这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 天士力的普佑克新增适应症获批 9月22日，天士力(600535.SH)公告称，公司全资子公司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》，批准注射用重组人尿激酶原（普佑克）新增急性缺血性脑卒中的溶栓治疗适应症。 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。 资本市场 政策动向 驻国家卫生健康委纪检监察组聚焦整治重点 加力推进医药领域纠风治乱 9月22日，中央纪委国家监委网站发布《驻国家卫生健康委纪检监察组聚焦整治重点 加力推进医药领域 纠风治乱》一文，指出持续净化医药领域政治生态和行业生态，是维护人民群众切身利益的必然要求。 记者近日从中央纪委国家监委驻国家卫生健康委纪检监察组了解到，该纪检监察组今年以来加力推进医 药领域纠风治乱，督促综合监督单位重点纠治医务人员收受"红包"、假借学术交 ...

Group 1: Huadong Medicine - Huadong Medicine's subsidiary received FDA approval for the clinical trial of HDM2017, a new antibody-drug conjugate targeting Cadherin17 for advanced malignant solid tumors [1] Group 2: Tianjin Tasly - Tasly's subsidiary received approval for the new indication of Pu You Ke for thrombolytic treatment of acute ischemic stroke, making it the only approved recombinant human urokinase product in China [2] Group 3: Yabao Pharmaceutical - Yabao Pharmaceutical decided to terminate the clinical trial of SY-009 and fully provision for asset impairment of 55.793 million yuan, which will reduce the company's profit for 2025 [3][4] Group 4: Zhixiang Jintai - Zhixiang Jintai signed exclusive cooperation agreements with Kangzhe Pharmaceutical for the commercialization of GR2001 and GR1801 monoclonal antibodies, with expected payments totaling approximately 510 million yuan [4] Group 5: Lepu Medical - Lepu Medical entered a strategic partnership with Hanhai Information to jointly develop the medical aesthetics business, aiming to enhance sales channels and improve performance amid industry competition [5]

Group 1 - Huadong Medicine's subsidiary received FDA approval for the clinical trial of HDM2017, a new antibody-drug conjugate targeting Cadherin 17, for advanced malignant solid tumors [1] - Tianjin Pharmaceutical's subsidiary obtained approval for the new indication of Pu You Ke for thrombolytic treatment of acute ischemic stroke, making it the only approved recombinant human urokinase product in China [2] - Yabao Pharmaceutical decided to terminate the clinical trial of SY-009 and fully provision for asset impairment of 55.793 million yuan, which will reduce the company's profit for 2025 [3] Group 2 - Zhixiang Jintai signed exclusive cooperation agreements with Kangzhe Pharmaceutical for the commercialization of GR2001 and GR1801 monoclonal antibodies, with expected payments totaling approximately 510 million yuan [4] - Lepu Medical established a strategic partnership with Hanhai Information to jointly develop the medical aesthetics business, aiming to enhance sales channels and improve performance amid industry competition [5][6]

证券代码：600535 证券简称：天士力 编号：临2025-064号 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 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 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），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。现就相关 情况公告如下： 一、基本情况 生产企业：天士力生物医 ...

Group 1 - Changchuan Technology expects a net profit of 827 million to 877 million yuan for the first three quarters of 2025, representing a year-on-year growth of 131% to 145% due to strong market demand in the semiconductor industry [1] - Tianqi Materials' subsidiary signed an agreement with Ruipu Lanjun for the supply of at least 800,000 tons of electrolyte products until December 31, 2030, with a minimum monthly supply of 20,000 tons [2] - Zhixiang Jintai entered into exclusive cooperation agreements with Kangzhe Pharmaceutical for two monoclonal antibody injection products, securing upfront and milestone payments totaling approximately 510 million yuan [2] Group 2 - Hangdian Co. reported that its optical communication business is currently in a loss state, while its copper foil business is still in the early stages of development [3] - Guangli Micro announced an inquiry transfer price of 65 yuan per share, which is a 28% discount from the closing price, with 24 institutional investors participating in the inquiry [4] - Tianshili's subsidiary received approval for a new indication for its recombinant human urokinase product, making it the only approved product of its kind in China [5] Group 3 - Kairun Co. plans to acquire 20% of Shanghai Jiale for 280 million yuan through its wholly-owned subsidiary [6] - Sanyou Medical's shareholder QM5 LIMITED intends to transfer 6.67 million shares, accounting for 2% of the total share capital [7] - Various companies, including Youxunda and Xinyuan Zhizao, are expected to win bids for projects with the State Grid, with total bid amounts ranging from approximately 5.58 million to 1.93 billion yuan [7]

Group 1 - Xinxiang Chemical Fiber will suspend production for approximately 90 days starting October 1, 2025, affecting an annual capacity of 31,200 tons, resulting in a revenue decrease of approximately 185 million yuan and a profit reduction of about 48 million yuan [1] - Bozhong Precision plans to transfer 18.29% of its stake in Suzhou Linghou Robot for 64 million yuan, retaining a 21.61% ownership post-transaction [1] - Haixing Electric is a recommended candidate for a State Grid procurement project, with an expected bid amount of approximately 128 million yuan [2] Group 2 - Samsung Medical is a recommended candidate for multiple State Grid procurement projects, with a total expected bid amount of approximately 193 million yuan [2][3] - Youxunda is a recommended candidate for a State Grid procurement project, with a bid amount of approximately 107 million yuan, representing 10.55% of its 2024 revenue [3] - Tiancheng Self-Control has received a notification for a seat assembly project from a well-known domestic new energy vehicle company, expected to start mass production in June 2026 [4] Group 3 - YKYY013 injection has received FDA approval for clinical trials to treat chronic hepatitis B virus infection [4] - Pulaide has signed a strategic cooperation agreement with an international electric tool brand, with a total procurement amount exceeding 700 million yuan over five years [4] - Sichuan Shuangma's subsidiary has obtained GMP certification from Russia, covering core aspects of drug quality and production systems [6] Group 4 - Boshi Co. has signed an industrial service contract worth approximately 96.99 million yuan with Guoneng Baotou Coal Chemical [7] - Wansheng Intelligent is a recommended candidate for a State Grid project, with an expected bid amount of approximately 67.98 million yuan, representing 7.25% of its 2024 revenue [9][10] - Huazi Industrial plans to sell its dairy farm assets for 38.5 million yuan, expecting a positive impact of approximately 11.7 million yuan on its current profits [10] Group 5 - Jinguang Electric has won a State Grid project with a total bid amount of approximately 28.4 million yuan, accounting for 3.82% of its 2024 revenue [11] - Nanjiao Food reported a net profit of 10,410 yuan for August, a year-on-year decrease of 98.31% [13] - Dongfang Bio's subsidiary has obtained registration certificates for two medical device products [15] Group 6 - Lanhua Kecai has signed a strategic cooperation agreement with Shanghai Pangu Power to promote intelligent and efficient transformation in the coal mining industry [17] - Yabao Pharmaceutical has decided to terminate the SY-009 research project, with a total investment of approximately 87.87 million yuan to be fully impaired [18] - Tian Shili's subsidiary has received approval for a new indication for its recombinant human urokinase injection for acute ischemic stroke treatment [20] Group 7 - Su Yan Jingshen's executives plan to increase their shareholding in the company, with a total investment of between 1.9 million and 2.66 million yuan [22] - Baiyun Electric and its subsidiary have won a State Grid project with a total bid amount of approximately 162 million yuan, covering multiple equipment types [23] - China West Electric's director has resigned due to work reasons, effective September 19, 2025 [25] Group 8 - Jianan Intelligent is a recommended candidate for a State Grid project with a total expected bid amount of approximately 73.12 million yuan [26] - Juhua Technology is a recommended candidate for a State Grid project with a total expected bid amount of approximately 142 million yuan [27] - Tengyuan Cobalt's actual controller has committed not to reduce holdings for the next 12 months, holding 37.89% of the total shares [28] Group 9 - Changfei Optical Fiber announced that Draka Comteq B.V. no longer holds H shares in the company after selling 37.59 million shares [28] - Mongcao Ecological's subsidiary has signed a contract for an ecological restoration project worth 225.2 million yuan [29] - Weiao Co. plans to distribute a cash dividend of 0.1 yuan per share, totaling approximately 39.29 million yuan [30]

Group 1 - The domestic innovative drug industry is experiencing unprecedented development opportunities, with the number of approved innovative drugs reaching a five-year high in the first half of this year [1] - The State-owned Assets Supervision and Administration Commission has indicated that the government is preparing to create a national team for biomedicine [1] - Tian Shi Li's innovative drug, Pu You Ke, has received approval for a new indication for the treatment of acute ischemic stroke (AIS) [1][4] Group 2 - Pu You Ke is recognized as a safe thrombolytic drug by the prestigious medical journal The Lancet Neurology, and it has a unique thrombolytic mechanism with a low risk of systemic bleeding [1][2] - Clinical trials have shown that Pu You Ke significantly reduces the incidence of symptomatic intracranial hemorrhage compared to control groups [2][4] - The drug is effective in improving neurological function and quality of life for AIS patients when administered within 4.5 hours of symptom onset [4] Group 3 - Tian Shi Li has undergone a change in controlling shareholder to China Resources Sanjiu, positioning itself as a member of the China Resources group [5] - The company aims to become a leading innovative pharmaceutical enterprise in China, focusing on innovation-driven strategies [5][6] - Tian Shi Li has a pipeline of 31 innovative drugs in development, including several high-profile CGT and antibody drugs [5][6] Group 4 - The company is transitioning from a traditional pharmaceutical enterprise to an innovative pharmaceutical company, leveraging the support of the China Resources system [6] - The approval of Pu You Ke for the AIS indication demonstrates Tian Shi Li's accumulated experience and capability in biopharmaceutical innovation [6] - The market has not fully priced in the value of Tian Shi Li's innovative biopharmaceutical pipeline, indicating potential for value re-evaluation [6]

Core Viewpoint - Tianjin Tasly Pharmaceutical 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, marking its second approved indication in China [1] Group 1 - The drug Puyouke was developed under the "Major New Drug Creation" project supported by the national "11th Five-Year Plan" and is classified as a Class 1 biological innovative drug [1] - The newly approved indication for acute ischemic stroke expands the therapeutic applications of Puyouke, which was previously approved for acute ST-segment elevation myocardial infarction [1]

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, marking its second approved indication in China [1] Group 1 - The drug Puyouke was initially approved for acute ST-segment elevation myocardial infarction during the "11th Five-Year Plan" under a major national project for new drug development [1] - The newly approved indication for acute ischemic stroke expands the therapeutic applications of Puyouke, enhancing its market potential [1]

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]