2nd NDA for Chi-Med's surufatinib accepted by China's NMPA

Chinese biotech company Hutchison China MediTech (AIM: HCM), commonly-known as Chi-Med, today announced that its New Drug Application (NDA) for surufatinib for the treatment of patients with advanced pancreatic neuroendocrine tumors (NET) has been accepted for review by the China National Medical Products Administration (NMPA).

The NDA is supported by data from the successful SANET-p study, a Phase III pivotal study of surufatinib in advanced neuroendocrine tumors – pancreatic patients in China for whom there is no effective therapy. 0The study was terminated early following positive interim analysis completed in January 2020. The positive results of the study demonstrating improvement in progression free survival (PFS) will be presented at the 2020 European Society for Medical Oncology Congress (ESMO).

This is the second NDA acceptance for surufatinib. The first NDA for non-pancreatic NET was accepted by the NMPA in November 2019 and was granted priority review status in December 2019.