INNOVENT BIO (01801): TYVYT® (Ipilimumab N01 Injection) Approved by NMPA for Combined Use with Sintilimab in Neoadjuvant Treatment of Colon Cancer

Stock News2025-12-29

INNOVENT BIO (01801) announced that TYVYT® (Ipilimumab N01 Injection, a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) monoclonal antibody, R&D code: IBI310) has received approval for marketing from China's National Medical Products Administration (NMPA). The approval is for its use in combination with sintilimab as a neoadjuvant treatment for patients with operable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer. TYVYT® (Ipilimumab N01 Injection) is the first domestically developed anti-CTLA-4 monoclonal antibody approved in China and the first anti-CTLA-4 therapy globally approved for the neoadjuvant treatment of colon cancer. This short-term neoadjuvant regimen, used in combination with sintilimab, can significantly increase the pathological complete response rate, benefiting patients with MSI-H/dMMR colon cancer.

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