May 25, 2016 1:38 PM 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

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
Head of Oncology Research and Vice President
Compensation as of Fiscal Year 2015.

Hutchison MediPharma Limited Key Developments

Hutchison MediPharma Limited Initiates First-In-Human Clinical Trial of Novel PI3K inhibitor HMPL-689

Hutchison China MediTech Limited announced that Hutchison MediPharma Limited (HMP), its drug R&D subsidiary, has initiated the first-in-human (FIH) Phase I clinical trial of HMPL-689 in Australia. HMPL-689 is a novel, highly selective and potent small molecule inhibitor targeting the delta isoform of the phosphatidylinositol-3-kinase, also known as PI3Kd, a key component in the B-cell receptor signaling pathway. The first drug dose was administered on April 7, 2016. The FIH trial aims to evaluate the safety, tolerability, and pharmacokinetics properties of HMPL-689. This randomized, double blind, placebo-controlled, dose-escalating Phase I study of HMPL-689 will be conducted in healthy adult volunteers. Following this FIH Phase I trial, HMP plans to investigate HMPL-689 in hematological malignancies. In pre-clinical studies, not only did HMPL-689 demonstrate a superior potency and better kinase selectivity as compared to drugs in the same class, but it also showed significant efficacy and a favorable safety profile.

Hutchison MediPharma Limited Initiates Sulfatinib Phase III Registration Study in Pancreatic Neuroendocrine Tumor Patients

Hutchison MediPharma Limited has initiated SANET-p, a Phase III registration trial of sulfatinib (HMPL-012) in China in patients with pancreatic neuroendocrine tumors. The first patient was dosed on March 18, 2016. The protocol for SANET-p is similar to SAbNET-ep, a Phase III registration trial in patients with extra-pancreatic NETs. SANET-p is a randomized, double-blind, placebo-controlled, multi-center Phase III sulfatinib registration study to treat patients with low or intermediate grade advanced NET whose disease has progressed, locally advanced or distant metastasized and for whom there is no effective therapy. Patients are randomized at a 2:1 ratio to receive either 300 milligrams of sulfatinib orally once per day, or placebo, on an every 28-day treatment cycle. The primary objective of this study is to evaluate the progression-free survival of sulfatinib as compared to that of placebo, with secondary endpoints including objective response rate, disease control rate, time to response, duration of response, overall survival, safety and tolerability. Approximately 195 patients are expected to be enrolled in the SANET-p study from more than 20 centers across China, with top-line results expected in 2018. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02589821.

Hutchison MediPharma Limited Initiates Open-Label Phase II Clinical Trial to Evaluate Efficacy and Safety

Hutchison MediPharma Limited has initiated an open-label Phase II clinical trial to evaluate the efficacy and safety of sulfatinib (HMPL-012) in patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer or medullary thyroid cancer in China. The first patient was dosed on March 1, 2016. The company plans to enroll approximately 50 DTC and MTC patients into this study, with approximately 25 patients in each tumor type. The primary objective is to evaluate the objective response rate, while secondary and exploratory objectives include the evaluation of safety and tolerability, other efficacy parameters, pharmacokinetics, and tumor biomarkers. The study employs a two-stage design in which 15 subjects of each tumor type will be enrolled in the first stage. An additional 10 subjects in each tumor type will be enrolled after efficacy assessment in the second stage. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02614495. Sulfatinib is an oral drug candidate that selectively inhibits the tyrosine kinase activity associated with the vascular endothelial growth factor receptor and fibroblast growth receptor, two tyrosine kinase receptors associated with angiogenesis and tumor growth. The company believes that sulfatinib's VEGFR/FGFR1 inhibition profile has strong potential in second-line thyroid cancer patients, particularly in China where there are few safe and effective treatment options for this patient population.

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