Core Viewpoint - The announcement by Hutchison China MediTech Limited (00013.HK) regarding the acceptance of the new drug application for Fanregratinib (HMPL-453) by the National Medical Products Administration of China highlights a significant advancement in the treatment options for advanced intrahepatic cholangiocarcinoma (ICC) patients with FGFR2 fusion or rearrangement [1] Company Summary - Hutchison China MediTech Limited has received acceptance for its new drug application for Fanregratinib, a selective oral inhibitor targeting FGFR1, 2, and 3, specifically for adult patients with advanced, metastatic, or unresectable ICC who have previously undergone systemic therapy [1] - The drug application has been prioritized for review by the National Medical Products Administration, indicating its potential significance in the market [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 Fanregratinib [1]
和黄医药(00013.HK)：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