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

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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. 
 

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

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

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

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

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

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

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

Final results

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

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

Maximum amount per annum for the 2017-2019 LTIP



Mr Christian Hogg (Executive Director and Chief Executive Officer)

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

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

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

Cash Amount for Non-performance LTIP



Mr Christian Hogg (Executive Director and Chief Executive Officer)

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

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

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

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

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

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

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

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

Director share dealing