康方生物(09926.HK)新型肿瘤免疫治疗新药之临床试验提前完成患者筛选入组
康方生物(09926.HK)公布,公司核心自主研发的、全球首创的新型肿瘤免疫治疗新药Cadonilimab (PD-1/CTLA-4双特异性抗体,研发代号:AK104)在中国用於经标准治疗後复发或转移性宫颈癌的注册性II期临床试验完成患者筛选入组。
公司後续将根据主要终点分析结果与中国国家药品监督管理局药品审评中心进行新药上市申请前(Pre-NDA)沟通。如後续程序进展顺利,Cadonilimab将有望成为全球首款获批上市的基於PD-1的双特异性抗体新药。
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