Hutchmed Regulatory News (HCM)

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

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

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

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

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

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

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About vascular endothelial growth factor ("VEGF") and colorectal cancer in China

At an advanced stage, tumours secrete large amounts of VEGF, a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumour in order to provide greater blood flow, oxygen, and nutrients to the tumour. VEGF and VEGF receptors ("VEGFRs") play a pivotal role in tumour-related angiogenesis, and inhibition of the VEGF/VEGFR pathway therefore represents an exciting therapeutic strategy in blocking the development of new blood vessels essential for tumour to grow and invade.

Colorectal cancer is the third most commonly diagnosed cancer in China, with 10.2% incidence in 2012. An estimated 390,000 cases of colorectal cancer were diagnosed in China. It is the fifth most common cause of cancer death after lung, liver, stomach and oesophagus cancer.

To date, several anti-VEGF/VEGFR agents have shown clinical efficacy against a number of tumour types. Given the scale and growth in the China oncology market, the market for VEGF/VEGFR inhibitors in China is expected to develop quickly in the next few years.

About HMP

HMP is a novel drug R&D company focusing on discovering, developing and commercialising innovative therapeutics in oncology and autoimmune diseases. With a team of around 200 scientists and staff, its pipeline is comprised of novel oral compounds for cancer and inflammation in development in North America, Europe, Australia and Greater China.

HMP is majority owned by Chi-Med. For more information, please visit: www.hmplglobal.com.

About Chi-Med

Chi-Med is a China-based healthcare group focused on researching, developing, manufacturing and selling pharmaceuticals and health-related consumer products. Its China Healthcare Division manufactures, markets and distributes prescription and over-the-counter pharmaceuticals in China. Its Drug R&D Division focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases. Its emerging Consumer Products Division focuses on organic and natural consumer products in Asia.

Chi-Med is majority owned by the multinational conglomerate Hutchison Whampoa Limited (SEHK:13). For more information, please visit: www.chi-med.com.