Core Insights - Tianshili's "Jiangcha" has released the first human clinical trial report for sugar-free tea in China, marking a significant step from conceptual consumption to scientific and standardized development in the sugar-free tea beverage sector [2][4] - The company has filled a research gap in the domestic market by completing a scientific validation process for sugar-free tea, which has been lacking in evidence-based research and standardized verification compared to Japan [3][4] Research and Development - Tianshili's "Jiangcha" has successfully completed both animal and human clinical trials, establishing a complete scientific loop from basic experiments to clinical validation, thus filling a research void in the field [4][9] - The animal trials involved a 16-week study on male SD rats, using a high-fructose high-fat diet to induce metabolic syndrome, with various intervention groups to assess the effects of tea polyphenols [5][6] Clinical Trial Results - The human clinical trial was designed as a randomized, open-label, controlled study with 72 participants, showing significant improvements in blood sugar and lipid levels after consuming high doses of tea polyphenols [7][12] - Results indicated that the "Jiangcha" group had statistically significant lower postprandial blood sugar levels compared to the control group, confirming its effectiveness in inhibiting post-meal blood sugar spikes [12] Key Ingredients - The core component of Tianshili's "Jiangcha" is tea polyphenols, which have been recognized for their role in regulating sugar and lipid metabolism, improving gut microbiota, and maintaining overall health [13] - Recent studies have highlighted the mechanisms through which tea polyphenols exert their effects, including modulation of gut microbiota and activation of specific metabolic pathways [13] Future Directions - Tianshili aims to continue its research on sugar and lipid metabolism, focusing on the development of health products based on evidence and scientific validation [15] - The company is committed to leveraging its extensive pharmaceutical research experience to innovate in the health product sector, aspiring to become a leader in the global market for sugar and lipid metabolism management [15]

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]

证券代码：600535 证券简称：天士力 编号：临 2025-064 号 天士力医药集团股份有限公司 关于全资子公司注射用重组人尿激酶原增加急性缺血性脑卒中 新适应症获得药品注册证书的公告 药品名称：注射用重组人尿激酶原（商品名称：普佑克） 剂型：注射剂 规格：5mg（50 万 IU）/支 申请事项：新增急性缺血性脑卒中的溶栓治疗适应症 受理号：CXSS2400083 通知书编号：2025S02596 注册分类：治疗用生物制品 药品批准文号：国药准字 S20110003 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 近日，天士力医药集团股份有限公司（以下简称"公司"）全资子公司天士 力生物医药股份有限公司（以下简称"天士力生物"）收到国家药品监督管理局 核准签发的《药品注册证书》，批准公司拥有自主知识产权的生物创新药注射用 重组人尿激酶原（普佑克）新增适应症，用于急性缺血性脑卒中的溶栓治疗。普 佑克是"十一五"规划期间国家"重大新药创制"科技重大专项支持下获批的 1 类生物创新药（急性 ST 段抬高型心肌梗死适应症）， ...

Core Viewpoint - Tianjin Tasly Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its innovative drug, recombinant human urokinase (Puyouke), to be used for thrombolytic treatment of acute ischemic stroke, expanding its market potential and product line in the neurology/psychiatry sector [1] Group 1 - The company’s subsidiary, Tasly Biopharmaceuticals, has been granted a drug registration certificate for Puyouke, which now has a new indication for acute ischemic stroke [1] - Puyouke is the only approved recombinant human urokinase product in China and is the first class of innovative biological drug supported by the national "Major New Drug Creation" project during the "11th Five-Year Plan" [1] - The approval of the new indication enhances the company's product offerings and competitiveness in the market by targeting a broader patient population [1]

Core Viewpoint - Tianjin Tasly Pharmaceutical Co., Ltd. (600535.SH) announced that its wholly-owned subsidiary, Tasly Biopharmaceuticals Co., Ltd., received approval from the National Medical Products Administration for a new indication of its innovative biological drug, Recombinant Human Urokinase (Puyouke), for thrombolytic treatment of acute ischemic stroke [1] Group 1 - The drug Puyouke is a Class 1 innovative biological drug that was supported by the "Major New Drug Creation" technology major project during the "Eleventh Five-Year Plan" period [1] - This new indication for acute ischemic stroke is the second approved indication for the drug in China, following its initial approval for acute ST-segment elevation myocardial infarction [1]

普佑克作为国内目前唯一获批上市的重组人尿激酶原产品，也是首个获批"十一五"规划期间国家"重大 新药创制"科技重大专项支持下的1类生物创新药。该药已上市适应症为急性ST段抬高型心肌梗死，本 次新增急性缺血性脑卒中溶栓治疗适应症的获批丰富了公司神经/精神领域产品线，进一步拓展了产品 目标患者人群，有利于提升公司及产品市场竞争力。 天士力（600535）(600535.SH)发布公告，近日，公司全资子公司天士力生物医药股份有限公司(简称"天 士力生物")收到国家药品监督管理局核准签发的《药品注册证书》，批准公司拥有自主知识产权的生物 创新药注射用重组人尿激酶原(普佑克)新增适应症，用于急性缺血性脑卒中的溶栓治疗。普佑克是"十 一五"规划期间国家"重大新药创制"科技重大专项支持下获批的1类生物创新药(急性ST段抬高型心肌梗 死适应症)，本次急性缺血性脑卒中适应症是该药在国内获批的第二个适应症。 ...

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]

Core Viewpoint - Tianjin Tasly Pharmaceutical Group Co., Ltd. has received approval from the National Medical Products Administration for a new indication of its innovative biological drug, recombinant human urokinase (Puyouke), for thrombolytic treatment of acute ischemic stroke [1] Company Summary - Tasly's subsidiary, Tasly Biopharmaceuticals, has been granted a drug registration certificate for the new indication, marking the second approved indication for Puyouke in China [1] - The drug was developed under the "Major New Drug Creation" program during the 11th Five-Year Plan and is classified as a Class 1 innovative biological drug [1] - As of the latest report, Tasly's market capitalization stands at 23.5 billion yuan [1] Revenue Composition - For the year 2024, Tasly's revenue composition is as follows: Traditional Chinese medicine accounts for 70.89%, chemical drugs for 15.38%, pharmaceutical commerce for 10.53%, biological drugs for 2.25%, and chemical raw materials for 0.61% [1]

天士力公告，全资子公司天士力生物医药股份有限公司收到国家药品监督管理局核准签发的《药品注册 证书》，批准注射用重组人尿激酶原（普佑克）新增适应症，用于急性缺血性脑卒中的溶栓治疗。普佑 克是国内首个获批的1类生物创新药，本次新增适应症丰富了公司神经/精神领域产品线，有利于提升公 司及产品市场竞争力。 ...

Industry Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Outperform the Market" and is maintained [1]. Core Insights - The adjustment of the National Essential Medicines List (NEML) is expected to continue, with a focus on opportunities for the inclusion of traditional Chinese medicine (TCM) products [4][5][18]. - The report highlights the importance of the NEML adjustment cycle, which is generally not more than three years, and the potential for TCM products to be added to the list [5][17]. - The report suggests focusing on innovative drug research and development, particularly in TCM, and recommends specific companies as potential investment targets [19][34]. Summary by Sections Industry Overview - The closing index for the pharmaceutical and biotechnology sector is 9096.29, with a weekly high of 9323.49 and a low of 6070.89 [1]. Recent Market Performance - During the week of September 15-19, 2025, the A-share pharmaceutical and biotechnology sector fell by 2.07%, underperforming the CSI 300 index by 1.63 percentage points and the ChiNext index by 4.41 percentage points [6][20]. - The sector ranked 25th among 31 first-level sub-industries in terms of weekly performance [6]. Investment Recommendations 1. **Innovative Drugs**: The report suggests that the innovative drug sector may experience fluctuations but emphasizes the importance of identifying high-quality assets. Recommended companies include Innovent Biologics, 3SBio, and others [7][24]. 2. **CXO Services**: The report indicates that the domestic innovative drug sector is stabilizing, with expected improvements in the CRO industry performance. Recommended companies include WuXi AppTec and Tigermed [25][26]. 3. **Biological Products**: Focus on opportunities for core product volume growth and potential valuation adjustments based on product data or business development expectations. Recommended companies include TianTan Bio and others [29]. 4. **Medical Devices**: The report anticipates a turning point in the medical device sector due to improved procurement funding and anti-corruption measures. Recommended companies include Mindray and others [30]. 5. **Traditional Chinese Medicine**: The report highlights the potential for TCM products to benefit from NEML policies and suggests companies like Zhaoke Ophthalmology and others as beneficiaries [33][34]. Market Trends - The report notes that the pharmaceutical sector's overall valuation (TTM) is 31.24, with a relative valuation premium of 136.13% compared to the CSI 300 index [44].