港股异动 | 康宁杰瑞制药-B(09966)涨超6% 恩尼妥®一线治疗HER2阳性晚期乳腺癌III期临床研究达到主要终点

智通财经
Jun 11

智通财经APP获悉,康宁杰瑞制药-B(09966)涨超6%,截至发稿,涨4.22%,报6.92港元,成交额515.34万港元。

消息面上,6月10日,康宁杰瑞制药-B发布公告,与石药集团(01093)附属公司上海津曼特生物科技有限公司(津曼特生物)合作开发的安尼妥单抗(商品名:恩尼妥®,研发代号:KN026)联合注射用多西他赛(白蛋白结合型)(HB1801)用于人类表皮生长因子受体2(HER2)阳性(HER2+)晚期乳腺癌一线治疗的III期临床研究(研究代号:KN026-003),经独立数据监察委员会(IDMC)评估,成功达到预先设定的主要终点无进展生存期(PFS),结果具有显著的统计学和临床双重意义。

KN026-003是一项随机、对照、开放、多中心III期临床研究,计划纳入约880例 HER2+晚期乳腺癌患者,按照1:1比例随机分配,旨在比较KN026联合HB1801对比THP方案用于HER2+晚期乳腺癌一线治疗的有效性和安全性,其主要研究终点为盲态独立评估委员会(BIRC)评估的PFS。经IDMC评估,KN026联合HB1801较 THP方案显著延长了患者的PFS,降低了疾病进展或死亡风险,且具有总生存期 (OS)获益趋势。该研究的详细数据将在近期国际学术会议上公布。

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