国产首个!皮下注射PD-L1 新适应症国内申报上市

新浪医药
Jan 12

近日,CDE 官网显示,恩沃利单抗注射液新适应症申报上市,联合吉西他滨和奥沙利铂(GEMOX)方案,用于一线治疗不可切除或转移性胆道癌。截图来源:CDE 官网此次新适应症上市申请获受理是基于 III期临床试验 KN035-CN-005 的积极结果。这是一项针对中国晚期一线胆道癌患者设计的随机、平行对照、多中心 III 期研究,旨在评估恩沃利单抗联合GEMOX 方案对比单纯GEMOX 方案的疗效与...

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