Health
China's First Domestic Anti-CTLA-4 Monoclonal Antibody, Innovent's TABOSUN® (Ipilimumab N01 Injection) Received NMPA Approval
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the New Drug Application (NDA) for TABOSUN® (ipilimumab N01 injection; R&D Code: IBI310), the first domestic cytotoxic lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody (mAb), has been approved by C
About this update from Innovent Biologics, Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"TABOSUN® (ipilimumab N01 injection) has been approved in combination with TYVYT® (sintilimab injection) for the neoadjuvant treatment of patients with stage IIB-III resectable microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) colon cancer.","length":263,"tagName":"p"}]},{"val":[{"type":"text","content":"The TABOSUN® and TYVYT® combination therapy significantly improved pathological complete response (pCR) rates and enabled most patients to avoid the burden of postoperative adjuvant chemotherapy.","length":200,"tagName":"p"}]},{"val":[{"type":"text","content":"This therapy is the first and only dual-IO regimen approved globally for neoadjuvant treatment of colon cancer[i], filling a critical gap in neoadjuvant treatment of colon cancer and benefiting more patients with MSI-H/dMMR colon cancer.","length":242,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":705,"olType":false},{"type":"text","content":"SAN FRANCISCO and SUZHOU, China, Dec. 25, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the New Drug Application (NDA) for TABOSUN® (ipilimumab N01 injection; R&D Code: IBI310), the first domestic cytotoxic lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody (mAb), has been approved by China's National Medical Products Administration (NMPA), in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer. TABOSUN® (ipilimumab N01 injection) is the world's first approved CTLA-4 mAb for neoadjuvant treatment of colon cancer. Short-term neoadjuvant treatment with the ipilimumab N01 and sintilimab combination demonstrated a substantial improvement in pathological complete response, offering the potential to benefit a broader population of patients with MSI-H/dMMR colon cancer.","length":1205,"tagName":"p"},{"type":"text","content":"Resectable MSI-H/dMMR colon cancer urgently requires effective neoadjuvant therapies to improve prognosis","length":...