Core Viewpoint - The announcement by Hutchison China MediTech regarding the acceptance of the new drug application for Fruquintinib for advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) patients with FGFR2 fusion or rearrangement has been prioritized for review by the National Medical Products Administration of China [1] Company Summary - Hutchison China MediTech has developed Fruquintinib, a novel selective oral inhibitor targeting FGFR1, 2, and 3 [1] - The drug is aimed at adult patients who have previously undergone systemic treatment and have specific genetic markers related to their cancer [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 five-year overall survival rate of about 9% [1] - Approximately 10-15% of global ICC patients have FGFR2 fusion or rearrangement, indicating a specific target population for Fruquintinib [1]
和黄医药：凡瑞格拉替尼 (HMPL-453) 用于二线治疗肝内胆管癌的上市申请获受理并获纳入优先审评