China’s National Medical Products Administration approved Innovent Biologics’ Tabosun (ipilimumab N01, IBI-310) in combination with sintilimab as a neoadjuvant treatment for resectable stage IIB–III MSI‑high or mismatch repair‑deficient colon cancer. The decision makes Tabosun the first domestically developed CTLA‑4 monoclonal antibody approved in China for this indication. Innovent positioned the approval as a regulatory milestone for domestically developed immune‑oncology agents and for neoadjuvant strategies in MSI‑high colorectal cancer. The label covers a defined surgical setting where tumor downstaging can affect resectability and outcomes. The approval may accelerate adoption of combination checkpoint approaches in China and spur competitive responses from multinational and local developers targeting immune combinations for colorectal cancer.
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