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

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

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

Director share dealing

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

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

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



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


Story provided by StockMarketWire.com

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

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

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

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

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

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

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

Going into orbit. :-))

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

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

Proposed offering of ADSs

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

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

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

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

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

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

Chi-Med to Announce 2017 Final Results

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

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

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

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