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抗IL - 17A单抗治疗银屑病
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君实生物(01877):抗IL-17A单抗治疗中重度斑块状银屑病的Ⅲ期临床研究达到主要研究终点
智通财经网· 2025-09-07 10:34
Core Viewpoint - Junshi Biosciences (01877) announced positive results from a pivotal Phase III clinical trial of its product JS005, a humanized anti-IL-17A monoclonal antibody, for the treatment of moderate to severe plaque psoriasis, achieving statistically significant and clinically meaningful improvements in primary and key secondary endpoints [1][2][3] Group 1: Clinical Trial Results - The Phase III clinical trial (study number: JS005-005-III-PsO) successfully met its primary and key secondary endpoints, demonstrating significant improvement in psoriasis severity compared to placebo [1][2] - The study was conducted across 60 research centers in China, led by Professor Zhang Jianzhong from Peking University People's Hospital, with the main objective being to achieve at least a 90% improvement in the Psoriasis Area and Severity Index (PASI90) and a static Physician Global Assessment (sPGA) score of 0 or 1 by week 12 [2] Group 2: Product Information - JS005 is a proprietary monoclonal antibody developed by the company that selectively blocks IL-17A, a cytokine involved in autoimmune diseases, thereby alleviating symptoms of conditions like psoriasis, rheumatoid arthritis, and ankylosing spondylitis [1] - The safety profile of JS005 in moderate to severe plaque psoriasis participants was reported to be good, with plans to present the study results at future international academic conferences [3] Group 3: Disease Context - Psoriasis is a common chronic, relapsing, inflammatory systemic disease with a global prevalence of 2.0%-3.0%, while in China, the prevalence is 0.47%, affecting approximately 125 million people worldwide [2] - Moderate to severe psoriasis is associated with increased risks of metabolic syndrome, atherosclerotic cardiovascular diseases, and mental health issues such as depression and anxiety, highlighting the urgent need for effective treatments [2]