复宏汉霖获批PD-1单抗新适应症

财中社12-03

财中社12月3日电复宏汉霖（02696）发布公告，国家药品监督管理局已批准公司自主研发的创新抗PD-1单抗汉斯状®（斯鲁利单抗注射液）联合化疗用于局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）的一线治疗新适应症的上市注册申请（NDA）。此次获批基于一项随机、双盲、多中心的3期临床研究，结果显示汉斯状®联合化疗的无进展生存期（PFS）显著延长，达到预设的优效标准，且安全性良好。　　汉斯状®是公司...

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