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热点栏目自选股数据中心行情中心资金流向模拟交易客户端

  和黄医药(00013)早盘上涨6.56%,现报23.55港元,成交额7066.69万港元。

  4月22日,和黄医药发布公告,赛沃替尼用于治疗MET扩增胃癌患者的II期研究的注册阶段已完成患者入组。

  据介绍,该临床试验是一项单臂、多中心、开放标签的II期注册研究,旨在评估赛沃替尼用于治疗伴有MET扩增的胃癌和胃食管结合部(GEJ)腺癌的疗效、安全性和耐受性。研究的主要终点为独立审查委员会(IRC)评估的客观缓解率(ORR)(依据RECIST1.1进行评估)。次要终点包括无进展生存期(PFS)、各种不良事件的发生率等。研究共纳入64名患者。

  中国国家药品监督管理局(国家药监局)已将赛沃替尼纳入突破性治疗药物品种,用于治疗既往接受过至少两线标准疗法失败的MET扩增的局部晚期或转移性胃癌或胃食管结合部(GEJ)腺癌患者。如果研究取得积极结果,和黄医药有望于2025年年底在中国启动向国家药监局递交赛沃替尼用于治疗胃癌的上市许可申请。

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