Core Viewpoint - Junshi Biosciences has received acceptance for the new drug application (NDA) of roconkibart injection, a treatment for moderate to severe plaque psoriasis, by the National Medical Products Administration (NMPA) in China [1][5]. Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of innovative therapeutics [8]. - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas: cancer, autoimmune, metabolic, neurological, and infectious diseases [8]. - Junshi Biosciences has achieved significant milestones, including the approval of five products in China and international markets, notably toripalimab, which is China's first domestically produced anti-PD-1 monoclonal antibody [8]. Product Details - Roconkibart (JS005) is a recombinant humanized anti-IL-17A monoclonal antibody injection designed to treat adult patients with moderate to severe plaque psoriasis [1][6]. - The drug works by selectively blocking IL-17A, a cytokine involved in the inflammatory pathway of psoriasis, thereby alleviating symptoms of autoimmune diseases [6]. Clinical Study Insights - The NDA is based on a pivotal phase 3 clinical study involving 747 patients across 60 clinical sites in China, demonstrating significant efficacy in improving psoriasis severity scores compared to placebo [3][4]. - Results indicated that treatment with roconkibart for 12 weeks led to substantial improvements in the Psoriasis Area and Severity Index (PASI) and static Physician Global Assessment (sPGA) scores, with a favorable safety profile maintained over 52 weeks [4]. Future Prospects - The acceptance of the NDA is seen as a critical step in transitioning roconkibart from clinical research to real-world application, with expectations for early approval to enhance treatment options for patients in China [5].