中国生物制药公告集团开发的“注射用重组人凝血因子VIIA N01”获中国国家药品监督管理局批准上市。该产品是集团首个注射

智通财经
03 Jul
中国生物制药公告集团开发的“注射用重组人凝血因子VIIA N01”获中国国家药品监督管理局批准上市。该产品是集团首个注射用重组人凝血因子VIIa产品也是国内首个同类产品。重组人凝血因子VIIa的生产工艺复杂存在降解和氧化位点较多、杂质种类较多等挑战。集团创新地开发了细胞培养、分离纯化和制剂处方等具有自主知识产权的工艺并获得两项原创专利。产品已成功进行多批次商业化生产放大批间质量一致性良好证明了生产工艺的稳健性。安启新作为国内首个获批的国产注射用重组人凝血因子VIIa产品将为患者提供更经济优质的治疗选择。集团将通过安恒吉与安启新的组合治疗方案覆盖从常规替代治疗到抑制物管理的全病程需求有望惠及更广泛的血友病患者群体。

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