Core Viewpoint - The new drug application for Fanregratinib (HMPL-453) for adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) has been accepted by the National Medical Products Administration of China and is prioritized for review [1] Company Summary - Hutchison China MediTech Limited (和黄医药) announced the acceptance of the new drug application for Fanregratinib, a selective oral inhibitor targeting FGFR1, 2, and 3 [1] - The drug is aimed at patients who have previously undergone systemic treatment and have FGFR2 fusion or rearrangement [1] Industry Summary - Intrahepatic cholangiocarcinoma (ICC) is a highly aggressive malignancy originating from the intrahepatic bile duct epithelium, accounting for approximately 8.2% to 15.0% of primary liver cancers, making it the second most common type after hepatocellular carcinoma [1] - The incidence of ICC has been steadily increasing, with a 5-year overall survival rate of about 9% [1] - Approximately 10-15% of global ICC patients have FGFR2 fusion or rearrangement [1] Research Summary - A Phase II registration study conducted in China, which was single-arm, multicenter, and open-label, provided data supporting the new drug application [1] - The study achieved the primary endpoint of objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), and overall survival (OS) also supporting the primary findings [1] - Complete study data is expected to be presented at an upcoming academic conference [1]