SIMCERE PHARMA has announced that on April 29, 2026, the new drug application for Ledokibai monoclonal antibody, resubmitted by the group in collaboration with Hong Kong-based Connetics Medical, was accepted by the National Medical Products Administration. The application seeks approval for the treatment of atopic dermatitis in adults and adolescents. Ledokibai is a fully human monoclonal antibody targeting IL-4Rα, a shared subunit of the IL-4 and IL-13 receptors. By binding to IL-4Rα, Ledokibai effectively blocks the functions of IL-4 and IL-13, thereby inhibiting the Th2 inflammatory pathway and offering a therapeutic approach for Th2-related inflammatory diseases such as atopic dermatitis and asthma. Phase III clinical studies demonstrated that Ledokibai not only acts rapidly but also shows increasingly significant cumulative benefits with continued treatment, suggesting potential superiority over similar products. At week 16, response rates for EASI-75, EASI-90, and IGA 0/1 in the Ledokibai group reached 74.2%, 43.0%, and 47.7%, respectively, indicating clear clinical benefits for patients early in treatment. By week 52, these response rates rose to 96.6%, 85.3%, and 87.1%, highlighting the drug's enhanced deep remission advantages under sustained therapy.