SIMCERE PHARMA (02096) has announced that the new drug application for its innovative drug Ledokibart, developed in collaboration with Hong Kong-based Connect Biopharma, has been accepted by the National Medical Products Administration for the treatment of atopic dermatitis in adults and adolescents. For strategic optimization of the product's overall commercial plan, the company has proactively withdrawn the NDA and expects to resubmit it within this month. The company will maintain close communication with regulatory authorities to expedite approval. Phase III clinical trial results demonstrated that Ledokibart not only acts rapidly but also shows increasing benefits with continued treatment, indicating potential superiority over similar therapies. By week 16, response rates for EASI-75, EASI-90, and IGA 0/1 in the Ledokibart group reached 74.2%, 43.0%, and 47.7% respectively, with statistical significance, suggesting early clinical improvement. By week 52, these rates increased to 96.6%, 85.3%, and 87.1%, highlighting the drug's advantage in achieving deep and sustained remission with prolonged use.