Core Viewpoint - The announcement highlights the successful top-line analysis data from a Phase III clinical trial of the drug Secukinumab Injection, developed by the subsidiary of the company, for the treatment of moderate to severe plaque psoriasis, indicating its clinical equivalence to an existing treatment [1][2] Group 1: Product Development - The product is a fully human IgG1 monoclonal antibody drug, serving as a biosimilar to Cosentyx, which has been approved in China for multiple indications including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa [1] - The company follows the research guidelines for biosimilars and conducted a head-to-head equivalence study to validate the product's efficacy against Cosentyx in treating moderate to severe plaque psoriasis [2] Group 2: Clinical Trial Details - The Phase III clinical trial was a multicenter, randomized, double-blind, parallel, positive-controlled study, aimed at verifying the consistency of treatment efficacy between the product and Cosentyx [2] - The trial enrolled patients with moderate to severe plaque psoriasis, randomly assigning them in a 1:1 ratio to either the test group (the product) or the control group (Cosentyx), with the primary endpoint being the proportion of patients achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI) score by week 12 [2] - The key study achieved its pre-set primary endpoint, demonstrating clinical equivalence to Cosentyx, with good safety profiles and no new or unexpected safety signals, indicating potential for long-term patient safety [2]
石药集团：司库奇尤单抗注射液III期临床试验获得顶线分析数据