Shots:

• The NDA is based on two P-III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China. The anticipated PDUFA date is April 30- 2022
• The same data from the studies will be used to file MAA to the EMA imminently- based on scientific advice from the EMA’s Committee for Medicinal Products for Human Use
• Surufatinib received FTD in Apr’20 and ODD in Nov’19 for the treatment of pancreatic and extra-pancreatic NET. Hutchmed currently retains all rights to surufatinib globally

  | Ref: Hutchmed | Image: Hutchmed