Globenewswire·2025-12-29 08:35Core Insights - HUTCHMED's New Drug Application (NDA) for fanregratinib has been accepted and granted priority review by the China National Medical Products Administration (NMPA) for treating advanced intrahepatic cholangiocarcinoma (ICC) patients with FGFR2 fusion/rearrangement who have previously undergone systemic therapy [1][3]. Company Overview - HUTCHMED is an innovative, commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [5]. - The company retains all global rights to fanregratinib, which is a selective oral inhibitor targeting FGFR 1, 2, and 3 [4]. Industry Context - ICC is the second most common form of liver cancer, accounting for 8.2-15.0% of primary liver cancers, with a rising incidence and a 5-year overall survival rate of approximately 9% [2]. - About 10-15% of ICC patients globally have tumors with FGFR2 fusions or rearrangements, indicating a specific target for fanregratinib [2]. Clinical Data - The NDA is supported by a Phase II registration study in China, which met its primary endpoint of objective response rate (ORR) and showed positive results in secondary endpoints such as progression-free survival (PFS) and overall survival (OS) [3].