康宁杰瑞JSKN022新药临床试验申请获CDE受理

格隆汇
Yesterday

康宁杰瑞制药(9966.HK)公布,公司自主研发的程序性死亡配体1(PD-L1)/整合素αvβ6双特异性抗体偶联药物(ADC) JSKN022新药临床试验(IND)申请,已获中国国家药品监督管理局药品审评中心(CDE)正式受理。该公司计划开展用于治疗晚期恶性实体瘤的JSKN022首次人体临床研究。 目前全球范围内尚无靶向整合素αvβ6或PD-L1的ADC上市,相关在研药物均处于临床研究阶段。临床前数据显示,JSKN022在体外和体内模型中,对整合素αvβ6和/或PD-L1表达阳性的肿瘤细胞具有抗肿瘤活性,有望为PD-1/PD-L1抑制剂耐药或治疗无效的肿瘤(如非小细胞肺癌、头颈部鳞状细胞癌、结直肠癌等)患者提供新的治疗选择。

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