复宏汉霖获批PD-1单抗新适应症
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®是公司第一款自主研发并获批上市的生物创新药，适应症的获批将增强其市场竞争力，并为国内非鳞状非小细胞肺癌患者提供更多治疗选择。根据IQVIA的资料，2023年度，靶向PD-1的单克隆抗体药品在全球的销售金额约为399.2亿美元。公司还在积极推进汉斯状®及相关联合疗法的多项临床试验，覆盖多个癌症适应症。
（文章来源：财中社）
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