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February 06, 2016 5:45 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
Age: 58
Head of Drug Metabolism & Pharmacokinetics and Vice President
Senior Vice President of Pharmaceutical Sciences
Age: 56
Senior Vice President and Head of Clinical Development & Regulatory Affairs
Compensation as of Fiscal Year 2015.

Hutchison MediPharma Limited Key Developments

Hutchison MediPharma Limited Initiates Phase I Trial in Australia in Patients with Haematological Malignancies

Hutchison China MediTech Limited announced that Hutchison MediPharma Limited has initiated a Phase I trial in Australia in patients with haematological malignancies. HMPL-523 is a novel, highly selective and potent small molecule oral inhibitor targeting spleen tyrosine kinase, also known as Syk, a key component in B-cell receptor signalling. Preparations and site selection began in late 2015 and the first patient was dosed on 13 January 2016. This trial follows the successful completion of a first-in-human Phase I clinical trial in healthy volunteers in October 2015. The new study is a Phase I, open-label, dose escalation study of HMPL-523 as monotherapy administered orally to patients with relapsed or refractory haematological malignancies who are unable to tolerate standard therapy or for whom there is no effective therapy. Two stages for this study are planned: a dose escalation stage and a dose-expansion stage. The primary objectives of the study are to evaluate safety and tolerability, and to determine the maximum tolerated dose and/or recommended Phase II dose of HMPL-523 in this patient population. Other objectives include the evaluation and characterisation of the pharmacokinetics of HMPL-523 and its metabolites, and to make preliminary assessments of the anti-tumour activity of HMPL-523 in certain sub-populations in the dose expansion phase of the trial. The successful completion of the first-in-human study in healthy volunteers in 2015 has established the safety profile of HMPL-523. HMP now hopes that this Phase I study in haematological malignancies could provide clinical proof-of-concept that modulation of the B-cell signalling pathway through inhibition of Syk will provide patients with a clinical benefit.

Hutchison MediPharma Initiates Sulfatinib U.S. Clinical Trials

Hutchison China MediTech Limited announced that Hutchison MediPharma Limited has initiated the Phase I clinical trial of sulfatinib (HMPL-012) in the United States. Its U.S. HMP is also planning to initiate two Phase III registration studies for the treatment of neuroendocrine tumours ("NET") and a Phase Ib study for the treatment of thyroid cancer with sulfatinib in China by the end of 2015. This Phase I dose escalation study is to assess the safety and tolerability of sulfatinib in U.S. patients with advanced solid tumours. A U.S. Phase II study in NET is expected to be initiated based on the conclusion of this Phase I dose escalation study. Sulfatinib is an oral drug candidate that selectively inhibits the tyrosine kinase activity associated with the vascular endothelial growth factor receptor ("VEGFR") and fibroblast growth receptor ("FGFR"), a receptor for a protein which also plays a role in tumour growth. In a Phase I clinical trial in China focusing on NET patients, sulfatinib's objective response rate among the 18 efficacy-evaluable NET patients was 44.4%. By comparison, sunitinib and everolimus, the two approved single agent therapies for pancreatic NET, achieved objective response rates of less than 10% in their pivotal clinical trials. Furthermore, NET responses to sulfatinib have been observed to improve gradually with time. Results of the Phase I trial in China will be reported at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in November 2015.

Hutchison MediPharma Limited Completes First-In-Human Phase I Clinical Trial of HMPL-523

Hutchison China MediTech Limited announced that Hutchison MediPharma Limited has successfully completed its first-in-human Phase I clinical trial of HMPL-523. HMPL-523 is a novel, highly selective and potent small molecule inhibitor targeting spleen tyrosine kinase, also known as Syk, a key component in B-cell receptor signaling. The first-in-human Phase I study of HMPL-523 was a dose-escalating study conducted to assess the safety, tolerability and pharmacokinetics of both single and repeat doses of HMPL-523 in healthy volunteers in Australia. The study began in June 2014, and completed ten single dose cohorts, with eight patients per cohort, from 5 mg single dose through 800 mg single dose. In April 2015, the multiple ascending dose section of the Phase I study commenced in which HMPL-523 was administered once daily for 14 consecutive days. Four dose cohorts have now completed this section of the study, again with eight patients per cohort, from 200 mg multiple dose through to 400 mg multiple dose. At 400 mg daily, HMPL-523 drug exposures are believed to be well above the predicted efficacious dose level and, consequently, there is no intention to escalate further in healthy volunteers.

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