中国生物制药(01177.HK) 公布，其自主研发的1类创新药贝莫苏拜单抗注射液联合化疗后序贯联合盐酸安罗替尼胶囊对比替雷利珠单抗注射液联合化疗用于晚期鳞状非小细胞肺癌(sq-NSCLC)一线治疗的III期研究(TQB2450-III-12)，已完成方案预设的期中分析，独立数据监查委员会(IDMC)判定主要研究终点无进展生存期(PFS)达到方案预设的优效界值。
集团已与国家药监局(NMPA)药品审评中心(CDE)就该适应症的上市申请进行沟通，并获得CDE书面同意提交贝莫苏拜单抗注射液、盐酸安罗替尼胶囊新增该一线适应症的上市申请。集团将于近期递交上市申请。
贝莫苏拜单抗联合化疗后序贯联合安罗替尼用于晚期sq-NSCLC一线治疗是安罗替尼即将申报上市的第13个适应症、贝莫苏拜单抗即将申报上市的第6个适应症，有望为sq-NSCLC患者带来新的临床治疗选择。
此外，集团指TQB2450-III-12研究是全球首个对比免疫治疗(PD-1)联合化疗一线治疗sq-NSCLC取得阳性结果的III期临床研究。集团计划于近期开展的国际权威学术大会公布详细研究数据。(jl/w)(港股报价延迟最少十五分钟。沽空资料截至 2024-12-24 12:25。)
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