Core Viewpoint - Junshi Biosciences announced the acceptance of the new drug application (NDA) for 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 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 designed to treat moderate to severe plaque psoriasis by targeting the inflammatory pathway associated with the disease [1][6]. - The NDA submission is based on a pivotal phase 3 clinical study involving 747 patients across 60 clinical sites in China, demonstrating significant efficacy and a favorable safety profile [3][4]. Clinical Study Insights - The phase 3 clinical study showed that treatment with roconkibart for 12 weeks resulted in significant improvements in the Psoriasis Area and Severity Index (PASI) scores and static Physician Global Assessment (sPGA) scores compared to the placebo group [4]. - The efficacy of roconkibart was maintained throughout a 52-week treatment period, indicating its potential as a long-term treatment option for patients [4]. Market Implications - 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]. - The company aims to collaborate closely with regulatory authorities to expedite the product's market approval process [5].