Innovent Biologics: TABOSUN Receives NMPA Approval

(RTTNews) - Innovent Biologics (IVBXF, 1801.HK) announced that the New Drug Application for TABOSUN has been approved by China's National Medical Products Administration, in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high or mismatch repair deficient colon cancer. TABOSUN is the world's first approved CTLA-4 mAb for neoadjuvant treatment of colon cancer.

The approval is based on results from the randomized, controlled, multicenter, pivotal Phase 3 clinical trial, which evaluated the safety and efficacy of ipilimumab N01 combined with sintilimab as neoadjuvant therapy compared with direct radical surgery for MSI-H/dMMR colon cancer.

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