Innovent Biologics Wins NMPA Approval for First Domestic CTLA-4 Antibody TABOSUN in Colon Cancer

Reuters2025-12-25
Innovent Biologics Wins NMPA Approval for First Domestic CTLA-4 Antibody TABOSUN in Colon Cancer

Innovent Biologics Inc. has received regulatory approval from China's National Medical Products Administration (NMPA) for TABOSUN® (ipilimumab N01 injection), the first domestic cytotoxic lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody. The approval is for use in combination with TYVYT® (sintilimab injection) as a neoadjuvant treatment for patients with stage IIB-III resectable microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) colon cancer. This dual-immunotherapy regimen is the first and only approved globally for neoadjuvant treatment of colon cancer, addressing a significant unmet clinical need and offering a new therapeutic option for patients in China.

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