China’s National Medical Products Administration approved Innovent Biologics’ ipilimumab N01 (Tabosun, IBI‑310) in combination with sintilimab as neoadjuvant therapy for stage IIB–III resectable, microsatellite instability‑high (MSI‑H) or mismatch‑repair‑deficient (dMMR) colon cancer. The approval marks a regulatory win for domestic biologics and adds a CTLA‑4‑based option to China’s oncology arsenal. Innovent positioned Tabosun as the first domestic CTLA‑4 monoclonal antibody approval in China for this indication. The label targets a biomarker‑defined surgical population where immune checkpoint combinations have shown neoadjuvant activity. Clinicians and payors will evaluate the approval’s impact on preoperative treatment patterns and biomarker testing uptake. The decision underscores China’s accelerating oncology approvals and the strategic value of biomarker‑driven neoadjuvant regimens for resectable disease.
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