Simcere drug Rademikibart NDA accepted by national authorities

Simcere Pharmaceutical Group announced that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for Rademikibart, an innovative drug developed in collaboration with Connect Biopharma HongKong Limited. This acceptance, dated July 8, 2025, marks a significant step toward the drug's potential use in treating atopic dermatitis in adults and adolescents. Rademikibart, a fully human monoclonal antibody targeting IL-4R a, aims to block the Th2 inflammatory pathway, offering a targeted approach to managing inflammatory diseases. Connect Biopharma is also conducting global studies of Rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need.