智通财经APP获悉，周五，和黄医药(HCM.US)涨近4%，报16.64美元。消息面上，3月6日，和黄医药公告，HMPL-453 (fanregratinib)用于治疗伴有成纤维细胞生长因子受体(FGFR)2融合/重排的肝内胆管癌患者的II期临床试验已完成患者入组。
该研究是一项单臂、多中心、开放标签的II期注册研究，旨在评估HMPL-453用于治疗伴有FGFR2融合/重排的晚期肝内胆管癌患者的疗效、安全性和药代动力学。研究的主要终点是客观缓解率(ORR)。次要终点包括无进展生存期(PFS)、疾病控制率(DCR)、缓解持续时间(DoR)和总生存期(OS)。注册研究阶段共纳入87名患者 。
研究的首名患者于2023年3月接受首次给药治疗，和黄医药预计将在2025年年底左右公布该研究的顶线结果。若取得积极结果，将支持向中国国家药品监督管理局提交新药上市申请。
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