【港股通】中国生物制药(01177)：创新药用于晚期肝细胞癌一线治疗新适应症上市申请获受理

金吾财讯11-21 12:30

金吾财讯 | 中国生物制药(01177)公告，集团自主研发的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(ALTN-AK105-III-02）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)以及总生存期(OS)均达到方案预设的优效界值。基于这一积极成果，本集团近期已向中国国家药品监督管理局药品审评中心(CDE)递交新适应症上市申请并获得受理。原发性肝癌是全球第七大常见的恶性肿瘤，其中肝细胞癌(HCC)占80-85%。中国是肝癌高发地区，2020年中国新发病例41万，占全球新发病例的45%，死亡病例达39万，占全球死亡病例的47%。在中国，约70%的HCC患者初诊时即为中晚期2。但目前针对晚期HCC的治疗选择有限，随着免疫治疗的推广，免疫联合抗血管治疗逐步成为一线系统治疗的新选择。

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