中国生物制药创新药III期临床研究获重大突破
财中社11月21日电中国生物制药（01177）发布自愿公告，宣布其自主研发的1类创新药盐酸安罗替尼胶囊联合派安普利单抗注射液用于晚期肝细胞癌一线治疗的III期临床研究已完成期中分析，独立数据监察委员会判定主要研究终点无进展生存期（PFS）及总生存期（OS）均达到预设的优效界值。因此，公司已向中国国家药品监督管理局药品审评中心递交新适应症上市申请并获得受理。
根据研究结果，试验组中位PFS为6.9个月，对照组为2.8个月，疾病进展或死亡风险显著降低47%；试验组中位OS为16.5个月，对照组为13.2个月，死亡风险显著降低31%。此次申请为盐酸安罗替尼胶囊上市的第10个适应症，预计将为晚期肝细胞癌患者提供更安全、更便捷的治疗选择。随着公司在创新研发上的持续投入，创新管线迎来收获期。
（文章来源：财中社）
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