HUTCHMED NDA for Fanregratinib in China Gets Priority Review
HUTCHMED (Nasdaq/AIM: HCM) announced that the New Drug Application for fanregratinib (HMPL-453) in second-line intrahepatic cholangiocarcinoma (ICC) with FGFR2 fusion/rearrangement has been accepted and granted priority review by the China NMPA on Dec 29, 2025. Fanregratinib is an oral selective FGFR 1/2/3 inhibitor. The NDA is supported by a single-arm, multi-center Phase…
