NMPA Accepts NDA and Grants Priority Review Designation to Innovent's Ipilimumab Injection, China's First Domestic CTLA-4 Inhibitor, in Combination with Sintilimab as Neoadjuvant Treatment for Colon Cancer

Core Viewpoint - Innovent Biologics has received acceptance for the New Drug Application (NDA) of ipilimumab injection, a CTLA-4 inhibitor, for use in combination with sintilimab as a neoadjuvant treatment for resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer, which has been granted Priority Review designation by China's National Medical Products Administration (NMPA) [1][2][7]. Group 1: NDA Acceptance and Clinical Trials - The NDA acceptance and Priority Review designation are based on the results from the NeoShot Phase 3 clinical trial, which demonstrated the safety and efficacy of ipilimumab combined with sintilimab compared to direct radical surgery for MSI-H/dMMR colon cancer [3][4]. - Interim analysis from the NeoShot trial indicated that the primary endpoint of pathologic complete response (pCR) rate was met, with detailed results to be shared in future academic forums [3][5]. Group 2: Treatment Efficacy - The combination of ipilimumab and sintilimab showed a significantly higher pCR rate of 80.0% compared to 47.7% for sintilimab alone, with no disease recurrence observed during a median follow-up of 5.65 months [6]. - The treatment is expected to increase the R0 resection rate, achieve pathological complete response, and alleviate the need for adjuvant chemotherapy in most patients [2][5]. Group 3: Market Position and Future Prospects - This NDA marks the first for a domestic CTLA-4 inhibitor in China, reinforcing sintilimab's leadership in cancer immunotherapy [2]. - The company aims to address the significant unmet clinical need for neoadjuvant therapy in resectable MSI-H/dMMR colon cancer, with plans to expedite regulatory approval [5][6]. Group 4: Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including oncology, and has launched 14 products to date [10]. - The company collaborates with over 30 global healthcare firms, enhancing its capabilities in drug development and commercialization [10].