信达生物(01801)：达伯欣® (伊匹木单抗N01注射液)获国家药监局批准联合信迪利单抗用于结肠癌新辅助治疗

智通财经2025-12-29

智通财经APP讯，信达生物(01801)发布公告，达伯欣^® (伊匹木单抗N01注射液，细胞毒性T 淋巴细胞相关蛋白4(CTLA-4)单克隆抗体(单抗)，研发代号：IBI310)获得中国国家药品监督管理局(NMPA)批准上市，联合信迪利单抗用于可手术切除的IIB-III期微卫星高度不稳定型(MSI-H)或错配修复缺陷型(dMMR)结肠癌患者的新辅助治疗。达伯欣^® (伊匹木单抗N01注射液)是中国首个获批的国产抗 CTLA-4单抗，也是全球首个获批的用于结肠癌新辅助治疗的抗CTLA-4单抗，通过联合信迪利单抗的短期新辅助治疗，可显著提升病理完全缓解率，惠及MSI-H/ dMMR结肠癌患者。

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