格隆汇2月24日丨康方生物-B(09926.HK)发布公告，公司与中国生物制药(01177.HK)共同开发的抗PD-1单抗药物派安普利(安尼可)(研发代号：AK105)联合紫杉醇和卡铂用于局部晚期或转移性鳞状非小细胞肺癌一线治疗的III期临床试验中期分析，达到主要研究终点。
该临床研究的中期分析结果经独立数据监查委员会(IDMC)审核，显示派安普利单抗联合紫杉醇和卡铂对比安慰剂联合紫杉醇和卡铂，可显著降低疾病进展或死亡风险，主要研究终点达到方案预设的优效界值，安全性特征与既往报导的派安普利单抗研究结果一致，无新的安全性问题。详细的研究结果将在后续的学术会议上予以公布。
公司和中国生物制药有限公司计划就递交派安普利单抗联合紫杉醇和卡铂用于鳞状非小细胞肺癌一线治疗的新适应症上市申请与中国国家药品监督管理局(“NMPA”)药品审核中心(CDE)进行沟通。肺癌是中国目前发病率和死亡率均排名第一的恶性肿瘤，在所有肺癌中非小细胞肺癌大约占总数的80%。
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