Core Viewpoint - The announcement indicates that CSPC Pharmaceutical Group (01093.HK) has received approval from the National Medical Products Administration of China to conduct clinical trials for Dupilumab Injection, a biosimilar to Dupixent, targeting moderate to severe atopic dermatitis in adults [1] Group 1: Product Development - The product is a recombinant fully human monoclonal antibody drug targeting IL-4Rα, classified as a biosimilar to Dupixent [1] - The application was submitted under the category of biological products for therapeutic use, specifically Class 3.3 [1] - The research results from pharmaceutical and non-clinical studies demonstrate high similarity in quality, safety, and efficacy compared to the reference drug, supporting the initiation of subsequent clinical studies [1]
石药集团(01093.HK)：度普利尤单抗注射液在中国获临床试验批准