Core Viewpoint - The company announced that its subsidiary, Stone Pharma Biotech Co., Ltd., has achieved positive topline analysis data from a Phase III clinical trial for its drug, Secukinumab Injection, aimed at treating moderate to severe plaque psoriasis [1][2] Group 1: Product Development - Secukinumab Injection is a fully human IgG1 monoclonal antibody that specifically binds to IL-17A, a key molecule in the pathogenesis of psoriasis, thereby inhibiting inflammatory signals [1] - The product is a biosimilar to Cosentyx® (Secukinumab), which has been approved in China for multiple indications including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa [1] Group 2: Clinical Trial Details - The clinical trial was a multicenter, randomized, double-blind, parallel, positive-controlled equivalence study designed to verify the consistency of efficacy between Secukinumab Injection and Cosentyx® in treating moderate to severe plaque psoriasis [2] - The study enrolled patients with moderate to severe plaque psoriasis, randomly assigning them in a 1:1 ratio to either the trial group (Secukinumab Injection) or the control group (Cosentyx®) [2] - The primary endpoint was the proportion of patients achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI-75) score from baseline at week 12, which the study successfully met [2] Group 3: Safety and Future Plans - The study demonstrated clinical equivalence between the two products, with good safety profiles and no new or unexpected safety signals, indicating potential for long-term safety in patients [2] - Detailed data from the study will be presented at upcoming academic conferences and published in journals [2]
石药集团(01093)：司库奇尤单抗注射液III期临床试验获得顶线分析数据