Zheng Quan Zhi Xing·2025-09-07 08:17Core Viewpoint - Shanghai Junshi Biosciences has announced positive results from a 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 both primary and key secondary endpoints with statistical significance and clinical relevance [1][3]. Group 1: Drug Information - JS005 is a specific anti-IL-17A monoclonal antibody developed by the company, targeting IL-17A, a cytokine associated with autoimmune diseases such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis [1]. - The drug works by binding with high affinity to IL-17A, selectively blocking its interaction with receptors IL-17RA/IL-17RC, thereby inhibiting downstream signaling pathways and the release of inflammatory factors [1]. - The Phase III clinical trial for moderate to severe plaque psoriasis has met its primary and key secondary endpoints, while the Phase II trial for active ankylosing spondylitis has completed its primary endpoint visits and entered an extended treatment phase [1][3]. Group 2: Clinical Trial Details - The Phase III clinical trial (study number: JS005-005-III-PsO) was a multicenter, randomized, double-blind, parallel, placebo-controlled study conducted across 60 research centers in China, led by Professor Zhang Jianzhong from Peking University People's Hospital [3]. - The primary objective was to achieve at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician's Global Assessment (sPGA) score of 0 or 1 at week 12, with results showing significant improvement compared to placebo [3]. - The study demonstrated that JS005 significantly improved the psoriasis lesions and severity in participants, with a favorable safety profile, and results are planned to be presented 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, with an increasing trend [2]. - The disease is associated with increased risks of metabolic syndrome, atherosclerotic cardiovascular diseases, and mental health issues such as depression and anxiety, significantly impacting patients' physical and mental well-being [2].