中国生物制药（01177）发布公告，宣布其自主研发的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一线治疗的III期研究取得阳性结果。该研究的期中分析显示，主要研究终点无进展生存期（PFS）达到了预设的优效界值，表明贝莫苏拜单抗联合化疗后序贯联合安罗替尼显著延长了患者的PFS，并降低了疾病进展风险。
此外，公司已与中国国家药品监督管理局药品审评中心就该适应症的上市申请进行沟通，并获得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。这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，预计将为晚期鳞状非小细胞肺癌患者提供新的临床治疗选择。公司还计划在近期的国际权威学术大会上公布详细研究数据。
（文章来源：财中社）
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