China’s National Medical Products Administration approved Innovent Biologics’ Tabosun (ipilimumab N01, IBI‑310) in combination with sintilimab as neoadjuvant treatment for stage IIB–III resectable MSI‑high or dMMR colon cancer. The approval marks a domestically developed CTLA‑4 antibody’s regulatory win and expands neoadjuvant options for a biomarker‑defined colorectal cancer population in China. Innovent positioned Tabosun as the country’s first domestic cytotoxic lymphocyte antigen‑4 (CTLA‑4) monoclonal antibody approval, signaling growing local capability in checkpoint inhibitor development. The neoadjuvant label targets a surgically resectable, biomarker‑selected cohort where preoperative immune modulation may improve resection outcomes. The decision could accelerate adoption of combination immunotherapy strategies in China and influence competitive positioning for international checkpoint developers seeking the colorectal cancer market.
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