港股异动 | 康宁杰瑞制药-B(09966)涨超12% HER2双抗ADC皮下注射复方制剂首次公布临床结果

智通财经
14 Nov 2024

智通财经APP获悉,康宁杰瑞制药-B(09966)涨超12%,截至发稿,涨12.67%,报5.07港元,成交额4735.2万港元。

消息面上,11月13日,康宁杰瑞生物制药宣布,HER2双特异性抗体偶联药物(ADC)与PD-L1抑制剂的高浓度皮下注射复方制剂JSKN033的一项临床试验(研究编号:JSKN033-102)符合《优化创新药临床试验审评审批试点工作方案》相关要求,获得上海市药品监督管理局(经药品审评中心(CDE)同意)纳入试点项目,将按要求向CDE提交临床试验申请,预计通过快速通道进行审评审批,以加速启动该项针对晚期恶性肿瘤的Ⅰ/Ⅱ期临床研究。

此前,康宁杰瑞公布HER2双特异性抗体偶联药物(ADC)与PD-L1抑制剂的高浓度皮下注射复方制剂JSKN033的首次人体临床研究结果。该研究入选了2024年第39届癌症免疫治疗学会(SITC)年会最新突破性摘要,于会议期间以壁报形式首次公布。研究结论显示,JSKN033安全性良好,在多线治疗后疾病进展的实体瘤患者中初步显示出令人鼓舞的抗肿瘤活性。本研究进一步证明了ADC联合免疫治疗的潜力,并支持对JSKN033的持续探索。

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