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)或错配修復缺陷型(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。 ...

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)或错配修復缺陷型(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。 ...

Core Viewpoint - Innovent Biologics (01801.HK) announced that its drug, IBI310 (Ipilimumab N01 injection), has been approved by the National Medical Products Administration (NMPA) in China for use in neoadjuvant therapy for resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer patients when combined with Sintilimab [1] Group 1 - IBI310 is the first domestically approved anti-CTLA-4 monoclonal antibody in China [1] - It is also the first anti-CTLA-4 monoclonal antibody globally approved for neoadjuvant therapy in colorectal cancer [1] - The combination therapy significantly improves the pathological complete response rate for MSI-H/dMMR colorectal cancer patients [1]