Zheng Quan Shi Bao Wang·2025-09-07 09:57Core Viewpoint - The company has achieved positive results in a pivotal Phase III clinical trial for its humanized anti-IL-17A monoclonal antibody (JS005) for the treatment of moderate to severe plaque psoriasis, with significant statistical and clinical improvements in primary and key secondary endpoints [1][4]. Company Summary - The company plans to submit a marketing authorization application for JS005 to regulatory authorities in the near future [1]. - The company reported a revenue increase of approximately 382 million yuan, a growth rate of 48.64% year-on-year for the first half of 2025, primarily driven by sales of commercialized drugs, with Tuoyi® achieving sales of 954 million yuan, a year-on-year increase of about 42% [1]. Product Summary - JS005 is a specific anti-IL-17A monoclonal antibody developed by the company, which effectively alleviates symptoms of autoimmune diseases by blocking the interaction between IL-17A and its receptors [2]. - The Phase III clinical trial for JS005 in treating moderate to severe plaque psoriasis has met its primary and key secondary endpoints, while the Phase II trial for treating active ankylosing spondylitis has completed its primary endpoint visits and entered an extended treatment phase [2][4]. Industry Context - Psoriasis is a common chronic, relapsing, inflammatory systemic disease with a global prevalence of 2%-3%, and approximately 47% in China, affecting around 125 million people worldwide [4]. - Moderate to severe psoriasis significantly impacts patients' physical and mental health, increasing the risk of comorbidities such as metabolic syndrome and cardiovascular diseases, as well as mental health issues like depression and anxiety [4].