CCHT(SZ:000661) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2026-01-28 23:11Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received a notice of acceptance from the National Medical Products Administration for the clinical trial application of Fuxin Qibai monoclonal antibody injection, aimed at treating non-infectious uveitis [1][2]. Group 1: Drug Information - The drug Fuxin Qibai monoclonal antibody injection is a fully human anti-IL-1β monoclonal antibody developed by Jinsai Pharmaceutical, intended for the treatment of non-infectious uveitis [1][2]. - The clinical trial application has been accepted under the registration numbers CXSL2600136 and CXSL2600137, indicating a positive step towards further development [1][2]. - There are currently no similar drugs approved for the same indication in the domestic and international markets, highlighting the potential market opportunity for Fuxin Qibai [1][2]. Group 2: Disease Context - Non-infectious uveitis is a heterogeneous inflammatory disease affecting the uveal tract and surrounding tissues, with a global annual incidence rate of 17 to 52 per 100,000 and a prevalence rate of 115 to 204 per 100,000, representing a significant public health burden [2]. - Existing biological agents approved for this indication are primarily anti-TNFα drugs, with many patients experiencing inadequate response or intolerance, indicating a strong demand for safer and more effective treatment options [2]. Group 3: Company Impact - If the clinical trial progresses smoothly, it will help the company expand its business structure, optimize its product portfolio, and enhance its core competitiveness [3]. - The company is committed to actively advancing the research and development projects and will fulfill its information disclosure obligations regarding the project's progress [4].