信达生物(01801.HK):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
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]