China-based biopharmaceutical company Innovent Biologics, Inc. (HKEX: 01801) announced on Sunday that China's National Medical Products Administration's (NMPA) Centre for Drug Evaluation (CDE) has accepted the New Drug Application (NDA) for Ipilimumab injection (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) and granted Priority Review designation for the product in combination with Sintilimab as neoadjuvant treatment for resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer.

Innovent says that Ipilimumab with sintilimab as a neoadjuvant treatment could increase R0 resection rate, achieve pathological complete response and relieve the majority of patients from adjuvant chemotherapy burdens. This novel treatment is also expected to reduce recurrence rate and improve long-term prognosis, anticipated to benefit MSI-H/dMMR colon cancer patients upon NDA approval.

The NDA acceptance and Priority Review designation are based on results from a randomised, controlled, multicentre, pivotal Phase 3 clinical trial (NeoShot, NCT05890742) which evaluated the safety and efficacy of ipilimumab combined with sintilimab as neoadjuvant therapy and as compared with direct radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pathologic complete response (pCR) rate and event-free survival (EFS). Interim analysis by the Independent Data Monitoring Committee (IDMC) showed that the NeoShot trial has met its primary endpoint. Detailed results will be presented at future academic conferences or published in academic journals.

Ipilimumab (R&D code: IBI310) is a fully human monoclonal antibody injection independently developed by Innovent.