China-based Innovent Biologics, Inc. (HKG: 1801) announced that the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA), has accepted the New Drug Application (NDA) for ipilimumab, an anti-CTLA-4 monoclonal antibody (mAb), and granted it Priority Review designation. The application covers the drug’s use in combination with sintilimab as neoadjuvant treatment for resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer.
Drug Profile
- Ipilimumab: The first homegrown CTLA-4 mAb in China, previously awarded breakthrough therapy designation.
- Sintilimab: A PD-1 immunoglobulin G4 mAb co-developed by Innovent and Eli Lilly and Company, with seven indications included in the National Reimbursement Drug List (NRDL) in China.-Fineline Info & Tech
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