Innovent Biologics has received China’s National Medical Products Administration (NMPA) approval for the New Drug Application (NDA) for Tabosun (ipilimumab N01 injection), a CTLA-4 monoclonal antibody for colon cancer.
The approval covers its use in combination with sintilimab as a neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer.
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This marks a significant regulatory milestone for the combination therapy, providing a new treatment option for patients with MSI-H or dMMR colon cancer in China.
Short-term neoadjuvant treatment with the ipilimumab N01 and sintilimab combination has shown a substantial improvement in pathological complete response rate, potentially benefiting a wider group of patients with MSI-H/dMMR colon cancer.
Innovent stated that immune checkpoint blockade therapies, including PD-1 and CTLA-4 agents, have changed the landscape of cancer treatment.
The combination of ipilimumab N01 and sintilimab as a neoadjuvant therapy has been found to significantly improve pathological complete response rates and may reduce the need for adjuvant chemotherapy in many patients.
A Phase Ib trial published in the Cancer Cell journal enrolled 101 patients as of 17 June 2025 and randomised them to receive ipilimumab N01 plus sintilimab (n=52) or sintilimab alone (n=49).
In the per-protocol population, the pathological complete response rate was 80% in the combination arm compared to 47.7% with sintilimab alone. Neither group experienced recurrence over a median follow-up of 21.4 months.
Approval was based on the pivotal Phase III NeoShot trial, which assessed efficacy and safety for neoadjuvant ipilimumab N01 and sintilimab versus direct radical surgery.
Primary endpoints included event-free survival and pathological complete response rate. Interim analysis by the Independent Data Monitoring Committee (iDMC) confirmed the primary endpoint was met.
