康宁杰瑞制药-B(09966)：KN035一线治疗BTC的NDA已获国家药监局受理

智通财经01-09

智通财经APP讯，康宁杰瑞制药-B(09966)发布公告，中国国家药品监督管理局已正式受理KN035(恩沃利单抗注射液)(商标名：恩维达®)联合吉西他滨和奥沙利铂方案，用于一线治疗不可切除或转移性胆道癌的新药上市申请。此次受理基于III期临床试验(KN035-CN-005)的临床研究结果，这是一项针对中国晚期一线BTC患者设计的随机、平行对照、多中心III期临床试验。试验旨在评估 KN035联合...

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