Core Insights - The introduction of the innovative biopharmaceutical Puyouke by Tianshili represents a significant breakthrough in thrombolytic therapy for acute ischemic stroke, particularly for elderly patients who face high bleeding risks during treatment [1][2] - Recent studies published in top medical journals indicate that patients treated with Puyouke experience lower rates of hemorrhagic complications compared to control groups, highlighting its unique advantages in stroke treatment [2] - The "Lung·New Life" stroke prevention project, supported by Tianshili, aims to enhance the quality and quantity of ischemic stroke treatments in line with national health strategies, focusing on training healthcare professionals and improving public awareness [3][4] Company Developments - Tianshili's Puyouke is positioned to balance effective thrombolysis with reduced bleeding risks, enhancing its market potential and expanding the company's product line in the neurology sector [2][4] - The company is actively involved in community outreach and education initiatives to improve stroke prevention and treatment awareness, particularly in underserved areas [6][5] - Tianshili's commitment to innovation and social responsibility is evident in its support for the "Lung·New Life" project, which aims to provide comprehensive stroke care and improve healthcare access [5][7] Industry Trends - The evolution of thrombolytic therapies has shifted towards safer and more effective treatments, with Puyouke exemplifying this trend through its unique molecular structure and mechanism of action [4] - The national health strategy emphasizes the need for increased access to intravenous thrombolysis treatments in medical institutions, aligning with Tianshili's initiatives [3] - The dual focus on clinical needs and technological innovation in the pharmaceutical industry is highlighted by Tianshili's approach, which serves as a model for sustainable development in China's healthcare sector [7]

Core Insights - The approval of the new indication for the thrombolytic drug Puyouke (recombinant human urokinase) marks a significant advancement in the treatment of acute ischemic stroke in China, addressing a critical healthcare need [1][2][4] - The drug's unique mechanism significantly reduces the risk of bleeding, a major concern in thrombolytic therapy, thereby enhancing its clinical value and safety profile [4][8] - The market for thrombolytic treatments in China is projected to grow from 3.81 billion yuan in 2023 to 4.96 billion yuan by 2027, indicating a robust demand for effective stroke treatments [8][9] Industry Challenges - Stroke remains the leading cause of death and disability among adults in China, with a rising incidence and mortality rate, highlighting the urgent need for improved prevention and treatment strategies [1][2] - Public awareness and early recognition of stroke symptoms are critically low, with less than 30% of cases being identified early, leading to wasted golden hours for treatment [1][2] Company Initiatives - Tianjin Tasly Pharmaceutical Co., Ltd. is actively supporting the "Rebirth through Thrombolysis" public welfare project, which aims to enhance stroke prevention and treatment capabilities through education and community engagement [2][5] - The company plans to leverage its strong academic marketing team and clinical evidence to expand the market for Puyouke, focusing on building awareness among neurologists and integrating treatment protocols [6][7] Market Potential - The approval of Puyouke is expected to fill a significant gap in the market, particularly as imported thrombolytic drugs are often expensive and carry higher bleeding risks, making them less accessible to patients [8][9] - The Chinese Stroke Society's goal to increase the intravenous thrombolysis rate for ischemic stroke patients to 80% by 2030 presents a substantial opportunity for Puyouke to capture market share [8][9] Production and Quality - Tasly has established a comprehensive quality control system and stable production capacity for Puyouke, which has received regulatory approval for large-scale manufacturing [9] - The drug's unique production process and high-quality standards create a competitive advantage, making it difficult for generic alternatives to emerge [8][9]

脑卒中，是指由于脑部血管突然破裂或血管阻塞而引起脑组织损伤的一组疾病。由于高死亡率和高致残 率的特点，脑卒中长期以来都被视作"人类健康的头号杀手"。据统计，我国每年约有440万脑卒中新发 病例，其中缺血性脑卒中约占80%，给家庭和社会带来了沉重负担。 在临床治疗上，静脉溶栓被确立为急性缺血性脑卒中（AIS）的标准治疗手段。然而，目前我国整体静 脉溶栓率仅约7.6%，与发达国家存在差距。这背后，一方面是患者就诊时间与治疗窗口错配，另一方 面也与溶栓药物治疗过程伴发的高出血风险，导致了临床用药的顾虑。 近日，天士力宣布，其自主研发的生物创新药注射用重组人尿激酶原（普佑克）获批新适应症，用于急 性缺血性脑卒中的溶栓治疗。国产创新药普佑克的出现，不仅有望缓解我国AIS患者治疗中的痛点问 题，也标志着天士力从传统中药企业向创新药领军企业转型迈出了关键一步。 卒中防治的时代命题：如何推动药物走下基层？ 在卒中防治中，救治率低始终是绕不开的临床痛点。 "发病后4.5小时内"是静脉溶栓的黄金时间窗。然而，CHINA QUEST研究显示，我国有67%-75%的急性 缺血性卒中患者因延迟就诊或发病时间不明而错过溶栓机会。公众对卒 ...

对于急性脑梗患者而言，时间就是生命。只有在有效的时间窗内进行溶栓治疗，才能真正避免脑细胞死亡和后遗症。 脑卒中，也就是常见的"中风"，已成为我国成年人致死、致残的首位病因。 "受年龄增长等各种因素影响，人的血管内可能出现斑块，一旦发生斑块破裂或者脱落，将出现中风，要通过神经介入和溶栓等再灌注治疗，尽快把堵住的 血管通开，不然每延迟一分钟，患者大脑中就有190万个神经细胞死亡。"谈及脑卒中这一当下成年人的"头号杀手"，一位三甲医院的医生极为感慨道，大脑 一旦损伤则是不可逆的，所以越早识别中风，抢救的可能性越大，愈后恢复的效果也越好。 突破时间窗，国产创新药展现治疗新希望 中国卒中学会发布的《中国卒中报告2020》统计，我国每年新发脑卒中约340万例，其中缺血性脑卒中（脑梗）占比超过70%，且发病率仍以每年4%-6%的 速度增长。 在此前宣武医院宋海庆教授团队公布的一项关于普佑克的Ⅱa期临床试验中，首次证明了普佑克静脉溶栓治疗对发病后4.5-6h的AIS患者安全有效，患者90d 功能独立率超过60%，且不增加死亡和症状性脑出血（sICH）的风险。 无论是急诊室里的争分夺秒，还是药企研发中的技术攻坚，一场围绕时间、 ...

Core Viewpoint - Tianjin Tasly Pharmaceutical has received approval from the National Medical Products Administration for its recombinant human urokinase (brand name: Puyouke) to be used for thrombolytic treatment of acute ischemic stroke, expanding its product line in the neurology/psychiatry sector [1] Group 1 - The product Puyouke is currently the only approved recombinant human urokinase product in China [1] - Puyouke is the first Class 1 biological innovative drug supported by the "Major New Drug Creation" technology major project during the "11th Five-Year Plan" period [1] - The drug is already approved for the treatment of acute ST-segment elevation myocardial infarction, and the new indication enhances the company's offerings in the neurological field [1]

Core Viewpoint - Tianjin Tasly Pharmaceutical has received approval from the National Medical Products Administration for its product, recombinant human urokinase (Puyouke), to be used for thrombolytic treatment of acute ischemic stroke, expanding its product line in the neurology/psychiatry sector [1] Group 1 - The company’s wholly-owned subsidiary, Tasly Biopharmaceuticals, has been granted a drug registration certificate for Puyouke, which is the only approved recombinant human urokinase product in China [1] - Puyouke was previously approved for the treatment of acute ST-segment elevation myocardial infarction, and the new indication for acute ischemic stroke enhances the company's offerings in the neurological field [1] - This product is recognized as a Class 1 innovative biological drug supported by the "Major New Drug Creation" project during the "11th Five-Year Plan" period [1]