【中国生物制药(01177.HK):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一线治疗III期研究取得阳性结果】中国生物制药(01177.HK)发布公告,集团自主研发的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。本集团已与中国国家药品监督管理局(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。本集团将于近期递交上市申请。

金融界
27 Dec 2024
中国生物制药(01177.HK)发布公告,集团自主研发的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。本集团已与中国国家药品监督管理局(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。本集团将于近期递交上市申请。

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