China's regulator accepts surufatinib NDA in non-pancreatic neuroendocrine tumors

One year after achieving landmark approval in China for the first ever China-discovered and developed targeted oncology drug to receive unconditional approval (fruquintinib, for colorectal cancer), the Hong Kong-headquartered and Nasdaq-listed Chi-Med is on the way to commercializing its second China-developed drug, this time for advanced non-pancreatic neuroendocrine tumors (NETs).

China’s National Medical Products Administration (NMPA) has accepted Hutchison China MediTech’s (Nasdaq: HCM), also known as Chi-Med, New Drug Application (NDA) for surufatinib to treat non-pancreatic NETs, reflecting the accelerated pace of drugs approvals in China and Chi-Med’s commitment to advance its pipeline of novel therapies in China and globally. Chi-Med’s shares closed up 3.5% at 360 pence today

Unlike Chi-Med’s first approved drug, Elunate (fruquintinib), which is marketed by Eli Lilly (NYSE: LLY) in China, the company plans to commercialize surufatinib using its own commercial organization, which covers over 24,400 hospitals in over 330 cities and towns in China. Both drugs are undergoing proof of concept trials in the USA.