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

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.

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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.