SIMCERE PHARMA (02096): has voluntarily withdrawn the NDA for Ludechig Bai monoclonal antibody and is expected to resubmit the NDA later this month.

SIMCERE PHARMA (02096) announced that the New Drug Application (NDA) for the innovative drug Ledorchibai monoclonal antibody, which the group is collaborating on with Hong Kong Conord Biotech Limited, has been accepted by the National Medical Products Administration (NMPA) for the treatment of atopic dermatitis in adults and adolescents. For strategic optimization of the overall commercialization layout, the company has voluntarily withdrawn the NDA for Ledorchibai monoclonal antibody and is expected to resubmit the NDA later this month. The company will closely communicate with regulatory agencies to strive for early approval for market launch. Phase III clinical studies have shown that Ledorchibai monoclonal antibody not only works quickly, but also has a more significant cumulative benefit with continued treatment, demonstrating greater potential effectiveness compared to similar products. At week 16, the response rates for EASI-75, EASI-90, and IGA 0/1 in the Ledorchibai monoclonal antibody group reached 74.2%, 43.0%, and 47.7%, respectively (p < 0.0001), indicating that patients can achieve clear clinical benefits early in treatment. By week 52, the response rates for EASI-75, EASI-90, and IGA 0/1 increased to 96.6%, 85.3%, and 87.1%, respectively, demonstrating a more prominent depth of remission advantage with continuous treatment.