TASLY(SH:600535) Di Yi Cai Jing·2025-11-18 02:57Core Viewpoint - Tianjin Tasly Pharmaceutical Group Co., Ltd. has received approval from the National Medical Products Administration for its innovative biological drug "Recombinant Human Urokinase (Puyouke)" for the treatment of acute ischemic stroke (AIS), addressing the specificity issues of traditional thrombolytic drugs in the stroke field [4][9]. Group 1: Product Approval and Market Impact - The new indication approval for Puyouke follows its previous approval for treating acute ST-segment elevation myocardial infarction, enhancing its role in stroke treatment [4]. - Puyouke targets occlusive thrombus specifically, activating plasminogen at the site of occlusion, which reduces systemic activation of the fibrinolytic system, thus lowering the risk of bleeding and improving patient outcomes [7][9]. Group 2: Challenges in Stroke Treatment - China faces significant challenges in the prevention and treatment of acute ischemic stroke, with approximately 3.3 million new cases annually, making it the leading cause of death and disability among adults [6]. - Public awareness of stroke symptoms and emergency response is low, with 67%-75% of patients missing the thrombolysis window due to delayed treatment [6]. - The rate of intravenous thrombolysis is only about 10%, and endovascular treatment is less than 1%, indicating a substantial gap compared to developed countries [6]. Group 3: Innovation and Production Challenges - The development of Puyouke required overcoming multiple technical barriers, including the stability and yield of the active ingredient, recombinant human urokinase [8]. - Tasly has established a comprehensive quality control system and stable production capacity, addressing the high barriers to commercial production of unstable enzyme products [8]. Group 4: Public Health Initiatives - The "Stroke Prevention and Treatment Capacity Enhancement and Health Promotion" project, initiated by the Chinese Stroke Association and supported by Tasly, aims to improve public awareness and enhance grassroots medical capabilities in stroke prevention and treatment [10][11]. - The project focuses on educating the public about stroke prevention and early treatment, as well as improving the diagnostic and treatment skills of primary care physicians [11].