上海君实生物医药科技股份有限公司 自愿披露关于偌考奇拜单抗注射液新药上市申请获得受理的公告

Core Viewpoint - Shanghai Junshi Biosciences Co., Ltd. has received a notice of acceptance from the National Medical Products Administration for its new drug application for JS005, a monoclonal antibody injection for treating moderate to severe plaque psoriasis in adults [1][2]. Drug Basic Information - Drug Name: JS005 (Rocacitinib Injection) - Application: Domestic production drug registration and marketing license - Acceptance Number: CXSS2500129, CXSS2500130 - Applicant: Shanghai Junshi Biosciences Co., Ltd. - Specifications: 150mg (1ml) per pre-filled syringe and 150mg (1ml) per pre-filled auto-injector - Approval Conclusion: The application has been accepted according to the Administrative Licensing Law of the People's Republic of China [1]. Drug Development and Clinical Research - JS005 is a specific anti-IL-17A monoclonal antibody developed by the company, targeting IL-17A, a cytokine associated with autoimmune diseases like psoriasis [2]. - The drug works by binding to IL-17A and blocking its interaction with receptors, thereby alleviating symptoms of autoimmune diseases [2]. - A pivotal Phase III clinical study (JS005-005-III-PsO) involving 747 moderate to severe plaque psoriasis patients showed significant improvement in psoriasis area and severity index (PASI) scores after 12 weeks of treatment, with sustained efficacy over 52 weeks [3].