BRIEF—Hutchmed’s fanregratinib NDA accepted in China

Chinese biotech Hutchmed today announces that the New Drug Application (NDA) for fanregratinib (HMPL-453) for the treatment of adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma (ICC) with fibroblast growth factor receptor (FGFR) 2 fusion/rearrangement who have previously received systemic therapy has been accepted and granted priority review by the China National Medical Products Administration (NMPA).

Fanregratinib (HMPL‑453) is a novel, selective, oral inhibitor targeting FGFR 1/2/3.

ICC is a highly aggressive malignancy arising from the intrahepatic biliary epithelium. It accounts for 8.2%-15.0% of primary liver cancers, and consequently it is the second most common type after hepatocellular carcinoma.