subsequent patient selection strategies.



In February 2012, HMP commenced the first-in-human Phase I clinical trial of Volitinib in Australia which has progressed well through multiple dose levels and continues as a study of safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy against multiple tumour types, particularly among Caucasian patients. Results of the Phase I trial in Australia are expected in late 2013. Furthermore, the Phase I trial in Australia provides a guide for the selection of the recommended starting dose for the Phase I study in China.



Volitinib is a potent ATP-competitive c-Met inhibitor with high selectivity over a 274 kinase panel. Pre-clinical studies of Volitinib have demonstrated tumour growth inhibitory activity in a series of human tumour xenografts, especially for those tumours with c-Met gene amplification or c-Met over-expression.




Ends

Global Phase III HPML-004 maintenance study starts

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17 July 2013












Hutchison China MediTech Limited ("Chi-Med")
(AIM: HCM)





Nutrition Science Partners announces initiation of NATRUL-4,
the maintenance study of the global Phase III trial for HMPL-004





London: Wednesday, 17 July 2013: Nutrition Science Partners, a 50/50 joint venture between Chi-Med and Nestlé Health Science, today announces that the first patient has begun treatment in the second global Phase III study of HMPL-004, NATRUL-4, for mild-to-moderate ulcerative colitis ("UC").



HMPL-004 is a proprietary, novel, botanical oral drug in late stage development for the treatment of inflammatory bowel disease ("IBD"). It has undergone multiple clinical trials in North America, Europe and Asia, which showed efficacy in the induction of clinical response, remission, and mucosal healing; as well as a clean safety profile.



NATRUL-4 is a global Phase III study designed to evaluate the efficacy and safety of HMPL-004 as maintenance therapy in adults with mild-to-moderate active UC. It consists of an open-label induction treatment phase and a randomised, double-blind, placebo controlled maintenance therapy phase. Patients entering the maintenance phase of this study are those who have achieved clinical remission or response during their participation in either a randomised double-blind, placebo controlled HMPL-004 induction study (NATRUL-3 or NATRUL-5), or the 8-week open-label HMPL-004 induction treatment phase of the study. Eligible patients (clinical remitters and responders) will be randomised to receive either HMPL-004 at 1,800 mg/day or placebo for 52 weeks as maintenance therapy.



The primary endpoint of this study is the proportion of patients who are in remission after 52 weeks of maintenance treatment, following either successful induction therapy to achieve remission, or successful induction therapy to achieve response.



Key secondary endpoints of this study include the proportion of patients that have maintained remission only after induction into remission; the proportion of patients that are in response after induction into either remission or response; and the proportion of patients that have maintained response following induction into response.





Ends

Interim Results

RNS


RNS Number : 4081K

Hutchison China Meditech Limited

30 July 2013










Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)



Interim Results for the Six Months Ended 30 June 2013



Continued strong growth, especially in Drug R&D and China Healthcare. Outlook positive.





London: Tuesday, 30 July 2013: Chi-Med, the China-based healthcare and consumer products group, today announces its unaudited financial results for the six months ended 30 June 2013.



Group results are reported for the first time under the new International Financial Reporting Standard, IFRS 11 "Joint Arrangements" ("IFRS11"), which establishes the equity accounting principle for the reporting of joint ventures ("JVs") and means that the income statements and statements of financial position of JVs will no longer be proportionately consolidated. However, total revenues of the JVs will continue to be disclosed under the divisional summaries below.



Results are reported in US dollar currency unless otherwise stated.





Group Results

· Revenue, under IFRS11, on continuing operations up 74% to $17.6 million (H1 2012: $10.1m).

· Net profit attributable to Chi-Med equity holdersgrew 598% to$3.3 million (H1 2012: -$0.7m).

· Solid cash position: cash and cash equivalents at the Chi-Med Group level of $43.8 million (31 December 2012: $30.8m) in addition, and not included at the Group level, cash and cash equivalents held at the JV level totalled $101.4 million (31 December 2012: $62.4m).



China Healthcare Division

· Sales of subsidiaries and JVs up 22% to $227.5 million (H1 2012: $187.0m).

· Net profit attributable to Chi-Med equity holders up 18% to $14.4 million (H1 2012: $12.3m).

· Continued substantial growth in prescription drug and distribution businesses; over-the-counter ("OTC") drug business surge due to H7N9 outbreak in China, raw material prices however remain high.

· Value of land holdings expected to more than cover the cost of planned relocation and expansion of production facilities.

· Cash and cash equivalents held in our China Healthcare Division JVs totalled $75.2 million (31 December 2012: $62.4m).



Drug R&D Division

· Revenue up 265% to $10.5 million (H1 2012: $2.9m) due to a development milestone from AstraZeneca Plc ("AstraZeneca") and service income from Nutrition Science Partners Limited ("NSP") and Janssen Pharmaceuticals Inc. part of the Johnson & Johnson group of companies ("J&J").

· Net loss attributable to Chi-Med equity holders up 8% to $4.8 million (H1 2012: -$4.5m) due to start of NSP investment in HMPL-004 Phase III trials.

· Aggregate cash and equityinjections and contractual obligations from partners into Drug R&D Division subsidiaries and JVs during the period totalled $38.1 million (H1 2012: $0.6 m).

· Seven clinical trials accelerating rapidly and building value. Six Phase I/Ib oncology trials in China and Australia as well as NSP's Phase III inflammatory bowel disease ("IBD") trial on HMPL-004 in the United States. Spending during the period by Hutchison MediPharma Limited ("HMP") and its partners on these seven clinical programmes totalled $15.2 million (H1 2012: $6.9m).

· Cash and cash equivalents held in our Drug R&D Division JVs totalled $26.2 million (31 December 2012: nil).





Consumer Products Division

· Sales on continuing operations up 32% to $5.5 million (H1 2012: $4.2m).

· Net loss on continuing operations attributable to Chi-Med equity holders of $0.4 million (H1 2012: -$0.5m).

· Discontinuation of operations of Sen France and infant formula in China with total net loss attributable to Chi-Med equity holders of $1.4 million, of which $0.4 million is non-cash.

· Continuing expansion of the broad organic and natural product line of Hutchison Hain Organic Holdings Limited ("Hutchison Hain Organic").



Christian Hogg, CEO of Chi-Med, said:



"The new IFRS11 accounting standard means we can no longer consolidate the revenues of our JVs, and we therefore report a considerable reduction in Group consolidated revenues. However, the Divisional results show continued strong revenue growth, as does our Consolidated Group profit.



There has been much comment on whether economic growth in China is slowing, but it is quite clear this is not the case in the pharmaceutical sector, where the progressive widening and deepening of the State's National Healthcare Plan and the growth in personal incomes continue to drive strong growth. This is reflected in the results for our China Healthcare Division, which will also benefit in future from planned pricing and the easing of currently high raw material costs on one of our lead products. We also expect to benefit from the values of our JVs' land holdings which we expect to more than cover the costs of the planned relocation and expansion of the production facilities.



Our Drug R&D Division continues to make very impressive strides in its drug development programme and in partnership agreements with leading multinational pharmaceutical companies, all of which are adding substantial shareholder value and are set for continued major growth. Aggregate cash and equity injections and contractual obligations to HMP from these partnerships were $38.1 million compared to $0.6 million in the same period last year. Our partnerships are funding the seven clinical trials we now have under way, including Phase III trials of our lead drug candidate HMPL-004 in the US and the six Phase I trials of our other drug candidates, which are showing exciting promise. We look for further continued strong progress and for potential additional steps in partnership agreements.



Our Consumer Products Division is now focused on expanding its profitable growth categories with Hutchison Hain Organic by launching new products into the Hong Kong and mainland China market, as well as into selected other countries in Asia.



Overall, this has been another period of good progress, which further demonstrates the strength of our growth platform and its continued long-term potential. We expect profitable growth to continue for the second half of 2013 and beyond with further substantial creation of shareholder value."



Ends

IC VIEW

China's economy may be slowing, but spending on healthcare is not. Trading on a 15 per cent discount to analysts' 600p a share sum-of-the-parts valuations, the shares remain a buy.

A buy in this weeks IC- China's economy may be slowing, but spending on healthcare is not. Trading on 15% discount to analysts 600p a share sum of the parts valuation .

Back to its highs.

Director Deals - Hutchison China Meditech Ltd (HCM)

BFN

Christopher Nash, Non Executive Director, bought 8,506 shares in the company on the 7th August 2013 at a price of 584.00p. The Director now holds 26,506 shares.

Story provided by StockMarketWire.com
Director deals data provided by www.directorsholdings.com

Analyst briefing on Chi-Med's R&D business

RNS


RNS Number : 5607P

Hutchison China Meditech Limited

03 October 2013












Hutchison China MediTech Limited ("Chi-Med")
(AIM: HCM)





Analyst briefing on Chi-Med's pharmaceutical R&D business on 9 October 2013





London: Thursday, 3 October 2013: Chi-Med today announces that it will host a briefing to update investors and analysts on Hutchison MediPharma ("HMP"), its majority owned pharmaceutical R&D division, in London on 9 October 2013.



Over the past several years, HMP has built an impressive pipeline of oral, small molecule cancer drugs and proprietary botanical drugs for inflammatory diseases. The briefing will focus on this pipeline.



HMP's current clinical pipeline includes: Fruquintinib, Sulfatinib, Epitinib, Theliatinib and Volitinib, each of which has the potential to treat a number of cancers, and HMPL-004, its lead candidate for ulcerative colitis and Crohn's disease.



In addition, HMP has formed key partnerships with major global pharmaceutical companies, including AstraZeneca and Nestlé Health Science.



The briefing will also cover HMP's pre-clinical research and the ongoing Phase III clinical development of HMPL-004, which is being undertaken by Nutrition Science Partners, a 50:50 joint venture between Chi-Med and Nestlé Health Science.



During the briefing, Dr Andrew Mortlock, Vice President of Cancer Research and Development Projects of AstraZeneca will give a presentation entitled, "Oncology in China".



Other key presenters at the briefing will be:



· Dr Weiguo Su, Ph.D. Chief Scientific Officer of HMP. Prior to joining HMP, Dr Su spent fifteen years with Pfizer's US R&D organisation where he was responsible for the delivery of several high quality new drug candidates into the clinic.



· Dr Hua Mu, Chief Medical Officer of HMP. Prior to joining HMP, Dr Mu worked at Roche, Biogen Idec, Abraxis and most recently, Genentech. During his career, he has been involved in the development of a number of successful oncology drugs including Xeloda ®, Abraxane ® and Avastin ®.



Mr Christian Hogg, Chief Executive Officer of Chi-Med, and Mr Johnny Cheng, Chief Financial Officer of Chi-Med, will also give presentations covering HMP's overall R&D strategy and its funding.



The briefing will take place at The Brewery (The James Watt room), 52 Chiswell Street, London, EC1Y 4SD on 9 October 2013 at 9:30 am, with registration starting from 9:15 am. Please contact Ms Janine Hagan by email at janine.hagan@citigatedr.co.uk for registration.



Ends

Lilly Deal for Fruquintinib

RNS


RNS Number : 0695Q

Hutchison China Meditech Limited

09 October 2013












Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





Cancer Therapy Collaboration with Lilly





London: Wednesday, 9 October 2013: Hutchison MediPharma Limited ("HMP"), an R&D company majority owned by Chi-Med, today announces that it has entered into a licensing, co-development, and commercialisation agreement in China with Eli Lilly and Company ("Lilly") for Fruquintinib (HMPL-013), a targeted oncology therapy for the potential treatment of various types of solid tumours. Fruquintinib, a selective inhibitor of the Vascular Endothelial Growth Factor ("VEGF") receptor tyrosine kinases, was discovered by HMP and is currently in Phase II testing in China.



Under the terms of the agreement, the costs of future development of Fruquintinib in China, to be carried out by HMP, will be shared between HMP and Lilly. HMP will potentially receive a series of payments of up to US$86.5 million, including upfront payments and development and regulatory approval milestones. Should Fruquintinib be successfully commercialised in China, HMP would receive tiered royalties starting in the mid-teens percentage of net sales. Additional terms of the agreement were not disclosed.



Christian Hogg, Chief Executive Officer of Chi-Med said: "Our belief is that Fruquintinib has potential activity against multiple tumour types with high incidence rates and may benefit patients with significant unmet medical needs in China. The collaboration with Lilly will allow for Fruquintinib to be developed across various tumour types in China and at a far greater speed than if we went alone."



"We are excited to collaborate with Hutchison MediPharma in the development of this potential new cancer therapy," said Jacques Tapiero, Lilly Senior Vice President and President of Emerging Markets. "In Lilly's emerging markets business, we are focused on providing patients with innovative medicines from our own pipeline and through collaborations with respected science-based companies such as HMP. Together, we are committed to help meet the medical needs of oncology patients in China."



Ends

Payment From Janssen Pharmaceuticals

RNS


RNS Number : 0697Q

Hutchison China Meditech Limited

09 October 2013


Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)


Candidate Nomination of Novel Small-Molecule Therapy in Inflammation Triggers Milestone Payment From Janssen Pharmaceuticals, Inc.



London: Wednesday, 9 October 2013: Chi-Med today announces that Hutchison MediPharma Limited ("HMP"), its majority owned R&D company, is set to receive a milestone payment of US$6 million from Janssen Pharmaceuticals, Inc. ("Janssen"), pursuant to the global strategic alliance (the "Agreement") to develop novel small-molecule therapeutics against a target in the area of inflammation/immunology entered into by the companies in June 2010.

The US$6 million milestone was triggered by a compound, the Candidate, discovered by HMP in collaboration with Janssen meeting certain development candidate criteria pursuant to the Agreement. Upon achievement of specific clinical development and approval milestones, HMP may potentially receive up to an additional US$90.5 million and is entitled to royalties on worldwide sales upon commercialisation of a product by Janssen.



Ends

Director/PDMR Shareholding

RNS


RNS Number : 6600Q

Hutchison China Meditech Limited

16 October 2013












Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





Director's Shareholding





London: Wednesday, 16 October 2013: Chi-Med received notification on 16 October 2013 that Ms Edith Shih, Non-executive Director and Company Secretary of Chi-Med, purchased 20,000 ordinary shares of US$1.00 each in Chi-Med (the "Shares") at a price of GBP6.20 each on 15 October 2013.



Following this purchase, Ms Shih is beneficially interested in 20,000 Shares, representing approximately 0.04% of the current issued share capital of Chi-Med.





Ends

IC this week - Shares in the Chinese drug developer, which is part of the giant Hong Kong based conglomerate Huchison Whampoa, have gained 25% over the past 12 months after an important deal with Swiss company Nestle to co-develop plant derived medicine HPML- 004 for gastric treatment. The drug is currently undergoing extensive phase lll clinical trials that will report sometime in mid 2014. The biotech research division also has at least five oncology products in its pipeline that are currently at the phase I stage of development. In addition, there is also an extensive Chinese medicine business which analysts value at around £247m . The company also earned a £3m milestone from Janssen Pharmaceuticals as part of an agreement to develop novel inflammation/immunology medicines.


But the major news flow in 2014 will be in connection with the Nestle joint venture and analysts will wait for this before revising their forecasts.

In Shares - Mark Slater manager of MFM Slater growth. Less well understood , are the rich property assets on the balance sheet and the progress being made by Chi-Med's majority owned research and development company , a biotechnology arm he describes as being 'years ahead of the next best Chinese R&D business'.
' I think the shares could double from here quite easily', says Slater.

IC this week continue to rate the shares a buy. Game changer, aim company with 10 bagger innovations.

In IGI this week - Mark Slater Boasting a 'huge pipeline of products' 'I think the shares could double from here quite easily'.

Sinopharm distribution joint venture in China

RNS


RNS Number : 8467V

Hutchison China Meditech Limited

18 December 2013












Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





Chi-Med and Sinopharm form China drug distribution and marketing joint venture





London: Wednesday, 18 December 2013: Chi-Med, the pharmaceutical and healthcare company based primarily in China, today announces the establishment of a new joint venture with Sinopharm Group Co. Ltd. ("Sinopharm"). Sinopharm is the largest distributor of pharmaceutical and healthcare products and a leading value added supply chain service provider in China. The joint venture will provide distribution and marketing services to both related and third party pharmaceutical companies in China.



Chi-Med will, through a wholly-owned subsidiary, invest approximately US$9.8 million in cash into Sinopharm Holding HuYong Pharmaceutical (Shanghai) Co., Ltd. ("Huyong") for the subscription of 51% of the equity in the enlarged share capital of Huyong, which will mean that Huyong will be consolidated as a Chi-Med subsidiary. The Chi-Med investment will be largely deployed for expanding future commercial activities, particularly in the area of third party drug sales and marketing. Sinopharm will hold the balance of 49% of the equity in Huyong.



Huyong is a Good Supply Practice ("GSP") certified pharmaceutical and healthcare distribution and marketing company that was originally established in 1993 and subsequently acquired by Sinopharm in 2010. Huyong will be renamed as Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited ("Hutchison Sinopharm"). Huyong's profit before tax for the year ended 31 December 2012 was US$1.0 million, and had gross assets at 31 December 2012 of US$29.9 million.



Hutchison Sinopharm will be reported under the China Healthcare Division of Chi-Med which currently comprises three companies: Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited ("HBYS"); Shanghai Hutchison Pharmaceuticals Limited ("SHPL"); and Hutchison Healthcare Limited ("HHL"). The 2012 sales of the China Healthcare Division subsidiaries and jointly controlled entities of Chi-Med were US$350.5 million and net profit attributable to Chi-Med equity holders was US$15.5 million.



Hutchison Sinopharm will provide a platform for synergy across the China Healthcare Division of Chi-Med by utilising the services of the approximately 2,800-person prescription drug and over-the-counter drug sales teams of SHPL and HBYS. A major aspect of the Hutchison Sinopharm business strategy will be to provide sales, distribution, and marketing services to major domestic and multi-national third party pharmaceutical manufacturers. It will also provide a broadened sales and marketing platform for HHL's products and potentially the future novel drugs registered by Hutchison MediPharma Limited, Chi-Med's Drug R&D Division.



This transaction is subject to regulatory approval in China.



Christian Hogg, Chi-Med CEO said: "This strategic investment widens the scope of our China Healthcare Division dramatically by allowing Chi-Med's commercial organisation to market third party pharmaceutical products. We are honoured to partner with Sinopharm in the area of drug distribution and marketing and expect to build a material business based on the complementary strengths of our two groups over the coming years."

Notice of Results

RNS


RNS Number : 6998X

Hutchison China Meditech Limited

16 January 2014














Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





Notice of Announcement of 2013 Final Results





London: Thursday, 16 January 2014: Chi-Med will be announcing its final results for the year ended 31 December 2013 on Tuesday, 18 February 2014. An analyst presentation will be held at 9:00am on the same day at Panmure Gordon, 3rd Floor, One New Change, London, EC4M 9AF.





Ends

Final Results

RNS


RNS Number : 2681A

Hutchison China Meditech Limited

18 February 2014














Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)



Final Results for the year ended 31 December 2013

Continued momentum. Continued very considerable growth potential.



London: Tuesday, 18 February 2014: Chi-Med today announces its final results for the year ended 31 December 2013.



Consolidated Group Results (IFRS11)

· Revenue from continuing operations up 106% to $46.0 million (2012: $22.4m), not including sales at the JV level which totalled $390.6 million (2012: $345.3m).

· Operating profit up 65% to $9.6 million (2012: $5.8m) including non-recurring charge of $2.0 million.

· Net profit attributable to Chi-Med equity holders up 63% to $5.9million (2012: $3.6m).

· Cash and cash equivalents at the Chi-Med Group level of $46.9 million (31 December 2012: $30.8m) in addition, and not included at the Group level, cash and cash equivalents held at the JV level totalled $99.0 million (31 December 2012: $62.4m).



Results are reported in US dollar currency unless otherwise stated.



Christian Hogg, Chi-Med CEO, said: "Chi-Med has had a highly successful 2013. We have propelled our revenues and profit, and the drivers of this success are set to continue.



Our Drug R&D Division has taken a major step forward by signing a new licensing deal with Eli Lilly and cementing its collaboration with Janssen to add to those it already has with AstraZeneca and Nestlé Health Science. Its revenues have increased sharply due to payments from these partners. It has significantly progressed its six clinical stage drug candidates either reaching, or closing in on, proof-of-concept. We have spent over $30 million on clinical trials in 2013, with our partners funding the great majority of these clinical costs. Several of our compounds in clinical development showed impressive results in 2013 - in two cases for treatment of certain tumour types, for which there are few, if any, treatment options approved on the global market.



By the end of 2013, Chi-Med had received $72 million of upfront and milestone payments and equity injections from our four partners. Looking ahead, this cash flow should escalate. In addition to funding the vast majority of clinical costs on our partnered drug candidates, our partners will contribute, subject to clinical success, up to approximately $1.2 billion in development, approval, and commercial milestones and option payments, as well as customary royalties on net sales.



Our China Healthcare Division continues to grow rapidly with net profit attributable to Chi-Med equity holders up 20% in 2013, again demonstrating the major potential in the China pharmaceutical market. Its sales and profitability are now benefitting from the normalisation of raw material prices and, this year, we hope to start crystallising the value in our manufacturing property portfolio. To take advantage of the opportunity for Chi-Med to provide sales, distribution and marketing services to major Chinese and multi-national third party pharmaceutical manufacturers as well as our own Drug R&D Division, we have formed a joint venture with Sinopharm.



Our Consumer Products Division grew sales 23%, driven by the progress of Hutchison Hain Organic, while Sen France and aspects of our China infant formula businesses have been discontinued.



Trading has started well this year. Sales and profit in our China Healthcare Division are well ahead of 2013 levels, as a result of effective execution and continued normalisation of raw material costs. We expect 2014 to be a breakout year for our Drug R&D Division as we publish clinical data on Volitinib, Fruquintinib and Sulfatinib, in each case outlining next stage clinical plans. On HMPL-004 we will reach our Interim Analysis on NATRUL-3, our Phase III induction study, and publish status in mid-2014. We expect also to start Phase I trials on our spleen tyrosine kinase ("Syk") inhibitor for inflammation in Australia, which would elevate the profile of this very high potential programme. Our Consumer Products Division's continuing operations have started well and we expect the refocused operations to be profitable this year.



The opportunities facing us are very considerable and we believe we will deliver further substantial shareholder value this year and beyond."



Highlights

China Healthcare Division - Continuing strong growth

· Sales of subsidiaries and joint ventures ("JVs") up 13% to $394.6 million (2012: $350.5m). Organic expansion of own brands (up 14% to $343.0m) with both prescription and over-the-counter ("OTC") cardiovascular drug sales being the strongest. Third party OTC drug distribution business up only 2% to $51.6 million due to shedding of lower margin activity.

· Net profit attributable to Chi-Med equity holders up 20% to $18.6 million (2012: $15.5m).

· Entered into an agreement to establish a new 51% Chi-Med owned JV, subject to regulatory approval, with Sinopharm Group Co. Ltd. (HKSE:1099) ("Sinopharm") to provide sales, distribution, and marketing services to major Chinese and multi-national third party pharmaceutical manufacturers.



Drug R&D Division - Step-change developments approaching

· Revenue up 327% to $29.5 million (2012: $6.9m) as a result of $22.2 million in upfront and milestone income and $7.3 million in service income from our partners.

· Secured $54.8 million in third party cash injections for Hutchison MediPharma Limited's ("HMP") activities during 2013, bringing the total to $103.6 million since 2010.

· Net lossattributable to Chi-Med equity holders of $2.4 million (2012: net profit $2.8m) due primarily to the consolidation of $8.8 million (2012: nil) non-cash share of the loss of Nutrition Science Partners Limited ("NSP"), the JV with Nestlé Health Science SA ("Nestlé Health Science"). NSP, which is enrolling patients in the HMPL-004 global Phase III registration trial, was entirely self-funded in 2013, and will be until the Interim Analysis in mid-2014, by the initial cash equity investment in NSP by Nestlé Health Science.

· Progressed global development of Volitinib (HMPL-504), a c-Met inhibitor in oncology, in partnership with AstraZeneca AB (publ) ("AstraZeneca") in Phase I in Australia and China. Phase I dose escalation, initiation of which triggered a $5 million milestone in mid-2013, will be completed by early 2014 and results will be published at the American Society of Clinical Oncology ("ASCO") meetings in June 2014. Volitinib has demonstrated very encouraging anti-tumour activity in Phase I in certain tumour-types, some of which have no approved therapies on the global market. Phase II studies in papillary renal cell carcinoma ("PRCC") will start in early 2014 in the United States and global Phase III initiation is scheduled for 2015.

· Completed exclusive license and collaboration agreement for China with Eli Lilly and Company ("Lilly") on Fruquintinib (HMPL-013), our highly selective vascular endothelial growth factor receptor ("VEGFR") inhibitor. Lilly will share development costs and pay HMP up to $86.5 million in upfront payments and development and regulatory milestones and upon commercialisation in China tiered royalties starting in the mid-teens percentage of net sales. Fruquintinib, which received Phase II/III clearance from the China Food & Drug Administration ("CFDA") in mid-2013, will start Phase II studies in several tumour types, and a Phase III registration study on one tumour type, in China in 2014.

· Immunology collaboration with Janssen Pharmaceuticals, Inc. ("Janssen"), the pharmaceutical division of Johnson & Johnson, progressed well in 2013. Janssen nominated a compound, HMPL-507, discovered by HMP, for further development thereby triggering a $6 million milestone payment. Janssen will be responsible for all development costs and will potentially pay HMP up to an additional $90.5 million in development and regulatory approval milestones, and royalties on worldwide sales upon commercialisation.

· Beyond the four partnered drug candidates, HMP has effectively progressed three further high potential small molecule oncology drug candidates with stand-out results on Sulfatinib which in 2013 demonstrated very encouraging anti-tumour activity in certain tumour types, some of which have very limited treatment options approved on the global market.

· In discovery, HMP nominated HMPL-523 in early 2013, a novel Syk inhibitor, for rheumatoid arthritis and intends to start Phase I trials in Australia in early 2014.



Consumer Products Division - Refocused

· Sales on continuing operations up 23% to $12.5 million (2012: $10.2m) driven by progress on the expansion of the range of Hutchison Hain Organic Holdings Limited ("HHO") products in Asia.

· Non-recurring $2.0 million in costs associated with the discontinuation of the Sen France and aspects of the China infant formula businesses.

· Net loss attributable to Chi-Med equity holders on continuing operations of $0.5 million (2012: -$0.9m).



Group results are reported for the full year for the first time under IFRS11 "Joint Arrangements" ("IFRS11"), which establishes the equity accounting principle for the reporting of JVs and means that the income statements and statements of financial position of JVs will no longer be proportionately consolidated. However, total revenues of the JVs will continue to be disclosed throughout the announcement.



A presentation for analysts will be held at 9:00 a.m. today at the offices of Panmure Gordon at 3rd Floor, One New Change, London EC4M 9AF.

The Annual General Meeting of Chi-Med will be held at 4th Floor, Hutchison House, 5 Hester Road, Battersea, London SW11 4AN on Thursday, 8 May 2014 at 10:00 a.m.



Ends

Hutchison China MediTech Ltd (HCM:LSE) set a new 52-week high during today's trading session when it reached 735.00. Over this period, the share price is up 67.05%.

A buy in last weeks IC

Doing very well since the new year.

Edison - Valuation: Increased to $791m (932p a share)
Updating our sum-of-the-parts model for the FY13 results and the progress in the R&D pipeline sees our valuation rising from $577m (705p a share) to $791m (932p a share) – ex property windfalls. MediPharma is valued, using an rNPV, at $257m (303p a share); placing China Healthcare on a peer group rating gives $505m (595p per share); with Consumer Products adding $36m (42p a share). Netting out group net cash/debt results in our $791m (932p a share) value.

Hutchison China MediTech Ltd (HCM:LSE) set a new 52-week high during today's trading session when it reached 900.00. Over this period, the share price is up 104.55%.

Really Taken off in March, a new high.

Hutchison China MediTech Ltd (HCM:LSE) set a new 52-week high during today's trading session when it reached 973.00. Over this period, the share price is up 121.14%.

Shares - has stated that Huchison MediTech Ltd in the coming months is poised to close a number of deals. In the light of the Chinese newsflow it demands caution.

Hutchison China MediTech: UBS raises target price from 820p to 1000p, but downgrades from buy to neutral.

Hutchison China Meditech: Panmure Gordon increases target price from 750p to 950p and stays with its buy recommendation.

Presentations at the 2014 AACR Annual Meeting

RNS


RNS Number : 0130E

Hutchison China Meditech Limited

04 April 2014






Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)



Presentations of volitinib and epitinib data at the 2014 AACR Annual Meeting



London: Friday, 4 April 2014: Chi-Med today announces that data from certain preclinical and clinical studies by Hutchison MediPharma Limited ("HMP"), its majority owned R&D company, will be presented at the 105th Annual Meeting of the American Association for Cancer Research ("AACR") to be held in San Diego, California, USA from 5 to 9 April 2014. These presentations will include additional data on volitinib (HMPL-504/AZD6094) and epitinib (HMPL-813), two novel and highly selective small molecule drugs discovered by HMP. Presentations on volitinib were prepared jointly with HMP's collaboration partner AstraZeneca AB (publ) ("AstraZeneca").



AACR is the world's first and largest professional organisation dedicated to advancing cancer research and its mission to prevent and cure cancer. AACR membership includes more than 34,000 laboratory, translational and clinical researchers; population scientists; other health care professionals; and cancer advocates residing in more than 90 countries. AACR marshals the full spectrum of expertise of the cancer community to accelerate progress in the prevention, biology, diagnosis and treatment of cancer by annually convening more than 20 conferences and educational workshops, the largest of which is the AACR Annual Meeting with more than 18,000 attendees.



HMP will have one oral presentation encompassing the substantial research and early clinical evaluation of volitinib, as well as two poster presentations focused specifically on c-Met models in preclinical studies of volitinib, and on epidermal growth factor receptor ("EGFR") inhibition in oesophagus cancer.

Chi-Med and Sinopharm Deal Approved

RNS


RNS Number : 0531F

Hutchison China Meditech Limited

17 April 2014














Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





Chi-Med and Sinopharm complete regulatory approval for the establishment of new China drug distribution and marketing Joint Venture





London: Thursday, 17 April 2014: Following the announcement on Wednesday, 18 December 2013, Chi-Med today announces that Chi-Med and Sinopharm Group Co. Ltd. ("Sinopharm") (SEHK:1099) have received regulatory approval for the establishment of their new joint venture, Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited ("Hutchison Sinopharm") (formerly known as Sinopharm Holding HuYong Pharmaceutical (Shanghai) Co., Ltd.). Hutchison Sinopharm, which formally commences operations on 25 April 2014, is 51% held by Chi-Med and will be consolidated as a Chi-Med subsidiary and reported under its China Healthcare Division.



Sinopharm is the largest distributor of pharmaceutical and healthcare products and a leading value added supply chain service provider in China. The purpose of Hutchison Sinopharm is to provide sales, distribution, and marketing services to major domestic and multi-national third party pharmaceutical manufacturers. It will also provide a broadened sales and marketing platform for synergy across Chi-Med group.





Ends

Mark Slater's winning shares

The Zulu Principle also places heavy emphasis on a catalyst being in place to help drive shares higher, an aspect highlighted by some of the winners that Slater’s fund has thrown up in recent years.


Parents will need no introduction to the catalyst that lies behind the success of the fund’s most famous winner, Entertainment One, which has posted huge gains off the back of its all-conquering cartoon show Peppa Pig.


It is a member of the illustrious ten-bagger club of shares that have risen at least tenfold, with its price soaring from below 20p during the 2009 market lows to just a few pence shy of 300p now. It has been a star performer since Slater bought in 2010 – he tipped This is Money readers as to why he was a buyer back in 2011.


Entertainment One remains in the fund’s top ten shares but is now the seventh biggest holding, after Slater took some profits from a stock that was his second biggest asset at the start of the year and had posted a 54 per cent gain in 2013.


Slater’s biggest holding is one of his stalwarts, Hutchison China Meditech. This is the UK-listed holding company of a healthcare group based in China, which has a strong growth record and net cash and surplus property on its books.


He describes the firm’s main business as having a wonderful tailwind from government health spending, demographics and rising living standards, adding that while ‘China would normally fill us with fear’ this is a subsidiary of Hutchison Whampoa, which is largely owned by Li Ka-shing – a man dubbed Asia’s Warren Buffett.


The fund’s holding in Hutchison China Meditech has risen from about 180p to around 800p. Slater likes it because he believes it also contains some unrecognised value. It includes a research and development business which is a Chinese biotech leader, has invested heavily in oncology and immunology therapies and is partnering with major Western pharmaceutical companies on potential blockbuster drugs. He says: ‘This is a very nice kicker to have.’


The manager cites consulting and software firm First Derivatives as another share with great potential thanks to its opportunity to expand through big data, and describes data storage firm Restore as a very steady, very fast growing company with a reliable customer base.


Among the other shares he highlights now are engineer Pressure Technologies and energy cost specialist UtilityWise.

Slater likes to hold between 25 and 50 shares in the fund and a glance at the fund’s top holdings right now could lead investors to believe he was a smaller companies specialist, but Slater says he is not concerned about size


'There is a bigger upside in smaller and medium sized companies but we do screen across the board. On occasion we have owned a lot of large companies,’ he says.


http://www.dailymail.co.uk/money/investing/article-2624331/Invest-growth-dont-overpay-Star-fund-manager-Mark-Slaters-tips.html

Hutchison China MediTech: UBS upgrades from neutral to buy with a target price of 1000p.

Phase I data to be presented at ASCO

RNS


RNS Number : 6785H

Hutchison China Meditech Limited

22 May 2014






Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)



Phase I clinical data for selective VEGFR, c-Met and VEGFR/FGFR inhibitors to be presented at the 2014 ASCO Annual Meeting



London: Thursday, 22 May 2014: Chi-Med today announces that data from recent Phase I and Phase Ib clinical studies by Hutchison MediPharma Limited ("HMP"), its majority owned R&D company, will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology ("ASCO") to be held in Chicago, Illinois, USA from 30 May to 3 June 2014. These presentations will include additional data on fruquintinib (HMPL-013), AZD6094 (HMPL-504/volitinib) and sulfatinib (HMPL-012), three novel and highly selective small molecule drugs discovered by HMP. Presentations on AZD6094 were prepared jointly with HMP's collaboration partner AstraZeneca AB (publ) ("AstraZeneca").



ASCO is a non-profit organisation founded in 1964 with the goals of improving cancer care and prevention. Nearly 30,000 oncology practitioners belong to ASCO, representing all oncology disciplines and subspecialties. Members include physicians and health-care professionals in all levels of the practice of oncology. The ASCO Annual Meeting brings these people together to find cutting-edge scientific presentations and comprehensive educational content.



HMP will have one presentation on each of the three novel kinase inhibitors, as follows:




Title:

A Phase Ib study of VEGFR inhibitor fruquintinib in patients with pre-treated advanced colorectal cancer


Abstract:

#3548


Track:

Gastrointestinal (Colorectal) Cancer


Date & Time:

Saturday, 31 May 2014, 8:00 AM







Title:

First-in-human Phase I study of a selective c-Met inhibitor AZD6094 (HMPL-504/volitinib) in patients with advanced solid tumours


Abstract:

#11111


Track:

Tumour Biology


Date & Time:

Saturday, 31 May 2014, 1:15 PM







Title:

First-in-human (FIH) Phase I study of a selective VEGFR/FGFR dual inhibitor sulfatinib with milled formulation in patients with advanced solid tumours


Abstract:

#2615


Track:

Developmental Therapeutics


Date & Time:

Sunday, 1 June 2014, 8:00 AM




Presentations will be made available at http://chi-med.com/eng/irinfo/presentations.htm. Further information about the 2014 ASCO Annual Meeting and the abstracts are available in Notes to Editors and at am.asco.org.



Ends

Initiation of Phase II Study in Renal Cancer

RNS


RNS Number : 8477H

Hutchison China Meditech Limited

23 May 2014






Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)



Initiation of AZD6094 (HMPL-504/volitinib) Global Phase II Study in Papillary Renal Cell Carcinoma



London: Friday, 23 May 2014: Chi-Med today announces that Hutchison MediPharma Limited ("HMP"), Chi-Med's majority owned R&D company, and AstraZeneca AB (publ) ("AstraZeneca") have initiated a global Phase II study to evaluate the efficacy and safety of AZD6094 (HMPL-504/volitinib) ("AZD6094"), HMP's potent and highly selective c-Met inhibitor, in patients with papillary renal cell carcinoma ("PRCC"). Under the terms of the global licence granted to AstraZeneca by HMP in 2011, AstraZeneca will now make a milestone payment to HMP, and will lead and fund this development outside of China.



PRCC represents about 10 to 15% of all new cases of kidney cancer and advanced disease has no approved therapy today. Molecular alterations leading to aberrant activation of the c-Met signalling pathway have been well documented in PRCC and effective inhibition of c-Met has been considered a potential treatment pathway for PRCC.



AZD6094 has been demonstrated to inhibit the growth of tumours in a series of preclinical disease models, selectively for those tumours with aberrant c-Met signalling. Phase I dose escalation studies were initiated in Australia and China in 2012 and 2013 respectively. AZD6094 has demonstrated good safety and tolerability and favourable pharmacokinetic properties in late stage cancer patients, and has shown encouraging anti-tumour activity in several tumour-types, in particular for metastatic PRCC. The results from the Phase I studies are planned to be released at the 50th annual meeting of the American Society of Clinical Oncology which will be held from 30 May to 3 June 2014 in Chicago, Illinois, USA.



This trial is an open-label, single-arm, multicentre, Phase II, study designed to evaluate the efficacy and safety of AZD6094 in patients with locally advanced or metastatic PRCC. Approximately 20 centres in the United States, Canada, and Europe will participate in the study. The primary objective of this study is to assess the anti-tumour activity of AZD6094 in patients with PRCC as measured by overall response rate according to Response Evaluation Criteria in Solid Tumours ("RECIST") (version 1.1). The secondary objectives for this study are to: assess the progression free survival and duration of response in patients with PRCC according to RECIST (version 1.1); assess the safety and tolerability of AZD6094 in the treatment of patients with PRCC; characterise the pharmacokinetics and pharmacodynamics of AZD6094 and metabolites following administration to steady state after multiple dosing when given orally; and obtain a preliminary assessment of AZD6094 activity in blood and tumour by evaluation of biomarker changes which may include, but not limited to, phosphorylated c-Met. Exploratory objectives include an investigation of predictive markers and acquired resistance to AZD6094 that may be observed in blood and tumour from patients treated with AZD6094.



"It is pretty exciting to see trials being developed in this rare histology. PRCC is an unmet medical need in the field of kidney cancer and targeting MET is a very reasonable strategy," said Toni Choueiri, MD, of the Dana-Farber Cancer Institute and Head of the Steering Committee of the Phase II trial.



Christian Hogg, Chief Executive Officer of Chi-Med said, "We are delighted to see the initiation of this Phase II trial for AZD6094 in PRCC as this represents a major milestone for both the compound and for HMP. The data which has driven this decision to invest in a PRCC study is compelling and shows the quality of both the compound itself and the joint development team which has been built between HMP and AstraZeneca. There are enormous opportunities for AZD6094 in other cancer types and we are particularly excited by the potential to combine with other compounds."



"Through this great collaboration we are able to increase our understanding of the genetic changes which drive different cancers to grow and to develop medicines designed to address and overcome those genetic drivers. This is a core part of our oncology strategy to deliver personalised healthcare to patients," said Susan Galbraith, Vice President, Head of Oncology Innovative Medicines, AstraZeneca.

Gains rights to six prescription drug products

RNS


RNS Number : 4440I

Hutchison China Meditech Limited

30 May 2014












Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





Chi-Med and Shanghai Traditional Chinese Medicine expand commercial cooperation





London: Friday, 30 May 2014: Chi-Med, the pharmaceutical and healthcare company based primarily in China, today announces that its long-term joint venture partner, Shanghai Traditional Chinese Medicine Co. Ltd. ("STCM"), through its affiliates, have agreed to grant Shanghai Hutchison Pharmaceuticals Limited ("SHPL", a joint venture between Chi-Med and STCM) exclusive rights to sell six prescription drug products in China.



Chi-Med, through its SHPL joint venture, will exclusively commercialise these six products in China for an initial ten-year term. The six prescription drug products, which had aggregate sales in 2013 of RMB45 million (US$7.3 million), cover multiple therapeutic areas including cerebrovascular disease, prostate health, bronchitis, cancer pain and kidney disease. The grant of these rights comes as part of a broader commercial restructuring of the SHPL joint venture, which although having no impact on equity structure or day-to-day operations, will allow for the expansion of its business scope.



Christian Hogg, Chief Executive Officer of Chi-Med said: "Chi-Med's partnership with STCM has enjoyed great success over the past thirteen years and has built a considerable commercial presence, with over 1,600 medical sales representatives operating in about 600 towns and cities covering over 13,000 hospitals throughout China. We appreciate the faith that STCM is entrusting in us to commercialise these important products. We expect this to build material value for our SHPL joint venture over the coming years."





Ends

Director's Shareholding

RNS


RNS Number : 8479I

Hutchison China Meditech Limited

04 June 2014












Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





Director's Shareholding





London: Wednesday, 4 June 2014: Chi-Med received notification on 3 June 2014 that Mr Christopher Nash, Independent Non-executive Director of Chi-Med, purchased 4,036 ordinary shares of US$1.00 each in Chi-Med (the "Shares") at a price of GBP8.42 each on
3 June 2014.



Following this purchase, Mr Nash is beneficially interested in 30,542 Shares, representing approximately 0.06% of the current issued share capital of Chi-Med.

Initiation of fruquintinib Phase II study

RNS


RNS Number : 9070I

Hutchison China Meditech Limited

05 June 2014






Hutchison China MediTech Limited ("Chi-Med")
(AIM: HCM)

Initiation of fruquintinib Phase II study in non-small cell lung cancer



London: Thursday, 5 June 2014: Chi-Med today announces that Hutchison MediPharma Limited ("HMP"), its majority owned R&D company, has initiated a Phase II clinical trial in non-small cell lung cancer ("NSCLC") patients in China for fruquintinib (HMPL-013), its investigational small molecule agent that is designed to selectively inhibit vascular endothelial growth factor receptors ("VEGFR"). Preparations and patient screening began earlier this year, with the first patient dosed on 4 June 2014.



This randomised, double-blind, placebo-controlled, multi-centre, proof-of-concept ("POC") Phase II study is targeted at treating non-squamous NSCLC patients who have failed second-line standard chemotherapy. This trial is to evaluate the efficacy and safety of fruquintinib versus placebo in NSCLC patients. All patients will receive best supportive care. The primary endpoint is progression free survival, with secondary endpoints including disease control rate, overall response rate, overall survival and safety. Approximately 90 patients will be enrolled, with top-line results expected in 2015.



Fruquintinib is designed to selectively inhibit VEGF receptors, including VEGFR1, 2, and 3. In the first-in-human Phase I clinical trial, 40 late-stage cancer patients were treated with fruquintinib. Detailed results of the Phase I clinical trial were presented at the annual meeting of the American Association for Cancer Research in April 2013, and are available at http://chi-med.com/eng/irinfo/presentations.htm. Based on the Phase I data, the first POC Phase II study was initiated on 2 April 2014, which was a randomized, double-blind, placebo-controlled, multi-centre Phase II clinical trial targeted at treating patients with locally advanced or metastatic colorectal cancer.



In October 2013, HMP entered into a licensing, co-development and commercialisation agreement in China with Eli Lilly and Company for fruquintinib.





Ends

Start of Phase I clinical trial with HMPL-523

RNS


RNS Number : 8004J

Hutchison China Meditech Limited

18 June 2014






Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)



Initiation of Phase I clinical trial of novel Syk Inhibitor HMPL-523 for autoimmune diseases



London: Wednesday, 18 June 2014: Chi-Med today announces that Hutchison MediPharma Limited ("HMP"), the majority owned R&D company of Chi-Med, has initiated the first-in-human Phase I clinical trial of HMPL-523 in Australia. HMPL-523 is a novel, highly selective and potent small molecule inhibitor targeting spleen tyrosine kinase, also known as Syk, a key component in B-cell receptor signalling. HMPL-523 is HMP's second active immunology programme in clinical development. The first drug dose was administered on 17 June 2014.



As one of the major cellular components of the immune system, B-cells play pivotal roles in autoimmune diseases. Targeted B-cell receptor signalling therapy has been proven to be clinically effective for the treatment of rheumatoid arthritis ("RA") and B-cell malignancies, leading to scientific and commercial success. Syk is an essential enzyme involved in B-cell receptor signalling pathway and a novel target for investigational therapies in immunology and oncology.



HMPL-523 is being developed as an oral formulation for the treatment of autoimmune diseases such as RA and lupus. In preclinical studies, HMPL-523 demonstrated superior potency and kinase selectivity, a reversal of the progression of joint inflammation and bone erosion along with a reduced production of multiple pro-inflammatory cytokines, as well as a favourable safety margin in both rodent and non-rodent toxicology studies.



The first-in-human trial aims to establish the safety profile of HMPL-523. This randomised, double blind, placebo-controlled, dose-escalating study of the safety, tolerability and pharmacokinetics of single and repeat doses of HMPL-523 will be conducted in healthy volunteers. Initial results are expected around the end of this year.



"For these chronic inflammatory conditions, it is critically important to understand if the high Syk selectivity and very good pharmacokinetic properties of HMPL-523 in preclinical studies bear out into a good human safety profile," said Christian Hogg, CEO of Chi-Med. "Should this be proven in this Phase I trial, this drug candidate will have potential as an effective oral treatment for patients with debilitating autoimmune diseases, for whom many existing treatments are limited or only modestly efficacious at safe doses," he added.



Ends

Interim Result
29 Jul 14 Hutchison China Meditech Ltd [HCM]

Interim Results

RNS


RNS Number : 5395N

Hutchison China Meditech Limited

29 July 2014












Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)



Interim Results for the Six Months Ended 30 June 2014



China Healthcare Division profit up 20%. Drug R&D Division progressing 10 clinical trials.

Strong outlook.





London: Tuesday, 29 July 2014: Chi-Med, the China-based healthcare and consumer products group, today announces its unaudited financial results for the six months ended 30 June 2014.

Chi-Med Group results are reported under International Financial Reporting Standard, IFRS 11 "Joint Arrangements" ("IFRS11"), which requires the equity accounting principle for the reporting of joint ventures ("JVs") which means that the income statements and statements of financial position of JVs are not proportionately consolidated as they have been in the past. However, total revenues of the JVs will continue to be disclosed on a voluntary basis under the divisional summaries below.

Results are reported in US dollar currency unless otherwise stated.



Group Results

· Revenue, under IFRS11, on continuing operations up 73% to $30.3 million (H1 2013: $17.6m).

· Net profit attributable to Chi-Med equity holdersup 97% to$6.4 million (H1 2013: $3.3m).

· Stable cash position: cash and cash equivalents at the Chi-Med Group level of $59.4 million (31 December2013: $46.9m); in addition, and not included at Chi-Med Group level, cash and cash equivalents held at the JV level of $91.6 million (31 December 2013: $99.0m).



China Healthcare Division

· Total sales of subsidiaries and JVs up 15% to $261.7 million (H1 2013: $227.5m).

· Net profit attributable to Chi-Med equity holders up 20% to $17.3 million (H1 2013: $14.4m).

· Commercial restructure complete - Good Supply Practice ("GSP") distribution companies now in place to enable the 2,700-person commercial team to sell third party/related party products.

· China low-price drug policy and key raw material price declines providing profitability tailwind.



Drug R&D Division

· Revenue of $9.9 million (H1 2013: $10.5m) from an AZD6094 (HMPL-504/volitinib) development milestone and service income from Nutrition Science Partners Limited ("NSP") and Janssen Pharmaceuticals Inc. (part of the Johnson & Johnson group of companies) ("Janssen").

· Net loss attributable to Chi-Med equity holders up 31% to $6.3 million (H1 2013: -$4.8m) due to continuing NSP investment in HMPL-004 global Phase III registration trials.

· 10 clinical trials progressing rapidly and building value. 2 Phase III registration studies on HMPL-004 in ulcerative colitis (NATRUL-3 and NATRUL-4); 3 Phase II proof-of-concept studies (AZD6094 in papillary renal cell carcinoma and fruquintinib in third-line colorectal and non-small cell lung cancer); 3 Phase Ib expansion studies (AZD6094 non-small cell lung cancer, sulfatinib in neuroendocrine tumours, and epitinib in non-small cell lung cancer with brain metastasis); and 2 Phase I studies (HMPL-523/Syk inhibitor for inflammation and theliatinib in solid tumours).

· Spending of $19.8 million (H1 2013: $15.2m) on clinical trials balanced by aggregate $20.1 million (H1 2013: $38.1m) cash and equity injections and contractual obligations from partners received by Drug R&D Division subsidiaries and JVs.



Consumer Products Division

· Sales from continuing operations up 16% to $6.4 million (H1 2013: $5.5m) from expansion of the broad organic and natural product line of Hutchison Hain Organic Holdings Limited ("Hutchison Hain Organic").

· Breakeven net profit on continuing operations attributable to Chi-Med equity holders of $0.0 million (H1 2013: -$0.4m).



Christian Hogg, CEO of Chi-Med, said:

"Chi-Med has significantly increased its net profit at a time when it is managing 10 clinical trial programmes and maintaining a deep and active discovery research programme, which together is adding substantial shareholder value. This is an achievement which is testimony to the balance of our businesses, our common sense approach to financing and our strategy of collaboration with powerful industry partners to help accelerate and enhance our own programmes.

We expect to continue adding significant shareholder value in the second half and beyond."

Hutchison China Meditech: Panmure Gordon raises target price from 950p to 1200p keeping a buy recommendation.

Hutchison China MediTech: UBS raises target price from 1000p to 1250p keeping a buy recommendation.

MIDAS SHARE TIPS: Chinese drugs firm MediTech looks healthy after doubling in three years

By Joanne Hart, Financial Mail On Sunday

Published: 22:18, 9 August 2014 | Updated: 22:18, 9 August 2014

The Chinese spend an average £160 per head a year on healthcare compared with more than £5,000 in the US.

The figure is so low because for decades Chinese communism did not involve state healthcare. If people fell ill, they paid for treatment or went without.


However, government spending on healthcare rose tenfold from 2005 to 2013, hitting £80billion last year and further expansion is scheduled for years to come.


Good prognosis: Chinese spending on healthcare is rising



Fast-growing drugs firm Hutchison China MediTech is well-positioned to reap the benefits. Midas recommended the shares in May 2011, when they were 447½p.


After struggling during that year, they have progressed in leaps and bounds and are now trading at 1032½p.

City brokers believe they have further to run, but investors who have more than doubled their money in the past three years may be wondering if they should hedge their bets and sell some stock now.


Founded in 2000, Hutchison China MediTech was set up as a subsidiary of the giant Hong Kong conglomerate Hutchison Whampoa. Focused on developing, manufacturing and selling drugs and wellbeing products in China, the business, known as Chi-Med, listed on Aim in 2006.


The group has grown fast since then, running three main divisions: a consumer products arm selling wellbeing items such as organic tea and healthy snacks; a healthcare arm selling prescription and overthe- counter drugs; and a research and development arm working on new drugs.

It is this last division which is expected to deliver the most exciting growth over the next few years. The firm has set up joint ventures with international players such as AstraZeneca, Johnson & Johnson and Lilly, and is in advanced trials on a number of cancer treatments.

Chi-Med is also working with Nestle on a drug based on traditional Chinese herbal remedies for Crohn’s disease and related conditions.


News on the latest trial of this product is expected later this month and could trigger further investment by Nestle if results are good or a winding down of the trial if results are poor.

The healthcare business used to focus on traditional Chinese medicine – still the first option for many Chinese. Increasingly, however, consumers take conventional drugs alongside herbal remedies, so Chi-Med has broadened its offer.


The group sells more than 200 drugs, mainly for colds, flu and heart disease, and runs a sales force of more than 2,500 across 600 Chinese cities.


Until recently, Chi-Med sold only its own products, including two household brands, but it now sells other manufacturers’ drugs too, which should boost profits.

The consumer business has been slow to take off, as many Chinese are as yet uninterested in designer teas and upmarket organic crisps. Looking further ahead however, this subsidiary has serious potential. In the first six months of this year, group profits after tax doubled to $6.4million (£3.8million) compared with the same period last year.


Analysts forecast a 45 per cent increase in full-year figures to $17.5million, rising to $25million next year.


Midas verdict: Chi-Med has made good progress and should continue to deliver. Investors who bought in 2011 should hedge their bets and sell 50 to 60 per cent of their stock. New investors should buy on any short-term weakness.


Traded on: Aim


Ticker: HCM

HMPL-004 Interim Analysis

RNS


RNS Number : 9920O

Hutchison China Meditech Limited

13 August 2014






Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)



HMPL-004 NATRUL-3 interim analysis result



London: Wednesday, 13 August 2014: Nutrition Science Partners Limited ("NSP"), a 50/50 joint venture between Chi-Med and Nestlé Health Science SA, today announces that a planned interim analysis was conducted on NATRUL-3, the global Phase III induction trial of HMPL-004 vs. placebo in ulcerative colitis. An independent Data Safety and Monitoring Committee ("DSMC") evaluated the unblinded data of two doses of HMPL-004 vs. placebo, and has recommended that NSP terminate the study. No meaningful safety signals or risks for patients were identified, and further analysis and review of the data will be conducted. The NSP Board will continue to evaluate the potential opportunities of HMPL-004 in new indication areas and alternative regulatory pathways.

Patient enrolment in Phase II study completed

RNS


RNS Number : 6607P

Hutchison China Meditech Limited

21 August 2014












Hutchison China MediTech Limited ("Chi-Med")
(AIM: HCM)



Patient enrolment completed ahead of schedule for fruquintinib's Phase II study in colorectal cancer



London: Thursday, 21 August 2014: Chi-Med, today announces that Hutchison MediPharma Limited ("HMP"), its majority owned drug R&D company, has completed patient enrolment in a Phase II clinical trial of fruquintinib (HMPL-013) in colorectal cancer ("CRC") in China. The proof-of-concept study is investigating the efficacy and safety of fruquintinib, HMP's investigational small molecule inhibitor of vascular endothelial growth factor receptors ("VEGFR").



This randomised, double-blind, placebo-controlled, multi-centre, proof-of-concept Phase II study is targeted at treating patients with metastatic CRC, who have failed at least two prior chemotherapies, including fluoropyrimidine, oxaliplatin and irinotecan. A total of 71 patients have now been randomised to receive fruquintinib plus best supportive care ("BSC") or placebo plus BSC at a 2:1 ratio. The primary endpoint is progression free survival, with secondary endpoints including disease control rate, overall response rate, overall survival and safety. As a result of the rapid patient enrolment, data from this trial is expected in early 2015.



Fruquintinib is designed to selectively inhibit VEGF receptors, namely VEGFR1, VEGFR2, and VEGFR3. In the first-in-human Phase I clinical trial 40 patients were treated with fruquintinib. Detailed results of the Phase I clinical trial are available at http://chi-med.com/eng/irinfo/presentations.htm, and were presented at the annual meeting of the American Association for Cancer Research in April 2013. Based on the Phase I data in CRC, a Phase Ib study was initiated which treated a further 62 CRC patients. Detailed results of the Phase Ib clinical trial were presented at the annual meeting of the American Society of Clinical Oncology in May 2014, and also can be found at http://chi-med.com/eng/irinfo/presentations.htm.



In October 2013, HMP entered into a licensing, co-development and commercialisation agreement in China with Eli Lilly and Company for fruquintinib.





Ends

Co-promotion agreement with Merck Serono

RNS


RNS Number : 0157T

Hutchison China Meditech Limited

01 October 2014








Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)



Press Release

Chi-Med and Merck Serono sign co-promotion agreement



London: Wednesday, 1 October 2014: Chi-Med, the pharmaceutical and healthcare company based primarily in China, today announces that Chi-Med, through its subsidiary Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited ("Hutchison Sinopharm"), has signed a co-promotion agreement with Merck Serono Co., Ltd. ("Merck Serono") a subsidiary of Merck in China to market certain cardiovascular prescription drug products in China.



Hutchison Sinopharm will exclusively co-promote Merck Serono's Bisoprolol Fumarate tablets, under the Concor® trademark, in several provinces in China. Concor® is a major brand in the beta-blocker sub-segment of the cardiovascular prescription drug market in China.



Chi-Med today operates a commercial network in China of approximately 1,600 cardiovascular market focused medical sales representatives, covering more than 13,000 hospitals, through its joint ventures, Shanghai Hutchison Pharmaceuticals Limited and Hutchison Sinopharm.

Ends

Enquiries

Signal Update

Our system’s recommendation today is to BUY. The BULLISH STOP LOSS pattern finally received a confirmation because the prices crossed above the Stop Loss level which was at 1,229.4000, and our valid average buying price stands now at 1,246.5000. The previous SELL signal was issued on 10/11/2014, 2 days ago, when the stock price was 1,198.7500. Since then HCM.L has risen by +3.98%.

Market Outlook

A rally after a bear setup can occasionally turn into an explosive long trade. We may be on the verge of catching one of them. There is now a strong positive sentiment in the market despite the absence of a bullish pattern. The bullish stop loss is finally confirmed and a BUY signal is generated. Market wants to reward the bulls. It may be now the right time to be part of this boost and bullish market sentiment by joining the growing bullish crowd.



http://www.britishbulls.com/SignalPage.aspx?lang=en&Ticker=HCM.L

Signal Update

Our system’s recommendation today is to STAY LONG. The previous BUY signal was issued on 12/11/2014, 6 days ago, when the stock price was 1,246.5000. Since then HCM.L has risen by +6.70%.

Market Outlook

The bulls are in full control. The negative sentiment that led to the last bearish pattern has evaporated. Besides, the signal is suggesting to STAY LONG. It is best to follow the signal and continue to hold this security


http://www.britishbulls.com/SignalPage.aspx?lang=en&Ticker=HCM.L

Hutchison China Meditech: Panmure Gordon raises target price from 1200p to 1500p and keeps a 'buy' recommendation.

Director's Shareholding

RNS


RNS Number : 5784X

Hutchison China Meditech Limited

20 November 2014












Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





Director's Shareholding





London: Thursday, 20 November 2014: Chi-Med received notification on 20 November 2014 that Mr Simon To, Executive Chairman and Director of Chi-Med, purchased 41,000 ordinary shares of US$1.00 each in Chi-Med (the "Shares") at a price of GBP13.50 per share on 18 November 2014.



Following this purchase, Mr To is beneficially interested in 41,000 Shares, representing approximately 0.08% of the current issued share capital of Chi-Med.

Hutchison China MediTech: UBS raises target price from 1200p to 1590p and reiterates a 'buy' recommendation.

Initiation of fruquintinib Phase III study

RNS


RNS Number : 7343Z

Hutchison China Meditech Limited

15 December 2014






Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)



Initiation of fruquintinib Phase III registration study in colorectal cancer



London: Monday, 15 December 2014: Chi-Med today announces that Hutchison MediPharma Limited ("HMP"), its majority owned R&D company, has initiated FRESCO, a Phase III registration study in colorectal cancer ("CRC") patients in China, for fruquintinib (HMPL-013), its investigational small molecule which selectively inhibits vascular endothelial growth factor receptors ("VEGFR"). Preparations and site selection began in the middle of this year, with the first patient dosed on 12 December 2014.



This randomised, double-blind, placebo-controlled, multicentre, Phase III registration study is targeted at treating patients with locally advanced or metastatic CRC, who have failed at least two prior systemic antineoplastic therapies, including fluoropyrimidine, oxaliplatin and irinotecan. Patients will be randomised at a 2:1 ratio to receive either: 5 milligrams of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus best supportive care ("BSC"); or placebo plus BSC. The primary endpoint is overall survival, with secondary endpoints including progression free survival, objective response rate, disease control rate and duration of response. More than 400 patients will be enrolled in about 25 centres, with top-line results expected in 2016.



Fruquintinib is designed to selectively inhibit VEGF receptors, namely VEGFR1, VEGFR2, and VEGFR3. In the first-in-human Phase I clinical trial 40 patients were treated with fruquintinib. Detailed results of the Phase I clinical trial are available at http://chi-med.com/eng/irinfo/presentations.htm, and were presented at the annual meeting of the American Association for Cancer Research in April 2013. Based on the Phase I data in CRC, a Phase Ib study was initiated which treated a further 62 CRC patients. Detailed results of the Phase Ib clinical trial were presented at the annual meeting of the American Society of Clinical Oncology in May 2014, and also can be found at http://chi-med.com/eng/irinfo/presentations.htm. Clinical trials for solid tumours including CRC, non-small cell lung cancer and gastric cancer are ongoing at various stages in China as either single-agent therapy or combined with chemotherapy.



In October 2013, HMP entered into a licensing, co-development and commercialisation agreement in China with Eli Lilly and Company for fruquintinib.



Ends
---------------------------------------------------------------------------------------------
15 Dec Panmure Gordon 1,500.00 Buy

Notice of Results
RNS
RNS Number : 9946C
Hutchison China Meditech Limited
26 January 2015









Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





Notice of Announcement of 2014 Final Results





London: Monday, 26 January 2015: Chi-Med will be announcing its final results for the year ended 31 December 2014 on Thursday, 26 February 2015. An analyst presentation will be held at 9:00 am on the same day at Citigate Dewe Rogerson, 3 London Wall Buildings, London, EC2M 5SY.

Distribution Agreement for Seroquel in China
RNS
RNS Number : 4649D
Hutchison China Meditech Limited
29 January 2015







Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)



Press Release

Hutchison Sinopharm and AstraZeneca China

signed an exclusive distribution agreement on Seroquel® in China



London: Thursday, 29 January 2015: Chi-Med, the pharmaceutical and healthcare company based primarily in China, today announces thatHutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited ("Hutchison Sinopharm"), a subsidiary of Chi-Med, has entered intoan exclusive distributionagreement with AstraZeneca (Wuxi) Trading Co., Ltd. ("AstraZeneca"), a subsidiary of AstraZeneca PLC, to distribute and market in China the product Seroquel®, an antipsychotic prescription drug owned by AstraZeneca PLC.



Hutchison Sinopharm will be the exclusive first-tier distributor todistribute and marketAstraZeneca's Quetiapine Tablets, under the Seroquel® trademarkin China. Seroquel® is a first-line antipsychotic medicine for the treatment of schizophrenia and bipolar disorder, which was launched in China in 2001. The compound annual growth rate of the antipsychotic prescription drug market in China was approximately 21%from 2009 to 2013 driven by increasing awareness, diagnosis and treatment of central nervous system related diseases in China.



Hutchison Sinopharm, established in April 2014, provides marketing and commercialisation services to pharmaceutical companies in China. Chi-Med, through Hutchison Sinopharm as well as Shanghai Hutchison Pharmaceuticals Limited, currently operates a commercial network in China of over 1,600 medical sales representatives covering more than 13,000 hospitals.



Christian Hogg, Chi-Med CEO said: "This exciting collaboration with AstraZeneca, a most important strategic partner for Chi-Med, will allow us to leverage our considerable commercial presence in China against a highly attractive and fast growing commercial opportunity. Seroquel® is a very strong global brand and we look forward to helping to grow its distribution and business in China."





Ends

29 Jan Panmure Gordon 1,600.00 Buy

Final Results


Consolidated Group Results (IFRS11)

· Revenue up 100% to $91.8 million (2013: $46.0m).

· Net profit attributable to Chi-Med equity holders of $5.4 million (2013: $5.9m) as the Company continues to balance a dramatic increase in clinical trial activity on seven new drug candidates with rapidly increasing profit in the China Healthcare Division.

· Cash positive overall during 2014 with Group level cash and bank balances of $51.1 million (31 December 2013: $46.9m). In addition, cash and bank balances held at the joint venture ("JV") level $77.0 million (31 December 2013: $99.0m) which is being used to fund construction of two new large-scale factories.

26 Feb Panmure Gordon 1,600.00 Buy

Patient enrolment completion for Phase II study
RNS
RNS Number : 7433G
Hutchison China Meditech Limited
06 March 2015







Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





Patient enrolment completion for fruquintinib's Phase II study in non-small cell lung cancer. Fruquintinib development moving rapidly in four parallel studies in non-small cell lung cancer, colorectal cancer and gastric cancer.



London: Friday, 6 March 2015: Chi-Med, today announces that Hutchison MediPharma Limited ("HMP"), its majority owned drug R&D company, has completed patient enrolment in a Phase II clinical trial of fruquintinib (HMPL-013) in non-small cell lung cancer ("NSCLC") patients in China. The proof-of-concept ("POC") study is investigating the efficacy and safety of fruquintinib, HMP's investigational small molecule inhibitor of vascular endothelial growth factor receptors ("VEGFR").



This randomised, double-blind, placebo-controlled, multi-centre, POC Phase II study is targeted at treating non-squamous NSCLC patients who have failed second-line standard chemotherapy. A total of 91 patients have now been randomised to receive fruquintinib plus best supportive care ("BSC") or placebo plus BSC at a 2:1 ratio. The primary endpoint is progression free survival, with secondary endpoints including disease control rate, overall response rate, overall survival and safety. As a result of the rapid patient enrolment, data from this trial is expected in mid of 2015.



Fruquintinib is designed to selectively inhibit VEGF receptors, namely VEGFR1, VEGFR2, and VEGFR3. In the first-in-human Phase I clinical trial 40 patients were treated with fruquintinib. Detailed results of the Phase I clinical trial are available at http://chi-med.com/eng/irinfo/presentations.htm, and were presented at the annual meeting of the American Association for Cancer Research in April 2013.



Based on the Phase I data in colorectal cancer ("CRC"), a Phase Ib study was initiated which treated a further 62 CRC patients. Detailed results of the Phase Ib clinical trial were presented at the annual meeting of the American Society of Clinical Oncology in May 2014, and also can be found at http://chi-med.com/eng/irinfo/presentations.htm.



In April 2014, HMP initiated the first POC Phase II study, which was a randomised, double-blind, placebo-controlled, multi-centre Phase II clinical trial targeted at patients with metastatic CRC. The POC Phase II study subsequently completed enrolment in August 2014, and will report data during the first half of 2015.



In October 2014, HMP initiated a Phase Ib dose-finding study of fruquintinib, in combination with paclitaxel, in second line gastric cancer patients.



In December 2014, HMP initiated FRESCO, a Phase III registration study in patients with locally advanced or metastatic CRC, who have failed at least two prior systemic antineoplastic therapies, including flouropyrimidine, oxaliplatin and irinotecan. FRESCO will enrol more than 400 patients in 25 centres in China, with top-line results expected in 2016.



In October 2013, HMP entered into a licensing, co-development and commercialisation agreement in China with Eli Lilly and Company for fruquintinib.





Ends

Trial of fruquintinib achieves primary endpoint
RNS
RNS Number : 7809I
Hutchison China Meditech Limited
30 March 2015







Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





The first proof-of-concept trial of fruquintinib achieves primary efficacy endpoint



London: Monday, 30 March 2015: Chi-Med, today announces that Hutchison MediPharma Limited ("HMP"), its majority owned drug R&D company, successfully achieved the primary endpoint in the first proof-of-concept ("POC") trial of fruquintinib in patients with metastatic colorectal cancer ("mCRC") in China. The top-line results demonstrated that the trial clearly succeeded in meeting the primary efficacy endpoint of progression free survival.



Assessment of secondary efficacy endpoints, including objective response rate, disease control rate, and overall survival is ongoing, with all appearing in-line with expectations at the February 2015 six-month data cut-off. The adverse events demonstrated in this POC study are consistent with the known safety profile for fruquintinib without major unexpected safety issues. Full detailed results from this trial will be disclosed in due course.



This is the first POC Phase II study for fruquintinib aimed at comparing the efficacy and safety of fruquintinib plus best supportive care ("BSC") versus placebo plus BSC in patients with mCRC as a third-line or above therapy. It is a randomised, double-blind, placebo-controlled, multi-centre, POC Phase II study to treat mCRC patients who have failed at least two prior chemotherapies, including fluoropyrimidine, oxaliplatin and irinotecan. A total of 71 patients were randomised to receive fruquintinib plus BSC or placebo plus BSC at a 2:1 ratio. The trial was initiated in April 2014 and completed patient enrolment in August 2014.



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Director's Shareholding
RNS
RNS Number : 9717J
Hutchison China Meditech Limited
13 April 2015







Hutchison China MediTech Limited ("Chi-Med")

(AIM: HCM)





Director's Shareholding





London: Monday, 13 April 2015: Chi-Med received notification on 13 April 2015 that Simon To, Executive Director and Chairman, has purchased 25,000 ordinary shares of US$1.00 each in
Chi-Med (the "Shares") at a price of GBP14.215 per share on 10 April 2015.



Following this purchase, Mr To is beneficially interested in 152,000 Shares, representing approximately 0.29% of the current issued share capital of Chi-Med.

Hutchison China MediTech Ltd (HCM:LSE) set a new 52-week high during Tuesday's trading session when it reached 1,605. Over this period, the share price is up 100.25%.

Director Deals - Hutchison China Meditech Ltd (HCM)
BFN
Simon To, Chairman, bought 28,000 shares in the company on the 15th April 2015 at a price of 1585.00p. The Director now holds 180,000 shares.

Story provided by StockMarketWire.com
Director deals data provided by www.directorsholdings.com

Hutchison China MediTech Ltd (HCM:LSE) set a new 52-week high during today's trading session when it reached 1,785. Over this period, the share price is up 120.63%.

Director Deals - (HCM)
BFN
Christopher Nash, Non Executive Director, bought 1,388 shares in the company on the 21st April 2015 at a price of 1800.00p. The Director now holds 31,930 shares.

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Director deals data provided by www.directorsholdings.com

Savolitinib preliminary Phase Ib data presented
RNS
RNS Number : 7558O
Hutchison China Meditech Limited
01 June 2015









Savolitinib (AZD6094) preliminary Phase Ib clinical data in lung cancer presented at the 2015 ASCO Annual Meeting




London: Monday, 1 June 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM), today announces that AstraZeneca AB (publ) ("AstraZeneca"), Hutchison MediPharma Limited's ("HMP") collaboration partner, presented preliminary data from the ongoing Phase Ib clinical trial of HMP's c-Met inhibitor savolitinib (AZD6094) combined with AstraZeneca's drug candidate AZD9291 in non-small cell lung cancer ("NSCLC").



AZD9291 is AstraZeneca's investigational inhibitor of the epidermal growth factor receptor (EGFR). Preliminary data on the activity of AZD9291 in patients with EGFR mutation positive NSCLC who had failed currently-approved EGFR tyrosine kinase inhibitors was presented at the American Society of Clinical Oncology (ASCO) meeting in June 2014. In mid-2014 AstraZeneca commenced the TATTON study, a multi-arm Phase Ib study of AZD9291 in combination with either savolitinib (AZD6094) (c-MET inhibitor), MEDI4736 (anti-PD-L1 mAb) or selumetinib (MEK1/2 inhibitor) in EGFR mutation positive NSCLC. For those patients who received AZD9291 and savolitinib, the primary objective of the TATTON study was to establish a safe and effective combination dose. All patients were screened for their T790M status (+/-) as well as some, if sufficient tissue samples were available, for their c-Met (+/-) status.



The following poster was presented at the American Society of Clinical Oncology annual meeting in Chicago on 30 May 2015.



Title:
Preliminary results of TATTON, a multi-arm phase Ib trial of AZD9291 combined with MEDI4736, AZD6094 or selumetinib in EGFR-mutant lung cancer.

Authors:
Oxnard G.R., et al.

Abstract:
#2509 - available at abstracts.asco.org/156/AbstView_156_148945.html

Session:
Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics

Date & Time:
Saturday 30 May 8:00 AM-11:30 AM




A total of 12 patients were dosed with either 600mg or 800mg daily doses of savolitinib (AZD6094) in combination with 80mg (once daily) AZD9291. In terms of the primary aims of the study, the 600mg combination dose was well tolerated with toxicity profiles that allow for combination at doses previously demonstrated to be biologically active. Of the 11 evaluable patients in the study, 6 partial responses (confirmed and unconfirmed) have been observed to date. Responses to date include 4 of 7 patients with confirmed T790M negative status.



The presentation will be made available at http://chi-med.com/eng/irinfo/presentations.htm.



Christian Hogg, Chief Executive Officer of Chi-Med said: "Savolitinib is a highly selective c-Met inhibitor designed to eliminate the toxicities experienced by the first wave of c-Met inhibitors in their early development. We are now very pleased to see encouraging early efficacy data emerge in non-small cell lung cancer to add to the efficacy already reported in papillary renal cell carcinoma and colorectal cancer."



Ends

Invention patent granted for SXBXP
RNS
RNS Number : 2903T
Hutchison China Meditech Limited
17 July 2015







20-year invention patent granted on Chi-Med's best selling prescription drug





London: Friday, 17 July 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Shanghai Hutchison Pharmaceuticals Limited ("SHPL"), its prescription drug joint venture, has been granted an invention patent in China ("Invention Patent") covering the formulation for the best selling prescription drug of Chi-Med for the treatment of cardiovascular diseases, She Xiang Bao Xin pill ("SXBXP"), until 2029, twenty years from its original filing date.



SXBXP is the most important prescription drug product of SHPL with sales in 2014 of US$138.8 million (2013: US$123.6m). SXBXP represents 90% of current SHPL sales and has grown at a compound annual average growth rate of 29% per year since 2007. It underpins the commercial operation of SHPL of over 1,700 medical representatives and marketing staff who manage the distribution and sales of SXBXP in approximately 13,500 hospitals, covering over 80,000 physicians, in China.



SXBXP was first approved for use in cardiovascular diseases in 1983 and subsequently enjoyed 22 years of proprietary commercial protection under the then regulatory system in China. In 2005, SHPL was able to attain "Confidential State Secret Technology" status protection on SXBXP, as certified by China's Ministry of Science and Technology and State Secrecy Bureau which extended proprietary protection of SXBXP until late 2016. The above Invention Patent will extend proprietary protection of SXBXP through 2029.



Christian Hogg, Chief Executive Officer of Chi-Med said: "The grant of this new patent will allow for this important cardiovascular therapy, to maintain its proprietary position in China for many years to come. SXBXP is the cornerstone proprietary prescription drug in Chi-Med's Commercial Platform in China -- a platform that we intend to leverage to launch many of the novel oncology and immunology drug candidates that we are currently developing in China if and when they receive regulatory approval."





Ends

Shares - Drug developer and distributor Hutchinson China MediTech is likely to see earnings forecasts upgraded after extending the patient on its top selling drug by 13 years. The China focused company , will now fend off generic competition for cardiovascular disease drug SXBXP until at least 2029. It was due to lose exclusivity of the drug , which accounts for 90% of the company's sales next year. Broker Panmure Gordon was quick to lift its price target to £17.50 from £16.50 following the news and is reviewing its forecasts.

Interims Tues 28 July

Interim Results
RNS
RNS Number : 2239U
Hutchison China Meditech Limited
28 July 2015




Interim Results for the Six Months Ended 30 June 2015





Drug R&D Division - our Innovation Platform: enrolling 17 clinical trials (H1 2014: 10), with 24 targeted by year-end.



China Healthcare and Consumer Products Divisions - our Commercial Platform: sales of subsidiaries and JVs up 17%, net profit up 15%.



Strong outlook for full year and beyond.





London: Tuesday, 28 July 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM), the China-based healthcare group, today announces its unaudited financial results for the six months ended 30 June 2015.

Results are reported in US dollar currency unless otherwise stated.

Group Results

· Revenue on continuing operations up 117% to $65.7 million (H1 2014: $30.3m).

· Net profit attributable to Chi-Med equity holders of $2.3 million (H1 2014: $5.6m), despite major increase in spending on clinical activity.

· Continued stable cash position: cash and bank balances at the Chi-Med Group level of $48.8 million (31 December 2014: $51.1m); in addition, and not included at Chi-Med Group level, cash and bank balances held at the Joint Venture ("JV") level of $70.4 million (31 December 2014: $77.0m).



Innovation Platform (formerly Drug R&D Division)

· Revenue of $10.2 million (H1 2014: $9.9m) and net loss attributable to Chi-Med equity holders of $11.7 million (H1 2014: -$6.3m) driven by major expansion of clinical trial activity.

· Total first half spending on clinical activities estimated at $30.3 million (H1 2014: $22.3m) balanced by aggregate $22.9 million (H1 2014: $20.1m) in cash milestone and service payments from our partners AstraZeneca AB (publ) ("AstraZeneca"), Eli Lilly and Company ("Lilly"), Nutrition Science Partners Limited ("NSP") (our JV with Nestlé Health Science SA) and Janssen Pharmaceuticals, Inc. (part of the Johnson & Johnson group of companies).



Commercial Platform (formerly China Healthcare and Consumer Products Divisions)

· Total sales of subsidiaries and JVs up 17% to $285.4 million (H1 2014: $244.9m) with the majority from expansion of both own-brand and third party prescription drugs sales.

· Net profit attributable to Chi-Med equity holders on continuing operations up 15% to $19.9 million (H1 2014: $17.3m) due to steady growth in the Prescription Drugs business.

Christian Hogg, CEO of Chi-Med, said: "Chi-Med has made great progress on all fronts so far this year. Our vision is to become a major China-based pharmaceutical company - we believe we will achieve this by being an important innovator in the global targeted therapy arena. In line with this, during the first half, Chi-Med and its partners invested over $30 million pushing our oncology and immunology clinical pipeline as hard and fast as we could.

We now have 17 clinical trials (H1 2014: 10) underway, with a further seven to start in the second half - and we expect to be enrolling four pivotal Phase III oncology studies by year end. Almost all of our drug candidates have global first-in-class or best-in-class potential, and many are being tested in potential Breakthrough Therapy indications. Our drug candidates have all been designed in-house over the last decade and are highly selective, allowing for high drug exposure, potent target coverage and minimal off-target toxicity. This has resulted in some of the highest clinical response rates ever seen in the tumour types we are studying. Most importantly, we are closing in on approvals, with our first drug candidates targeting New Drug Application ("NDA") submissions next year in the US and China.

Our Commercial Platform continues to grow rapidly with strong profit growth and cash flow. Our focus today is the commercialisation of our own-brand as well as third party prescription drugs through a powerful network of over 1,800 medical sales staff, covering about 13,500 hospitals and detailing our products to over 80,000 doctors. Soon however, we intend to leverage this organisation to commercialise our own Innovation Platform drugs once they are approved in China.

With our high potential clinical pipeline, our efficient and highly productive discovery engine and our powerful, profitable, high growth commercial and distribution platform, we believe Chi-Med is uniquely positioned to achieve its vision and to generate considerable shareholder value this year and beyond."

H1 2015 Highlights



Innovation Platform: Across the board clinical trial progress - now expect to be enrolling four pivotal Phase III oncology studies by year end - two on fruquintinib and two on sulfatinib.



· Savolitinib: Nine clinical trials underway and three more in final planning - Highlights:

1. Kidney Cancer: First-line papillary renal cell carcinoma ("PRCC") global Phase II study progressing as expected, now over 50 patients enrolled and will complete in late-2015. We are seeing obvious efficacy in patients with high levels of c-Met amplification and plan to report results at the American Society of Clinical Oncology ("ASCO") meeting in mid-2016;

2. Lung cancer: Results of the Phase Ib dose finding study ("TATTON") in combination with AZD9291 (T790M inhibitor) were reported at the ASCO meeting in mid-2015. We published astonishing tumour shrinkage visuals and very encouraging efficacy data - a 55% objective response rate ("ORR"), in second-line gefitinib/erlotinib refractory non-small cell lung cancer ("NSCLC"). The TATTON study is now being expanded (30 patients) and is expected to complete enrolment in early-2016 and, subject to continued high ORR, could then move directly to Phase III;

3. Gastric cancer: Four clinical trials are underway in c-Met aberrant gastric cancer patients. During H1 2015 we observed clear response to savolitinib monotherapy, for the first time, in the c-Met amplified gastric cancer setting;

4. Immunotherapy combinations planned: AstraZeneca is an important innovator in the immunotherapy field with MEDI4736/durvalumab (PD-L1) particularly in the use of this immunotherapy agent in combination with other anti-cancer agents. In H2 2015 we intend to start three further clinical studies in kidney cancer, two of which will combine savolitinib with MEDI4736.



· Fruquintinib: Four clinical trials underway - Highlights:

1. Colorectal cancer (third-line): Clearly met Phase II study primary endpoint, Progression Free Survival ("PFS"), triggering $18 million milestone and reimbursement payments from Lilly. Full Phase II results to report at European Society of Medical Oncology meeting in September 2015. We have now enrolled over 120 patients in the FRESCO pivotal Phase III study and expect completion in early 2016 and NDA submission in China in late 2016;

2. NSCLC (third-line): Phase II study completed enrolment in March 2015 and we will report top-line results in Q3-2015, and if positive, we intend to start a pivotal Phase III study in late 2015;

3.Gastric cancer (second-line): Fruquintinib in combination with chemotherapy (paclitaxel) - Phase Ib dose-finding study 3mg fruquintinib dose was shown safe and tolerable and we are now in 4mg cohort (a dose that provides full target inhibition). We expect to start a Phase II/III study in late 2015 which will be used to prove combinability with chemotherapy, the key to much broader indications and hence fruquintinib's global potential.



· Sulfatinib: One clinical trial underway and three more in final planning - Highlights:

1. Neuroendocrine tumours ("NET") (first-line): Reported 35% ORR in our Phase I study, which is about four times the ORR of current approved therapies, then started Phase Ib study in China in NET (over 50 patients already enrolled). We have submitted a Phase II/III clinical trial application in China and upon clearance in late 2015 we will start two pivotal Phase III studies in China, one in pancreatic NET and a second in advanced carcinoid patients;

2. Thyroid cancer: We expect to initiate a Phase Ib study in China in Q3 2015;

3. US Development: Sulfatinib is the first wholly-owned cancer drug candidate that we are developing in the US. Our US Investigational New Drug application was cleared in early 2015 and, after a dose confirmation study in Caucasians, we expect to start a US Phase II NET study in early 2016.



· HMPL-523: Very high potential first-in-class Syk inhibitor for immunology and oncology - Highlights:

1. Immunology: Phase I single ascending dose section completed with 800mg single dose showing no material toxicities in healthy volunteers - with higher doses providing drug exposures well above expected efficacious dose. The 14-day multiple ascending dose section of the Phase I study is now underway with 200mg daily cohort successfully complete - we expect to determine Phase II dose for rheumatoid arthritis by the end of 2015;

2. Hematological Cancer: Phase I, primarily in lymphoma and leukemia patients, set to start in Australia in H2-2015, the fastest route to a possible efficacy signal for HMPL-523 by early 2016.



· Other clinical/near clinical drug candidates: Highlights:

1. Epitinib (HMPL-813): Emerging early human efficacy data in Phase Ib study of NSCLC patients with brain mets. Seeing clear partial responses in both primary lung and metastasised brain lesions;

2. Theliatinib (HMPL-309): Phase I dose-escalation study nearing completion with dose well above efficacious dose already qualified;

3.HMPL-689: Our selective PI3Kδ inhibitor is set to start Australian Phase I study in hematological cancer patients in late 2015;

4. HMPL-453: Our selective FGFR 1-3 inhibitor is set to start Australian Phase I study in solid tumour patients in early 2016.



Commercial Platform: Focus on broadening scope and capacity of higher margin Prescription Drugs business.



· Expansion in our Prescription Drugs business: Shanghai Hutchison Pharmaceuticals Limited ("SHPL") and Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited ("Hutchison Sinopharm") - the main strategic prescription drugs focus area of our Commercial Platform - grew sales of subsidiaries and JVs by 44% to $149.3 million (H1 2014: up 31% to $103.9m).



· Important 20-year invention patent granted: A new patent covering formulation was granted in July 2015 on our largest prescription drugs product, She Xiang Bao Xin pill ("SXBXP") which will extend our proprietary protection in China through 2029. SXBXP sales grew by 14% to $94.9 million in the first half of 2015, representing 64% of Prescription Drugs business sales.



· Great progress on Seroquel®: Within our third party Prescription Drugs business, we have now established a dedicated over 80-person psychiatric disorder medical sales team to commercialise Seroquel® on behalf of AstraZeneca. Monthly in-market Seroquel® sales are progressing well - evidence of the strength and adaptability of our Commercial Platform to enter new therapeutic areas in future, including oncology and immunology.



· New factories: Coming online at the end of 2015 or early 2016 leading to about three-fold production capacity expansion in own-brand products and likely conclusion of property compensation deal, particularly in Shanghai.



Ends

//////////////////////////////////////////////////////////////////////////////////////////////////
sharecast -

Hutchison China first-half profit drops as research spending rises

Tue, 28 July 2015






Hutchison China first-half profit drops as research spending rises



(ShareCast News) - Healthcare group Hutchison China MediTech posted a drop in first-half pre-tax profit as it invested more heavily in research and development.
For the six months ended 30 June, pre-tax profit came in at $3.9m from $7.3m as a higher spend in R&D and cost of sales offset an increase in revenue to $65.7m from £30.3m.

Hutchison said the revenue growth was driven mainly by a full period of consolidation of Hutchison Sinopharm, which began operations in the second quarter of last year.

The company said spending on clinical activities was around $30.3m, up from $22.3m in the first half of last year, with 17 clinical trials now underway, compared with 10 last year, and a further seven due to start in the second half.

Chief executive officer Christian Hogg said: "Chi-Med has made great progress on all fronts so far this year. Our vision is to become a major China-based pharmaceutical company - we believe we will achieve this by being an important innovator in the global targeted therapy arena. In line with this, during the first half, Chi-Med and its partners invested over $30 million pushing our oncology and immunology clinical pipeline as hard and fast as we could."

At 1042 BST, shares were down 4.3% at 1,641p.

Termination of R&D agreement with Janssen
RNS
RNS Number : 5122W
Hutchison China Meditech Limited
19 August 2015







Termination of Research & Development Alliance Agreement with Janssen Relating to HMPL-507 Project





London: Wednesday, 19 August 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that, Hutchison MediPharma Limited ("HMP"), its R&D subsidiary, has received notice from Janssen Pharmaceutical, Inc. ("Janssen") of Janssen's decision to terminate the Restated Research and Development Alliance Agreement dated 7 June 2010 (the "Agreement") relating to HMPL-507 project.



The almost seven year alliance, which began in 2008, was amended in 2010 to refocus the target of the research on developing small molecule therapeutics against a specific novel molecular target in the area of inflammation/immunology. During this time, Janssen paid HMP an aggregate of approximately US$13 million in upfront and milestone payments and service fees and costs, which enabled both parties to generate substantial intellectual property, understanding and know-how relating to compounds in this designated area.



Janssen, at its sole discretion, has decided not to proceed with either HMPL-507 or any of the backup compounds developed under the Agreement.



The scientific view of HMP is that the specific molecular target represents a potential opportunity for targeted therapies in inflammation/immunology and possibly oncology and the compounds developed are of high quality and merit further development. HMP intends, in due course, and subject to final regulatory toxicity testing results, to independently commence clinical study.



HMP and Janssen will continue to work together on projects in other contexts.







Ends

Trial of fruquintinib achieves primary endpoint
RNS
RNS Number : 8520X
Hutchison China Meditech Limited
02 September 2015







Second proof-of-concept trial of fruquintinib achieves its primary endpoint




London: Wednesday, 2 September 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, successfully achieved the primary endpoint in the second proof-of-concept ("POC") trial of fruquintinib in patients with advanced non-squamous non-small cell lung cancer ("NSCLC") in China. The top-line results demonstrated that the trial clearly succeeded in meeting the primary efficacy endpoint of progression free survival ("PFS").



Assessment of secondary efficacy endpoints, including objective response rate, disease control rate, and overall survival is ongoing, with all appearing in-line with expectations at the August 2015 five-month data cut-off. The adverse events demonstrated in this POC study are consistent with the known safety profile for fruquintinib without major unexpected safety issues. Full detailed results from this trial will be disclosed in due course.



This is the second POC Phase II study for fruquintinib aimed at comparing the efficacy and safety of fruquintinib plus best supportive care ("BSC") versus placebo plus BSC in patients with NSCLC as a third-line therapy. It is a randomised, double-blind, placebo-controlled, multi-centre, POC Phase II study to treat NSCLC patients who have failed second-line chemotherapy. A total of 91 patients were randomised to receive fruquintinib plus BSC or placebo plus BSC at a 2:1 ratio. The trial was initiated in June 2014 and completed patient enrolment in March 2015.



The first POC Phase II study for fruquintinib, targeted at patients with metastatic third-line colorectal cancer, clearly met its primary endpoint of superior median PFS versus placebo in March 2015 and detailed results will be presented at the upcoming 2015 European Cancer Congress later this month.





Ends

Presentation at 2015 European Cancer Congress
RNS
RNS Number : 9209Y
Hutchison China Meditech Limited
14 September 2015







Fruquintinib Phase II clinical results in colorectal cancer to be presented at the 2015 European Cancer Congress





London: Monday, 14 September 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, will present the detailed clinical results of its Phase II proof-of-concept ("POC") clinical trial of fruquintinib in metastatic colorectal cancer ("mCRC") at the European Cancer Congress, which will be held in Vienna, Austria from 25 to 29 September 2015.



Fruquintinib is a highly selective vascular endothelial growth factor ("VEGF") receptor inhibitor that is being evaluated across several solid tumour types in clinical trials, including colorectal cancer, non-small cell lung cancer and gastric cancer. In March 2015, Chi-Med announced that the first POC study of fruquintinib in patients with mCRC clearly met its primary endpoint of progression free survival ("PFS") by demonstrating superiority compared with placebo. Fruquintinib was well tolerated in this study, showing no major unexpected safety issues and a safety profile consistent with that of its class.



The POC study was a randomised, double-blind, placebo-controlled, multi-centre Phase II clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care against placebo plus best supportive care in mCRC patients who had failed at least 2 prior lines of chemotherapy, including fluoropyrimidine, oxaliplatin and irinotecan. Patients were randomised at a 2:1 ratio to receive either 5 mg of fruquintinib orally once per day on a three-weeks-on, one-week-off schedule or placebo. Treatment was given in 28-day cycles until disease progressed or non-tolerable toxicity occurred. Tumour assessments were conducted using RECIST 1.1 criteria. The primary efficacy endpoint for the trial was PFS. Secondary efficacy endpoints included objective response rate, disease control rate and overall survival. Safety endpoints included adverse events, laboratory tests, vital signs and electrocardiogram measurements. Data was analysed up to 11 February 2015, approximately six months after the last patient had been enrolled.



71 patients were enrolled in the trial, of which 47 were enrolled into the fruquintinib arm and 24 into the placebo arm. Patient baseline characteristics were similar between the two treatment arms. The median fruquintinib exposure was 84 days whereas the median was 21 days in the placebo arm. Median PFS was 4.73 months in the fruquintinib arm compared with 0.99 month in the placebo arm, with a hazard ratio of 0.30 (p<0.001). The disease control rate in the fruquintinib arm was 68.1%, compared with 20.8% in the placebo arm (p<0.001). 46.8% (22/47) and 62.5% (15/24) of patients died in the fruquintinib and placebo arms, respectively, by the date of data cut-off, with median overall survival of 7.6 months and 5.5 months in the fruquintinib and placebo arms, respectively. The five most common fruquintinib treatment-related adverse events were hand-foot syndrome, hypertension, dysphonia, proteinuria and AST elevation, which is similar to those reported in this class.



The detailed study results will be presented on 27 September 2015 at the European Cancer Congress and will then be made available at http://chi-med.com/eng/irinfo/presentations.htm:



Title:
A randomised, double-blind, placebo-controlled, multi-centre Phase II clinical trial of fruquintinib in patients with metastatic colorectal cancer.



Authors:
Jin Li, et al.



Abstract:
#2111



Session:
Gastrointestinal Malignancies - Colorectal Cancer



Date & Time:
Sunday 27 September 2015, 09:15 AM-11:15 AM




The European Cancer Congress, organised by the European Society for Medical Oncology and the European Cancer Organisation this year, is the largest European multidisciplinary oncology platform for presenting data to a global audience.





Ends

Hutchison China MediTech Ltd (HCM.GB:ISD) set a new 52-week high during today's trading session when it reached 2,075. Over this period, the share price is up 18.74%.

aims-best-companies-confirmed


International company of the year


Hutchison China Meditech

Hutchison China Meditech (HCM) has finally won this category having been up for the award in 2010. For the second year running, Somero Enterprises Inc (SOM) did not win - as I thought it might this year. Hutchison is the third-largest company among the winners with a market capitalisation of more than £1.1 billion, making it one of the top ten companies on AIM. When it joined AIM in May 2006 it was valued at £141 million. The share price has risen from 275p to 2,050p over that period. Hutchison has successfully combined a revenue and cash generating healthcare business with a cash hungry drug development operation.

Enrolment complete in Savolitinib Phase II trial
RNS
RNS Number : 0214C
Hutchison China Meditech Limited
13 October 2015





Press Release

Savolitinib completes enrolment for Phase II clinical trial in Papillary Renal Cell Carcinoma





London: Tuesday, 13 October 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, and AstraZeneca AB (publ) ("AstraZeneca") have completed enrolment in a global Phase II study of savolitinib (AZD6094), a potent and highly selective mesenchymal epithelial transition factor ("c-Met") inhibitor. This is a Phase II study to evaluate the efficacy and safety of savolitinib monotherapy (600 mg once daily) in papillary renal cell carcinoma ("PRCC") in the United States, Canada and Europe. PRCC represents about 14% of all new cases of kidney cancer.



Savolitinib is a potential global first-in-class inhibitor of c-Met, receptor tyrosine kinase, an enzyme which exhibits aberrant behaviour (e.g. gene amplification, over-expression and mutation) in many types of solid tumours. Savolitinib was developed as a potent and highly selective oral c-Met inhibitor that was designed to address renal toxicity, the primary issue that has to-date prevented other selective c-Met inhibitors from gaining regulatory approval. In Phase I/Ib clinical studies, savolitinib has shown promising signs of clinical efficacy, causing tumour size reduction, in c-Met aberrant patients in PRCC, non-small cell lung cancer, colorectal cancer and gastric cancer.



This Phase II study is an open-label, single-arm, multicentre study designed to evaluate the efficacy and safety of savolitinib in patients with locally advanced or metastatic PRCC. A total of 90 patients have been enrolled in 22 centres, making it the largest prospective clinical study in PRCC ever conducted. The primary objective of this study is to assess the anti-tumour activity of savolitinib in patients with PRCC, with secondary assessment objectives including progression free survival, duration of response, safety and tolerability and pharmacokinetics and pharmacodynamics. Importantly, tumour samples from each patient are concurrently being subjected to molecular analysis to determine c-Met status in order to better understand the relationship between c-Met aberration and clinical outcome.



The interim data of the Phase II trial is expected to be published at the American Society of Clinical Oncology meeting in 2016.







Ends

Chi-Med files Nasdaq Registration Statement
RNS
RNS Number : 5322C
Hutchison China Meditech Limited
16 October 2015





Press Release

Hutchison China MediTech Limited Files Registration Statement for Potential Nasdaq Stock Market Listing





London: Friday, 16 October 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) announces that it has publicly filed today a registration statement on Form F-1 (the "Registration Statement") with the United States Securities and Exchange Commission (the "SEC") in relation to a potential listing of American depositary shares ("ADSs") representing its ordinary shares on the Nasdaq Stock Market (the "Offering"). As of the date of this press release, Chi-Med has not yet set a definite timetable or decided on further details of the potential Offering, and there can be no assurance that the potential Offering will be completed. Accordingly, the number of ADSs which may be offered and the offering price of the potential Offering have not yet been determined. The directors of Chi-Med will assess various factors, including market conditions, in considering whether to formally launch the transaction.



Bank of America Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the potential Offering.



The Registration Statement relating to the ADSs has been filed with the SEC but has not yet become effective. The ADSs may not be sold, nor may offers to buy be accepted, prior to the time the Registration Statement becomes effective. The Registration Statement and all subsequent amendments may be accessed through the SEC's website at www.sec.gov.



The Offering, if it does proceed, will be made only by means of a prospectus that will form part of the effective Registration Statement. Copies of the preliminary prospectus, when available, may be obtained from (in alphabetical order) (i) Bank of America Merrill Lynch, Attn: Prospectus Department, 222 Broadway, New York, NY 10038, or by email at dg.prospectus_requests@baml.com, or (ii) Deutsche Bank Securities Inc., Attn: Prospectus Group, 60 Wall Street, New York, NY 10005, or by email at prospectus.cpdg@db.com.



This press release does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.



Shareholders and potential investors should note that the potential Offering may or may not proceed, and accordingly are advised to exercise caution when dealing in the securities of Chi-Med.





Ends

Proactive investor -

Hutchison China MediTech (LON:HCM) up 5.5%. The Remuneration Committee has granted conditional awards under the Long Term Incentive Plan to the chief executive and the chief financial officer.

Director Deals - Hutchison China Meditech Ltd (HCM)
BFN
Christopher Nash, Non Executive Director, bought 4,512 shares in the company on the 19th October 2015 at a price of 2195.00p. The Director now holds 36,442 shares.

Story provided by StockMarketWire.com
Director deals data provided by www.directorsholdings.com

Milestone Payment from Lilly Triggered
RNS
RNS Number : 2160D
Hutchison China Meditech Limited
23 October 2015







Proof-of-concept study of fruquintinib in non-small cell lung cancer triggers milestone payment


London: Friday, 23 October 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, is set to receive a US$10 million milestone payment, in the fourth quarter of 2015, from its partner Eli Lilly and Company ("Lilly").



The milestone payment was triggered by the positive proof-of-concept ("POC") Phase II study of fruquintinib in the treatment of patients with advanced non-squamous non-small cell lung cancer ("NSCLC") in China. Last month, top line results of this POC Phase II study were reported showing fruquintinib met the primary endpoint of progression free survival ("PFS"). The adverse events demonstrated in the POC study are consistent with the known safety profile for fruquintinib. Full details of the NSCLC Phase II POC results will be presented at a global medical conference in 2016.



Pursuant to the fruquintinib licensing, co-development, and commercialisation agreement entered into by HMP and Lilly in October 2013, HMP will receive reimbursements for costs associated with further clinical development in China for NSCLC according to a pre-specified cost-sharing rate. We now intend to initiate a pivotal Phase III study of fruquintinib in non-squamous NSCLC in China.



Including this US$10 million NSCLC POC milestone payment, HMP will have received a total of US$31.7 million from Lilly so far this year.





Ends

Hutchison China MediTech Ltd (HCM:LSE) set a new 52-week high during today's trading session when it reached 2,792.5. Over this period, the share price is up 140.73%.

Clinical results presented
RNS
RNS Number : 9704D
Hutchison China Meditech Limited
30 October 2015









Press Release




Sulfatinib clinical results and fruquintinib-savolitinib combination preclinical results to be presented at the 2015 AACR‑NCI‑EORTC Molecular Targets and Cancer Therapeutics conference




London: Friday, 30 October 2015: Hutchison China MediTech Limited ("Chi‑Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, will present further scientific data on sulfatinib (HMPL‑012), fruquintinib (HMPL‑013) and savolitinib (AZD6094, HMPL‑504) at the International Conference on Molecular Targets and Cancer Therapeutics, which will be held in Boston, Massachusetts, USA from 5 to 9 November 2015. Sulfatinib, fruquintinib and savolitinib were all discovered by HMP and are currently being evaluated in clinical trials for the treatment of various cancers.



Sulfatinib is an oral drug candidate that selectively inhibits the tyrosine kinase activity associated with the vascular endothelial growth factor receptor ("VEGFR") and fibroblast growth receptor ("FGFR"), a receptor for a protein which also plays a role in tumour growth. HMP will present clinical data from its Phase I trial in China, focusing on neuroendocrine tumour ("NET") patients. In this study, sulfatinib's objective response rate among the 18 efficacy-evaluable NET patients was 44.4% and disease control rate was 100%. By comparison, sunitinib and everolimus, the two approved single agent therapies for neuroendocrine tumours, achieve objective response rates of less than 10% in their pivotal clinical trials. Furthermore, neuroendocrine tumour responses to sulfatinib have been observed to improve gradually with time.



Savolitinib is an inhibitor of the c-Met receptor tyrosine kinase, an enzyme which has been shown to function abnormally in many types of solid tumours, and fruquintinib is a highly selective inhibitor of VEGFR1, 2 and 3. In clear cell renal cell carcinoma ("ccRCC"), c-Met activation has emerged as one of the mechanisms for resistance to anti-VEGF/VEGFR therapies, implying that inhibition of the c-Met and VEGFR pathways in a combination therapy could produce additional clinical benefit. HMP will present data from a preclinical study to assess the effect of savolitinib and fruquintinib combined in ccRCC xenograft models. In this study, while single-agent treatment at clinically relevant doses only exhibited mild to moderate tumour growth inhibition, a significantly increased anti-tumour effect was observed for the group receiving combination therapy.



Preclinical data will also be presented regarding savolitinib in non-small cell lung cancer ("NSCLC") and mechanisms of acquired savolitinib resistance.

Completion of Phase I clinical trial of HMPL 523
RNS
RNS Number : 9695D
Hutchison China Meditech Limited
30 October 2015







Completion of Phase I clinical trial of novel Syk Inhibitor HMPL‑523 for autoimmune diseases in healthy volunteers




London: Friday, 30 October 2015: Hutchison China MediTech Limited ("Chi‑Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has successfully completed its first-in-human Phase I clinical trial of HMPL‑523. HMPL‑523 is a novel, highly selective and potent small molecule inhibitor targeting spleen tyrosine kinase, also known as Syk, a key component in B-cell receptor signalling.



The first-in-human Phase I study of HMPL‑523 was a dose-escalating study conducted to assess the safety, tolerability and pharmacokinetics of both single and repeat doses of HMPL‑523 in healthy volunteers in Australia. The study began in June 2014, and completed ten single dose cohorts, with eight patients per cohort, from 5mg single dose through 800mg single dose. In April 2015, the multiple ascending dose section of the Phase I study commenced in which HMPL‑523 was administered once daily for 14 consecutive days. Four dose cohorts have now completed this section of the study, again with eight patients per cohort, from 200mg multiple dose through to 400mg multiple dose. At 400mg daily, HMPL‑523 drug exposures are believed to be well above the predicted efficacious dose level and, consequently, there is no intention to escalate further in healthy volunteers.



The preliminary safety profile of HMPL‑523 was in-line with our expectations. No material off-target toxicities such as hypertension and severe diarrhoea were observed with HMPL‑523 in this study. Furthermore, HMPL‑523 exhibited a linear pharmacokinetic profile and a dose dependent suppression of B-cell activation. Full results of the Phase I study will be published in due course.



Christian Hogg, CEO of Chi‑Med, said, "We have now established what we believe is a dose range for the further development of HMPL‑523. This will now allow Chi-Med to move this important, potentially first-in-class compound into global Phase II proof-of-concept studies against multiple indications both in autoimmune diseases and oncology."







Ends

2 Nov Beaufort... N/A Buy

Chi-Med initiates sulfatinib U.S. clinical trials
RNS
RNS Number : 7256E
Hutchison China Meditech Limited
06 November 2015







Chi-Med initiates sulfatinib U.S. clinical trials


London: Friday, 6 November 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has initiated the Phase I clinical trial of sulfatinib (HMPL-012) in the United States. Its U.S. Investigational New Drug application was submitted and cleared earlier this year and the first patient was dosed on 4 November 2015. HMP is also planning to initiate two Phase III registration studies for the treatment of neuroendocrine tumours ("NET") and a Phase Ib study for the treatment of thyroid cancer with sulfatinib in China by the end of 2015.



This Phase I dose escalation study is to assess the safety and tolerability of sulfatinib in U.S. patients with advanced solid tumours. A U.S. Phase II study in NET is expected to be initiated based on the conclusion of this Phase I dose escalation study.



Sulfatinib is an oral drug candidate that selectively inhibits the tyrosine kinase activity associated with the vascular endothelial growth factor receptor ("VEGFR") and fibroblast growth receptor ("FGFR"), a receptor for a protein which also plays a role in tumour growth. In a Phase I clinical trial in China focusing on NET patients, sulfatinib's objective response rate among the 18 efficacy-evaluable NET patients was 44.4%. By comparison, sunitinib and everolimus, the two approved single agent therapies for pancreatic NET, achieved objective response rates of less than 10% in their pivotal clinical trials. Furthermore, NET responses to sulfatinib have been observed to improve gradually with time. Results of the Phase I trial in China will be reported at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in November 2015 and will be made available at www.chi‑med.com/news/.



Sulfatinib is the first oncology candidate that HMP has taken through proof-of-concept in China and expanded to a U.S. clinical study without a partner.





Ends

Second Public Filing of Registration Statement
RNS
RNS Number : 6812F
Hutchison China Meditech Limited
13 November 2015

NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, TO U.S. NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION OR DISSEMINATION IN OR INTO OR FROM THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION







Second Public Filing of Registration Statement on Form F‑1 for potential Nasdaq Stock Market Listing



London: Friday, 13 November 2015: Further to its announcement on 16 October 2015, Hutchison China MediTech Limited ("Chi‑Med") (AIM: HCM) announces that it has publicly filed today a second draft of the registration statement on Form F-1 (the "Form F-1 Registration Statement") with the United States Securities and Exchange Commission (the "SEC") in relation to a potential listing of American depositary shares ("ADSs") representing its ordinary shares on the Nasdaq Stock Market (the "Offering"). As of the date of this announcement, Chi-Med has not yet set a definite timetable or decided on further details of the potential Offering and there can be no assurance that the potential Offering will be completed. Accordingly, the number of ADSs which may be offered and the offering price of the potential Offering have not yet been determined. The directors of Chi-Med will assess various factors, including market conditions, in considering whether formally to launch the transaction.

Bank of America Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the potential Offering.

The second draft of the Form F-1 Registration Statement relating to the ADSs has been filed with the SEC but has not yet become effective. The ADSs may not be sold, nor may offers to buy be accepted, prior to the time the Form F-1 Registration Statement becomes effective. The Form F-1 Registration Statement and all subsequent amendments may be accessed through the SEC's website at www.sec.gov.

This announcement does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Shareholders and potential investors should note that the potential Offering may or may not proceed, and accordingly are advised to exercise caution when dealing in the securities of Chi-Med.


Presentation of Financial Information

As announced by Chi-Med on 16 October 2015, the consolidated financial statements of Chi-Med included in the Form F‑1 Registration Statement have been prepared in accordance with U.S. GAAP, while the historical consolidated financial statements of Chi-Med published prior to the potential Offering were prepared in accordance with IFRS. The second draft of the Form F-1 Registration Statement filed with the SEC today supplementally contains the unaudited condensed consolidated financial statements of Chi-Med as of and for the nine months ended 30 September 2015 and 30 September 2014. In addition, the second draft of the Form F-1 Registration Statement filed today supplementally contains unaudited condensed consolidated accounts for the three non-consolidated joint ventures of Chi-Med, namely, Shanghai Hutchison Pharmaceuticals Limited, Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited and Nutrition Science Partners Limited, as of and for the nine months ended 30 September 2015 and 30 September 2014, which are prepared in accordance with IFRS. Such unaudited condensed consolidated financial statements are set out in the Appendix to this announcement.

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Initiation of fruquintinib Phase 3 trial in NSCLC
RNS
RNS Number : 3100I
Hutchison China Meditech Limited
08 December 2015







Initiation of fruquintinib Phase III registration trial in non-small cell lung cancer


London: Tuesday, 8 December 2015: Hutchison China MediTech Limited ("Chi‑Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has initiated FALUCA, a Phase III registration study for fruquintinib (HMPL‑013) in third-line non-squamous non-small cell lung cancer ("NSCLC") patients in China. Fruquintinib is an investigational small molecule which selectively inhibits vascular endothelial growth factor receptors ("VEGFR"). Preparations and site selection began in August this year, with the first patient dosed on 8 December 2015.



FALUCA is a randomised, double-blind, placebo-controlled, multi-centre, Phase III registration study targeted at treating patients with advanced non-squamous NSCLC, who have failed two lines of systemic chemotherapy. Patients will be randomised at a 2:1 ratio to receive either 5mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus best supportive care ("BSC"); or placebo plus BSC. The primary endpoint is overall survival, with secondary endpoints including progression free survival, objective response rate, disease control rate and duration of response. HMP plans to enrol approximately 520 patients in about 45 centres across China, with top-line results expected in 2017.



In September this year, Chi-Med announced that the Phase II proof-of-concept ("POC") trial of fruquintinib in patients with third-line non-squamous NSCLC in China had successfully achieved the primary endpoint of progression free survival ("PFS") with no unexpected safety issues. The detailed results of this Phase II study will be presented in a global scientific conference in 2016.





Ends

US$105 m Shanghai land compensation agreement
RNS
RNS Number : 4611I
Hutchison China Meditech Limited
09 December 2015



Press Release

US$105 million Shanghai land compensation agreement



London: Wednesday, 9 December 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Shanghai Hutchison Pharmaceuticals Limited ("SHPL"), its 50:50 joint venture with a subsidiary of Shanghai Pharmaceuticals Holding Co., Limited, has today entered into an agreement (the "Agreement") with the Shanghai government for the surrender of SHPL's remaining 36 years land-use rights on its approximately 58,000 square metres old factory site at 2098 Zhennan Road, Taopu Town, Putuo District, Shanghai (the "Site").

The Site is located in an area of Shanghai 12 kilometres from the city centre, which was re-zoned in 2014 from industrial use into usage as a new science and technology, commercial and residential development area called Smart City.

The Agreement signed between SHPL and (i) Land Development Centre of Putuo District of Shanghai Municipality and (ii) Shanghai Taopu Smart City of Science and Technology Development and Construction Company Limited (together the "Acquirers") provides that SHPL will return the Site to the Acquirers in consideration for cash compensation of approximately US$105 million (the "Compensation"). Under the Agreement, SHPL will receive the Compensation in three stages over a period of approximately one year as the transaction progresses to completion.

The re-zoning of the Site prompted SHPL to develop plans to build a new factory, 40 kilometres south of Shanghai city centre, in Fengpu District. Due to the strong growth of SHPL which recorded first half sales in 2015 of US$103.9 million, up nine-fold versus the same period in 2005, the new factory was designed to accommodate an approximately three-fold production capacity increase compared to the old factory. SHPL began construction on this new factory in 2014 and the full transition of production from the old factory to the new factory is expected to complete by mid-2016. The cost of the new factory, expected to total approximately US$100 million, has already been over 80% incurred and funded to-date through SHPL cash reserves and bank borrowings of US$38 million as at 30 November 2015.

Christian Hogg, CEO of Chi-Med, said, "This is good news. The move to our new factory in Fengpu has been a major effort for the SHPL team and positions us well for the future with a tripling of production capacity. This modern facility will support continued business expansion and further scale efficiency at SHPL. Meanwhile, we plan to use the cash compensation to pay off debt, retain cash for working capital and look to pay dividends to the shareholders of SHPL."

Initiation sulfatinib Phase III registration study
RNS
RNS Number : 4500J
Hutchison China Meditech Limited
18 December 2015

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Initiation of sulfatinib Phase III registration study in neuroendocrine tumour patients


London: Friday, 18 December 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has initiated SANET-ep, a Phase III sulfatinib (HMPL-012) registration trial in China in patients with extra-pancreatic neuroendocrine tumours ("NETs"), which are all non-pancreatic NETs, including, for example, NETs originating in the lymph, lung and across the gastrointestinal tract. Preparations and site selection had begun in the middle of this year and the first patient was dosed on 17 December 2015.



SANET-ep is a randomised, double-blind, placebo-controlled, multi-centre Phase III sulfatinib registration study to treat pathologically low or intermediate grade NET patients whose disease has progressed, locally advanced or distant metastasised and for whom there is no effective therapy. Patients will be randomised at a 2:1 ratio to receive either 300 milligrams of sulfatinib orally once per day, or placebo, on every 28-day treatment cycle. The primary objective of this study is to evaluate the progression-free survival of sulfatinib as compared to that of placebo, with secondary endpoints including objective response rate ("ORR"), disease control rate, time to response, duration of response, overall survival, safety and tolerability. Approximately 270 patients will be enrolled in the SANET-ep study from more than 20 centres across China, with top-line results expected in 2018.



Additionally, the second Phase III sulfatinib registration trial, SANET-p, in pancreatic NET patients, is expected to be initiated imminently in China. SANET-p employs a similar treatment regimen and has primary and secondary endpoints similar to those for SANET-ep trial. Approximately 195 patients will be enrolled in SANET-p and is expected to start by the end of 2015, with top-line results expected in 2017.



Sulfatinib is an oral drug candidate that demonstrates dual inhibition of the tyrosine kinase activity associated with vascular endothelial growth factor receptor ("VEGFR") and fibroblast growth factor receptor ("FGFR") 1, a receptor kinase which also plays a role in tumour angiogenesis. In 2014, HMP completed the first-in-human Phase I clinical trial of sulfatinib in China; the detailed results were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in early November 2015 (http://www.chi-med.com/sulfatinib-ph1-eortc-2015/). The Phase I clinical data indicates that sulfatinib has the highest ORR reported to date in NET patients. An ORR of 44% was observed for sulfatinib in 18 evaluable patients, compared to less than 10% for sunitinib and everolimus, the two approved targeted therapies for pancreatic NET patients.



In October 2014, HMP initiated a multi-centre, single-arm, open-label Phase Ib/II study in NET patients in China to further evaluate the efficacy, safety, tolerability and pharmacokinetic characteristics of sulfatinib. This study, projected to enrol approximately 80 patients, is near to completion of patient enrolment.



Furthermore, the Phase I and Phase Ib/II studies in China provide a guide for the selection of the recommended starting dose for the Phase I study in patients with advanced solid tumours in the United States, which had the first patient enrolled in early November 2015.



In addition to these four NET studies, HMP also plans to initiate a Phase Ib study in China to evaluate the safety, pharmacokinetics and efficacy of sulfatinib in patients with both medullary and differentiated thyroid cancer by the end of 2015.



Ends

Chi-Med initiates HMPL-523 Phase I clinical trial
RNS
RNS Number : 9858L
Hutchison China Meditech Limited
15 January 2016







Initiation of HMPL-523 Phase I clinical trial in haematological cancer in Australia


London: Friday, 15 January 2016: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has initiated a Phase I trial in Australia in patients with haematological malignancies. HMPL‑523 is a novel, highly selective and potent small molecule oral inhibitor targeting spleen tyrosine kinase, also known as Syk, a key component in B-cell receptor signalling. Preparations and site selection began in late 2015 and the first patient was dosed on 13 January 2016. This trial follows the successful completion of a first-in-human Phase I clinical trial in healthy volunteers in October 2015.



The new study is a Phase I, open-label, dose escalation study of HMPL‑523 as monotherapy administered orally to patients with relapsed or refractory haematological malignancies who are unable to tolerate standard therapy or for whom there is no effective therapy. Two stages for this study are planned: a dose escalation stage and a dose-expansion stage. The primary objectives of the study are to evaluate safety and tolerability, and to determine the maximum tolerated dose and/or recommended Phase II dose of HMPL‑523 in this patient population. Other objectives include the evaluation and characterisation of the pharmacokinetics of HMPL‑523 and its metabolites, and to make preliminary assessments of the anti-tumour activity of HMPL‑523 in certain sub-populations in the dose expansion phase of the trial.



The successful completion of the first-in-human study in healthy volunteers in 2015 has established the safety profile of HMPL‑523. HMP now hopes that this Phase I study in haematological malignancies could provide clinical proof-of-concept that modulation of the B-cell signalling pathway through inhibition of Syk will provide patients with a clinical benefit.





Ends

Chi-Med schedules FY results
StockMarketWire.com
Hutchison China MediTech will announce its final results for the year ended 31 December on 1 March.

At 8:08am: (LON:HCM) Hutchison China Meditech Ltd share price was 0p at 2247.5p


Story provided by StockMarketWire.com

Final Results

Group Results

· Revenue up 104% to $178.2 million (2014: $87.3m).

· Net profit from operations attributable to Chi-Med of $8.0 million (2014: net loss -$7.3m), including our booking of $3.1 million in one-time preparation costs for our proposed Nasdaq listing.

· Stable cash position: Available cash of over $90 million as of today, at the Chi-Med Group level, including cash and cash equivalents and unutilized banking facilities.

1. $31.9 million in cash and cash equivalents at Chi-Med Group level as at 31 December 2015;

2. $6.9 million in unutilized bank facilities at Chi-Med Group level as at 31 December 2015;

3. $60.0 million additional unsecured bank facilities established in February 2016;

4. $76.9 million in further cash and cash equivalents held at 50/50 Joint Venture ("JV") level and not consolidated at Chi-Med Group level. Shanghai property compensation of approximately $73.9 million expected at JV level in 2016, which is in addition to the $31.1 million that we already received in late 2015.

· Continued focus on proposed Nasdaq dual listing - fourth public filing of registration statement on Form F-1 expected to be made today.

Sulfatinib Phase II initation in thyroid cancer
RNS
RNS Number : 7393Q
Hutchison China Meditech Limited
02 March 2016







Chi-Med initiates sulfatinib Phase II clinical trial in thyroid cancer


London: Wednesday, 2 March 2016: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has initiated an open-label Phase II clinical trial to evaluate the efficacy and safety of sulfatinib (HMPL-012) in patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer ("DTC") or medullary thyroid cancer ("MTC") in China. The first patient was dosed on 1 March 2016.



HMP plans to enroll approximately 50 DTC and MTC patients into this study, with approximately 25 patients in each tumor type. The primary objective is to evaluate the objective response rate ("ORR"), while secondary and exploratory objectives include the evaluation of safety and tolerability, other efficacy parameters, pharmacokinetics, and tumor biomarkers. The study employs a two-stage design in which 15 subjects of each tumor type will be enrolled in the first stage. An additional 10 subjects in each tumor type will be enrolled after efficacy assessment in the second stage. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02614495.



Sulfatinib is an oral drug candidate that selectively inhibits the tyrosine kinase activity associated with the vascular endothelial growth factor receptor ("VEGFR") and fibroblast growth receptor ("FGFR"), two tyrosine kinase receptors associated with angiogenesis and tumor growth. HMP believes that sulfatinib's VEGFR/FGFR1 inhibition profile has strong potential in second-line thyroid cancer patients, particularly in China where there are few safe and effective treatment options for this patient population.



In addition to the thyroid cancer trial, HMP is conducting or in the process of initiating four clinical trials in neuroendocrine tumors ("NETs").





Ends

Pricing of U.S. Public Offering of ADSs
RNS
RNS Number : 3714S
Hutchison China Meditech Limited
17 March 2016

NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, TO U.S. NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION OR DISSEMINATION IN OR INTO OR FROM THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION







Pricing of U.S. Public Offering of ADSs



London: Wednesday, March 16, 2016: Further to its announcements on October 16, 2015, November 13, 2015, February 11, 2016, March 1, 2016 and March 4, 2016, Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) announces the pricing of its U.S. public offering of American depositary shares ("ADSs") (the "Offering"), raising gross proceeds of approximately US$101.25 million.

7,500,000 ADSs were sold in the Offering at a price of US$13.50 per ADS, and the offering price is thus equivalent to approximately £19.42 per ordinary share (on the basis of an assumed exchange rate as quoted in the preliminary prospectus of £1.00 to US$1.39). Each ADS represents one-half of one ordinary share of Chi-Med. The ADSs have been approved for listing on the Nasdaq Global Select Market and are expected to begin trading on March 17, 2016 under the ticker symbol "HCM." Chi-Med's ordinary shares will continue to be traded on the AIM market of the London Stock Exchange following the Offering under the ticker symbol "HCM."

In addition, Chi-Med has granted the underwriters a 30-day option to purchase up to an additional 1,125,000 ADSs at the Offering price. Closing of the Offering is expected to occur on or about March 22, 2016, subject to customary closing conditions.

BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the Offering. Stifel, Canaccord Genuity, Panmure Gordon & Co. and CITIC CLSA are acting as co-managers for the Offering.

Mr Simon To, Chairman of Chi-Med, said, "We are delighted with the way our roadshow has been received by investors. We believe investors share our view of Chi-Med's prospects, and we look forward to our Nasdaq presence increasing our profile within the world's largest pharmaceutical market."

In connection with the Offering, a registration statement on Form F-1 (the "Form F-1 Registration Statement") has been filed with, and declared effective by, the United States Securities and Exchange Commission (the "SEC"). Copies of this document may be accessed through the SEC's website at www.sec.gov. A final prospectus, when available, may be obtained from (in alphabetical order): (i) BofA Merrill Lynch, Attn: Prospectus Department, 222 Broadway, New York, NY 10038, or by email at dg.prospectus_requests@baml.com, or (ii) Deutsche Bank Securities Inc., Attn: Prospectus Group, 60 Wall Street, New York, NY 10005, or by email at prospectus.cpdg@db.com.

This announcement does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Application will be made for the 3,750,000 new ordinary shares of Chi-Med, represented by the 7,500,000 ADSs to be issued at closing of the Offering, to be admitted to trading on AIM and it is expected that the admission will become effective at 8.00 am (GMT) on March 23, 2016.

Ends

Sulfatinib Phase III registration study

RNS


RNS Number : 6975S

Hutchison China Meditech Limited

21 March 2016










Chi-Med initiates sulfatinib Phase III registration study in pancreatic neuroendocrine tumor patients



London: Monday, March 21, 2016: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has initiated SANET-p, a Phase III registration trial of sulfatinib (HMPL-012) in China in patients with pancreatic neuroendocrine tumors ("NETs"). The first patient was dosed on March 18, 2016.



The protocol for SANET-p is similar to SANET-ep, a Phase III registration trial in patients with extra-pancreatic NETs. SANET-p is a randomized, double-blind, placebo-controlled, multi-center Phase III sulfatinib registration study to treat patients with low or intermediate grade advanced NET whose disease has progressed, locally advanced or distant metastasized and for whom there is no effective therapy. Patients are randomized at a 2:1 ratio to receive either 300 milligrams of sulfatinib orally once per day, or placebo, on an every 28-day treatment cycle. The primary objective of this study is to evaluate the progression-free survival of sulfatinib as compared to that of placebo, with secondary endpoints including objective response rate ("ORR"), disease control rate, time to response, duration of response, overall survival, safety and tolerability. Approximately 195 patients are expected to be enrolled in the SANET-p study from more than 20 centers across China, with top-line results expected in 2018. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02589821.



Sulfatinib is an oral drug candidate that selectively inhibits the tyrosine kinase activity associated with the vascular endothelial growth factor receptor ("VEGFR") and fibroblast growth receptor ("FGFR"), two tyrosine kinase receptors associated with angiogenesis and tumor growth. HMP believes that sulfatinib's VEGFR/FGFR1 inhibition profile has strong potential in second-line thyroid cancer patients, particularly in China where there are few safe and effective treatment options for this patient population.



Including this trial, HMP is conducting five Phase II and Phase III clinical trials of sulfatinib in China and the U.S.





Ends

Director/PDMR Shareholding

RNS


RNS Number : 3462T

Hutchison China Meditech Limited

29 March 2016










Director's Shareholding





London: Tuesday, March 29, 2016: Hutchison China MediTech Limited ("Chi-Med") (AIM / Nasdaq: HCM) received notification on March 25, 2016 that Mr Christian Hogg, Executive Director and Chief Executive Officer, has purchased 36,600 American Depositary Shares ("ADSs", each representing one-half of one ordinary share) of the Company at a price of US$13.5 per ADS on March 25, 2016.



Following this purchase, Mr Hogg is beneficially interested in 36,600 ADSs and 1,088,182 ordinary shares, representing approximately 1.84% of the current issued share capital of Chi-Med.

Clinical trial of novel PI3K inhibitor HMPL-689

RNS


RNS Number : 8854U

Hutchison China Meditech Limited

12 April 2016










Chi-Med initiates first-in-human clinical trial of novel PI3K inhibitor HMPL-689





London: Tuesday, April 12, 2016: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has initiated the first-in-human ("FIH") Phase I clinical trial of HMPL-689 in Australia. HMPL-689 is a novel, highly selective and potent small molecule inhibitor targeting the delta isoform of the phosphatidylinositol-3-kinase, also known as PI3Kδ, a key component in the B-cell receptor signaling pathway. The first drug dose was administered on April 7, 2016.



The FIH trial aims to evaluate the safety, tolerability, and pharmacokinetics properties of HMPL-689. This randomized, double blind, placebo-controlled, dose-escalating Phase I study of HMPL-689 will be conducted in healthy adult volunteers. Following this FIH Phase I trial, HMP plans to investigate HMPL-689 in hematological malignancies. In pre-clinical studies, not only did HMPL-689 demonstrate a superior potency and better kinase selectivity as compared to drugs in the same class, but it also showed significant efficacy and a favorable safety profile. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02631642.





Ends

Savolitinib Global Phase II Trial Initiated

RNS


RNS Number : 6461B

Hutchison China Meditech Limited

20 June 2016






Savolitinib Global Phase II Trial Initiated in EGFR Mutant Non-Small Cell Lung Cancer





Initiation of expanded Phase II trials in NSCLC triggers US$10 million milestone from AstraZeneca to Chi-Med



New study builds on encouraging data from initial small Phase II studies of savolitinib in combination with Tagrisso or Iressa in c-Met-amplified NSCLC





London: Monday, June 20, 2016: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces the initiation of a Phase II expansion of the ongoing TATTON trial (NCT02143466) to evaluate the selective c-Met inhibitor savolitinib (AZD6094) in epidermal growth factor receptor ("EGFR") mutant non-small cell lung cancer ("NSCLC") patients. Savolitinib has the potential to address major unmet medical needs in c-Met-driven subsets of NSCLC, a disease that is estimated to afflict approximately 1.7 million new patients annually worldwide.



The trial is a single-arm global Phase II study of savolitinib in combination with Tagrisso (osimertinib/AZD9291) in advanced NSCLC patients who have developed resistance to approved EGFR tyrosine kinase inhibitors ("TKIs"). This expansion was initiated following encouraging early data from a number of patients enrolled in the TATTON study who received savolitinib in combination with Tagrisso.



The initiation of the expanded Phase II study has triggered a US$10 million milestone payment to Hutchison MediPharma Limited ("HMP") (a 99.8% held subsidiary of Chi-Med) under the terms of the agreement with AstraZeneca PLC ("AstraZeneca") signed in December 2011. HMP and AstraZeneca are conducting Phase II studies in NSCLC with savolitinib in monotherapy, as well as in combination with either Tagrisso or Iressa (gefitinib). AstraZeneca continues to lead and invest in the global NSCLC development program for savolitinib.



Susan Galbraith, Senior Vice President, Head of Oncology Innovative Medicines, AstraZeneca, said: "Savolitinib is a highly selective c-Met inhibitor that is being investigated in a number of cancers including in patients with lung cancer whose disease is driven by aberrant c-Met / HGF signaling. We are extremely excited by the data we have seen for savolitinib when used in combination with our EGFR tyrosine kinase inhibitors. We are committed to advancing research to develop a broad range of potential treatment options for patients with lung cancer."



Christian Hogg, Chief Executive Officer of Chi-Med, said: "We estimate that the annual incidence of patients with MET-driven NSCLC in the U.S., European Union and Japan totals about 40,000-50,000 in all treatment settings. This is an important unmet medical need and one that we believe savolitinib is well suited to address because of its very high selectivity. This allows for effective target coverage of c-Met, as well as safe and tolerable combinations with other oncology agents. We believe that savolitinib either as a monotherapy in first-line NSCLC, or in proprietary combinations with AstraZeneca's Iressa and Tagrisso in second- and third-line NSCLC, will address the key genetic drivers of cancer cell proliferation in these very difficult-to-treat NSCLC patients. We are hopeful about proceeding into Phase III in 2017 based on future data from this study."



NSCLC DEVELOPMENT PROGRAM HIGHLIGHTS

Savolitinib continues to be explored in a range of MET-driven NSCLC settings including:

- Savolitinib in combination with Tagrisso or Iressa in Phase II expansions of ongoing studies in advanced EGFR mutant NSCLC

- Savolitinib + Tagrisso combination Phase II study in third-line NSCLC (for patients progressing on T790M-directed therapies)



- Savolitinib monotherapy Phase II study in NSCLC



Savolitinib is in clinical development in multiple MET-driven solid tumor indications including NSCLC, kidney, gastric and colorectal cancer. For a detailed summary of all current savolitinib clinical trials covering multiple patient populations, please click here.





NOTES TO EDITORS

About NSCLC and TKIs to address MET-driven and EGFR-driven NSCLC

Every year, it is estimated that approximately 1.7 million new patients around the world are diagnosed with NSCLC, according to Frost & Sullivan. Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths, and more than breast, prostate and colorectal cancers combined. TKIs are used in many cancer therapies and act by blocking the cell signaling pathways that drive the growth of tumor cells.



Around 4-5% of first-line NSCLC patients have MET-driven NSCLC, including approximately 3-4% with MET Exon-14 mutations and approximately 1-2% with c-Met gene amplification, and are generally sensitive to treatment with selective c-Met inhibitors such as savolitinib. Currently there are no approved selective c-Met TKIs for these NSCLC patients.



Separately, patients who have the EGFR mutation form of NSCLC, which occurs in an estimated 10-15% of NSCLC patients in Europe and 30-40% of NSCLC patients in Asia, are particularly sensitive to treatment with currently available EGFR-TKIs. However, tumors almost always develop resistance to treatment leading to disease progression, with median progression-free periods of approximately nine months. Among NSCLC patients treated with the approved EGFR-TKIs Iressa, Tarceva (erlotinib) or Gilotrif (afatinib), who build resistance to EGFR-TKIs and thus become second-line patients, approximately half of this resistance is driven by T790M, and approximately one-fifth is driven by c-Met gene amplification.



In third-line NSCLC patients treated with EGFR T790M mutation-positive TKIs, resistance pathways are only beginning to emerge as more patients are being treated with TKIs in clinical trials and Tagrisso was approved in the U.S., European Union, Japan and South Korea. Data is limited, but as patients become resistant to Tagrisso (median progression-free survival of nine months), c-Met gene amplification is emerging as a resistance pathway of significant interest.





About savolitinib, a uniquely selective c-Met inhibitor

Savolitinib is a potential global first-in-class inhibitor of c-Met (also known as mesenchymal epithelial transition factor) receptor tyrosine kinase, an enzyme which has been shown to function abnormally in many types of solid tumors. It was developed as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with first-generation c-Met inhibitors, including renal toxicity.





About Tagrisso, a selective inhibitor against EGFR and T790M mutations

Tagrisso (osimertinib) 80mg once-daily tablet, developed by AstraZeneca, is the first medicine indicated for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. Non-clinical in vitro studies have demonstrated that osimertinib has high potency and inhibitory activity against mutant EGFR phosphorylation across the range of clinically relevant EGFRm and T790M mutant NSCLC cell lines, with significantly less activity against EGFR in wild-type cell lines.



Tagrisso is being compared with platinum-based doublet chemotherapy in the confirmatory AURA3 Phase III study in patients with EGFR T790M-positive, locally advanced or metastatic NSCLC who have progressed after EGFR-TKI therapy. It is also being investigated in the adjuvant and metastatic first-line settings, including in patients with and without brain metastases, in leptomeningeal disease, and in combination treatment.





About Iressa, an EGFR mutation inhibitor

Iressa (gefitinib) is a targeted monotherapy developed by AstraZeneca for the treatment of patients with advanced or metastatic EGFR mutation-positive NSCLC. Iressa acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking the transmission of signals involved in the growth and spread of tumors. EGFR mutations occur in approximately 10-15% of NSCLC Caucasian patients and 30-40% of NSCLC patients in Asia. Iressa is approved in 91 countries worldwide.





About Chi-Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform, Hutchison MediPharma Limited, is focused on discovering, developing and commercializing innovative therapeutics in oncology and autoimmune diseases. Its pipeline of eight novel oral compounds for cancer and inflammation is in development in North America, Europe, Australia and Greater China.



Chi-Med's Commercial Platform manufactures, markets and distributes prescription drugs and consumer health products in China.



Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.





About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca's six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology.



By harnessing the power of four scientific platforms - immuno-oncology, the genetic drivers of cancer and resistance, DNA damage response and antibody drug conjugates - and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.





About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology - as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.





Forward-Looking Statements

This announcement contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of savolitinib, plans to initiate clinical studies for savolitinib in solid tumor indications, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of a drug candidate to meet the primary or secondary endpoint of a study, the ability of a drug candidate to obtain regulatory approval in different jurisdictions, the ability of a drug candidate to gain commercial acceptance after obtaining regulatory approval, the potential market of a drug candidate for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.

Chi-Med to Announce 2016 HY Financial Results

RNS


RNS Number : 1164D

Hutchison China Meditech Limited

05 July 2016




Chi-Med to Announce 2016 Half-Year Financial Results



London: Tuesday, July 5, 2016: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) will be announcing its interim results for the six months ended June 30, 2016 on Tuesday, August 2, 2016 at 7:00 am British Summer Time (BST).



An analyst presentation will be held at 9:00 am BST (4:00 pm Hong Kong Time) on the same day at Citigate Dewe Rogerson, 3 London Wall Buildings, London, EC2M 5SY, UK, which will be webcast via the company website at www.chi-med.com/investors/event-information/. The presentation will be available to download before the analyst presentation begins.



For North America based analysts and investors, Chi-Med will also host a conference call with Q&A at 9:00 am Eastern Daylight Time (2:00 pm BST).



Details of the analyst presentation and conference call dial-in will be provided in the financial results announcement. A replay will also be available on the website shortly after each event.

Chi-Med and AstraZeneca to Accelerate Savolitinib

RNS


RNS Number : 7926F

Hutchison China Meditech Limited

01 August 2016









AstraZeneca PLC ("AstraZeneca")

(LON/STO/NYSE: AZN)



Hutchison China MediTech Limited ("Chi-Med")

(AIM/Nasdaq: HCM)


Chi-Med and AstraZeneca Amend Co-development Agreement to Accelerate Savolitinib Global Development Program



First global pivotal Phase III in c-Met-driven papillary renal cell carcinoma ("PRCC") to be initiated in the near future



London: Monday, August 1, 2016: Chi-Med and AstraZeneca today announced an amendment (the "Amendment") to the 2011 global licensing, co-development, and commercialisation agreement (the "2011 Agreement") regarding savolitinib. Based on data from multiple Phase I/II studies, savolitinib has shown early clinical benefit as a highly selective c-Met inhibitor in a number of cancers.



As a consequence, savolitinib's global development plan now covers multiple c-Met-driven solid tumor indications including non-small cell lung cancer ("NSCLC"), kidney, gastric and colorectal cancers. For a detailed summary of all current savolitinib clinical trials, please click here.



Chi-Med and AstraZeneca have agreed to the amendment in order to accelerate savolitinib's global development and increase Chi-Med's participation in the programme. The Amendment provides that Chi-Med will contribute up to $50 million, spread primarily over three years, to the joint development costs of the global pivotal Phase III study in c-Met-driven PRCC. Subject to approval in the PRCC indication, Chi-Med will receive a 5 percentage point increase in the global (excluding China) tiered royalty rate payable on savolitinib sales across all indications. All other provisions of the 2011 Agreement will remain unchanged.



Final results from savolitinib's recently completed open-label global PRCC Phase II study (NCT02127710) will be presented at an upcoming scientific meeting. Chi-Med and AstraZeneca have now agreed to proceed to Phase III.



The global Phase III trial of savolitinib will be the first pivotal study conducted in c-Met-driven PRCC, a rare histological subtype of renal cell carcinoma ("RCC") that is associated with alterations in the c-Met gene (e.g. mutations, amplifications, and/or chromosomal changes). Currently, available RCC therapies have demonstrated only modest benefit in PRCC and there are no therapies specifically approved for the treatment of c-Met-driven PRCC. Ongoing interactions with health authorities will determine the final design of the global pivotal Phase III trial, and its initiation will be aligned with availability of a companion diagnostic for c-Met-driven PRCC. The PRCC Phase III companion diagnostic platform will be largely similar for other indications such as NSCLC and gastric cancer.



AstraZeneca is also continuing to lead the development of savolitinib in other c-Met-driven types of cancer. Most notably, a Phase II expansion of the ongoing TATTON trial (NCT02143466) to evaluate savolitinib in epidermal growth factor receptor ("EGFR") mutant NSCLC patients has been initiated. This trial is a single-arm global Phase II study of savolitinib in combination with Tagrisso (osimertinib) in advanced NSCLC patients who have developed resistance to approved EGFR tyrosine kinase inhibitors. The Phase II expansion was initiated following early data from the TATTON study.



Susan Galbraith, Senior Vice President, Head of Oncology, Innovative Medicines and Early Development, AstraZeneca, said: "The accelerated development of savolitinib in RCC and NSCLC reflects our ongoing commitment to deliver world-class medicines to patients with limited treatment options. We are pleased to be building on our established collaboration with Chi-Med, as this reinforces our enterprise leadership approach to drug development."



Christian Hogg, Chief Executive Officer of Chi-Med, said: "Bringing savolitinib to a global launch in multiple areas of unmet medical need is our very clear focus. We believe that savolitinib has the potential to become the first approved therapy in kidney cancer in a molecularly selected patient population, as well as in multiple c-Met-driven lung and gastrointestinal tract cancers. As we enter a period where pivotal trials in multiple indications are close at hand, we are now happy to take on a small minority of the investment in order to help accelerate development while increasing our share in the long-term economic value of savolitinib."

2016 interim results

Market Buzz

Director dealings: Chi-Med director's wife bags a bargain?

Tue, 09 August 2016







Director dealings: Chi-Med director's wife bags a bargain?



(ShareCast News) - The wife of Hutchison China MediTech (Chi-Med) director Christopher Nash has swooped into the market to pick up a few of the company's shares a after hearing good reports on the China-based biopharma outfit's recent interim results and bulging drug pipeline.
Mrs Nash, wife of the company's senior independent non-executive director, snapped up 3,120 shares at the price of 1,900p and 42 at 1,899p last week, Chi-Med announced on Tuesday, to inflate the Nash household's ownership to 39,596 of the company's shares.

A week ago, Chi-Med's interim results showed group revenue up 27% to $104.5m but net income down to $0.5m due to a sharp increase in clinical investment as it funds the progress of seven drug candidates in 25 clinical trials, of which four are pivotal Phase III studies.

Through the coming three quarters, Chi-Med plans to publish proof-of-concept or pivotal trial data on four drug candidates.

Also, last Monday Chi-Med and FTSE 100 giant AstraZeneca announced an amendment to their 2011 global licensing, co-development, and commercialisation agreement regarding Chi-Med's savolitinib cancer treatment, which is currently undergoing trials for non-small cell lung cancer, kidney, gastric and colorectal cancers.

Chi-Med has now agreed contribute up to $50m over three years to the joint development costs of the global pivotal Phase III study in the c-Met gene affect on papillary renal cell carcinoma (PRCC).

Subject to approval in the PRCC indication, Chi-Med will receive a 5 percentage point increase in the global - excluding China - tiered royalty rate payable on savolitinib sales across all indications.

Joint Venture - US$59.5m Land Compensation Payment
RNS
RNS Number : 8354N
Hutchison China Meditech Limited
31 October 2016
 
Chi-Med Commercial Platform Joint Venture Receives US$59.5 Million Land Compensation Payment
l Shanghai agreement triggers a one-time gain to Chi-Med of US$38.2 million in Q4 2016
l Shanghai factory relocation complete: now operational with three-fold increase in capacity
l Cash from Chi-Med Commercial Platform supports development of innovative therapies - first pivotal Phase III read-out expected early 2017
 
London: Monday, October 31, 2016: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that Shanghai Hutchison Pharmaceuticals Limited ("SHPL"), its 50:50 Prescription Drug joint venture with a subsidiary of Shanghai Pharmaceuticals Holding Co., Limited ("Shanghai Pharma"), has today received US$59.5 million from the Shanghai government under the terms of their December 2015 land compensation agreement (the "Compensation Agreement").
 
As announced on December 9, 2015, SHPL and the Shanghai government entered into the Compensation Agreement for the surrender of SHPL's remaining 35 year land-use rights on its approximately 58,000 square meter old factory site 12 kilometers northwest of Shanghai city center (the "Site").  The Site was re-zoned in 2014 from industrial use into usage as a new science and technology, commercial and residential development area.
 
Total compensation to SHPL, including cash and subsidies, is US$113.1 million.  SHPL has to date received an aggregate of US$97.2 million in cash, including a US$31.1 million first installment received in December 2015, US$6.6 million in subsidies already in-hand and today's US$59.5 million second installment at current exchange rates. The final US$15.9 million is expected to be received by the end of 2016 or early 2017. 
 
Chi-Med Group will now book an estimated one-time gain on the transaction of US$38.2 million in the fourth quarter of 2016.  This represents Chi-Med's share of the compensation less the US$10.3 million net book value of the old site and its buildings, as well as taxes and other costs.
 
The re-zoning of the Site prompted SHPL to build a new factory with an approximate three-fold production capacity increase outside Shanghai city. The new factory cost approximately US$95 million and was financed over the past three years mainly with operating cash flow and limited bank debt.  SHPL fully transitioned its 500-person manufacturing unit to, and began production at, the new factory in September 2016.  After repayment of bank debt and taxes, approximately US$80 million of the compensation is expected to be distributed equally to Chi-Med and Shanghai Pharma next year.
 
Christian Hogg, CEO of Chi-Med, said, "Under the Chi-Med Commercial Platform, our SHPL Prescription Drug business has grown sales over ten-fold during the past 10 years to US$126.8 million in the first half of 2016.  The establishment of a new production facility in Shanghai, with expanded production capacity, is important to support this profitable and cash generative business.  This cash flow, along with the cash provided by our partners AstraZeneca PLC, Eli Lilly & Company and Nestlé Health Science S.A., is what supports our core strategic objective of sustained investment in clinical development of Chi-Med's seven innovative small molecule drug candidates.  Chi-Med is currently enrolling patients in 25 clinical trials around the world, including four pivotal Phase III studies the first of which, fruquintinib in third-line colorectal cancer, will report top-line results in early 2017."
 
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
 
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
 
About Shanghai Hutchison Pharmaceuticals Limited
SHPL is one of the key companies in the Commercial Platform of Chi-Med which engages in the manufacture and sale of prescription drugs. SHPL operates a commercial organization of over 1,800 medical sales representatives across about 300 cities and towns in China detailing both its own prescription drug products as well as those of third party companies such as Seroquel® (AstraZeneca) and Concor® (Merck Serono).
 
References
Unless the context requires otherwise, references in this announcement to the "Group," the "Company," "Chi-Med," "Chi-Med Group," "we," "us" and "our" refer to Chi-Med and its consolidated subsidiaries and joint ventures unless otherwise stated or indicated by context.
 
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward looking statements reflect Chi-Med's current expectations regarding future events and can be identified by words like: "will," "expects," "believes" or similar terms, or by express or implied discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events and are subject to significant known and unknown risks and uncertainties. Such risks and uncertainties include, among other things, the risk that SHPL does not receive the third installment of cash compensation and subsidies, in whole or in part, owed for the surrender of its land-use rights. For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

China medic presents ph1 clinical data for HMPL523

Chi-Med to Present Data at the at the 17th WCLC
RNS
RNS Number : 9171P
Hutchison China Meditech Limited
23 November 2016
 
 
Press Release
 
Chi-Med to Present Data from Proof-of-Concept Clinical Trials for Fruquintinib and Epitinib at the 17th World Conference on Lung Cancer ("WCLC")
 
London: Wednesday, November 23, 2016: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that results from two non-small cell lung cancer ("NSCLC") clinical studies will be presented at WCLC in Vienna, Austria, from December 4 to 7, 2016.  Results from the positive Phase II third-line NSCLC clinical trial of fruquintinib, a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors ("VEGFR"), will be detailed in an oral presentation.  Results from the ongoing Phase Ib first-line NSCLC clinical trial of epitinib, a highly selective inhibitor of the epidermal growth factor receptor ("EGFR") designed to optimize brain penetration, will also be presented.
 
In September 2015, Chi-Med announced that the fruquintinib Phase II NSCLC clinical trial had successfully achieved its primary endpoint.  The oral and poster presentations will include more mature data than those included in the following fruquintinib and epitinib study abstracts.  
 
The results of the two studies will be presented in detail at WCLC as follows:
 
Type:
Oral Presentation
 
Title:
A Randomized, Multi-Center, Double-Blind Phase II Study of Fruquintinib in Patients with Advanced Non-Small Cell Lung Cancer
 
Presenter:
Shun Lu
 
Abstract:
#4571
 
Session:
OA11 - Angiogenesis in Advanced Lung Cancer, Oral Session
 
Date & Time:
Tuesday, December 6, 2016 (11:00 AM - 12:30 PM)
 
 
Type:
Poster Presentations
 
Title:
A Phase I Dose Expansion Study of Epitinib to Evaluate Efficacy and Safety in EGFR Mutation Positive (EGFRm+) NSCLC Patients with Brain Metastasis
 
Authors:
Qing Zhou, et al.
 
Abstract:
#4253
 
1st Session:
JCES01 Joint IASLC-Chinese Society for Clinical Oncology /
Chinese Alliance Against Lung Cancer Session (ID 413)
 
Date & Time:
Sunday, December 4, 2016 (10:30 AM - 11:30 AM)
 
2nd Session:
07. Advanced NSCLC
P2.03b - Poster Session with Presenters Present (ID 465)
 
Date & Time:
Tuesday, December 6, 2016 (2:30 PM - 3:45 PM)
 
 
The WCLC presentations will be made available for download at www.chi-med.com/news on the following day.
 
Organized by the International Association for the Study of Lung Cancer (IASLC) and held annually, WCLC is a global, multidisciplinary scientific forum for sharing current knowledge and research progress in lung cancer.  For more information, please visit: wclc2016.iaslc.com.

23 Nov
Panmure Gordon
2,630.00
Buy

5 Dec
Panmure Gordon
2,630.00
Buy

HMPL-523 Pre-clinical Data Presented at ASH
RNS
RNS Number : 0314R
Hutchison China Meditech Limited
06 December 2016
 
Press Release

Chi-Med Presents Pre-clinical Data for Selective Syk Inhibitor HMPL-523 at the 2016 American Society of Hematology Annual Meeting
London: Tuesday, December 6, 2016: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that data from a recent pre-clinical study, investigating the in vitro and in vivo anti-tumor activities of novel Spleen Tyrosine Kinase ("Syk") inhibitor, HMPL-523, was presented at the Annual Meeting of the American Society of Hematology ("ASH"), being held in San Diego, CA, USA from December 3 to December 6, 2016.
 
Syk, a non-receptor type of tyrosine kinase, plays a pivotal role in the regulation of the B-cell receptor (BCR) signaling pathway, which regulates proliferation, differentiation and survival of B lymphocytes.  The abnormal activation of BCR signaling is closely related to transformation and development of B-cell lymphoma.  
 
Presentation Title:
HMPL-523, a Novel Syk Inhibitor, Showed Anti-Tumor Activities in Vitro and in Vivo
 
Authors:
Na Yang, Wei Deng, Qiaoling Sun, Junqing Liang, Linfang Wang, Shiming Fan, Renxiang Tang, Ying Yu, Junen Sun, Feng Zhou, Guangxiu Dai, Weiguo Qing, Weiguo Su and Yongxin Ren
 
Abstract No:
3970
 
Session:
605. Molecular Pharmacology, Drug Resistance-Lymphoid and Other Diseases
 
Date & Time:
Monday, December 5, 2016, 6:00PM - 8:00PM (PST)
 
The presentation is available at www.chi-med.com/wp-content/uploads/2016/12/pre161206_523ash.pdf.
 
Potent anti-tumor activity and combination synergy with other therapies
In vitro in B-cell lymphoma cell lines with Syk/BCR dysregulation, HMPL-523 was found to block phosphorylation of B-cell linker protein as well as inhibit cell viability by inhibiting cell survival and increasing apoptotic rate.  HMPL-523 also showed synergistic anti-tumor activity on human diffused large B-cell lymphoma cells, in combination with other drugs such as Phosphoinositide-3-Kinase δ inhibitors, B-cell lymphoma 2 family inhibitors, or chemotherapies.  Potent anti-tumor activity was also demonstrated in nude mice bearing B-cell lymphoma xenograft tumors with Syk/BCR dysregulation.
 
Clinical development in oncology and immunology
In hematological malignancies, HMPL-523 is currently being studied in a Phase I dose escalation study, which was initiated in Australia in January 2016 and is expected to complete in the first half of 2017.  This study is in patients with relapsed and/or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia for whom there is no standard therapy.
 
HMPL-523 is also being studied in immunological indications.  Clinical data for HMPL-523 in a Phase I dose-escalating study in healthy volunteers in Australia was recently presented at the 2016 Annual Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals, which was held in November 2016.  The detailed poster presentation can be viewed at www.chi-med.com/wp-content/uploads/2016/11/pre1611141.png. The Company plans to initiate a Phase II study in the U.S. in 2017.
 
About the ASH Annual Meeting
The ASH annual meeting, a scientific conference focused on malignant and non-malignant hematology, brings together more than 20,000 hematology professionals from around the world.  The meeting provides an educational experience, with thousands of scientific abstracts highlighting the latest research in the field available for review, as well as the opportunity to network with a global community of professionals from every subspecialty.
 
About B-cell signaling
The BCR signaling pathway regulates proliferation, differentiation and survival of B lymphocytes, a major cellular component of the immune system.  The abnormal activation of BCR signaling is closely related to transformation and development of hematological cancers (i.e. B-cell malignancies) including lymphoma and leukemia, as well as autoimmune diseases, such as rheumatoid arthritis.  Targeted B-cell receptor signaling therapies, including monoclonal antibodies and small molecules, have been proven to be clinically effective for the treatment of B-cell malignancies, leading to scientific and commercial success.
 
Syk is a key protein involved in the B-cell signaling pathway.
 
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products.  Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
 
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
 
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995.  These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of HMPL-523, plans to initiate clinical studies for HMPL-523, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies.  Forward-looking statements involve risks and uncertainties.  Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate HMPL-523 to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of HMPL-523 for a targeted indication and the sufficiency of funding.  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. 
 

david-buiks-share-tips-2017

Director's Share Dealing
RNS
RNS Number : 8020R
Hutchison China Meditech Limited
14 December 2016
 
 
 
 
Director's Share Dealing
 
London: Wednesday, December 14, 2016: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) has received notification that Mr Simon To, Executive Director and Chairman, purchased a total of 52,161 American Depositary Shares of the Company ("ADSs", each representing one half of one ordinary share of US$1.00 each in the capital of Chi-Med ("Ordinary Share")) at an average price of US$14.18 per ADS on December 9, 2016, December 12, 2016 and December 13, 2016. 
 
Following the above purchase of 52,161 ADSs, Mr To is interested in 52,161 ADSs and 180,000 Ordinary Shares (including the holding of 78,000 Ordinary Shares in a family trust of which his family members are the beneficiaries), representing approximately 0.34% of the current issued share capital of Chi-Med.

Director's Share Dealing
RNS
RNS Number : 3267S
Hutchison China Meditech Limited
20 December 2016
 
 
 
 
Director's Share Dealing
 
London: Tuesday, December 20, 2016: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) has received notification that Mr Simon To, Executive Director and Chairman, purchased a total of 17,839 American Depositary Shares of the Company ("ADSs", each representing one half of one ordinary share of US$1.00 each in the capital of Chi-Med ("Ordinary Share")) at an average price of US$14.45 per ADS on December 15, 2016 and December 16, 2016. 
 
Following the above purchase of 17,839 ADSs, Mr To is interested in 70,000 ADSs and 180,000 Ordinary Shares (including the holding of 78,000 Ordinary Shares in a family trust of which his family members are the beneficiaries), representing approximately 0.35% of the current issued share capital of Chi-Med.

Chi-Med Initiates HMPL-523 Clinical Trials
RNS
RNS Number : 7618T
Hutchison China Meditech Limited
10 January 2017
 
Press Release
Chi-Med Initiates HMPL-523 Clinical Trials in Hematological Cancer in China
London: Tuesday, January 10, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that it has initiated a Phase I trial of its novel spleen tyrosine kinase ("Syk") inhibitor, HMPL-523, in patients with hematological malignancies in China.  The first patient was dosed on December 27, 2016.  This study complements the ongoing Phase I trial in patients in Australia with hematological malignancies, which is expected to complete dose-escalation in the first half of 2017.
 
Syk, a non-receptor type of tyrosine kinase, plays a pivotal role in the regulation of the B-cell receptor (BCR) signaling pathway, which regulates proliferation, differentiation and survival of B lymphocytes.  The abnormal activation of BCR signaling is closely related to transformation and development of B-cell lymphoma.  Data from a recent pre-clinical study investigating the in vitro and in vivo anti-tumor activities of HMPL-523 was presented at the annual meeting of the American Society of Hematology held in San Diego, CA on December 5, 2016.  The presentation is available at www.chi-med.com/wp-content/uploads/2016/12/pre161206_523ash.pdf.
 
Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02857998.
 
Clinical development in immunology
HMPL-523 is also being studied in immunological indications.  Clinical data for HMPL-523 in a Phase I dose-escalating study in healthy volunteers in Australia was recently presented at the 2016 annual meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals, which was held in November 2016.  The detailed poster presentation can be viewed at www.chi-med.com/wp-content/uploads/2016/11/pre1611141.png.  The Company plans to initiate proof-of-concept clinical trials in the United States in 2017.
 
About B-cell signaling
The BCR signaling pathway regulates proliferation, differentiation and survival of B lymphocytes, a major cellular component of the immune system.  The abnormal activation of BCR signaling is closely related to transformation and development of hematological cancers (i.e. B-cell malignancies), including lymphoma and leukemia, as well as autoimmune diseases, such as rheumatoid arthritis.  Targeted BCR signaling therapies, including monoclonal antibodies and small molecules, have been proven to be clinically effective for the treatment of B-cell malignancies, leading to scientific and commercial success.
 
Syk is a key protein involved in the BCR signaling pathway.
 
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products.  Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
 
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
 
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995.  These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of HMPL-523, plans to initiate clinical studies for HMPL-523 (including proof-of-concept trials in the United States), its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies.  Forward-looking statements involve risks and uncertainties.  Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate HMPL-523 to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of HMPL-523 for a targeted indication and the sufficiency of funding.  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. 
 

Fruquintinib Combination Study in 1st-Line NSCLC
RNS
RNS Number : 2196U
Hutchison China Meditech Limited
16 January 2017
 
Press Release

Chi-Med Initiates a Phase II Combination Study of Fruquintinib with Iressa® (gefitinib) in First-Line Non-Small Cell Lung Cancer
London: Monday, January 16, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that it has initiated a Phase II study of a combination therapy using fruquintinib and Iressa® in the first-line setting for patients with advanced or metastatic non-small cell lung cancer ("NSCLC") in China.  Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors ("VEGFR"). The first drug dose was administered on January 9, 2017.
 
This Phase II combination therapy study is a multi-center, single-arm, open-label study.  The objectives are to evaluate the safety and tolerability as well as preliminary efficacy of the combination therapy in the first-line setting for advanced or metastatic non-squamous NSCLC patients with epidermal growth factor receptor ("EGFR") activating mutations.  Treatment will be continued until disease progression or intolerable toxicity occurs.  Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02976116.
 
About NSCLC and Tyrosine Kinase Inhibitors ("TKIs") to address EGFR-driven NSCLC
At an advanced stage, tumors secrete large amounts of vascular endothelial growth factors ("VEGF"), which are protein ligandsthat stimulate formation of excessive vasculature (angiogenesis) around the tumor in order to provide greater blood flow, oxygen, and nutrients to the tumor.  VEGF and VEGFR play a pivotal role in tumor-related angiogenesis. Inhibition of the VEGF/VEGFR pathway represents an important therapeutic strategy in blocking the development of new blood vessels essential for tumors to grow and invade.
 
Every year, it is estimated that approximately 1.7 million new patients around the world are diagnosed with NSCLC, according to Frost & Sullivan.  Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-quarter of all cancer deaths (American Cancer Society), and more than breast, prostate and colorectal cancers combined.
 
NSCLC patients with EGFR activating mutations, which are an estimated 10-15% of NSCLC patients in the United States and Europe and 30-40% of NSCLC patients in Asia, are particularly sensitive to treatment with currently available EGFR-TKIs.  However, tumors almost always develop resistance to treatment leading to disease progression.  Combining therapies that inhibit different signaling pathways has the potential to be more effective than inhibition of a single pathway and to overcome tumor resistance.
 
About Fruquintinib
Fruquintinib (HMPL-013) is a highly selective small molecule drug candidate that has been shown to inhibit VEGFR 24 hours a day via an oral dose without known off-target toxicities.  It is currently under the joint development in China by Chi-Med and its partner Eli Lilly and Company.  Two late-stage, pivotal Phase III registration studies are ongoing in colorectal cancer (FRESCO) and lung cancer (FALUCA).  In addition, fruquintinib is also in clinical development for gastric cancer.
 
Colorectal: The FRESCO trial is a randomized, double-blind, placebo-controlled, multi-center, Phase III pivotal trial in patients with locally advanced or metastatic colorectal cancer who have failed at least two prior systemic antineoplastic therapies, including fluoropyrimidine, oxaliplatin and irinotecan.  Enrollment was completed in May 2016.  416 patients were randomized at a 2:1 ratio to receive either: 5 mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus best supportive care ("BSC"); or placebo plus BSC.  The primary endpoint is overall survival ("OS"), with secondary endpoints including progression free survival ("PFS"), objective response rate, disease control rate and duration of response.  Additional details of the FRESCO study may be found at clinicaltrials.gov, using identifier NCT02314819.
 
Lung: The FALUCA trial is a randomized, double-blind, placebo-controlled, multi-center, Phase III registration study targeted at treating patients with advanced non-squamous NSCLC, who have failed two lines of systemic chemotherapy.  Enrollment began in December 2015.  Patients are randomized at a 2:1 ratio to receive either: 5 mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus BSC; or placebo plus BSC . The primary endpoint is OS, with secondary endpoints including PFS, ORR, DCR and duration of response.  Chi-Med plans to enroll approximately 520 patients in about 45 centers across China. Additional details about FALUCA study may be found at clinicaltrials.gov, using identifier NCT02691299.
 
Gastric: Chi-Med completed a Phase Ib dose finding study of fruquintinib in combination with paclitaxel, which established a combination regimen that was well tolerated.  Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02415023.
 
About Iressa®, an EGFR-TKI
Iressa® (gefitinib) is a targeted monotherapy developed by AstraZeneca for the treatment of patients with advanced or metastatic EGFR activating mutation positive NSCLC.  Iressa® acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking the transmission of signals involved in the growth and spread of tumors.  Iressa® is approved in 91 countries worldwide.
 
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products.  Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market.  Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
 
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001).  For more information, please visit: www.chi-med.com.
 
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995.  These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of fruquintinib, plans to initiate clinical studies for fruquintinib, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies.  Forward-looking statements involve risks and uncertainties.  Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate fruquintinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of fruquintinib for a targeted indication and the sufficiency of funding.  In addition, as certain studies rely on the use of Iressa® as a combination therapeutic with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of Iressa®. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM.  Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. 
 

Savolitinib PRCC Results Presentation at ASCO GU
RNS
RNS Number : 8057W
Hutchison China Meditech Limited
14 February 2017
 
Press Release

Chi-Med and AstraZeneca Present Savolitinib Papillary Renal Cell Carcinoma Phase II Results at 2017 Genitourinary Cancers Symposium
London: Tuesday, February 14, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) and AstraZeneca PLC ("AstraZeneca") will present data from the ongoing Phase II clinical trial of savolitinib in patients with papillary renal cell carcinoma ("PRCC") at the 2017 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology ("ASCO-GU"), to be held in Orlando, Florida from February 16 to 18, 2017.  Savolitinib, a highly selective inhibitor of c-Met receptor tyrosine kinase, has shown early clinical benefit in multiple Phase I and II studies in a number of cancers.  It was developed as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with first-generation c-Met inhibitors, including renal toxicity.
 
PRCC, the second most common histologic subtype of renal cell carcinoma ("RCC"), is associated with alterations in the c-Met gene (e.g. mutations, amplifications, and/or chromosomal changes).  Therapies that are currently available for RCC patients have demonstrated only modest benefit in PRCC and there are no therapies specifically approved for the treatment of c-Met-driven PRCC.  National Comprehensive Cancer Network guidelines recommend enrolling patients in clinical trials for first-line systemic therapy.
 
"There is a clear unmet medical need in PRCC," said Toni Choueiri, Director of the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute.  "The dataset from this Phase II study is compelling, with a very clear efficacy signal in MET-driven patients and an encouraging long duration of response, while remaining very well tolerated."  He added, "These results support the initiation of the pivotal Phase III trial in a selected population of MET-driven PRCC.  This innovative patient selection approach would be the first ever molecularly selected trial in renal cell carcinoma."
 
"We are delighted to report this highly encouraging progression-free survival data in Met-driven papillary renal cell carcinoma, a disease with no approved treatment options," said Christian Hogg, Chief Executive Officer of Chi-Med.  "With development of the companion diagnostic assay to screen Met-driven disease now also complete we are preparing for the initiation of our global Phase III study, the first global registration trial for savolitinib."
 
The current Phase II trial is the largest prospective clinical study ever conducted in PRCC patients.  It is a global single arm study of savolitinib in 109 patients with locally advanced or metastatic PRCC and was initiated in May 2014.  It is being conducted in 22 clinical centers in the US, Canada, UK, and Spain, and completed enrollment in October 2015.  Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02127710.  The most recent results of the study will be presented in detail as follows:
 
Presentation Title:
A Single-Arm Biomarker-Based Phase II Trial of Savolitinib in Patients with Advanced Papillary Renal Cell Cancer
 
Authors:
Toni K. Choueiri, Elizabeth Plimack, Hendrik-Tobias Arkenau, Eric Jonasch, Daniel Y. C. Heng, Thomas Powles, Melanie M. Frigault, Edwin Clark, Amir Handzel, Humphrey Gardner, Shethah Morgan, Laurence Albiges, Sumanta Kumar Pal
 
Abstract No:
436
 
Session:
Session C: Penile, Urethral, and Testicular Cancers; Renal Cell Cancer
 
Date & Time:
Saturday, February 18, 2017, 7:00 AM-7:55 AM and 11:30 AM-1:00 PM (EST)
 
Once presented, the presentation will be available at www.chi-med.com/news.  Further information about ASCO-GU is available at gucasym.org.
 
Chi-Med and AstraZeneca are currently initiating a global pivotal Phase III trial, the first pivotal study ever conducted in c-Met-driven PRCC and the first molecularly selected trial in RCC. 
 
Over the course of 2017, Chi-Med and AstraZeneca are also conducting a comprehensive molecular epidemiology study of approximately 300 PRCC patient samples to further understand the correlations between c-Met alterations and patient outcomes, including any predictive biomarkers.
 
ABSTRACT
A single-arm biomarker-based phase II trial of savolitinib in patients with advanced papillary renal cell cancer (PRCC)
Toni K. Choueiri1, Elizabeth Plimack2, Hendrik-Tobias Arkenau3, Eric Jonasch4, Daniel Y. C. Heng5, Thomas Powles6, Melanie M. Frigault7, Edwin Clark7, Amir Handzel7, Humphrey Gardner7, Shethah Morgan8, Laurence Albiges9, Sumanta Kumar Pal10
 
1Dana-Farber Cancer Institute, Boston, US 2Fox Chase Cancer Center, Philadelphia, US 3Sarah Cannon Research Institute, London, UK 4MD Anderson Cancer Centre, Houston, US 5Tom Baker Cancer Center, Calgary, Canada  6Barts Cancer Institute, London, UK  7AstraZeneca, Waltham, US, 8AstraZeneca, Cambridge, UK 9Institute Gustave Roussy, Paris, France 10City of Hope, Duarte, US
 
Background: Savolitinib (HMPL-504/Volitinib, AZD6094) is a potent, selective mesenchymal epithelial transition ("MET") inhibitor (IC50 of 4 nM).  MET and its ligand, hepatocyte growth factor ("HGF"), are known to play an important role in the molecular events underlying oncogenesis in PRCC, a disease without a clear standard of care and marked by alterations of chromosome 7 (containing both MET and HGF genes) in a majority of patients as well as gene amplification or MET kinase domain mutations (Albiges et al 2014, Linehan et al, 2015). 
 
Methods: This study evaluates savolitinib in PRCC patients dosed at 600 mg daily until disease progression.  Objective Response Rate ("ORR") is the primary endpoint.  Progression-Free Survival ("PFS") & Duration of Response are secondary endpoints.  Patient Reported Outcome ("PRO") and Health-Related Quality of Life ("HRQoL") questionnaires are exploratory endpoints.  Eligibility includes naïve and previously treated metastatic PRCC, ECOG PS 0 or 1.  Archival tumor was used to centrally confirm PRCC pathology post hoc and to determine MET status using Next Generation Sequencing (Foundation Medicine Inc, US). 
 
Results: As of 27 June 2016, 109 patients were dosed.  Best response was PR n=8, SD n=43, PD n=48 & 10 patients were not evaluable for response.  44 patients are MET-driven (MET/HGF gene copy number gain or kinase domain mutations), 46 patients were MET-negative, 19 patients are status unknown.  MET-driven pts included Papillary Type I & II histologies.  All 8 responders were in the MET-driven group, 18% ORR in this subset.  Median PFS in the MET-driven group was 6.2 months (95% CI: 4.1-7.0) vs.  1.4 months (95% CI: 1.4-2.7) in the MET-negative group (p=0.002).  Overall 10/109 patients had adverse events ("AEs") leading to discontinuation.  23/109 patients had ≥ Grade 3 toxicity related to savolitinib.  The most common AEs (all grades) includes: nausea (39%), fatigue (27%), edema (18%) and abnormal liver function tests (LFTs) (17%).  One death from hepatic encephalopathy was considered related to savolitinib.  PRO & HRQoL data was not statistically analyzed, descriptive data support main efficacy findings. 
 
Conclusions:  In the largest biomarker-profiled trial dedicated to PRCC, savolitinib was generally well tolerated with anti-tumor activity in MET-driven patients.  These findings warrant further clinical investigation of savolitinib in MET-driven PRCC.
 
About the Unmet Medical Need in c-Met-Driven PRCC Patients
Worldwide, about 366,000 new patients are diagnosed with kidney cancer annually, and the total market for kidney cancer treatments is expected to reach US$4.5 billion in 2020, according to Frost & Sullivan.  RCC accounts for approximately 80-85% of kidney cancer and has several histological sub-types with different genetic and biochemical characteristics.  Among these histologic variants of RCC, clear cell RCC ("ccRCC") is the most common, accounting for 75-80% of RCC. 
 
PRCC is the most common of the non-clear cell renal carcinomas accounting for 10-15% of RCC.  The proportion of PRCC patients whose tumors are c-Met-driven has historically been estimated at 40-70%.  In the largest study to date, presented at the annual meeting of the American Association for Cancer Research 2014, analysis of 220 frozen tumor samples catalogued in the French RCC Network indicated that 55-60% of PRCC patients showed gains in Chromosome 7 (i.e.  c-Met amplification).
 
The biology and molecular characteristics of PRCC are different from those of ccRCC.  This results in significantly worse prognosis and treatment outcomes for patients with PRCC when compared to patients with ccRCC.  Highlighting the unmet need is the fact that, although there are several drugs approved for use in RCC (the latest being approved in April 2016), these approvals were generally on the basis of studies conducted with a preponderance of ccRCC patients.  The need for different agents and more specific data tailored to the PRCC disease setting has been identified as a critical gap in the care of these patients.
 
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare-related consumer products.  Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market.  Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
 
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001).  For more information, please visit: www.chi-med.com.
 
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future.  With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca's six Growth Platforms focused on lung, ovarian, breast and blood cancers.  In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology.
 
By harnessing the power of four scientific platforms - Immuno-Oncology, the genetic drivers of cancer and resistance, DNA Damage Response and Antibody Drug Conjugates - and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
 
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory.  The Company also is selectively active in the areas of autoimmunity, neuroscience and infection.  AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.  For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.
 
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the US Private Securities Litigation Reform Act of 1995.  These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of savolitinib, plans to initiate clinical studies for savolitinib in PRCC, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies.  Forward-looking statements involve risks and uncertainties.  Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate savolitinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of savolitinib for a targeted indication and the sufficiency of funding.  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  For further discussion of these and other risks, see Chi-Med's filings with the US Securities and Exchange Commission and on AIM.  Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. 

Positive Fruquintinib Pivotal Phase III Results
RNS
RNS Number : 4422Y
Hutchison China Meditech Limited
03 March 2017
 
Chi-Med Announces Positive Top-Line Results for FRESCO, its Phase III Pivotal Registration Trial of Fruquintinib in Patients with Locally Advanced or Metastatic Colorectal Cancer
 
- Trial met all primary and secondary endpoints -
- Safety as expected -
- Progressing to China NDA submission mid-2017 -
- Full data to be reported at an upcoming scientific meeting in mid-2017 -
London: Friday, March 3, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces top-line results from FRESCO, its Phase III pivotal registration trial of fruquintinib in 416 patients with locally advanced or metastatic colorectal cancer ("CRC") in China, who failed at least two prior chemotherapies, including fluoropyrimidine, oxaliplatin and irinotecan.  The trial met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in overall survival ("OS"), in the intention-to-treat (ITT) population of patients treated with fruquintinib plus best supportive care ("BSC") as compared to patients treated with placebo plus BSC.  Chi-Med is currently preparing to submit a new drug application ("NDA") for fruquintinib to the China Food and Drug Administration.
 
In addition to OS, a statistically significant improvement in progression-free survival ("PFS"), a key secondary endpoint, was observed.  The adverse events demonstrated in FRESCO did not identify any new or unexpected safety issues.  Full detailed results are subject to ongoing analysis and are expected to be disclosed at an upcoming scientific meeting in mid-2017.
 
Simon To, Chairman of Chi-Med, said, "Well over a decade of effort and investment has now paid-off with these compelling Phase III top-line results.  They reinforce fruquintinib's potential to address major unmet clinical needs for patients in both China and around the world.  They also open the way to our submitting a NDA on fruquintinib around the middle of this year."
 
"The success of the FRESCO trial is an important milestone not just for CRC patients and Chi-Med, but also for Chinese innovation," he added.  "We believe this is one of the first home-grown, China-discovered and developed, mainstream innovation in the field of oncology to succeed in a pivotal Phase III registration trial.  It shows that China has the resources, capability and perseverance to emerge as an innovator in the global oncology field.  With eight small molecule drug candidates in over 30 clinical studies worldwide, Chi-Med is at the forefront of this important evolution."  
 
"We are pleased to be working with the innovative biopharmaceutical company, Chi-Med, on the development of fruquintinib," said Kerry L. Blanchard, Senior Vice President of China Medicines Development Unit and External Innovation of Eli Lilly and Company ("Lilly") China Drug Development.  "This relationship highlights our commitment to help build a vibrant innovation ecosystem in China, and we look forward to our further collaboration to bring this novel medicine to patients."
 
In addition to the FRESCO colorectal cancer trial, fruquintinib is being studied in China in a Phase III pivotal trial in non-small cell lung cancer ("NSCLC"), known as FALUCA; and a Phase II study using fruquintinib combined with Iressa® (gefitinib) in the first-line setting for patients with advanced or metastatic NSCLC.  Other studies currently being planned, and soon to be initiated, include a Phase III study in gastric cancer in combination with paclitaxel in China, new studies in the U.S., and certain exploratory studies in combination with other oncology agents.
 
About VEGF and Fruquintinib
At an advanced stage, tumors secrete large amounts of vascular endothelial growth factors ("VEGF"), a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor to provide greater blood flow, oxygen, and nutrients to the tumor.  VEGF and VEGF receptors ("VEGFR") play a pivotal role in tumor-related angiogenesis, and the inhibition of the VEGF/VEGFR pathway.  This represents an important therapeutic strategy in blocking the development of new blood vessels essential for tumors to grow and invade.
 
Fruquintinib (HMPL-013) is a highly selective small molecule drug candidate that has been shown to inhibit VEGFR 24 hours a day via an oral dose.  It is currently under the joint development in China by Chi-Med and its partner Lilly.  Two clinical studies are ongoing in lung cancer, including a late stage, pivotal Phase III registration study (FALUCA).  In addition, fruquintinib is also in clinical development for the treatment of gastric cancer.
 
About FRESCO and Colorectal Cancer
The FRESCO trial is a randomized, double-blind, placebo-controlled, multicenter, Phase III pivotal trial in patients with locally advanced or metastatic CRC who have failed at least two prior systemic antineoplastic therapies, including fluoropyrimidine, oxaliplatin and irinotecan.  No drugs have been approved in third-line CRC in China, with BSC being the general standard of care.  Enrollment was completed in May 2016.  416 patients were randomized at a 2:1 ratio to receive either: 5mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus BSC; or placebo plus BSC.  The primary endpoint is OS, with secondary endpoints including PFS, objective response rate ("ORR"), disease control rate ("DCR") and duration of response ("DoR").  Additional details of the FRESCO study may be found at clinicaltrials.gov, using identifier NCT02314819.  Full results from the FRESCO study are planned to be published at a scientific event in mid-2017.
 
CRC is the second most common cancer type in China, with about 380,000 new cases per year, according to CA Cancer Journal for Clinicians 2016.  There were approximately 1.5 million new CRC cases globally in 2015 which are expected to increase to approximately 1.7 million new cases per year by 2020, according to Frost & Sullivan.
 
About Fruquintinib in Lung and Gastric Cancer
Lung: The FALUCA trial is a randomized, double-blind, placebo-controlled, multi-center, Phase III registration study targeted at treating patients with advanced non-squamous NSCLC, who have failed two lines of systemic chemotherapy.  Enrollment began in December 2015.  Patients are randomized at a 2:1 ratio to receive either: 5mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus BSC; or placebo plus BSC.  The primary endpoint is OS, with secondary endpoints including PFS, ORR, DCR and DoR.  Chi-Med plans to enroll approximately 520 patients in about 45 centers across China.  Additional details about this study can be found at clinicaltrials.gov, using identifier NCT02691299.  Topline results from the FALUCA study are expected to be released in early 2018. 
 
In January 2017 Chi-Med initiated a multi-center, single-arm, open-label Phase II study of a combination therapy using fruquintinib and Iressa® (gefitinib) in the first-line setting for patients with advanced or metastatic NSCLC.  The objectives are to evaluate the safety and tolerability as well as preliminary efficacy of the combination therapy in the first-line setting for advanced or metastatic non-squamous NSCLC patients with epidermal growth factor receptor (EGFR) activating mutations.  Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02976116.
 
Gastric: Chi-Med completed a Phase I/II dose finding study of fruquintinib in combination with paclitaxel, which established a combination regimen that was well tolerated.  Results of this study were published at the 2017 Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology in January 2017.  Additional details about this study can be found at clinicaltrials.gov, using identifier NCT02415023.  A pivotal Phase III registration study is expected to start during the first half of 2017.
 
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products.  Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
 
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001).  For more information, please visit: www.chi-med.com.
 
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995.  These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of fruquintinib, plans to initiate clinical studies for fruquintinib, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies.  Forward-looking statements involve risks and uncertainties.  Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate fruquintinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of fruquintinib for a targeted indication and the sufficiency of funding.  In addition, as certain studies rely on the use of Iressa® (gefitinib) as a combination therapeutic with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of Iressa® (gefitinib).  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM.  Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.  

Sulfatinib Phase Ib/II Results Presented at ENETS
RNS
RNS Number : 1145Z
Hutchison China Meditech Limited
10 March 2017
 
Press Release

Chi-Med Presented Sulfatinib Neuroendocrine Tumors Phase Ib/II Results at the 14th Annual Conference of European Neuroendocrine Tumor Society
London: Friday, March 10, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) presented data from the ongoing Phase Ib/II clinical trial of sulfatinib in patients with advanced neuroendocrine tumors ("NET") at the 14th Annual Conference of European Neuroendocrine Tumor Society ("ENETS"), held in Barcelona, Spain from March 8 to 10, 2017.  Sulfatinib is an oral, novel angio-immunokinase inhibitor that selectively targets vascular endothelial growth factor receptor ("VEGFR"), fibroblast growth factor receptor ("FGFR") and colony-stimulating factor-1 receptor ("CSF-1R"), three key tyrosine kinase receptors involved in tumor angiogenesis and immune evasion.  Five other sulfatinib clinical trials are underway in China and the US, including two Phase III studies in NET patients (SANET-p and SANET-ep), one Phase II study in thyroid cancer patients and one Phase II study in biliary tract cancer patients.
 
The most recent results of the study were presented in detail as follows:
 
Presentation Type:
Oral Presentation, Presidential Abstract - Plenary Meeting Room
 
Title:
An Open-Label Phase Ib/II Study of Sulfatinib in Patients with Advanced Neuroendocrine Tumors (NCT02267967)
 
Presented by:
Dr. JianMing Xu
 
Session:
Session 2B: Medical Therapies and Goals
 
Date & Time:
Thursday, March 9, 2017, 11:10 AM CET
 
 
Presentation summary
The current Phase Ib/II trial is an open-label, single-arm Phase II study to assess the efficacy and safety of sulfatinib monotherapy in patients with advanced grade 1 or 2 advanced NET.  81 patients (41 pancreatic NET and 40 extra-pancreatic NET) were enrolled between November 2014 and January 2016, in seven clinical centers across China.  The majority of patients had grade 2 disease (79%) and had failed previous systemic treatments (65%).  As of January 20, 2017, 13 patients had confirmed partial response ("PR") and 61 patients had stable disease ("SD") corresponding to an overall objective response rate ("ORR") of 16.0% (13/81), with 17.1% (7/41) in pancreatic NET and 15.0% (6/40) in extra-pancreatic NET, and an overall disease control rate ("DCR") of 91.4%.  Median overall progression-free survival ("PFS") has not been reached, but is estimated to be 16.6 months (95% CI: 13.4, 19.4) with longer median PFS in pancreatic NET estimated at 19.4 months and shorter median PFS in extra-pancreatic NET estimated at 13.4 months.  Importantly, there were 12 patients who had progressed after treatment with targeted therapies (e.g. Sutent® and Afinitor®) and all benefited from sulfatinib treatment (3 PRs and 9 SDs).  Sulfatinib was well tolerated with Grade ≥3 adverse events (AEs) with >5% incidence, regardless of causality, of hypertension (31%), proteinuria (14%), hyperuricemia (10%), hypertriglyceridemia (9%), diarrhea (7%) and ALT increase (6%).  Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02267967. 
 
Based on the promising Phase I and Phase II efficacy data and tolerability in patients with advanced NETs, two randomized Phase III trials are ongoing.
 
The presentation is available at www.chi-med.com/news/.  Further information about ENETS is available at enetsconference.org.

Final results

Hutchison China MediTech Ltd (HCM:LSE) set a new 52-week high during Tuesday's trading session when it reached 2,642.80. Over this period, the share price is up 19.03%.

Grant of Awards under Long Term Incentive Plan
RNS
RNS Number : 6898Z
Hutchison China Meditech Limited
16 March 2017
 
 
Press release
 
Grant of Awards under Long Term Incentive Plan
 
London: Thursday, March 16, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) announces that on March 15, 2017, it granted conditional awards ("LTIP Awards") under the Long Term Incentive Plan ("LTIP") adopted by Chi-Med at its Annual General Meeting on April 24, 2015.
 
The LTIP Awards grant participating directors, persons discharging managerial responsibilities ("PDMRs") or employees a conditional right to a cash amount which is used to purchase shares in Chi-Med ("Shares"), on-market by an independent third party trustee ("Trustee").
 
Two different types of LTIP Awards have been granted, namely:
 
1. Performance-related LTIP Award for the Chi-Med Financial Years 2017-2019 ("2017-2019 LTIP") - award based on a maximum cash amount, which amount is determined by the achievement of annual performance targets for each of the financial years 2017 to 2019.  The annual performance targets will be determined by the Remuneration Committee of Chi-Med based on the strategic objectives of Chi-Med. The Shares, to be purchased by the Trustee following determination of the cash amount based on actual achievement of each annual performance target, will then be held by the Trustee until the underlying LTIP Awards are vested.  Vesting will occur two business days after the date of announcement of the annual results of Chi-Med for the financial year falling two years after the financial year to which the LTIP Award relates.  Vesting will also depend upon the continued employment of the award holder with the Chi-Med group and will otherwise be at the discretion of the Board of Directors of Chi-Med. The LTIP Awards will cover a three-year period from 2017 to 2019.
 
Chi-Med has granted the following LTIP Awards for the 2017-2019 LTIP to the following PDMRs:
 
Award Holder

Maximum amount per annum for the 2017-2019 LTIP



Mr Christian Hogg (Executive Director and Chief Executive Officer)

US$523,615
Mr Johnny Cheng (Executive Director and Chief Financial Officer)

US$204,808
Dr Weiguo Su (Executive Vice President and Chief Scientific Officer)

US$366,255
 
An additional 86 senior managers and executives employed by Chi-Med and its subsidiaries have simultaneously been granted LTIP Awards under the 2017-2019 LTIP.
 
2. Non-performance LTIP Award ("Non-performance LTIP") - a one-off cash amount will be allocated to each grantee and used by the Trustee to purchase Shares which will be subject to a vesting period of one year. Chi-Med has granted the following LTIP Awards for the Non-performance LTIP to the following PDMRs:
 
Award Holder

Cash Amount for Non-performance LTIP



Mr Christian Hogg (Executive Director and Chief Executive Officer)

US$82,346
Mr Johnny Cheng (Executive Director and Chief Financial Officer)

US$25,405
 
Dr Weiguo Su (Executive Vice President and Chief Scientific Officer)

US$30,077
 
An additional 28 senior managers and executives employed by Chi-Med and its subsidiaries have simultaneously been granted LTIP Awards under the Non-performance LTIP.
 
Further announcements will be made in due course at the time the LTIP Awards are vested, when the number of the Shares to which each Executive Director and PDMR is entitled under such LTIP Awards will be known.
 
About Chi-Med
 
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products.  Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market.  Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
 
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001).  For more information, please visit: www.chi-med.com.
 
Forward Looking Statement
 
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995.  Forward-looking statements involve risks and uncertainties.  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM.  Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Directors' Share Dealing
RNS
RNS Number : 9126Z
Hutchison China Meditech Limited
20 March 2017
 
 
 
 
Directors' Share Dealing
 
London: Monday, March 20, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) has received notifications that:-
 
1.   Mr Paul Carter, Independent Non-executive Director, purchased a total of 2,800 ordinary shares of US$1.00 each in the capital of Chi-Med ("Ordinary Shares") at a price of GBP26.37 per share on March 15, 2017;
 
2.   Dr Dan Eldar, Non-executive Director, purchased a total of 6,225 American Depositary Shares of the Company ("ADSs", each representing one half of one Ordinary Share) at an average price of US$16.85 per ADS on March 15, 2017;
 
3.   Dr Karen Ferrante, Independent Non-executive Director, purchased a total of 2,540 ADSs at an average price of US$19.77 per ADS on March 16, 2017; and
 
4.   Ms Edith Shih, Non-executive Director and Company Secretary, purchased a total of 10,000 ADSs at an average price of US$19.10 per ADS on March 16, 2017.
 
Following the above purchases, Mr Carter is interested in 2,800 Ordinary Shares, representing approximately 0.005% of the current issued share capital of Chi-Med; Dr Eldar is interested in 6,225 ADSs, representing approximately 0.005% of the current issued share capital of Chi-Med; Dr Ferrante is interested in 2,540 ADSs, representing approximately 0.002% of the current issued share capital of Chi-Med; and Ms Shih is interested in                50,741 ADSs and 60,000 Ordinary Shares, representing approximately 0.14% of the current issued share capital of Chi-Med.

2016 Annual Report and Notice of AGM
RNS
RNS Number : 5450A
Hutchison China Meditech Limited
27 March 2017
 
 
2016 Annual Report and
Notice of Annual General Meeting
 
London: Monday, March 27, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that its 2016 Annual Report together with the Notice of Annual General Meeting and the Form of Proxy have been posted to shareholders.  The documents can be accessed from the website of Chi-Med (www.chi-med.com).
 
 
About Chi-Med
 
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products.  Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market.  Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
 
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001).  For more information, please visit: www.chi-med.com.

Chi-Med Presents Clinical Data at ASCO 2017
RNS
RNS Number : 5131F
Hutchison China Meditech Limited
18 May 2017
 
Press Release
 
Chi-Med Presents Clinical Data at ASCO 2017 Annual Meeting
- FRESCO Phase III trial results for fruquintinib in colorectal cancer in an oral presentation -
 
- Five abstracts in total accepted for fruquintinib, savolitinib and sulfatinib -
 
London: Thursday, May 18, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that new clinical data on three of its novel tyrosine kinase inhibitors, fruquintinib, savolitinib and sulfatinib, will be presented at the 2017 American Society of Clinical Oncology ("ASCO") Annual Meeting, to be held in Chicago, Illinois from June 2 to 6, 2017.  
 
The five presentations, one oral presentation and four poster presentations, cover the following studies: 
 
Fruquintinib: 
·    The full results of the FRESCO Phase III study in 416 patients with locally advanced or metastatic colorectal cancer ("CRC") will be highlighted in an oral presentation on June 5, 2017.  Primary endpoint median overall survival was 9.30 months for fruquintinib versus 6.57 months in the control group, with a hazard ratio of 0.65 and p< 0.001.  Fruquintinib was well tolerated, with manageable on-target treatment related adverse events consistent with previous studies.  
 
Savolitinib:
·    c-MET amplification ("amp") is a major acquired resistance ("AR") pathway to Tagrisso® (osimertinib). AstraZeneca PLC ("AstraZeneca") will highlight an analysis of 23 EGFR-mutant non-small-cell lung cancer ("NSCLC") patients with AR to Tagrisso®.  Analysis shows that about 30% (7/23 patients) of AR is c-MET amp and that among the 7 patients with c-MET amp, 3 patients received combination Tagrisso®/savolitinib therapy; all 3 had partial response ("PR") under RECIST (Response Evaluation Criteria in Solid Tumors) guidelines.  
 
·    Savolitinib included in PAPMET Phase II study (sponsored by NIH/NCI) of multiple c-MET and vascular endothelial growth factor receptor ("VEGFR") tyrosine kinase inhibitors in metastatic papillary renal cell carcinoma patients.  PAPMET will evaluate four therapies in a 1:1:1:1 randomization, sunitinib, cabozantinib, crizotinib and savolitinib in an about 275-patient study which began in 2016 and as at January 30, 2017 had registered 26 patients.  PAPMET will study efficacy, safety and correlation of clinical outcome with tumor molecular driver alterations such as c-MET.  
 
·    Update on the VIKTORY trial, a biomarker-based umbrella trial in gastric cancer.  From June 2014 to January 2017, a total of 432 metastatic gastric cancer patients were enrolled in VIKTORY, a total of 23 patients (5.3%) were guided into savolitinib monotherapy treatment (4/23 patients) or savolitinib/docetaxel combination therapy (19/23) based on molecular screening outcomes.  
 
Sulfatinib:  
·    Preliminary results of a Phase II study in advanced medullary thyroid cancer ("MTC") and radioiodine ("RAI")-refractory differentiated thyroid cancer ("DTC").  Sulfatinib is an oral, novel angio-immuno kinase inhibitor that selectively targets VEGFR, fibroblast growth factor receptor-1 ("FGFR") and colony-stimulating factor-1 receptor ("CSF-1R").  As at December 31, 2016 a total of 18 patients had been enrolled with 1/6 MTC patients and 3/12 RAI-DTC patients reporting confirmed PRs, and all other patients stable disease, under RECIST.  
 
 

12:30 18/05/2017
Broker Forecast - Panmure Gordon issues a broker note on Hutchison China Meditech Ltd
Panmure Gordon today reaffirms its buy investment rating on Hutchison China Meditech Ltd (LON:HCM) and raised its price target to 3530p (from 2900p). Story provided by StockMarketWire.com

Fruquintinib NDA for Advanced CRC Filed with CFDA
RNS
RNS Number : 7715H
Hutchison China Meditech Limited
12 June 2017
 
Chi-Med Submits New Drug Application to CFDA for Fruquintinib in Advanced Colorectal Cancer
- Application accepted by CFDA for technical review by the Center for Drug Evaluation -
 
- Triggers RMB30.8 million milestone payment from Eli Lilly and Company ("Lilly") -
 
London: Monday, June 12, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that the China Food and Drug Administration ("CFDA") has acknowledged acceptance of the New Drug Application ("NDA") for fruquintinib for the treatment of patients with advanced colorectal cancer, which triggers a milestone payment of RMB30.8 million (US$4.5 million) from Lilly to Chi-Med.  The NDA is supported by data from the successful FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with locally advanced or metastatic colorectal cancer ("CRC") in China, which was highlighted in an oral presentation at the American Society of Clinical Oncology Annual Meeting on June 5, 2017.
 
About CRC
CRC is the second most common cancer type in China, with about 380,000 new cases per year, according to National Central Cancer Registry of China.  There were approximately 1.5 million new CRC cases globally in 2015 which are expected to increase to approximately 1.7 million new cases per year by 2020, according to Frost & Sullivan.
 
About Fruquintinib
Fruquintinib is a highly selective small molecule drug candidate that has been shown to inhibit vascular endothelial growth factor receptor ("VEGFR") 24 hours a day via an oral dose, with lower off-target toxicities compared to other targeted therapies.  Its tolerability, along with its clean drug-drug interaction profile demonstrated to date, may enable rational combination with other cancer therapies such as in our ongoing clinical trials of fruquintinib in combination with chemotherapy and targeted therapy.
 
At an advanced stage, tumors secrete large amounts of VEGF, a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor to provide greater blood flow, oxygen, and nutrients to the tumor.  VEGF and VEGFR play pivotal roles in tumor-related angiogenesis, and fruquintinib inhibits the VEGF/VEGFR pathway.  This represents an important therapeutic strategy in blocking the development of new blood vessels essential for tumors to grow and invade.
 
Fruquintinib is currently under joint development in China by Chi-Med and its partner Lilly.  Chi-Med and Lilly jointly announced top-line results from the FRESCO CRC trial on March 3, 2017.  In addition, fruquintinib is being studied in China in a Phase III pivotal trial in non-small cell lung cancer ("NSCLC"), known as FALUCA; and a Phase II study using fruquintinib combined with Iressa® (gefitinib) in the first-line setting for patients with advanced or metastatic NSCLC.  Other studies currently being planned, and soon to be initiated, include a Phase III study in gastric cancer in combination with paclitaxel in China, new studies in the United States, and certain exploratory studies in combination with other oncology agents.
 
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products.  Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market.  Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
 
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001).  For more information, please visit: www.chi-med.com.
 
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995.  These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of fruquintinib, plans to initiate clinical studies for fruquintinib, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies.  Forward-looking statements involve risks and uncertainties.  Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate fruquintinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of fruquintinib for a targeted indication and the sufficiency of funding.  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM.  Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.  
 

Director share dealing

Chi-Med starts clinical trial in China
StockMarketWire.com
Hutchison China MediTech has initiated a phase I/II clinical trial of HMPL‑453 in China.

Chi-Med said HMPL‑453 was a novel, highly selective and potent small molecule inhibitor targeting fibroblast growth factor receptor and the first drug dose was administered on 19 June.

It said this study would complement the first-in-human phase I clinical trial in Australia that was initiated earlier this year.



At 9:22am: (LON:HCM) Hutchison China Meditech Ltd share price was 0p at 3600p


Story provided by StockMarketWire.com

Start of Savolitinib Global PRCC Phase III Trial
RNS
RNS Number : 5372J
Hutchison China Meditech Limited
29 June 2017
 
 
Chi-Med and AstraZeneca Initiate SAVOIR, a Global Phase III Trial of Savolitinib in Papillary Renal Cell Carcinoma
London: Thursday, June 29, 2017: Chi-Med and AstraZeneca today announce that they have initiated a global pivotal Phase III, open-label, randomized multi-center registration study of the highly selective inhibitor of c-MET receptor tyrosine kinase, savolitinib, in c-MET-driven papillary renal cell carcinoma ("PRCC").  This is the first pivotal study ever conducted in c-MET-driven PRCC and the first molecularly selected trial in renal cell carcinoma ("RCC").  
 
"The launch of the SAVOIR trial, designed to support product registration in the U.S. and Europe, continues to advance our strategy to deliver innovative medicines to major markets worldwide," said Christian Hogg, Chief Executive Officer of Chi-Med.  "Based on the results of our Phase II study, we believe savolitinib has the potential to bring meaningful clinical benefit to patients with c-MET-driven PRCC.  We also expect to further understand the correlations between c-MET alterations and patient outcomes through epidemiological analyses using our newly developed companion diagnostic assay."
 
Susan Galbraith, SVP IMED Oncology, AstraZeneca commented that "It is exciting to achieve this milestone in savolitinib's development.  The data building across our early development studies are encouraging, that savolitinib has the potential to be an important treatment option for c-MET driven cancers including kidney, lung and gastric cancers."
 
The initiation of this Phase III trial has triggered a US$5 million milestone payment to Hutchison MediPharma Limited (a 99.8% subsidiary of Chi-Med) from AstraZeneca under the terms of the license and collaboration agreement signed between them in 2011 (as amended).  
 
In addition to SAVOIR, Chi-Med and AstraZeneca are conducting a number of Phase Ib and II studies of savolitinib in kidney cancer, lung cancer and gastric cancer.  These studies involve savolitinib as a monotherapy or in combination with other targeted therapy, such as Tagrisso® (osimertinib) or Iressa® (gefitinib). Additional studies combining with Imfinzi® (durvalumab) and Taxotere® (docetaxel) are also in progress.
 
About SAVOIR
SAVOIR is a global Phase III, open-label, randomized, controlled trial evaluating the efficacy and safety of savolitinib, compared with sunitinib, in patients with c-MET-driven, unresectable, locally advanced or metastatic PRCC.  Approximately 180 patients will be randomized at 50 to 75 sites across five to ten countries.  c-MET status is confirmed by the novel targeted next-generation sequencing (NGS) assay developed for savolitinib.  Patients will be randomized in a 1:1 ratio to receive either continuous treatment with savolitinib 600 mg (400 mg if <50 kg) orally, once daily, or intermittent treatment with sunitinib 50 mg orally once daily (4 weeks on/2 weeks off), on a 6-week cycle.  
 
The primary objective is to evaluate the primary efficacy endpoint progression free survival ("PFS") of savolitinib as compared with sunitinib.  Secondary endpoints include overall survival, objective response rate ("ORR"), duration of response, best percentage change in tumor size, disease control rate, and safety and tolerability. The impact of savolitinib compared with sunitinib on disease symptoms and quality of life, along with the pharmacokinetics of savolitinib will also be assessed.  Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03091192.
 
About Savolitinib
Savolitinib (AZD6094/HMPL-504) is a potential first-in-class selective inhibitor of c-MET (also known as mesenchymal epithelial transition factor) receptor tyrosine kinase, an enzyme which has been shown to function abnormally in many types of solid tumors.  It was developed as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with other selective c-MET inhibitors, such as renal toxicity.
 
Savolitinib was discovered by Chi-Med and is being developed in collaboration with AstraZeneca.  Savolitinib is currently being studied in multiple tumor types worldwide including kidney, lung and gastric cancers, both as a monotherapy or in combination with other targeted and immunotherapy agents. 
 
About c-MET-Driven PRCC
Worldwide, about 366,000 new patients are diagnosed with kidney cancer annually.  RCC accounts for approximately 80-85% of kidney cancer and has several histological sub-types with different genetic and biochemical characteristics.  PRCC is the most common of the non-clear cell renal carcinomas accounting for 10-15% of RCC.  However, the biology and molecular characteristics of PRCC are different from those of clear cell RCC ("ccRCC").  Multiple studies indicate that PRCC is c-MET-driven in 40-70% of patients.
 
There are no therapies approved for patients with PRCC, who currently receive treatments approved for RCC such as sunitinib.  These RCC agents were mostly approved on the basis of studies where the majority of subjects were ccRCC patients and where the benefits to the PRCC minority were more modest.  Currently the National Comprehensive Cancer Network Guidelines advise PRCC patients to enter clinical trials.  
 
About Savolitinib in PRCC
In February 2017, the results of a global Phase II multicenter study in advanced PRCC was presented at the 2017 American Society of Clinical Oncology Genitourinary Cancers Symposium, which indicated a clear efficacy signal with savolitinib monotherapy in c-MET-driven patients.  Median PFS of 6.2 months in c-MET-driven patients as compared with 1.4 months (p<0.0001) in c-MET-independent patients.  ORR was 18.2% in c-MET-driven patients vs. 0% (p=0.002) in c-MET independent patients.  An encouraging durable response and safety profile were reported in savolitinib treated patients.  Further details are available at www.chi-med.com/asco-gu-2017-savolitinib-ph2-in-prcc-pres/.
 
Studies of c-MET-driven disease in gastric cancer and lung cancer suggest that c-MET amplification and/or overexpression can be a negative prognostic for disease progression.  Over the course of 2017, Chi-Med and AstraZeneca are also conducting a comprehensive molecular epidemiology study of approximately 300 PRCC patient samples to further understand the correlations between c-MET alterations and patient outcomes, including any predictive biomarkers.
 
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products.  Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market.  Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
 
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001).  For more information, please visit: www.chi-med.com.
 
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future.  With at least 6 new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance new oncology as one of AstraZeneca's six Growth Platforms focused on lung, ovarian, breast and blood cancers.  In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology.
 
By harnessing the power of four scientific platforms - immuno-oncology, the genetic drivers of cancer and resistance, DNA damage response and antibody drug conjugates - and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
 
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - oncology, cardiovascular & metabolic diseases and respiratory.  The Company also is selectively active in the areas of autoimmunity, neuroscience and infection.  AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.  For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.
 
 
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S.  Private Securities Litigation Reform Act of 1995.  These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of savolitinib, plans to initiate clinical studies for savolitinib, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies.  Forward-looking statements involve risks and uncertainties.  Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate savolitinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of savolitinib for a targeted indication and the sufficiency of funding.  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  For further discussion of these and other risks, see Chi-Med's filings with the U.S.  Securities and Exchange Commission and on AIM.  Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise. 

Chi-Med Reports 2017 Interim Results
RNS
RNS Number : 5072M
Hutchison China Meditech Limited
31 July 2017
 
 
Chi-Med Reports 2017 Interim Results and Updates Shareholders on Key Clinical Programs
 
London: Monday, July 31, 2017:  Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM), the China-based biopharmaceutical company focused on discovering and developing targeted therapies for oncology and immunological diseases for the global market, today announces its unaudited financial results for the six months ended June 30, 2017.
 
Group:  Record revenue; continued investment in clinical pipeline
·      Group revenue up 21% to $126.6 million (H1 2016: $104.5m).
·   Net income attributable to Chi‑Med of $1.7 million (H1 2016: $0.5m), including $37.5 million in research and development expenses on an as adjusted basis (H1 2016: $36.0m).
 
Innovation Platform:  Submitted first China New Drug Application ("NDA") on fruquintinib; initiated first global Phase III registration study on savolitinib; five other pivotal Phase III studies underway or completing; three more preparing to start
·      Deep clinical pipeline of novel small molecule tyrosine kinase inhibitors ("TKIs"):
o Eight clinical drug candidates now in 31 active or completing clinical trials (H1 2016: 25) around the world; over 3,100 subjects dosed in our trials to date, with over 300 dosed in the first half of 2017.
·      Fruquintinib - Highly selective TKI of vascular endothelial growth factor receptor ("VEGFR")-1/2/3:
o Positive outcome in Phase III study, the FRESCO study, in third-line colorectal cancer ("CRC") patients in China;
o Potentially best-in-class in terms of both efficacy and safety relative to Stivarga® (regorafenib);
o 2017 American Society of Clinical Oncology ("ASCO") oral presentation;
o NDA submitted in third-line CRC to the Center for Drug Evaluation of the China Food and Drug Administration ("CFDA").
·      Savolitinib - Highly selective TKI of the mesenchymal epithelial transition factor ("c-MET"):
o Presented positive Phase II data in c-MET-driven papillary renal cell carcinoma ("PRCC") at the ASCO Genitourinary Cancers Symposium;
o Initiated global Phase III study, the SAVOIR study, in c-MET-driven PRCC in a head-to-head comparison with current standard therapy Sutent® (sunitinib).  The first Phase III study ever conducted with molecularly selected patients in renal cell carcinoma;
o Initiated a global epidemiology study in c-MET-driven PRCC to demonstrate the importance of treatment with a c-MET inhibitor.
·      Presented positive proof-of-concept data on:
o Fruquintinib in gastric cancer in combination with Taxol® (paclitaxel);
o Sulfatinib in neuroendocrine tumors ("NET") as well as preliminary data in thyroid cancer.
·      Progressing multiple Phase I dose escalation studies in Australia and China on:
o HMPL-523 against spleen tyrosine kinase ("Syk");
o HMPL-453 against fibroblast growth factor receptor 1/2/3 ("FGFR");
o HMPL-689 against phosphoinositide 3-kinase delta ("PI3Kδ");
o Theliatinib against epidermal growth factor receptor ("EGFR") wild-type;
o Expect to complete dose escalation and initiate proof-of-concept expansion trials on these drug candidates towards end of 2017 or early 2018.
 
Commercial Platform:  High-performance drug marketing and distribution platform covers ~300 cities/towns in China with >3,300 sales people. High value products and household name brands
·      Total consolidated sales up 26% to $103.9 million (H1 2016: $82.3m).
·      Total sales of non-consolidated joint ventures were $253.1 million (H1 2016: $249.6m) mainly due to a price increase on a key product in late 2016; a relatively quiet influenza season; and -5% currency effect. Dividends paid to Chi-Med Group level from non-consolidated joint ventures totaled $42.6 million in first half of 2017 (H1 2016: $15.9m).
·      Total consolidated net income attributable to Chi-Med up 14% to $25.2 million (H1 2016: $22.1m).
 
Solid cash position:
·      Cash resources of $192.5 million at Chi-Med Group level as of June 30, 2017 ($173.7m as of December 31, 2016), including cash and cash equivalents, short-term investments and unutilized bank facilities.
 
Potential major milestones targeted for rest of 2017 and into 2018
·      Savolitinib in non-small cell lung cancer ("NSCLC"): 
o Data from Phase II studies to be presented later in 2017 at a major scientific conference:
1)  Savolitinib in combination with Tagrisso® (osimertinib) in second- and third-line NSCLC;
2)  Savolitinib in combination with Iressa® (gefitinib) in second-line NSCLC; 
o Subject to the strength of Phase II data, global Phase III registration and potential Breakthrough Therapy strategy for NSCLC will be determined.
·      Fruquintinib:
o Potential NDA approval and launch in China, via our partner Eli Lilly and Company ("Lilly"), as the first approved treatment for third-line CRC patients;
o Completion of enrollment in the FALUCA study, an approximately 520 patient Phase III registration study in third-line NSCLC in China;
o Initiation of Phase III registration study of fruquintinib in combination with Taxol® in second-line gastric cancer in China.
·      Epitinib (EGFR):  Initiation of Phase III registration study in first-line NSCLC patients with EGFR activating mutations with brain metastasis in China.
·      HMPL-523 (Syk):  Potential presentation of preliminary efficacy data from Phase I dose escalation study in hematological cancer.
 
 
References in this announcement to adjusted research and development expenses, consolidated net income attributable to Chi-Med from our Commercial Platform and consolidated net income attributable to Chi-Med from our Prescription Drugs business are based on non-GAAP financial measures. Please see the "Use of Non-GAAP Financial Measures and Reconciliation" below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.
 
U.K. Analysts Meeting and Webcast Scheduled Today at 9:00 a.m. BST (4:00 p.m. HKT) - at Panmure Gordon & Co, One New Change, London EC4M 9AF, U.K.. Investors may participate in the call at +44 20 3003 2666 or access a live video webcast of the call via Chi-Med's website at www.chi-med.com/investors/event-information/.
 
U.S. Conference Call Scheduled Today at 9:00 a.m. EDT - to participate in the call from the United States, please dial 1 866 966 5335.
 
Additional dial-in numbers are also available at Chi-Med's website. For both calls and all dial-in numbers, please use conference ID "Chi-Med."
 
 
Simon To, Chairman of Chi-Med, said:  "Chi-Med's consistent strategy over the past 16 years has generated considerable shareholder value, and we believe it is now poised to deliver substantially more.
 
In our Innovation Platform, we have progressed our deep portfolio of eight clinical drug candidates, now in 31 active or completing clinical trials around the world. In the process we have achieved two particularly important milestones:  the formal NDA submission for fruquintinib in third-line CRC in China; and the initiation of our first global Phase III registration study of savolitinib in c-MET-driven metastatic PRCC.  We also presented positive Phase Ib/II data at major scientific conferences in early 2017 on savolitinib in PRCC, fruquintinib in gastric cancer, and sulfatinib in NET and thyroid cancer.
 
Now, subject to approval, we expect to launch fruquintinib in China in 2018 with our commercial partner, Lilly.  Importantly also, later in 2017, we will present eagerly-awaited Phase II clinical trials data on savolitinib in combination with Tagrisso® and Iressa® in NSCLC thereby allowing AstraZeneca AB (publ) ("AstraZeneca") to clarify their plans for potential global Phase III registration.  Furthermore, we are also now preparing to initiate Phase III registration studies in China of fruquintinib in gastric cancer and of epitinib in NSCLC patients with brain metastasis.  The progress of our pipeline is testament to the quality of our in-house research organization, which has discovered all eight of our clinical drug candidates.  It also demonstrates that global quality drug discovery is now very much possible in China.
 
At the same time, regulatory reform is moving at speed in China, improving transparency and raising the standards of clinical data reliability.  This helps us, since, at Chi-Med we have always run all our clinical trials to global standards, be they inside or outside China.  Fruquintinib is now set to establish an important new reference point, under the reformed regulatory framework in China, for both quality and rigor of clinical trials and for speed to approval. Change is also underway on the National Drug Reimbursement List ("NDRL") in China, with the first steps having been taken this month to include multiple innovative cancer drugs for some level of reimbursement in a clear move to broaden accessibility.
 
In parallel, our Commercial Platform continues to grow sales and profits showing resilience against the normal pressures of dynamic and competitive markets.  During late 2016 and early 2017, we increased prices in our Prescription Drugs business; and moved our Consumer Health factory over 1,400 kilometers to a lower-cost, larger capacity site in central China.  Both had short-term effects; but both are now set to benefit our businesses materially. There were also market pressures on our Consumer Health business, with rapid raw material price increases, a relatively quiet influenza season and around a 5% fall in the Chinese RMB, which affected our U.S. dollar stated financial results.  Despite this, net income attributable to Chi-Med from our Commercial Platform increased by 14% to $25.2 million, and we expect to meet full year guidance on core operations.  We see this as a measure of the strength of our brands, teams and operations.
 
Our consistent commercial and scientific strategy, and our pragmatic approach to managing finance and risk, have led to the strength of both our position today and our prospects.  The first of our new drug candidates, led by fruquintinib, and including savolitinib, sulfatinib and epitinib, are all progressing towards potential registration and launch in major markets with the balance of our pipeline of drug candidates including theliatinib, HMPL-523, HMPL-689 and HMPL-453 now mostly in proof-of-concept studies.
 
In addition, our discovery platform is generating a third wave of innovation with a strong focus on immunotherapy.  Combining this innovation pipeline with our China marketing and distribution platform, our international partners and our financial stability, all lead Chi-Med to view our future with great confidence."
 
 
FINANCIAL HIGHLIGHTS:
 
Consolidated financial results of the Group are reported under U.S. generally accepted accounting principles ("U.S. GAAP") and in U.S. dollar currency unless otherwise stated.  Chi-Med also conducts its business through three non-consolidated joint ventures, which are accounted for under the equity accounting method as non-consolidated entities in our consolidated financial statements. Within this announcement, certain financial results reported by such non-consolidated joint ventures are referred to, which are based on figures reported in their respective consolidated financial statements prepared pursuant to International Financial Reporting Standards (as issued by the International Accounting Standards Board).  Unless otherwise indicated, references to "subsidiaries" mean the consolidated subsidiaries and joint ventures (excluding non-consolidated joint ventures) of Chi-Med.
 
Group Results
·      Consolidated revenue up 21% to $126.6 million (H1 2016: $104.5m).
·      Net income attributable to Chi-Med of $1.7 million (H1 2016: $0.5m).
·      Solid cash position:  Available cash resources of $192.5 million as of June 30, 2017 (December 31, 2016: $173.7m) at the Chi-Med Group level, including cash and cash equivalents, short-term investments and unutilized banking facilities.  During the first half of 2017, Chi-Med received dividends from its non-consolidated joint ventures of $42.6 million (H1 2016: $15.9m).
 
Innovation Platform - a deep broad, risk-balanced global oncology/immunology pipeline
·      Consolidated revenue of $22.7 million (H1 2016: $22.3m) from milestone payments from Lilly ($4.5m, fruquintinib NDA filing) and AstraZeneca ($5.0m, savolitinib Phase III initiation) and service fee payments from Lilly, AstraZeneca and Nutrition Science Partners Limited ("NSP"), our 50/50 joint venture with Nestlé Health Science S.A. ("Nestlé").
·      Net loss attributable to Chi-Med of $14.8 million (H1 2016: -$13.7m) driven by $31.6 million (H1 2016: $31.2m) in research and development expenses, or $37.5 million (H1 2016: $36.0m) on an as adjusted (non-GAAP) basis, spent on our 31 active or completing clinical trials, five of which are pivotal Phase III studies on fruquintinib, sulfatinib and savolitinib.
 
Commercial Platform - a deeply established, cash-generative, pharmaceutical business in China - a platform to commercialize our Innovation Platform candidate drugs
·      Total consolidated sales up 26% to $103.9 million (H1 2016: $82.3m) mainly resulting from growth in our Prescription Drug commercial services business.
·      Total sales of non-consolidated joint ventures were $253.1 million (H1 2016: $249.6m) resulting from flat sales on She Xiang Bao Xin ("SXBX") pill due to a price increase that we implemented in December 2016; and a relatively quiet influenza season on the over-the-counter ("OTC") drug business.
·      Total consolidated net income attributable to Chi-Med up 14% to $25.2 million (H1 2016: $22.1m) or up 2% to $22.7 million on an adjusted basis to exclude $2.5 million one-time government subsidies; strong Prescription Drug net income growth was offset by short-term pressures in OTC drugs caused by our factory move and certain raw material price increases.
·      Both top- and bottom-line growth were reduced by -5% in U.S. dollar terms during the first half of 2017 as a result of the weakening of the Chinese RMB as compared to the same period in 2016.
 
 
KEY H1 2017 OPERATIONAL HIGHLIGHTS:
 
Innovation Platform:  In June this year, we both completed our first NDA submission, for fruquintinib in third-line CRC, and initiated our first global Phase III study in oncology, for savolitinib in PRCC. Each triggered milestone payments from our partners Lilly and AstraZeneca, and each represents major achievements for Chi-Med and for the biotech industry in China.
 
·      Savolitinib:  Potential first-in-class selective c-MET inhibitor currently in 12 active clinical studies worldwide in multiple tumor types including kidney, lung and gastric cancers as a monotherapy or in combination with other targeted and immunotherapy agents.  Developing globally in partnership with AstraZeneca:
 
1.   Kidney cancer:
 
a.  Presented Phase II global multicenter study in advanced PRCC at the 2017 ASCO Genitourinary Cancers Symposium showing robust efficacy with savolitinib monotherapy in c-MET-driven patients.  Median progression free survival ("PFS") of 6.2 months in patients with c-MET-driven tumors as compared with 1.4 months (p<0.0001) in c-MET-independent patients.  Objective response rate ("ORR") was 18.2% in c-MET-driven patients vs. 0% (p=0.002) in c-MET independent patients.  Encouraging durable response and a tolerable safety profile were reported in savolitinib treated patients. The full article has now been published in the Journal of Clinical Oncology.
 
b.  A global Phase III study, the SAVOIR study, was initiated in late June 2017.  The SAVOIR study is an open-label, randomized, controlled trial evaluating the efficacy and safety of savolitinib, compared with Sutent®, in patients with c-MET-driven, unresectable, locally advanced or metastatic PRCC.  Approximately 180 patients will be randomized in the United States and Europe; c-MET-driven PRCC patients will be selected through the use of a companion diagnostic kit.
 
c.  Confirmed combination dose of savolitinib in combination with anti-programmed death-ligand 1 ("PD-L1") antibody, Imfinzi® (durvalumab), via Phase Ib study in clear cell renal cell carcinoma ("ccRCC") patients.  A ccRCC expansion phase is now underway.
 
2.   Lung cancer:
 
a.  Continued enrollment of Phase II studies in NSCLC patients with EGFR mutations who have progressed following first-line EGFR TKI therapy and harbor c-MET gene amplification.  We are preparing to present data on the following studies at major scientific conferences later in 2017: (1) a Phase II study, the TATTON study (Part B), of savolitinib in combination with Tagrisso® in second-line or third-line EGFR TKI refractory NSCLC patients; and (2) a Phase II study of savolitinib in combination with Iressa® in second-line EGFR TKI refractory NSCLC patients.
 
·      Fruquintinib:  Designed to be a best-in-class selective inhibitor of VEGFR 1/2/3 - we are developing outside of China and in partnership with Lilly within China:
 
1.  CRC (third-line or above):  Reported in March 2017 that fruquintinib convincingly met the primary endpoint of median overall survival ("OS"), 9.30 months versus 6.57 months (p<0.001), and all secondary endpoints in the FRESCO Phase III study as a monotherapy among third-line CRC patients in China; further, that the adverse events ("AEs") demonstrated in FRESCO did not identify any new or unexpected safety issues; then presented the full FRESCO data-set in an oral presentation at ASCO and completed submission of our China NDA in June 2017. Subject to CFDA approval, fruquintinib is expected to launch in China in 2018.  Based on the patient population in third-line CRC in China, as well as the sales performance of TKIs launched in recent years in China, we estimate peak fruquintinib revenues, in third-line CRC alone, could reach between $110-160 million annually resulting in peak net income to Chi-Med of around $20-35 million.
 
2.  NSCLC (third-line): Continue to enroll a Phase III study, named FALUCA, with a primary endpoint of OS, to evaluate fruquintinib in third-line NSCLC patients in China; expect to complete enrollment in early 2018; top-line Phase III data expected to be reported in late 2018; subject to positive FALUCA outcome, we target to submit a second China NDA shortly thereafter.
 
3.  Gastric cancer (second-line):  Presented positive interim results in the Phase I/Ib dose finding/expansion study in early 2017 at the ASCO Gastrointestinal Cancers Symposium.  Established a well-tolerated combination dose of 4mg fruquintinib with 80mg/m2 weekly of Taxol® with encouraging efficacy, including ORR of 36%; Disease Control Rate ("DCR") of 68%; ≥16 week PFS of 50% and ≥7 month OS of 50%.  On track now to initiate a Phase III registration study in China in 2017.
 
4.  NSCLC (first-line): In January 2017, we initiated a Phase II study of fruquintinib in combination with Iressa® in first-line NSCLC patients with EGFR activating mutations in China.
 
5.  Production facility in Suzhou, China operated by Chi-Med is now ready to support commercial launch of fruquintinib in 2018.
 
6.  Planning to initiate global development of fruquintinib in 2017, initially through a Phase I dose confirmation study in Caucasian patients in the United States.
 
·   Sulfatinib:  A unique angio-immuno TKI therapy with high potency against VEGFR, FGFR1 and colony stimulating factor-receptor 1 ("CSF-1R") with emerging strong efficacy in multiple solid tumor settings - enrolling two pivotal Phase III studies:
 
1.  NET:
 
a.  Presented positive Phase II study at the European Neuroendocrine Tumor Society ("ENETS") conference in early 2017.  Established that sulfatinib was well tolerated with highly encouraging efficacy in both pancreatic NET (ORR 17.1%; DCR 90.2%; and median PFS 19.4 months) and non-pancreatic NET (ORR 15.0%; DCR 92.5%; and median PFS 13.4 months) with 100% DCR in twelve patients who had disease progression on targeted therapies such as Sutent® and Afinitor® (everolimus); now enrolling two Phase III studies in China, named SANET-p (in pancreatic NET patients) and SANET-ep (in non-pancreatic NET patients), with primary endpoint median PFS.
 
b.  U.S. Phase I dose confirmation study in Caucasian patients is near completion, and a Phase II expansion study in the United States is expected to be initiated in late 2017 or early 2018.
 
2.  Thyroid cancer:  Presented Phase II data at ASCO in June 2017 in patients with locally advanced or metastatic radioactive iodine ("RAI")-refractory differentiated thyroid cancer ("DTC") or medullary thyroid cancer ("MTC") in China. Preliminary data in 18 patients showing an ORR of 25% in RAI-DTC and an ORR of 17% in MTC patients, with all other patients reporting stable disease ("SD").
 
3.  Biliary tract cancer: Initiated a Phase II proof-of-concept study in China in January 2017.
 
·    Epitinib:  Highly differentiated EGFR TKI designed for optimal blood-brain barrier penetration allowing for higher drug exposure in the brain than currently marketed first generation EGFR TKIs:
 
1.  NSCLC with brain metastasis:  Epitinib has been shown to be well tolerated with encouraging efficacy with an overall ORR (lung and brain) of 62% in all EGFR TKI naïve NSCLC patients (those patients not previously treated with an EGFR TKI) and an ORR of 70%, including both confirmed and unconfirmed partial responses ("PRs"), in EGFR TKI naïve NSCLC patients who also had measurable brain metastasis and were c-MET negative.  Based on these data we are preparing to initiate a Phase III registration study in China in late 2017 or early 2018.
 
2.  Glioblastoma: Planning underway to start a Phase II study in glioblastoma, a primary brain cancer that harbors high levels of EGFR gene amplification, in 2017.
 
·    HMPL-523:  Potential first-in-class Syk inhibitor in oncology and immunology:
 
Hematological cancer: Currently enrolling Phase I dose escalation studies in Australia and China in patients with hematologic malignancies.  Dose escalation continues to evaluate both once daily ("QD") and twice daily regimes and will begin dose expansion with single agent HMPL-523 in due course.  We target to present proof-of-concept data in 2018.
 
·   HMPL-689:  Potential best-in-class, highly selective PI3Kδ inhibitor, which we believe should have meaningful safety and tolerability advantages over Zydelig® (idelalisib):
 
Hematological cancer: Completed Phase I study in healthy volunteers in Australia, now preparing to start Phase I in patients with lymphomas in China where we received IND clearance in early 2017.
 
·    Theliatinib:  EGFR inhibitor, with high binding affinity to wild-type EGFR protein, with potential in patients with solid tumors presenting EGFR gene amplification or protein over-expression:
 
Esophageal cancer:  Phase I dose escalation study is continuing and a Phase II expansion in esophageal cancer patients with a high level of EGFR activation, including gene amplification and protein over-expression was initiated in early 2017.
 
·    HMPL-453:  Potential first-in-class and/or best-in-class selective FGFR 1/2/3 inhibitor:
 
Solid tumors:  During the first half of 2017, we initiated Phase I dose escalation studies in both Australia and China.
 
Commercial Platform:  Net profit increased 14% to $25.2 million (H1 2016: $22.1m) with strong Prescription Drugs growth and $2.5 million in one-time government subsidies more than offsetting the effect of challenging conditions in the OTC business; as well as the -5% weakening of the Chinese RMB.
 
·    Prescription Drugs business continuing profit growth - consolidated sales up 27% to $85.8 million (H1 2016: $67.6m); total sales of non-consolidated Prescription Drugs joint venture flat at $129.7 million (H1 2016: $126.8m); and total consolidated net income attributable to Chi-Med up 27% to $19.4 million (H1 2016: $15.3m).
 
1.  Shanghai Hutchison Pharmaceuticals Limited ("SHPL") - our large-scale non-consolidated Prescription Drugs joint venture - Continued progress on SXBX pill, our most important commercial product, a prescription vasodilator that accounts for about 12% of China's over $1.5 billion botanical coronary artery disease prescription drug market.  SXBX pill is a proprietary product with full patent protection through 2029.  During late 2016 and early 2017, we have been able to effectively implement a pricing strategy that provides an important foundation for future margin improvement and profit growth.
 
2.  Shanghai government subsidy - SHPL was awarded a significant one-time increase in its regular government research and development subsidies.  This totaled $5.9 million, equivalent to $2.5 million in net income attributable to Chi-Med.
 
3.  Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Limited ("Hutchison Sinopharm") - our Prescription Drugs commercial services business - Continued commercial success in the first half of 2017 on Seroquel® (bi-polar disorder/schizophrenia), which grew sales by 10% to $18.9 million (H1 2016: 17.2m), and Concor® (hypertension/high blood pressure) where strong results, 75% year-on-year growth, recently led Merck Serono to expand Hutchison Sinopharm's exclusive territory by over 70% to now cover a total of six provinces/municipalities with a population of over 360 million people.
 
·    Consumer Health business stable despite challenging conditions - consolidated sales up 24% to $18.1 million (H1 2016: $14.6m); total sales of non-consolidated Consumer Health joint venture flat at $123.4 million (H1 2016: $122.7m); and total consolidated net income attributable to Chi-Med down 16% to $5.8 million (H1 2016: $6.8m).
 
Short-term OTC profit pressure - capacity constraint and depreciation costs - caused by regulatory hiatus before the start of production at our new factory; an increase in certain key raw material prices; and the quietest influenza season since 2014.
 
2017 AND EARLY 2018 MILESTONES:  We target to present multiple clinical data updates during the balance of 2017 and early 2018, including:
 
·      Savolitinib:
1.  Phase II data in second- and third-line NSCLC in combination with Tagrisso®;
2.  Phase II data in second-line NSCLC in combination with Iressa®;
3.  Molecular epidemiology study (n >300) in PRCC.
·      Fruquintinib: Phase III FRESCO study full data sub-group analysis in third-line CRC.
·      HMPL-523 (Syk): Preliminary efficacy data from Phase I dose escalation study in hematological cancer.
·      HMPL-689 (PI3Kδ): Phase I dose escalation data in healthy volunteers.
 
We hope to achieve multiple clinical and regulatory milestones during 2017 and early 2018, including:
 
·      Savolitinib: Potential decision on Phase III registration and potential Breakthrough Therapy strategy in NSCLC in combination with Tagrisso®/Iressa®.
·      Fruquintinib:
1.  Potential NDA approval and launch in third-line CRC in China;
2.  Complete enrollment of Phase III FALUCA study in third-line NSCLC;
3.  Initiate China Phase III study in second-line gastric cancer;
4.  Initiate U.S. Phase I dose confirmation study in Caucasian patients.
·      Epitinib:
1.  Initiate China Phase III study in first-line EGFR-mutant NSCLC patients with brain metastasis;
2.  Initiate China Phase II study in glioblastoma (primary brain cancer).
·      Sulfatinib:  Initiate Phase II expansion study in NET patients in the United States.
·      HMPL-523 (Syk):  Initiate Australia and China dose expansion proof-of-concept studies in hematological cancer.
·      HMPL-689 (PI3Kδ):  Initiate Phase I dose escalation study in China in hematological cancer patients.
 
 
FINANCIAL GUIDANCE:  Our updated guidance for 2017, compared to the most recent guidance in our full year results announcement for the year ended December 31, 2016 dated March 13, 2017, reflects no overall change to estimated net income/(loss) for the Chi-Med Group.  The only adjustment that we would highlight is the potential for deferral, into 2018, of the one-time property gains resulting from Guangzhou government policy.  Full year 2017 financial guidance is detailed below:
 
Group Level:
2017 Previous
Guidance[1]
 
2017 Current
Guidance
 
Adjustment
·  Consolidated revenue
$225-240 million
 
$225-240 million
 
none
·  Admin., interest & tax
$(18)-(19) million
 
$(18)-(19) million
 
none
·  Net income/(loss)[2]
$(13)-(28) million
 
$(13)-(28) million
 
none
 
Innovation Platform:
 
 
 
 
 
·  Consolidated revenue
$35-40 million
 
$35-40 million
 
none
·  Adjusted R&D expenses
$(85)-(90) million
 
$(85)-(90) million
 
none
 
Commercial Platform:
 
 
 
 
 
·  Sales (consolidated)
$190-200 million
 
$190-200 million
 
none
·  Sales of non-consol. JVs[3]
$480-500 million
 
$480-500 million
 
none
·  One-time property/R&D gains[2]
$14-16 million[4]
 
$3-16 million[4]
 
$0-11 million less[4]
·  Net income[2]
$46-50 million
 
$35-50 million
 
$0-11 million less
 
Notes: [1] Company Guidance March 13, 2017; [2] Attributable to Chi-Med; [3] Joint ventures; [4] timing subject to Guangzhou government policy.

Director Deals - Hutchison China Meditech Ltd (HCM)
BFN
Dr Dan Eldar, Non Executive Director, bought 1,900 shares in the company on the 2nd August 2017 at a price of 3493.00p. The Director now holds 5,012 shares.

Story provided by StockMarketWire.com
Director deals data provided by www.directorsholdings.com

14:05 07/08/2017
Director Deals - Hutchison China Meditech Ltd (HCM)
Paul Carter, Non Executive Director, bought 724 shares in the company on the 2nd August 2017 at a price of 3425.00p. The Director now holds 3,524 shares. Story provided by StockMarketWire.com Director deals data provided by www.directorsholdings.com

Start of HMPL 689 Phase I Trial in China
RNS
RNS Number : 1286P
Hutchison China Meditech Limited
29 August 2017
 
Chi‑Med Initiates a Phase I Clinical Trial of Selective PI3Kδ Inhibitor HMPL‑689 in Lymphoma Patients in China
 
London: Tuesday, August 29, 2017: Hutchison China MediTech Limited ("Chi‑Med") (AIM/Nasdaq: HCM) has initiated a Phase I clinical trial of HMPL‑689 in China. HMPL-689 is a novel, highly selective and potent small molecule inhibitor targeting phosphoinositide-3 kinase delta isoform ("PI3Kδ"), a key component in the B-cell receptor ("BCR") signaling pathway.
 
This Phase I study is a multi‑center, open‑label, two‑stage study to evaluate safety, tolerability, pharmacokinetics ("PK") and preliminary efficacy of HMPL-689 monotherapy in relapsed and/or refractory non-Hodgkin lymphoma patients. During the initial dose-escalation stage, the primary objective is to determine the maximum tolerated dose (MTD) or the recommended Phase II dose ("RP2D"). Safety, tolerability and preliminary efficacy of HMPL-689 at the RP2D will be further studied in a subsequent dose-expansion stage in which several subtypes of lymphoma patients will be evaluated. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT03128164.
 
 
About HMPL-689
PI3K signaling is mediated by four different catalytic isoforms (p110α, β, ɣ, δ). The δ (delta) isoform is the most critical isoform and a proven target in the BCR signaling pathway. This isoform is restricted to hematopoietic cells and is highly expressed in lymphoid cells.
 
HMPL-689 is a novel, potential best-in-class, highly selective and potent small molecule inhibitor targeting the isoform PI3Kδ. HMPL-689 was designed for superior PI3Kδ isoform selectivity, in particular to not inhibit PI3Kɣ (gamma), to minimize the risk of serious infection caused by immune suppression. In preclinical PK studies, HMPL-689's PK properties have been found to be favorable with expected good oral absorption, moderate tissue distribution and low clearance. HMPL-689 is also expected to have low risk of drug accumulation and drug-to-drug interaction and is highly potent, particularly at the whole blood level.
 
A Phase I, first-in-human, dose escalation study in healthy adult volunteers in Australia to evaluate the PK and safety profile following single oral dosing HMPL-689 was completed in 2016. Results were as expected with linear PK properties and good safety profile. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT02631642.
 
 
About Chi‑Med
Chi‑Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
 
Chi‑Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi‑med.com.
 
 
Forward‑Looking Statements
This press release contains forward‑looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward‑looking statements reflect Chi‑Med's current expectations regarding future events, including its expectations for the clinical development of HMPL‑689, plans to initiate further clinical studies for HMPL‑689, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward‑looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate HMPL‑689 to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of HMPL‑689 for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward‑looking statements, which speak only as of the date hereof.  For further discussion of these and other risks, see Chi‑Med's filings with the U.S. Securities and Exchange Commission and on AIM. Chi‑Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.  
 

Director's Share Dealing
RNS
RNS Number : 4283P
Hutchison China Meditech Limited
31 August 2017
 
 
 
Director's Share Dealing
 
London: Thursday, August 31, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) has received notifications that Mr Simon To, Executive Director and Chairman, through Dynamic Drive Limited, a person closely associated with Mr To, purchased a total of 14,748 American Depositary Shares of the Company ("ADSs", each representing one half of one ordinary share of US$1.00 each in the capital of Chi-Med) on August 28 and 29, 2017 at an average price of US$24.40 per ADS. Dynamic Drive Limited is controlled by the trustee of Dynamic Drive Trust (the "DDT") which has been established for the benefit of Mr To's family members, of which Mr To is the settlor.
 
Following the above purchases, Mr To is interested in 133,237 ADSs (in DDT and Wencheng Trust of which his family members are the beneficiaries) and 180,000 Ordinary Shares (including the holding of 78,000 Ordinary Shares in DDT of which his family members are the beneficiaries), representing in aggregate approximately 0.41% of the current issued share capital of Chi-Med.

Going into orbit. :-))

Appointment of Director
RNS
RNS Number : 4095T
Hutchison China Meditech Limited
12 October 2017
 
 
 
Appointment of Director
 
London: Thursday, October 12, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that Professor Mok, Shu Kam Tony has been appointed as Independent Non-Executive Director and member of the Technical Committee with effect from October 12, 2017.
 
Professor Mok, aged 57, has more than 30 years of experience in clinical oncology with his main research interest focusing on biomarker and molecular targeted therapy in lung cancer.  He is currently Li Shu Fan Medical Foundation Named Professor and Chairman of Department of Clinical Oncology at The Chinese University of Hong Kong. He co-founded the Lung Cancer Research Group and has led a number of important multinational clinical trials, which include the IPASS, FASTAST 2, IMPRESS and PROFILE 1014 that contributed to the current standard of practice on management of advanced stage lung cancer.
 
Professor Mok has contributed to over 200 articles in international peer-reviewed journals, including the New England Journal of Medicine, Science, Lancet and Journal of Clinical Oncology, and contributed to multiple editorials and textbooks. He is Past Chair of the American Society of Clinical Oncology (ASCO) International Affairs Committee, a member of the ASCO Publications Committee and Vice Secretary of the Chinese Society of Clinical Oncology (CSCO).
 
Professor Mok is closely affiliated with the oncology community in China and has been awarded an Honorary Professorship at Guangdong Province People's Hospital, Guest Professorship at Peking University School of Oncology and Visiting Professorship at Shanghai Jiao Tong University and West China School of Medicine/West China Hospital, Sichuan University.
 
He received his Bachelor of Medical Science degree and Doctor of Medicine from University of Alberta, Canada. He is also a Fellow of Royal College of Physicians and Surgeons of Canada, Hong Kong College of Physicians, Hong Kong Academy of Medicine, Royal College of Physicians of Edinburgh and American Society of Clinical Oncology.
 
Professor Mok is currently a member of the board of directors of Sanomics Limited, the Chinese Lung Cancer Research Fund and the International Association for the Study of Lung Cancer (ISALC). He is also Chairman of The Hong Kong Cancer Therapy Society.
 
Professor Mok holds 10,002 American Depositary Shares of Chi-Med (each representing one half of one ordinary share of US$1.00 each in the capital of Chi-Med), representing approximately 0.008% of the current issued share capital of Chi-Med. Save for the information disclosed above, there is no other information in relation to Professor Mok that is required to be disclosed pursuant to Rule 17 and Schedule 2(g) of the AIM Rules for Companies.
 
Mr Simon To, Chairman of Chi-Med said, "We welcome Professor Mok to the Board.  His renowned expertise and extensive experience in clinical oncology, with particular emphasis in lung cancer, will be important to the Company."

Chi-Med Reports Preliminary Phase II data
RNS
RNS Number : 6323T
Hutchison China Meditech Limited
16 October 2017
 
Press Release
Chi-Med Reports Preliminary Phase II data on Fruquintinib Combination in First-Line Lung Cancer
- Fruquintinib in combination with Iressa® (gefitinib) shows promising efficacy and an acceptable safety profile -
 
- Further validation of strong potential for use of fruquintinib in combination with other cancer therapies due to its high kinase selectivity and attractive safety profile -
 
London: Monday, October 16, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today reported preliminary clinical activity, safety, and tolerability data of fruquintinib, an investigational selective inhibitor of vascular endothelial growth factor ("VEGF") receptor given in combination with Iressa®. These data were from an ongoing Phase II proof-of-concept trial conducted in patients with epidermal growth factor receptor ("EGFR") mutation-positive ("EGFRm") non-small cell lung cancer ("NSCLC"). Preliminary data from this Phase II proof-of-concept trial, the first study assessing combining fruquintinib with another tyrosine kinase inhibitor, demonstrated promising efficacy and an acceptable safety profile. The data were presented at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan, October 15 to 18, 2017[[1]].
 
"Having proven efficacy as a monotherapy in colorectal cancer, fruquintinib is now demonstrating its tolerability and efficacy in innovative combinations which are made possible because of its high kinase selectivity, negligible off-target toxicity, and clean drug-drug interaction profile," said Mr. Christian Hogg, Chief Executive Officer of Chi-Med. "In January 2017, preliminary tolerability and efficacy of fruquintinib in combination with chemotherapy, Taxol® (paclitaxel), was reported in a Phase I/II trial in gastric cancer. Now, this early Iressa® combination data further validates our long-held research approach to create highly selective and optimized drug candidates."
 
The study assessed fruquintinib (4 to 5mg, once daily 3-weeks-on/1-week-off) in combination with Iressa® (250mg, once daily) in China as a first-line treatment for patients with EGFRm advanced NSCLC. The most common treatment-emergent adverse events ("AEs") in 26 patients were increased aspartate aminotransferase ("AST") (54%), increased alanine aminotransferase ("ALT") (46%), increased total bilirubin (DBiL) (39%), increased thyroid stimulating hormone (TSH) (39%), and rash (35%). The eight (31%) grade 3 AEs were increased ALT (19%), increased AST (4%), proteinuria (4%), and hypertension (4%). There were no serious AEs or those that lead to death.
 
Preliminary results in 17 efficacy evaluable patients showed an overall response rate (ORR) of 76% (13/17) and a disease control rate (DCR) of 100% (17/17). Four partial responses were not yet confirmed at the time of data cut-off.

Proposed offering of ADSs

Chi-Med Announces Over-allotment Option
RNS
RNS Number : 8546U
Hutchison China Meditech Limited
27 October 2017
 
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION
Chi-Med Announces the Full Exercise of Underwriters' Over-allotment Option
London: Friday, October 27, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM), announced today that the underwriters of its underwritten public offering of American Depositary Shares ("ADSs") on the Nasdaq Global Select Market, previously announced by Chi-Med on October 24, 2017 and October 25, 2017 (the "Offering"), have given notice to Chi-Med that they are exercising, in full, their over-allotment option. The underwriters have elected to purchase an additional 1,483,018 ADSs at the Offering price of US$26.50 per ADS, raising approximately an additional US$39.3 million in gross proceeds for the Company and bringing the total gross proceeds of the Offering to approximately US$301.3 million. Closing of the Offering, including the over-allotment portion, is expected to occur on October 30, 2017. After the closing, the total number of ADSs sold by Chi-Med in the Offering will have increased to 11,369,810.
BofA Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the Offering. Stifel, Canaccord Genuity, Panmure Gordon and CITIC CLSA are acting as co-managers for the Offering.
The 741,509 new ordinary shares being issued by Chi-Med pursuant to the underwriters' full exercise of the over-allotment option ("New Shares") will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing ordinary shares of Chi-Med, including the right to receive all dividends and other distributions declared, made or paid in respect of such shares after the date of issue of the New Shares.
Application will be made to the London Stock Exchange for the New Shares to be admitted to the AIM market operated by the London Stock Exchange ("Admission"). It is expected that Admission will become effective at 8:00 a.m. on November 2, 2017.
This announcement does not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or  jurisdiction. The ADSs described above are being offered by Chi-Med pursuant to a shelf registration statement on Form F-3 (including a base prospectus) filed by Chi-Med with the United States Securities and Exchange Commission ("SEC") that became automatically effective on April 3, 2017. A prospectus supplement and an accompanying prospectus related to the Offering has been filed with the SEC. This prospectus supplement, the accompanying prospectus and any documents incorporated therein are available on the website of the SEC at www.sec.gov. 
No money, securities or other consideration is being solicited, and, if sent in response to the information contained in this announcement, will not be accepted.
This announcement is not directed to, or intended for distribution or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.
The distribution of this announcement into jurisdictions other than the UK may be restricted by law. Persons into whose possession this announcement come should inform themselves about and observe any such restrictions.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
 

FRUTIGA, a Phase III trial of Fruquintinib
RNS
RNS Number : 0641V
Hutchison China Meditech Limited
31 October 2017
 
Press Release 
 
Chi‑Med Initiates FRUTIGA, a Phase III Trial of Fruquintinib in Second-Line Gastric Cancer
 
London: Tuesday, October 31, 2017: Hutchison China MediTech Limited ("Chi‑Med") (AIM/Nasdaq: HCM) has initiated FRUTIGA, a pivotal Phase III clinical trial of fruquintinib in combination with paclitaxel (Taxol®) for the treatment in advanced gastric or gastroesophageal junction ("GEJ") adenocarcinoma patients in China. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors ("VEGFR") 1, 2 and 3. This randomized, double-blind, placebo-controlled, multicenter trial is being conducted in patients with advanced gastric cancer who have progressed after first-line standard chemotherapy. Advanced gastric cancer is a major medical need, particularly in Asian populations, with limited treatment options for patients who have failed first-line standard chemotherapy with 5-fluorouracil (5-FU) and platinum doublets. For gastric cancer, there are approximately 679,100 new cases and 498,000 deaths in China each year.[[1]]
 
"Fruquintinib was designed to be a highly selective inhibitor of VEGFR 1, 2 and 3, which has shown the potential ability to combine with chemotherapy - a novel approach in the treatment of advanced gastric cancer," said Christian Hogg, Chief Executive Officer of Chi-Med. "With fruquintinib's New Drug Application ("NDA") in third-line colorectal cancer ("CRC") under review and its Phase III trial in third-line non-small cell lung cancer nearing full enrollment, we are excited to now also enter the final phase of development in second-line gastric cancer, a very large indication in which there is significant patient need for new treatment options in China."
 
About FRUTIGA
Over 500 patients will be enrolled into FRUTIGA, a randomized, double-blind, Phase III trial to evaluate the efficacy and safety of fruquintinib combined with paclitaxel compared with paclitaxel monotherapy for second-line treatment of advanced gastric or GEJ adenocarcinoma. The trial will enroll patients with disease that has been confirmed through histology or cytology and who did not respond to first-line standard chemotherapy containing platinum and fluorouracil. All subjects will receive fruquintinib or placebo combined with paclitaxel. Patients will be randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumors and ECOG performance status. An Independent Data Monitoring Committee (IDMC) will be established to review safety and efficacy data.
 
The Primary efficacy endpoint is overall survival ("OS"). Secondary efficacy endpoints include progression-free survival ("PFS", as defined by RECIST 1.1), objective response rate ("ORR"), disease control rate ("DCR"), duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored.
 
Additional details about this study can be found at clinicaltrials.gov, using identifier NCT03223376.
 
FRUTIGA was initiated following the results of an open label, multi-center Phase Ib dose finding/expansion study of fruquintinib in combination with paclitaxel (Taxol®) in second-line patients with advanced gastric cancer (clinicaltrials.gov identifier NCT02415023). Results were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in January 2017. A total of 32 patients were enrolled in the study and 28 of 32 patients were evaluable for efficacy, with an ORR rate of 36% and a DCR of 68%. At the fruquintinib recommended Phase II dose ("RP2D"), ≥16 week PFS rate was 50% and ≥7 month OS was 50%. Tolerability of the RP2D combination was as expected with common treatment related Grade ≥3 adverse events (AEs) being neutropenia (41%), leukopenia (28%), decreased hemoglobin (6%), and hand-foot syndrome (6%).
 
About Gastric Cancer
Every year, it is estimated that approximately one million new patients around the world are diagnosed with gastric cancer, according to Frost & Sullivan, and in 2015 China represented approximately 44% of all newly diagnosed gastric cancer cases worldwide. In 2015, there were an estimated 679,100 incidence gastric cancer cases and 498,000 mortality cases in China, according to the National Central Cancer Registry of China.
 
Gastric cancer is the third most lethal cancer worldwide. As it is often diagnosed at an advanced stage, prognosis is poor with a median OS of less than 12 months. Although targeted therapy is under development in China, chemotherapy remains the mainstay of treatment for gastric cancer patients and confers only a moderate survival advantage. Accordingly, we see a high medical need for new targeted treatment options.
 
About Fruquintinib
Fruquintinib (HMPL-013) is a highly selective small molecule drug candidate that has been shown to inhibit VEGFR 24 hours a day via an oral dose, with lower off-target toxicities compared to other targeted therapies. Its tolerability, along with its clean drug-drug interaction profile demonstrated to date, may enable rational combination with other cancer therapies such as in our ongoing clinical trials of fruquintinib in combination with chemotherapy and targeted therapy.
 
At an advanced stage, tumors secrete large amounts of VEGF, a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor to provide greater blood flow, oxygen, and nutrients to the tumor. VEGF and VEGFR play pivotal roles in tumor-related angiogenesis, and fruquintinib inhibits the VEGF/VEGFR pathway. This represents an important therapeutic strategy in blocking the development of new blood vessels essential for tumors to grow and invade.
 
Fruquintinib is currently under joint development in China by Chi-Med and its partner Eli Lilly and Company.
 
About Fruquintinib Development in Other Cancer Types
The China Food and Drug Administration ("CFDA") acknowledged acceptance of the NDA for fruquintinib for the treatment of patients with advanced colorectal cancer in June 2017, and was subsequently awarded priority review status in view of its significant clinical value, according to the CFDA announcement in September 2017. The NDA is supported by data from the successful FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with CRC in China, which was highlighted in an oral presentation at the American Society of Clinical Oncology Annual Meeting on June 5, 2017 (clinicaltrials.gov identifier NCT02314819).
 
In addition to the FRUTIGA and FRESCO Phase III trials, fruquintinib is being studied in China in a Phase III pivotal trial in non-small cell lung cancer ("NSCLC"), known as FALUCA (clinicaltrials.gov identifier NCT02691299); and a Phase II study using fruquintinib combined with Iressa® (gefitinib) in the first-line setting for patients with advanced or metastatic NSCLC (clinicaltrials.gov identifier NCT02976116). Other studies currently being planned include new studies in the United States (clinicaltrials.gov identifier NCT03251378), and certain exploratory studies in combination with other oncology agents.
 

Hutchison China MediTech Ltd (HCM:LSE) set a new 52-week high during today's trading session when it reached 5,262.50. Over this period, the share price is up 181.04%.

Chi-Med Initiates Fruquintinib US Clinical Trials
RNS
RNS Number : 4687Z
Hutchison China Meditech Limited
15 December 2017
 
Press Release 
 
Chi-Med Initiates Fruquintinib U.S. Clinical Trials
 
London: Friday, December 15, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) has initiated the United States Phase I bridging clinical trial of fruquintinib. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors ("VEGFR") 1, 2 and 3, that has met its primary endpoint in several Phase II and III clinical trials in China for the treatment of colorectal, lung and gastric cancers. The clinical study in the U.S. is a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. The first drug dose was administered earlier this month. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03251378.
 
About Fruquintinib Development in China
Colorectal cancer: The China Food and Drug Administration ("CFDA") acknowledged acceptance of the New Drug Application ("NDA") for fruquintinib for the treatment of patients with advanced colorectal cancer ("CRC") in June 2017. Fruquintinib was subsequently awarded priority review status in view of its significant clinical value, according to a CFDA announcement in September 2017. The NDA is supported by data from the successful FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with CRC in China, which was highlighted in an oral presentation at the American Society of Clinical Oncology Annual Meeting held on June 5, 2017 (clinicaltrials.gov identifier NCT02314819). The FRESCO study followed an initial Phase I trial in 40 solid tumor patients, a Phase Ib study in 62 CRC patients, and a Phase II clinical trial in 71 CRC patients.
 
Lung cancer: Fruquintinib is being studied in a Phase III pivotal trial in approximately 520 third-line non-small cell lung cancer ("NSCLC") patients, known as the FALUCA study (clinicaltrials.gov identifier NCT02691299), following a Phase II clinical trial in 91 third-line NSCLC patients. Fruquintinib is concurrently being studied in a Phase II study in combination with Iressa® (gefitinib) in first-line setting for patients with advanced or metastatic NSCLC (clinicaltrials.gov identifier NCT02976116).
 
Gastric cancer: In October 2017, Chi-Med initiated a pivotal Phase III clinical trial of fruquintinib in combination with Taxol® (paclitaxel), known as the FRUTIGA study, for the treatment of over 500 patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma (clinicaltrials.gov identifier NCT03223376).
 
In China, fruquintinib is jointly developed with Eli Lilly and Company.
 
About Fruquintinib
Fruquintinib (HMPL-013) is a highly selective small molecule drug candidate that has been shown to inhibit VEGFR 24 hours a day via an oral dose, with lower off-target toxicities compared to other targeted therapies. Its tolerability, along with its clean drug-drug interaction profile demonstrated to date, may enable rational combination with other cancer therapies such as chemotherapy and other targeted therapies, which are being studied in our ongoing clinical trials of fruquintinib.
 
At an advanced stage, tumors secrete large amounts of vascular endothelial growth factor ("VEGF"), a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor to provide greater blood flow, oxygen, and nutrients to the tumor. VEGF and VEGFR play pivotal roles in tumor-related angiogenesis, and fruquintinib inhibits the VEGF/VEGFR pathway. This represents an important therapeutic strategy in blocking the development of new blood vessels essential for tumors to grow and invade.
 
About Chi‑Med
Chi‑Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
 
Chi‑Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi‑med.com.
 
Forward‑Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of fruquintinib, plans to initiate clinical studies for fruquintinib, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate fruquintinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of fruquintinib for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Ending 2017 near to its highs, plenty of news due in 2018.

Chi-Med to Announce 2017 Final Results
RNS
RNS Number : 7593D
Hutchison China Meditech Limited
05 February 2018

Chi-Med to Announce 2017 Final Results

London: Monday, February 5, 2018: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) will be announcing its final results for the year ended December 31, 2017 on Monday, March 12, 2018 at 7:00 am Greenwich Mean Time (GMT).

An analyst presentation will be held at 9:00 am GMT (5:00 pm Hong Kong Time) on the same day at Citigate Dewe Rogerson, 3 London Wall Buildings, London, EC2M 5SY, UK, which will be webcast via the company website at www.chi-med.com/investors/event-information/. The presentation will be available to download before the analyst presentation begins.

For North America based analysts and investors, Chi-Med will also host a conference call with Q&A at 9:00 am Eastern Daylight Time (1:00 pm GMT).

Details of the analyst presentation and conference call dial-in will be provided in the financial results announcement. A replay will also be available on the website shortly after each event.

Enrolment completed Ph III FALUCA Fruquintinib
RNS
RNS Number : 7097E
Hutchison China Meditech Limited
13 February 2018

Press Release

Chi-Med Completes Enrollment of 527 Patients in Pivotal Phase III FALUCA Trial with Fruquintinib in Lung Cancer
London: Tuesday, February 13, 2018: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) has completed patient enrollment of FALUCA, its Phase III pivotal trial of fruquintinib in advanced, third-line, non-small cell lung cancer ("NSCLC") patients in China. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors ("VEGFR") 1, 2 and 3, that has met its primary endpoint in several Phase II and III clinical trials in China for the treatment of lung, colorectal and gastric cancers. Top-line FALUCA data is expected to be reported in late 2018 when the overall survival ("OS") data is mature and, subject to a positive outcome, would be followed by a second New Drug Application ("NDA") submission thereafter. Fruquintinib's first NDA, for the treatment of colorectal cancer, was submitted to the China Food and Drug Administration ("CFDA") in June 2017.

About Fruquintinib
Fruquintinib (HMPL-013) is a highly selective small molecule drug candidate that has been shown to inhibit VEGFR 24 hours a day via an oral dose, with lower off-target toxicities compared to other targeted therapies. Its tolerability, along with its clean drug-drug interaction profile demonstrated to date, may enable rational combination with other cancer therapies such as in our ongoing clinical trials of fruquintinib in combination with chemotherapy and targeted therapy. VEGFR plays a pivotal role in tumor-related angiogenesis.

About FALUCA
FALUCA is a randomized, double-blind, placebo-controlled, multi-center, Phase III registration study of fruquintinib targeted at treating patients with advanced non-squamous NSCLC, who have failed two lines of systemic chemotherapy. Patients were randomised at a 2:1 ratio to receive either 5mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus best supportive care ("BSC"); or placebo plus BSC. Randomization was stratified by EGFR gene status and history of treatment by VEGF inhibitors. The primary endpoint is OS, with secondary endpoints including progression free survival ("PFS"), objective response rate (ORR), disease control rate (DCR) and duration of response (DoR). Additional details about this study can be found at clinicaltrials.gov, using identifier NCT02691299.

It was initiated following a similar Phase II clinical trial in 91 third-line NSCLC patients that succeeded in meeting its primary efficacy endpoint of PFS, with no unexpected safety issues. Results were highlighted in an oral presentation at the 17th World Conference on Lung Cancer on December 6, 2016 (clinicaltrials.gov identifier NCT02590965).

Other Fruquintinib Development Programs
Lung cancer in China: Along with FALUCA, fruquintinib is concurrently being studied in a Phase II study in combination with Iressa® (gefitinib) in first-line setting for patients with advanced or metastatic NSCLC (clinicaltrials.gov identifier NCT02976116). Preliminary results were highlighted in an oral presentation at the 18th World Conference on Lung Cancer on October 16, 2017.

Colorectal cancer in China: The CFDA acknowledged acceptance of the NDA for fruquintinib for the treatment of patients with advanced colorectal cancer ("CRC") in June 2017. Fruquintinib was subsequently awarded priority review status in view of its significant clinical value, according to a CFDA announcement in September 2017. The NDA is supported by data from the successful FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with CRC in China, which was highlighted in an oral presentation at the American Society of Clinical Oncology Annual Meeting held on June 5, 2017 (clinicaltrials.gov identifier NCT02314819). The FRESCO study followed an initial Phase I trial in 40 solid tumor patients, a Phase Ib study in 62 CRC patients, and a Phase II clinical trial in 71 CRC patients.

Gastric cancer in China: In October 2017, Chi-Med initiated a pivotal Phase III clinical trial of fruquintinib in combination with Taxol® (paclitaxel), known as the FRUTIGA study, for the treatment of over 500 patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after first-line standard chemotherapy (clinicaltrials.gov identifier NCT03223376). The FRUTIGA study followed a Phase I/II clinical trial in 34 patients that demonstrated that combination therapy of fruquintinib and Taxol® in such patients was generally well-tolerated with promising tumor response (clinicaltrials.gov identifier NCT02415023).

In China, fruquintinib is jointly developed with Eli Lilly and Company.

United States bridging trial: In December 2017, Chi-Med initiated a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03251378.

About Chi‑Med
Chi‑Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.

Chi‑Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi‑med.com.

Forward‑Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of fruquintinib, plans to initiate clinical studies for fruquintinib, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate fruquintinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of fruquintinib for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Phase Ib/II Trial of Epitinib in Glioblastoma
RNS
RNS Number : 7968G
Hutchison China Meditech Limited
06 March 2018

Press Release

Chi-Med Initiates a Phase Ib/II Proof-of-Concept Trial of Epitinib in Glioblastoma in China
London: Tuesday, March 6, 2018: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) has initiated a Phase Ib/II proof-of-concept study of epitinib in glioblastoma patients with epidermal growth factor receptor ("EGFR") gene amplification in China. Glioblastoma is a primary brain cancer that harbors high levels of EGFR gene amplification. Epitinib is a potent and highly selective oral EGFR inhibitor that has demonstrated penetration of the blood-brain barrier and encouraging efficacy in clinical studies in other indications.

This proof-of-concept study is a multi-center, single-arm, open-label study to evaluate the efficacy and safety of epitinib as a monotherapy in patients with EGFR gene amplified, histologically confirmed glioblastoma. The primary endpoint is objective response rate ("ORR"). Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03231501.

In addition to this glioblastoma study, epitinib is being developed for non-small cell lung cancer ("NSCLC") patients with activating EGFR mutations that have developed brain metastases. Epitinib has demonstrated brain penetration and encouraging efficacy in these clinical studies and in preclinical studies.

About glioblastoma and epitinib
Glioblastoma is the most aggressive of the gliomas, which are tumors that arise from glial cells or their precursors within the central nervous system ("CNS"). Glioblastoma is classified as Grade IV under the World Health Organization grading of CNS tumors[1] and is the most common brain and CNS malignancy, accounting for 47% of such tumors. In 2017, there were approximately 12,000 new glioblastoma cases in the United States, according to the Central Brain Tumor Registry of the United States.[2] In 2015, there were approximately 101,600 new brain or CNS cancer cases in China.[3] The standard of care for treatment is surgery, followed by radiotherapy and chemotherapy. Median survival is approximately 15 months, and the five-year survival rate is 5.5%.2,[4] There are limited treatment options for glioblastoma patients, particularly for patients with recurrent glioblastoma.

EGFR gene amplification has been identified in about half of glioblastoma patients, according to The Cancer Genome Atlas Research Network, and hence is a potential therapeutic target in glioblastoma.[5] However, currently marketed first generation EGFR inhibitors cannot penetrate the blood-brain barrier effectively, leaving patients without an effective targeted therapy.[6] In contrast, epitinib (HMPL-813) is designed for optimal blood-brain barrier penetration, allowing for higher drug exposure in the brain than the currently marketed first generation EGFR inhibitors.

About epitinib in NSCLC with brain metastasis
In December 2016, preliminary results were presented from a Phase Ib trial of epitinib in first-line NSCLC. Epitinib has been shown to be well tolerated with encouraging efficacy with an ORR (lung and brain) of 62% in all patients not previously treated with an EGFR inhibitor, and an ORR of 70% (including both confirmed and unconfirmed partial responses) in such patients who also had measurable brain metastasis and were c-MET negative (clinicaltrials.gov identifier NCT02590952). Based on further data from that Phase Ib and driven by the major unmet medical need, we are preparing to initiate a Phase III pivotal study of epitinib in EGFR mutant NSCLC patients with brain metastasis in China in 2018.

About Chi‑Med
Chi‑Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.

Final results and key clinical program update

Start of Sulfatinib US Phase Ib/II PoC trial
RNS
RNS Number : 4094V
Hutchison China Meditech Limited
23 July 2018

Press Release

Chi-Med Initiates a Phase Ib/II Proof-of-Concept Trial of Sulfatinib in Pancreatic Neuroendocrine Tumors and Biliary Tract Cancer in the United States
London: Monday, July 23, 2018: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) has initiated a Phase Ib/II proof-of-concept study of sulfatinib in pancreatic neuroendocrine tumors ("NET") patients and in biliary tract cancer ("BTC") patients in the U.S.. Sulfatinib is an oral small molecule angio-immuno kinase inhibitor that can simultaneously block tumor angiogenesis and immune evasion. This study follows several trials that are underway in China, including two Phase III studies in pancreatic and non-pancreatic NET that commenced after positive results from a Phase II study, and a Phase II study in BTC patients. In addition, a Phase I dose escalation part of this study in the U.S. was recently completed.

This proof-of-concept study is a multi-center, single-arm, open-label study to evaluate the efficacy and safety of sulfatinib as a monotherapy in (a) patients with advanced BTC that have progressed on standard first-line chemotherapy, and (b) in patients with advanced pancreatic NET. The primary and secondary endpoints include progression-free survival ("PFS") rate, objective response rate ("ORR"), disease control rate ("DCR"), duration of response ("DoR"), time to response, overall survival ("OS"), safety and tolerability. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT02549937.

About Sulfatinib
Sulfatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor ("VEGFR"), fibroblast growth factor receptor ("FGFR") and colony stimulating factor-1 receptor ("CSF-1R"), three key tyrosine kinase receptors involved in tumor angiogenesis and immune evasion. Inhibition of the VEGFR signaling pathway can act to stop angiogenesis, the growth of the vasculature around the tumor, and thereby starve the tumor of the nutrients and oxygen it needs to grow rapidly. Aberrant activation of the FGFR signaling pathway, which can be increased by anti-VEGFR therapy treatment, is shown to be associated with cancer progression by promoting tumor growth, angiogenesis and formation of the myeloid derived suppressor cells. Inhibition of the CSF-1R signaling pathway blocks the activation of tumor-associated macrophages, which are involved in suppressing immune responses against tumors. Its unique angio-immuno kinase profile supports sulfatinib as a potentially attractive candidate for exploration of possible combinations with checkpoint inhibitors against various cancers.

Sulfatinib is the first oncology candidate that we have taken through proof-of-concept in China and subsequently started clinical development in the U.S. We are currently conducting studies in six target patient populations on sulfatinib and retain all rights to sulfatinib worldwide.

About Sulfatinib Development in China
Sulfatinib is currently in development as a single agent for patients with NET, thyroid cancer and BTC in China.

Pancreatic NET: In March 2016, we initiated the SANET-p study, which is a randomized, double-blind, placebo-controlled, multi-center, Phase III pivotal registration trial to treat about 190 patients with low- or intermediate-grade, advanced pancreatic NET in China. The primary endpoint is PFS, with secondary endpoints including ORR, DCR, DoR, time to response, OS, safety and tolerability. Additional details of the SANET-p study may be found at clinicaltrials.gov, using identifier NCT02589821. We expect to complete enrollment in 2019 and present top-line results thereafter.

Extra-pancreatic NET: The SANET-ep study, which was initiated in December 2015, is similar to the SANET-p study and is targeted at treating about 270 patients with advanced extra-pancreatic NET in China. Additional details of the SANET-ep study may be found at clinicaltrials.gov, using identifier NCT02588170. We expect to complete enrollment in 2019 and present top-line results thereafter.

Thyroid cancer: In March 2016, we initiated Phase II in two target patient populations in China to evaluate the efficacy and safety of sulfatinib in patients with advanced medullary thyroid cancer and iodine-refractory differentiated thyroid cancer. Additional details of this study may be found at clinicaltrials.gov, using identifier NCT02614495.

BTC: In January 2017, we began a Phase II study in patients with BTC (also known as cholangiocarcinoma), a heterogeneous group of rare malignancies arising from the biliary tract epithelia. Gemzar is the currently approved first-line therapy for biliary tract cancer patients, with a total of approximately 18,000 new patients per year in the U.S. according to the National Cancer Institute, but median survival is less than 12 months for patients with unresectable or metastatic disease at diagnosis. As a result, we see a major unmet medical need for patients who have progressed when being treated with Gemzar, and sulfatinib may offer a new targeted treatment option in this tumor type. Additional details of this study may be found at clinicaltrials.gov, using identifier NCT02966821.

Interim results and clinical programs update

Fruquintinib Approved for CRC in China
RNS
RNS Number : 8102Z
Hutchison China Meditech Limited
05 September 2018

Chi-Med Announces the Approval of Fruquintinib Capsules for Previously Treated Colorectal Cancer in China
- Fruquintinib capsules provide a new oral treatment option for patients with metastatic colorectal cancer and will be marketed as Elunate® -

- Elunate® data published in JAMA demonstrated increased overall survival versus placebo -

- First ever approval of an innovative medicine by Chi-Med -

- The first China-discovered and developed treatment for CRC approved in China -


London: Wednesday, September 5, 2018: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that fruquintinib capsules have been granted approval for drug registration by the National Medical Products Administration of China ("NMPA", formerly the China Food and Drug Administration) for the treatment of metastatic colorectal cancer ("CRC") patients, who have failed at least two prior systemic antineoplastic therapies including fluoropyrimidine, oxaliplatin and irinotecan, with or without prior use of anti-vascular endothelial growth factor ("VEGF") or anti-epidermal growth factor receptor ("EGFR") therapies. Fruquintinib is a highly selective and potent small molecule oral inhibitor of vascular endothelial growth factor receptors ("VEGFR") 1, 2 and 3 designed to be a global best-in-class VEGFR inhibitor for many types of solid tumors. Fruquintinib capsules are to be marketed in China under the brand name Elunate®. The approval is based on results from the Phase III FRESCO trial, which were presented at the American Society of Clinical Oncology 2017 Meeting and published in the JAMA (Journal of the American Medical Association) in 2018.

"Today's approval is a major achievement for Chi-Med," said Simon To, Chairman of Chi-Med. "Elunate® is the first home-grown, China-discovered and developed drug we are aware of in an oncology indication to be unconditionally approved through a randomized clinical trial in China," he added, "This is the result of over a dozen years of steadfast commitment by Chi-Med in research and development in China's emerging biotech ecosystem."

"We are particularly grateful to the patients, their families, investigators, nurses, caregivers and study team members who participated in the clinical development of Elunate® and now look forward to making this world-class new therapy available as quickly as possible to patients with CRC in China."

In the FRESCO trial led by Dr. Jin Li and Dr. Shukui Qin, Elunate® was shown to provide a statistically significant and clinically meaningful improvement in overall survival ("OS") versus placebo, with median OS of 9.3 (95% CI 8.2, 10.5) vs. 6.6 (95% CI 5.9, 8.1) months, respectively (HR=0.65, 95% CI 0.51-0.83; p<0.001), and a manageable safety profile. In addition to the significant efficacy, fruquintinib's good kinase selectivity has been shown to limit off-target toxicity and deliver what Chi-Med assesses to be best-in-class tolerability. This allows it to be evaluated in combination with other agents such as chemotherapies, targeted therapies and immunotherapies, thereby maximizing the number of potential patients who may benefit from this novel cancer treatment.

CRC is the second most common cancer type in China,[1] with about 380,000 new cases per year.[2] There were approximately 1.5 million new CRC cases globally in 2015 which are expected to increase to approximately 1.7 million new cases per year by 2020, according to Frost & Sullivan.

The market launch of Elunate® in China will be through collaboration with our partner Eli Lilly & Company ("Lilly"). Dr. Wang Li, Senior Vice President, Head of Lilly China Drug Development & Medical Affairs Center, said, "The approval is a testament to the overall clinical profile of Elunate® and is an important step forward for our collaboration with Chi-Med." This approval also triggers an approximately US$13.6 million milestone payment to Chi-Med from Lilly.


About Elunate®
Elunate® is the brand name of fruquintinib capsules. Fruquintinib (HMPL-013) is a small molecule, selective and highly potent inhibitor of VEGFR 1, 2 and 3. VEGFR inhibitors play a pivotal role in tumor-related angiogenesis, cutting off the blood supply that a tumor needs to grow rapidly. The global market for anti-angiogenesis therapies was estimated at approximately US$18 billion in 2017, with both monoclonal antibodies and small molecules approved in around 30 tumor types. During the discovery research process, which began at Chi-Med in 2007, fruquintinib was successfully designed to be differentiated by improving kinase selectivity in comparison to other approved small molecule tyrosine kinase inhibitors (TKIs), to minimize off-target toxicities, improve tolerability and provide more consistent target coverage, resulting in better clinical efficacy. The superior tolerability, along with fruquintinib's low potential for drug-drug interaction based on preclinical assessment, suggests that it may be highly suitable for innovative combinations with other anti-cancer therapies.

In October 2013, Chi-Med entered into a licensing, co-development and commercialization agreement in China with Lilly for fruquintinib. Under the terms of the agreement, the costs of development of fruquintinib, carried out by Chi-Med, are shared; Chi-Med has received upfront payments and development and regulatory approval milestone payments; and upon commercialization in China, Chi-Med would receive royalties. Chi-Med and Lilly agreed to develop fruquintinib in three initial solid tumor indications, CRC, non-small cell lung cancer ("NSCLC") and gastric cancer.

The most common adverse reactions included hypertension, hand-foot syndrome and proteinuria. Clinically effective management of these adverse effects is feasible. For important safety information about Elunate®, please see www.chi-med.com.

About Fruquintinib Development in CRC in China
Clinical development of fruquintinib began in 2011 with an initial Phase I trial in 40 solid tumor patients, followed by a Phase Ib study in 62 CRC patients, and a Phase II clinical trial in 71 CRC patients. Chi-Med began enrollment in December 2014 of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients in China, and subsequently reported positive top-line results in March 2017.

In October 2016, fruquintinib was the first novel drug to be granted Market Authorization Holder ("MAH") designation under the Shanghai FDA, a new system designed to improve speed and efficiency of novel drug development in China. The New Drug Application ("NDA") for fruquintinib in CRC, that was submitted in June 2017 and awarded priority review status in September 2017, was supported by data from the successful FRESCO study. FRESCO was highlighted in an oral presentation at the ASCO Annual Meeting held on June 5, 2017, and then the full results were published in the JAMA on June 26, 2018. Additional details about the FRESCO study can be found at clinicaltrials.gov, using identifier NCT02314819.

Fruquintinib is only approved for use in mainland China with the approved dose in CRC being 5mg orally once per day, on a three-weeks-on / one-week-off cycle and it will be made available in the market in both 1mg and 5mg capsule packages.

About Other Fruquintinib Development Programs
Lung cancer in China: FALUCA is an ongoing randomized, double-blind, placebo-controlled, multi-center, Phase III registration study of fruquintinib treating patients with advanced non-squamous NSCLC, who have progressed after two lines of systemic chemotherapy. The trial completed enrollment of 527 patients in February 2018 (clinicaltrials.gov identifier NCT02691299) and top-line results are expected in late 2018. FALUCA was initiated following a similar Phase II clinical trial in 91 third-line NSCLC patients. Results were highlighted in an oral presentation at the 17th World Conference on Lung Cancer on December 6, 2016 (clinicaltrials.gov identifier NCT02590965).

Along with FALUCA, fruquintinib is concurrently being studied in a Phase II study in combination with Iressa® (gefitinib) in patients with untreated advanced or metastatic NSCLC (clinicaltrials.gov identifier NCT02976116). Preliminary results were highlighted in an oral presentation at the 18th World Conference on Lung Cancer on October 16, 2017.

Gastric cancer in China: In October 2017, Chi-Med initiated a pivotal Phase III clinical trial of fruquintinib in combination with Taxol® (paclitaxel), known as the FRUTIGA study, in approximately 500 patients with advanced gastric or gastroesophageal junction ("GEJ") adenocarcinoma who have progressed after first-line standard chemotherapy (clinicaltrials.gov identifier NCT03223376). An interim analysis on FRUTIGA, to establish proof-of-concept ("POC"), is anticipated during the first half of 2019 and if successful could trigger a POC milestone from Lilly. The FRUTIGA study followed a Phase I/II clinical trial in 34 patients with gastric cancer that demonstrated that combination therapy of fruquintinib and Taxol® was generally well-tolerated with promising tumor response (clinicaltrials.gov identifier NCT02415023).

United States: In December 2017, Chi-Med initiated a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors (clinicaltrials.gov identifier NCT03251378).

About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.

Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.


Iressa® is a trademark of the AstraZeneca PLC group of companies. Taxol® is a trademark of The Bristol-Myers Squibb Company group of companies.

Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the ability of Elunate® (fruquintinib capsules) to gain commercial acceptance in China, the potential market of Elunate® for patients with metastatic CRC who have failed two prior treatments in China, the ability for Chi-Med to quickly provide Elunate® to patients by year end, and the clinical development of Elunate® in other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding Chi-Med's ability to commercialize Elunate®, that the benefits obtained from Elunate® during clinical trials will be the same for all patients who are prescribed Elunate®, that no unidentified side effects will occur which could result in the NMPA pulling Elunate® from the market and the sufficiency of funding to support commercialization of Elunate® in metastatic CRC and the development of Elunate® in other indications. In addition, as certain studies rely on the use of Iressa® (gefitinib) or Taxol® (paclitaxel) as combination therapeutics with Elunate®, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of Iressa® and Taxol®. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.

Chi-Med Initiates a Ph I Trial of HMPL-523 for AML
RNS
RNS Number : 4449E
Hutchison China Meditech Limited
18 October 2018

Press Release

Chi-Med Initiates a Phase I Trial of HMPL-523 in Combination with Azacitidine in
Elderly Patients with Acute Myeloid Leukemia in China
London: Thursday, October 18, 2018: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) has initiated a Phase I study of HMPL-523, its novel spleen tyrosine kinase ("Syk") inhibitor, in combination with azacitidine, an approved nucleoside metabolic inhibitor, in elderly patients with acute myeloid leukemia ("AML") in China.

This is a Phase I, open-label, non-randomized, multicenter study to evaluate the safety, pharmacokinetics and preliminary efficacy of the combination in previously untreated elderly patients with AML who are not eligible for standard induction therapy. The primary outcome measures are overall response rate (ORR) and adverse events (AE). The two-stage study will have a dose escalation and dose expansion stage. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03483948.

This study complements the ongoing Phase Ib dose expansion program of HMPL-523 in a broad range of hematological cancers in Australia (clinicaltrials.gov identifier: NCT02503033) and China (clinicaltrials.gov identifier: NCT02857998). These include chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, diffuse large B-cell lymphoma and Waldenstrom's macroglobulinemia. Chi-Med targets to present dose escalation results at a major scientific conference later in 2018 or in 2019. Chi-Med's U.S. Investigational New Drug (IND) application for HMPL-523 in hematological cancers was cleared by the Food and Drug Administration (FDA) at the end of June 2018 and hence Chi-Med is now planning for proof-of-concept development in the U.S.

About Syk
Syk is a non-receptor cytoplasmic tyrosine kinase primarily expressed in cells of hematopoietic lineage. Constitutive activation of Syk in AML has been reported and targeted inhibition of Syk demonstrated anti-leukemia activity in AML mouse models. Syk has also been shown to directly phosphorylate the FLT3 receptor, modulating its activation and possibly promoting its role in leukemogenesis.

About AML
AML, a cancer of blood and bone marrow characterized by rapid disease progression, is the most common acute leukemia. Undifferentiated blast cells proliferate in the bone marrow rather than mature into normal blood cells. AML occurs in children and adults of all ages, but is primarily a disease of older adults, with a median age at diagnosis of 67 years. AML is universally fatal without treatment, with a median survival of approximately two months.[1] The vast majority of patients do not respond to chemotherapy and progress to relapsed/refractory AML. The five-year survival rate for AML is approximately 27%.[2]

Combination chemotherapy regimens with or without hematopoietic stem cell transplantation (HSCT) are a mainstay of therapy for patients with newly diagnosed AML. Older patients with newly diagnosed AML who are ineligible for intensive chemotherapy typically have poor outcomes and few available treatment options. There is a clear need for new treatments for AML.

About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.


Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of HMPL-523, including in combination with azacitidine, plans to initiate clinical studies for HMPL-523 as a monotherapy or in combinations, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate HMPL-523 as a monotherapy or in combinations to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of HMPL-523 for a targeted indication and the sufficiency of funding. In addition, as the new Phase I study in China relies on the use of azacitidine as combination therapeutics with HMPL-523, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of azacitidine. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

First Commercial Launch of Fruquintinib Capsules
RNS
RNS Number : 4492I
Hutchison China Meditech Limited
26 November 2018

Press Release

Chi-Med Announces First Commercial Launch of Fruquintinib Capsules (Elunate®)

London: Monday, November 26, 2018: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces the first commercial launch of fruquintinib capsules (Elunate®) with the initiation of product sales in China. Elunate® is for the treatment of patients with metastatic colorectal cancer ("CRC") that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received or are unsuitable for anti-vascular endothelial growth factor (VEGF) therapy and/or anti-epidermal growth factor receptor (EGFR) therapy (Ras wild type).

CRC is the second most common cancer type in China[1], with about 380,000 new cases per year[2]. The market launch of Elunate® in China is being conducted through collaboration with Chi-Med's partner Eli Lilly and Company ("Lilly").

"This launch is a major milestone for Chi-Med," said Simon To, Chairman of Chi-Med. "We are very proud to have brought fruquintinib from its initial discovery through to its first sale, and now look forward to seeing patients in China benefit from this important new therapy." He added, "This achievement reinforces Chi-Med's position as a fast emerging biotech company, and illustrates China's capability to emerge as an important global force in oncology innovation."

Fruquintinib was first approved by the National Medical Products Administration of China ("NMPA") in September 2018 for the treatment of advanced CRC, becoming the first China-discovered and -developed pharmaceutical for a mainstream oncology indication to be unconditionally approved in China. Chi-Med has established a manufacturing facility in Suzhou, China to produce fruquintinib.

Dr. Wang Li, Senior Vice President, Head of Lilly China Drug Development & Medical Affairs Center, said, "We look forward to working with Chi-Med to bring this novel medicine to patients, addressing the significant unmet need in colorectal cancer in China."

Given the broad relevance of anti-angiogenesis therapies in cancer biology and the observed effects in various cancers to date, Chi-Med is developing fruquintinib in multiple further indications, including in combination with other cancer therapies.

About Other Fruquintinib Development Programs
Global Development
Phase I monotherapy in the U.S.: In December 2017, Chi-Med initiated a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors (clinicaltrials.gov identifier NCT03251378). This study is almost complete, and proof-of-concept ("POC") studies are expected to begin in 2019.
China Development
Colorectal cancer in China: The NMPA approved the first NDA for fruquintinib for the treatment of patients with advanced CRC in September 2018. The NDA is supported by data from the successful FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with CRC in China, which was highlighted in an oral presentation at the American Society of Clinical Oncology Annual Meeting held on June 5, 2017 and was published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier NCT02314819).

Gastric cancer in China: In October 2017, Chi-Med initiated a pivotal Phase III clinical trial of fruquintinib in combination with Taxol® (paclitaxel), known as the FRUTIGA study, in approximately 500 patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after first-line standard chemotherapy (clinicaltrials.gov identifier NCT03223376). An interim analysis on FRUTIGA, to establish POC, is anticipated during the first half of 2019 and if successful could trigger a POC milestone payment from Lilly. The FRUTIGA study followed a Phase I/II clinical trial in 34 patients with gastric cancer that demonstrated that combination therapy of fruquintinib and Taxol® was generally well-tolerated with promising tumor response (clinicaltrials.gov identifier NCT02415023).

Lung cancer in China: The FALUCA trial is a randomized, double-blind, placebo-controlled, multi-center, Phase III registration study targeted at treating patients with advanced non-squamous non-small cell lung cancer ("NSCLC"), who have failed two lines of systemic chemotherapy. 527 patients were randomized at a 2:1 ratio to receive either: 5mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus best supportive care ("BSC"); or placebo plus BSC. On November 16, 2018, Chi-Med announced that FALUCA did not meet the primary endpoint to demonstrate a statistically significant increase in overall survival compared to placebo, however the data did show statistically significant improvement in all secondary endpoints including progression-free survival, objective response rate, disease control rate and duration of response as compared to the placebo. The safety profile of the trial was in line with that observed in prior clinical studies. Full detailed results are expected to be disclosed at an upcoming scientific meeting. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT02691299.

Along with FALUCA, fruquintinib is concurrently being studied in a Phase II study in combination with Iressa® (gefitinib) in patients with untreated advanced or metastatic NSCLC (clinicaltrials.gov identifier NCT02976116). Preliminary results were highlighted in an oral presentation at the 18th World Conference on Lung Cancer on October 16, 2017.

Programmed cell death protein-1 ("PD-1") checkpoint inhibitor combination: It is an important part of Chi-Med's strategy to explore the potential synergies of its drug candidates in combination with other anti-cancer treatments in several solid tumor settings. In October 2018, Chi-Med entered into a further collaboration in China to evaluate the combination of fruquintinib with genolimzumab (GB226), a PD-1 inhibitor being developed by Genor Biopharma Company Limited.

About Fruquintinib
Fruquintinib (brand name: Elunate®) is a small molecule, selective and highly potent inhibitor of VEGFR 1, 2 and 3. VEGFR inhibitors play a pivotal role in tumor-related angiogenesis, cutting off the blood supply that a tumor needs to grow rapidly. The global market for anti-angiogenesis therapies was estimated at over US$18 billion in 2017, including both monoclonal antibodies and small molecules approved in around 30 tumor settings. During the discovery research process, which began at Chi-Med in 2007, fruquintinib was successfully designed to be differentiated by improving kinase selectivity in comparison to other approved small molecule tyrosine kinase inhibitors (TKIs), to minimize off-target toxicities, improve tolerability and provide more consistent target coverage, resulting in better clinical efficacy. The superior tolerability, along with fruquintinib's low potential for drug-drug interaction based on preclinical assessment, suggests that it may be highly suitable for innovative combinations with other anti-cancer therapies.

In October 2013, Chi-Med entered into a licensing, co-development and commercialization agreement in China with Lilly for fruquintinib. Under the terms of the agreement, the costs of development of fruquintinib, carried out by Chi-Med, are shared; Chi-Med has received upfront payments and development and regulatory approval milestone payments; and upon commercialization in China, Chi-Med would receive royalties. Chi-Med and Lilly agreed to develop fruquintinib in three initial solid tumor indications, including CRC, NSCLC and gastric cancer.

The most common adverse reactions included hypertension, hand-foot syndrome and proteinuria. Clinically effective management of these adverse effects is feasible. For important safety information about fruquintinib, please see www.chi-med.com.

About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 400 scientists and staff focusing on discovering, developing and commercializing targeted therapeutics in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med's Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.

Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the ability of fruquintinib to gain commercial acceptance in China, the potential market of fruquintinib for patients with metastatic CRC who have failed two prior treatments in China, the ability for Chi-Med to quickly provide fruquintinib to patients by year end, and the clinical development of fruquintinib in other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding Chi-Med's ability to obtain regulatory approval in different jurisdictions, to commercialize fruquintinib, that the benefits obtained from fruquintinib during clinical trials will be the same for all patients who are prescribed fruquintinib, that no unidentified side effects will occur which could result in the NMPA pulling fruquintinib from the market and the sufficiency of funding to support commercialization of fruquintinib in metastatic CRC and the development of fruquintinib in other indications. In addition, as certain studies rely on the use of Iressa® (gefitinib), Taxol® (paclitaxel), or genolimzumab (GB226) as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of Iressa®, Taxol®, and genolimzumab. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Chi-Med Enters into Multiple Collaborations
RNS
RNS Number : 8771I
Hutchison China Meditech Limited
29 November 2018

Press Release

Chi-Med Enters into Multiple Collaborations to Evaluate Combinations of
Surufatinib and Fruquintinib with PD-1 Checkpoint Inhibitors
London: Thursday, November 29, 2018: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) entered into four collaboration agreements to evaluate the safety, tolerability and efficacy of Chi-Med's surufatinib (HMPL-012 or sulfatinib) and fruquintinib in combination with checkpoint inhibitors. It is an important part of Chi-Med's strategy to explore the potential synergies of its drug candidates in combination with other anti-cancer treatments. These four new immunotherapy collaborations add to our ongoing studies combining savolitinib, Chi-Med's highly selective c-Met inhibitor, with AstraZeneca PLC's checkpoint inhibitor, durvalumab (Imfinzi®).

Today, Chi-Med is announcing the first steps to develop its vascular endothelial growth factor receptor ("VEGFR") inhibitors, surufatinib and fruquintinib, in combination with various programmed cell death protein-1 ("PD-1") monoclonal antibodies in several solid tumor settings:

· A global collaboration to evaluate the combination of surufatinib with toripalimab (JS001), a PD-1 monoclonal antibody being developed by Shanghai Junshi Biosciences Co. Ltd.;

· A global collaboration to evaluate the combination of fruquintinib with sintilimab (IBI308), a PD-1 monoclonal antibody being developed by Innovent Biologics (Suzhou) Co. Ltd.;

· A collaboration in China to evaluate the combination of surufatinib with HX008, a PD-1 monoclonal antibody being developed by Taizhou Hanzhong Pharmaceuticals, Inc.; and

· A collaboration in China to evaluate the combination of fruquintinib with genolimzumab (GB226), a PD-1 monoclonal antibody being developed by Genor Biopharma Co. Ltd.

The global market for angiogenesis inhibitors was over US$18 billion in 2017, based on their use in around 30 different tumor settings. Each of the agreements announced today will pursue different initial indications within the field of solid tumors.

"Recent innovations in solid tumor drugs have focused on targeted therapies and immunotherapies which, as monotherapies, have both provided improved patients outcomes," said Christian Hogg, Chief Executive Officer of Chi-Med. "We believe that the future of oncology treatments increasingly lies in combining therapies, utilizing multiple mechanisms of action ("MOA") to confront tumors. Our unique next-generation anti-angiogenesis VEGFR inhibitors, with high selectivity and tolerability, make them ideal candidates for such combinations with immunotherapy agents such as PD-1/L1 monoclonal antibodies to prolong and expand the benefits of these therapies to more patients."

Chi-Med's proof-of-concept studies have already demonstrated the benefits of combinations with other kinase inhibitors or with chemotherapy.

Surufatinib (HMPL-012 or sulfatinib) is a novel, oral angio-immuno kinase inhibitor that inhibits VEGFR and fibroblast growth factor receptor (FGFR) which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R) which regulates tumor-associated macrophages, promoting the body's immune response against tumor cells. This dual angiogenesis-checkpoint inhibitor's MOA may be very suitable for combination use with other immunotherapies. Surufatinib, as a monotherapy, is in late-stage clinical trials in China and began proof-of-concept clinical trials in the United States in July 2018.

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR. Its unique kinase selectivity has been shown to reduce off-target toxicity thereby allowing possible use in combination with other agents. It was first approved for colorectal cancer in China in September 2018. It is in several late-stage clinical trials for lung and gastric cancer, including in combination with chemotherapy such as paclitaxel (Taxol®) and other kinase inhibitors such as gefitinib (Iressa®), and is in a Phase I clinical trial in the United States.

About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 400 scientists and staff focusing on discovering, developing and commercializing targeted therapeutics in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med's Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.

Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of surufatinib and fruquintinib including as combination therapy with toripalimab, sintilimab, HX008 or genolimzumab; plans to initiate clinical studies for surufatinib and fruquintinib including as a combination therapy with toripalimab, sintilimab, HX008 or genolimzumab; its expectations as to whether such studies would meet their primary or secondary endpoints; and its expectations as to the timing of the enrollment completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of surufatinib and fruquintinib including as a combination therapy with toripalimab, sintilimab, HX008 or genolimzumab to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of surufatinib and fruquintinib including as a combination therapy with toripalimab, sintilimab, HX008 or genolimzumab for a targeted indication and the sufficiency of funding. In particular, as certain studies rely on the use of toripalimab, sintilimab, HX008 or genolimzumab as a combination therapeutic with surufatinib and fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and regulatory approval of toripalimab, sintilimab, HX008 or genolimzumab. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Amendment to lilly agreement

Amendment to lilly agreement on Fruquintinib