Core Viewpoint - The new drug application for Fanregratinib (HMPL-453) for the treatment of advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) in adult patients has been accepted by the National Medical Products Administration of China and is included in priority 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 received 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 on the rise, 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 a single-arm, multicenter, open-label trial, 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]
和黄医药(00013)宣布凡瑞格拉替尼 (HMPL-453) 用于二线治疗肝内胆管癌的中国新药上市申请获受理并获纳入优先审评