康宁杰瑞制药-B现涨逾12% HER2双抗ADC皮下注射复方制剂首次公布临床结果

金融界
14 Nov 2024

康宁杰瑞制药-B早盘上涨12.67%,现报5.07港元,成交额4735.2万港元。

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。

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