Hutchison China Meditech Limited

Sulfatinib Phase II Study in 2nd Line BTC in China

HONG KONG, CHINA--(Marketwired - Jan 16, 2017) - Hutchison China Meditech Limited (NASDAQ: HCM) (AIM: HCM)

Press Release

Chi-Med Initiates a Phase II Study of Sulfatinib in Second-line Biliary Tract Cancer in China

London: Monday, January 16, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that it has initiated a Phase II study of sulfatinib in second-line biliary tract cancer ("BTC") patients in China. Sulfatinib is an oral, novel angio-immunokinase inhibitor that selectively targets vascular endothelial growth factor receptor ("VEGFR"), fibroblast growth factor receptor ("FGFR") and colony-stimulating factor-1 receptor ("CSF-1R"), three key tyrosine kinase receptors involved in tumor angiogenesis and immune evasion. The first drug dose was administered on January 9, 2017.

This Phase II study is a multi-center, single-arm, open-label study to evaluate the efficacy and safety of sulfatinib as a monotherapy in treating advanced or metastatic BTC patients who failed one prior systemic therapy. The primary endpoint is progression free survival ("PFS") at 16 weeks, with secondary endpoints including objective response rate ("ORR"), disease control rate ("DCR"), duration of response, PFS, overall survival ("OS") and safety. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02966821.

About BTC
BTC, also known as cholangiocarcinoma, is a heterogeneous group of rare but fatal malignancies arising from the biliary tract epithelia, including intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma. BTC is the second most frequently occurring type of liver cancer in the world, after hepatocellular carcinoma (HCC), accounting for approximately 15% of all liver cancer cases¹. In 2017, there will be approximately 18,000 new BTC cases in the United States, according to the National Cancer Institute. However, in China, the incidence can be up to 40 times the rate observed in the Western world².

Gemcitabine is the current first-line therapy for BTC patients, either as a monotherapy or in combination with cisplatin, and there is no established second-line therapy for this fatal disease worldwide. The median life expectancy is less than 12 months for patients with unresectable or metastatic disease at diagnosis. Accordingly, we see a high unmet medical need for new targeted treatment options.