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Innovation Platform, RNS Announcements | 1 Feb 2011

Fruquintinib receives SFDA IND approval Starts Phase I Clinical Trial for the treatment of cancer

London: Tuesday, 1 February 2011: Hutchison MediPharma Limited (“Hutchison MediPharma”), the drug R&D company majority owned by Chi-Med, today announces that it has started the first-in-human Phase I clinical trial of its anti-cancer drug candidate, Fruquintinib. This follows approval from the State Food and Drug Administration (“SFDA”) in China. Similar to Hutchison MediPharma’s drug candidate Sulfatinib, the investigational new drug (IND) application for Fruquintinib was reviewed through the SFDA’s Green Channel expedited application process. The first patients were dosed on 28 January 2011.

Fruquintinib (HMPL-013) is a novel small molecule that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFR). Pre-clinical data shows that this compound is a potent suppressor of angiogenesis, an established approach in anti-cancer treatment. In low doses, Fruquintinib has potent inhibitory effects on multiple human tumour xenografts, including some hard-to-treat tumours such as pancreatic cancer and melanoma. It is differentiated from Sulfatinib and other drugs in this class either on the market or in clinical development by its kinase selectivity in vitro and superior potency in vivo against a variety of human tumour xenografts. Fruquintinib was discovered and developed internally by Hutchison MediPharma.

The Phase I clinical study is being conducted in China. The trial is an open-label, dose-escalation study. The primary objective of the trial is to determine the maximum tolerated dose (MTD) and assess the safety and tolerability in patients with advanced solid tumours. The secondary objectives include the assessment of single and multiple dose pharmacokinetics and the evaluation of Fruquintinib’s antitumor activity.