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HUTCHMED (00013) announced that the New Drug Application (NDA) for fanregratinib (HMPL-453), a novel, selective oral inhibitor targeting fibroblast growth factor receptor (FGFR) 1, 2, and 3, has been formally accepted by China's National Medical Products Administration (NMPA) and granted priority review status. This application pertains to the treatment of adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) who have previously undergone systemic therapy and harbor FGFR2 fusions or rearrangements. Intrahepatic cholangiocarcinoma, a highly aggressive malignancy arising from the intrahepatic bile duct epithelium, constitutes approximately 8.2% to 15.0% of primary liver cancers, making it the second most common type of liver cancer following hepatocellular carcinoma. In recent years, its incidence has been steadily increasing, with a 5-year overall survival rate of merely around 9%. Globally, roughly 10-15% of intrahepatic cholangiocarcinoma patients present with FGFR2 fusions or rearrangements. The submission of this NDA is supported by data from a single-arm, multi-center, open-label Phase II registration study conducted in China. The study successfully achieved the primary endpoint of objective response rate (ORR), while secondary endpoints including progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), and overall survival (OS) further corroborated the findings of the primary endpoint. The complete study data is scheduled to be presented at an academic conference in the near future.