Updated: Oct 3, 2020
Chinese biotech company Hutchison China MediTech, popularly known as Chi-Med, on Thursday announced that its Second NDA for Surufatinib for the treatment of patients with advanced Pancreatic Neuroendocrine Tumors (NET) had been accepted for review by the China National Medical Products Administration (NMPA).
The NDA is backed by data from the successful SANET-p study, a Phase III pivotal study of Surufatinib in advanced pancreatic neuroendocrine tumors in China for patients in China for whom there is no effective therapy. The study was stopped early following positive interim analysis finalized in January 2020. The study's positive results demonstrating improved progression-free survival (PFS) will be presented at the 2020 European Society for Medical Oncology Congress (ESMO).
The first NDA targeted at non-pancreatic NET was approved by the NMPA in November 2019 and granted priority review status in December 2019.
Chi-Med retains exclusive rights to Surufatinib globally. The investigational drug is being tested in multiple solid tumors in China and the USA, both as a monotherapy and in combination with immunotherapies.
In April 2020, the company manage to get Fast Track designation from the FDA, to test Surufatinib for in pancreatic and non-pancreatic NET development programs Chi-Med has started preparatory work for the US NDA and plans to utilize a rolling submission, which is to begin late 2020. Additionally, the Marketing Authorization Application (MAA) submission in Europe is intended for 2021.