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                                    <figcaption>MSI-H/dMMR colon cancer comprises 15% of resectable cases and responds poorly to chemotherapy. Credit: NMK-Studio/Shutterstock.com.</figcaption>
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<p>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.</p>



<p>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.</p><div>
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<p>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.</p><div id="slot-one"></div><div id="Sgpollsputhere"></div>



<p>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.</p>



<p>Innovent stated that immune checkpoint blockade therapies, including PD-1 and CTLA-4 agents, have changed the landscape of cancer treatment.</p>



<p>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.</p><div> 
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<p>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).</p>



<p>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.</p><div id="slot-two"></div>



<p>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.</p>



<p>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.</p>
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<p>Innovent Biologics has received approval from China's NMPA for its CTLA-4 monoclonal antibody, Tabosun, for treating colon cancer. This approval allows its use in combination with sintilimab as a neoadjuvant treatment for stage IIB-III resectable MSI-H or dMMR colon cancer. The combination therapy has shown a significant improvement in pathological complete response rates, potentially reducing the need for adjuvant chemotherapy. The approval is based on the results of the pivotal Phase III NeoShot trial, which confirmed the efficacy and safety of the treatment.</p>

Innovent receives NMPA approval for Tabosun colon cancer treatment