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中国生物制药(01177.HK):盐酸安罗替尼胶囊联合化疗用于晚期软组织肉瘤一线治疗III期研究取得阳性结果

Sino Biopharmaceutical (01177.HK): Positive results obtained in phase III study of anlotinib hydrochloride capsules combined with chemotherapy for first-line treatment of advanced soft tissue sarcoma.

Gelonghui Finance ·  04:33

格隆汇7月16日丨中国生物制药(01177.HK)发布公告,集团自主研发的1类创新药盐酸安罗替尼胶囊联合化疗用于晚期不可切除或转移性软组织肉瘤一线治疗的III期临床研究(ALTN-III-04)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,且次要终点总生存期(OS)显示获益趋势。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同意提交盐酸安罗替尼胶囊联合化疗新增该一线适应症的上市申请。集团将于近期递交上市申请。

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