Core Insights - Company Junshi Biosciences announced positive results from a Phase III clinical trial of its recombinant humanized anti-IL-17A monoclonal antibody (code: JS005) for the treatment of moderate to severe plaque psoriasis, achieving both primary and key secondary endpoints with statistical significance and clinical relevance [1][2] - The company plans to submit a marketing authorization application to regulatory authorities in the near future for JS005 [1] Group 1 - 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 mechanism of JS005 involves high-affinity binding 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] Group 2 - As of the announcement date, the Phase III clinical trial for JS005 in moderate to severe plaque psoriasis has met its primary and key secondary endpoints, while the Phase II clinical trial for active ankylosing spondylitis has completed primary endpoint visits and entered an extended treatment phase [2]
君实生物:抗IL-17A单抗治疗Ⅲ期临床达到主要研究终点,将递交产品上市许可申请