Chi-Med Highlights Clinical Data to be Presented at the Upcoming ESMO Virtual Congress 2020 - Seite 2

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells.  Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies.

A New Drug Application (“NDA”) for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the China National Medical Products Administration (“NMPA”) and granted Priority Review status in December 2019.  A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET has been submitted to the NMPA.  We have completed a pre-NDA meeting in the U.S. and received scientific advice in Europe, regarding surufatinib’s respective paths to registration in both geographies.  Chi-Med is planning a rolling NDA submission from late 2020 into early 2021 to the U.S. Food and Drug Administration (FDA), followed by a marketing authorization application (MAA) to the European Medicines Agency (EMA) in 2021.  In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET, and Orphan Drug Designation for pancreatic NET.  Additionally, surufatinib is in several late-stage and proof-of-concept trials in China, including in combination with immunotherapies, and proof-of-concept clinical trials in the U.S.

Chi-Med currently retains all rights to surufatinib worldwide.

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR 1/2/3.  VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis.  Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage.  The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may be highly suitable for combinations with other anti-cancer therapies.