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

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.

Story provided by StockMarketWire.com
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

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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.





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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."







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