Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-09-07 23:26Core Viewpoint - Shanghai Junshi Biosciences Co., Ltd. has achieved positive results in a pivotal Phase III clinical trial for its product JS005, a humanized anti-IL-17A monoclonal antibody, for the treatment of moderate to severe plaque psoriasis, with plans to submit a marketing authorization application soon [1][3]. Group 1: Product 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][2]. - The drug works by binding with high affinity to IL-17A and selectively blocking its interaction with receptors IL-17RA/IL-17RC, thereby inhibiting downstream signaling pathways and the release of inflammatory factors [1][2]. Group 2: Clinical Trial Details - The Phase III clinical trial (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 Global Assessment (sPGA) score of 0 or 1 at week 12, with results showing significant improvement compared to placebo [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, it is approximately 0.47%, affecting around 125 million people worldwide [2]. - The disease 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].