港股异动 | 和黄医药(00013)午前涨超5% 宣布沃瑞沙与泰瑞沙联合疗法已获国家药监局批准

智通财经
02 Jul

智通财经APP获悉,和黄医药(00013)午前涨超5%,截至发稿,涨4.88%,报24.7港元,成交额1.88亿港元。

消息面上,6月30日,和黄医药发布公告,宣布沃瑞沙®和泰瑞沙®的联合疗法已获得中国国家药品监督管理局的批准,用于治疗伴有MET扩增的一线EGFR抑制剂治疗后疾病进展的肺癌患者。这一批准基于SACHIIII期研究的数据,结果显示该联合疗法能降低66%的疾病进展或死亡风险,且在所有一线EGFR抑制剂治疗后均显示出一致的获益。

据了解,此次批准还将触发来自阿斯利康的1100万美元里程碑付款。沃瑞沙®作为中国首个获批的选择性MET抑制剂,针对伴有MET外显子14跳变的局部晚期或转移性非小细胞肺癌患者。根据SACHI研究的评估,该联合疗法的中位无进展生存期(PFS)为8.2个月,而化疗组为4.5个月,显示出良好的安全性特征,3级或以上不良事件的发生率均为57%。

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