中国快速审查HutchMed的fanregratinib对带有特定基因突变的高级大肠杆菌癌进行快速审查。 China fast-tracked review of HutchMed’s fanregratinib for advanced bile duct cancer with specific gene mutation.

中国的NMPA已经接受并优先审查HutchMED的Fanregratinib新药物应用软件,这是一个针对先进的肝内胆固醇瘤的定向疗法,对以前接受过系统治疗的成人进行了FGFR2改造。 China’s NMPA has accepted and granted priority review to HUTCHMED’s New Drug Application for fanregratinib, a targeted therapy for advanced intrahepatic cholangiocarcinoma with FGFR2 alterations in adults who have previously received systemic treatment. 应用基于积极的第二阶段试验结果,显示有显著的客观答复率,以及关于无进展生存和总体生存的支持性数据。 The application is based on positive Phase II trial results showing a significant objective response rate, along with supportive data on progression-free survival and overall survival. Fanregratinib抑制了FGFR1、2和3肿瘤生长的主要驱动因素。 Fanregratinib inhibits FGFR1, 2, and 3, key drivers in tumor growth. 药品的批准仍须接受监管评价。 The drug’s approval remains subject to regulatory evaluation.