原标题:中生制药与康方生物开发肺癌药物派安普利中期分析达主要研究终点
中国生物制药(01177)及康方生物(09926)公布,其共同开发的抗PD-1单抗药物「派安普利」(商品名:安尼可)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期临床试验的中期分析,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,安全性特徵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。
中生制药及康方生物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上市申请,与中国国家药品监督管理局药品审核中心进行沟通。
(文章来源:经济通中国站)
(责任编辑:DF381)
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