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September 03, 2015 6:19 AM ET

Pharmaceuticals

Company Overview of Hutchison MediPharma Limited

Company Overview

Hutchison MediPharma Limited, a drug development company, focuses on discovering, developing, and commercializing therapeutics for oncology and autoimmune diseases. Its product portfolio includes HMPL-004, an oral botanical product that acts on multiple targets in the pathogenesis of inflammatory bowel disease; HMPL-504/AZD6094 (Volitinib), a potent ATP-competitive c-Met inhibitor for renal, gastric, and non-small cell lung cancer, as well as others with c-Met deregulation; Fruquintinib (HMPL-013), a small molecule compound that inhibits vascular endothelial growth factor (VEGF) receptors; and Sulfatinib (HMPL-012), a small molecule that inhibits the tyrosine kinase activity associated with ...

Building 4

917 Halei Road

Zhangjiang Hi-Tech Park

Pudong

Shanghai,  201203

China

Founded in 2002

Phone:

86 21 2067 3000

Fax:

86 21 2067 3186

Key Executives for Hutchison MediPharma Limited

Director and Chief Executive Officer of Hutchison China Meditech Limited
Age: 49
Chief Scientific Officer and Executive Vice President of Drug Research
Head of Drug Metabolism & Pharmacokinetics and Vice President
Senior Vice President of Pharmaceutical Sciences
Senior Vice President and Head of Clinical Development & Regulatory Affairs
Compensation as of Fiscal Year 2015.

Hutchison MediPharma Limited Key Developments

AstraZeneca AB (publ) and Hutchison MediPharma Limited Announce Savolitinib (AZD6094) Preliminary Phase Ib Clinical Data in Lung Cancer

AstraZeneca AB (publ) (AstraZeneca) and Hutchison MediPharma Limited's (HMP) collaboration partner, presented preliminary data from the ongoing Phase Ib clinical trial of HMP's c-Met inhibitor savolitinib (AZD6094) combined with AstraZeneca's drug candidate AZD9291 in non-small cell lung cancer ("NSCLC"). AZD9291 is AstraZeneca's investigational inhibitor of the epidermal growth factor receptor (EGFR). Preliminary data on the activity of AZD9291 in patients with EGFR mutation positive NSCLC who had failed currently-approved EGFR tyrosine kinase inhibitors was presented at the American Society of Clinical Oncology (ASCO) meeting in June 2014. In mid-2014 AstraZeneca commenced the TATTON study, a multi-arm Phase Ib study of AZD9291 in combination with either savolitinib (AZD6094) (c-MET inhibitor), MEDI4736 (anti-PD-L1 mAb) or selumetinib (MEK1/2 inhibitor) in EGFR mutation positive NSCLC. For those patients who received AZD9291 and savolitinib, the primary objective of the TATTON study was to establish a safe and effective combination dose. All patients were screened for their T790M status (+/-) as well as some, if sufficient tissue samples were available, for their c-Met (+/-) status. A total of 12 patients were dosed with either 600mg or 800mg daily doses of savolitinib (AZD6094) in combination with 80mg (once daily) AZD9291. In terms of the primary aims of the study, the 600mg combination dose was well tolerated with toxicity profiles that allow for combination at doses previously demonstrated to be biologically active. Of the 11 evaluable patients in the study, 6 partial responses (confirmed and unconfirmed) have been observed to date. Responses to date include 4 of 7 patients with confirmed T790M negative status.

Hutchison China Meditech Announces Patient Enrolment Completion for Phase II Study

Chi-Med announced that Hutchison MediPharma Limited has completed patient enrolment in a Phase II clinical trial of fruquintinib (HMPL-013) in non-small cell lung cancer patients 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. This randomized, double-blind, placebo-controlled, multi-centre, POC Phase II study is targeted at treating non-squamous NSCLC patients who have failed second-line standard chemotherapy. A total of 91 patients have now been randomized to receive fruquintinib plus best supportive care 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 mid of 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. Based on the Phase I data in colorectal cancer, 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. In April 2014, HMP initiated the first POC Phase II study, which was a randomized, double-blind, placebo-controlled, multi-centre Phase II clinical trial targeted at patients with metastatic CRC. The POC Phase II study subsequently completed enrolment in August 2014, and will report data during the first half of 2015. In October 2014, HMP initiated a Phase Ib dose-finding study of fruquintinib, in combination with paclitaxel, in second line gastric cancer patients. In December 2014, HMP initiated FRESCO, a Phase III registration study in patients with locally advanced or metastatic CRC, who have failed at least two prior systemic antineo-plastic therapies, including flouropyrimidine, oxaliplatin and irinotecan. FRESCO will enroll more than 400 patients in 25 centers in China, with top-line results expected in 2016.

Hutchison MediPharma Limited Announces Initiation of Fruquintinib Phase III Registration Study in Colorectal Cancer

Hutchison MediPharma Limited (HMP), has initiated FRESCO, a Phase III registration study in colorectal cancer (CRC) patients in China, for fruquintinib (HMPL-013), its investigational small molecule which selectively inhibits vascular endothelial growth factor receptors (VEGFR). Preparations and site selection began in the middle of this year, with the first patient dosed on 12 December 2014. This randomised, double-blind, placebo-controlled, multicentre, Phase III registration study is targeted at treating patients with locally advanced or metastatic CRC, who have failed at least two prior systemic antineoplastic therapies, including fluoropyrimidine, oxaliplatin and irinotecan. Patients will be randomised at a 2:1 ratio to receive either: 5 milligrams 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, with secondary endpoints including progression free survival, objective response rate, disease control rate and duration of response. More than 400 patients will be enrolled in about 25 centres, with top-line results expected in 2016. Fruquintinib is designed to selectively inhibit VEGF receptors, namely VEGFR1, VEGFR2, and VEGFR3. 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. This represents therapeutic strategy in blocking the development of new blood vessels essential for tumours to grow and invade. 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.

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