INNOVENT BIO (01801): Davixin (ipilimumab N01 injection) has been approved by the National Medical Products Administration for use in combination with sintilimab in neoadjuvant therapy for colorectal cancer.

INNOVENT BIO (01801) announced that Davixin (ipilimumab N01 injection, a cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody (mAb) developed under the codename IBI310) has been approved by the National Medical Products Administration (NMPA) in China for marketing. It is used in combination with sincilimab for neoadjuvant therapy in patients with stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer who are eligible for surgery. Davixin (ipilimumab N01 injection) is the first domestically approved anti-CTLA-4 mAb in China and the first globally approved anti-CTLA-4 mAb for neoadjuvant therapy in colorectal cancer. The short-term neoadjuvant therapy in combination with sincilimab significantly improves the rate of pathological complete response, benefiting patients with MSI-H/dMMR colorectal cancer.