中生制药(01177.HK)非小细胞肺癌放化疗后巩固治疗药物III期研究取得阳性结果将就适应症提上市申请

阿斯达克财经12-18 17:05

中生制药(01177.HK) 公布，集团自主研发的1类创新药贝莫苏拜单抗注射液联合或不联合盐酸安罗替尼胶囊作为巩固治疗在同步/序贯放化疗后未进展的、局部晚期/不可切除(III期)的非小细胞肺癌(NSCLC)患者中的III期临床研究(TQB2450-III-05)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。
集团已与中国国家药品监督管理局药品审评中心(CDE)就该适应症的上市申请进行沟通，并获得CDE书面同意提交上市申请。集团将于近期递交上市申请。
同步/序贯放化疗后未进展的、局部晚期/不可切除(III期)的NSCLC的巩固治疗是安罗替尼即将申报上市的第11个适应症、贝莫苏拜单抗即将申报上市的第4个适应症。(sl/w)(港股报价延迟最少十五分钟。沽空资料截至 2024-12-18 16:25。)

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中生制药(01177.HK)非小细胞肺癌放化疗后巩固治疗药物III期研究取得阳性结果 将就适应症提上市申请

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中生制药(01177.HK)非小细胞肺癌放化疗后巩固治疗药物III期研究取得阳性结果将就适应症提上市申请