新诺威(300765.SZ)：控股子公司司库奇尤单抗注射液III期临床试验获得顶线分析数据

Group 1 - New Horizon (300765.SZ) announced that its subsidiary, Giant Stone Biopharmaceutical Co., Ltd., has obtained topline analysis data from the Phase III clinical trial of its drug, Secukinumab injection, which is a fully human IgG1 monoclonal antibody and a biosimilar to Cosentyx® [1][2] - Secukinumab is approved in China for indications including plaque psoriasis for patients aged 6 and above, psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa, with its efficacy and safety widely recognized [1] - Psoriasis is a chronic, inflammatory, systemic disease related to the immune system, with approximately 7 million patients in China. The drug specifically binds to IL-17A, a key molecule in the pathogenesis of psoriasis, blocking IL-17 receptor signaling to suppress inflammation [1] Group 2 - The development of Secukinumab follows the research guidelines for biosimilars, and a head-to-head equivalence study was conducted against Cosentyx® [2] - This study is a multicenter, randomized, double-blind, parallel, positive-controlled Phase III clinical trial aimed at verifying the consistency of efficacy between Secukinumab and Cosentyx® in treating moderate to severe plaque psoriasis patients [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 by week 12. The study met its primary endpoint, demonstrating clinical equivalence and good safety profile without new or unexpected safety signals, indicating potential for long-term safety in patients [2]