异动解读 | 荣昌生物新药获CDE受理并纳入优先审评,股价大涨5.03%

异动解读
Oct 15, 2025

荣昌生物(09995.HK)今日盘中大涨5.03%,引发市场关注。

消息面上,荣昌生物于10月15日宣布,其自主研发的全球首创BLyS/APRIL双靶点融合蛋白创新药泰它西普(商品名:泰爱®)用于治疗原发性免疫球蛋白A(IgA)肾病的上市申请,已获国家药品监督管理局药品审评中心(CDE)受理,并纳入优先审评程序。这使得泰它西普成为IgA肾病领域首个申报上市的国产原研新药。

值得注意的是,此次申报的剂型为泰它西普注射液(预充式注射器装),这将为患者提供更加便捷的给药方式。这一重大进展表明荣昌生物在创新药研发领域的实力,也为公司未来在IgA肾病治疗市场的布局奠定了坚实基础,因此引发了投资者的积极反应。

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