TASLY(600535)
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天士力(600535):普佑克斩获AIS溶栓新适应症,核心单品价值凸显
KAIYUAN SECURITIES· 2025-09-23 01:42
Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company announced the approval of a new indication for its innovative drug, Puyouke, for thrombolytic treatment of acute ischemic stroke, enhancing its product portfolio and long-term growth potential [4][6] - The company is expected to maintain its net profit forecasts for 2025-2027 at 1.183 billion, 1.306 billion, and 1.455 billion yuan respectively, with corresponding EPS of 0.79, 0.87, and 0.97 yuan per share [4][7] - The current stock price corresponds to P/E ratios of 19.8, 18.0, and 16.1 for the years 2025, 2026, and 2027 respectively [4][7] Financial Summary - Revenue for 2023 is reported at 8.674 billion yuan, with a slight decrease expected in 2024 to 8.498 billion yuan, followed by a recovery to 8.827 billion yuan in 2025 [7][9] - The gross margin is projected to remain stable around 67% from 2025 to 2027, while the net profit margin is expected to improve from 13.4% in 2025 to 14.6% in 2027 [7][10] - The return on equity (ROE) is forecasted to increase from 9.3% in 2025 to 9.5% in 2027 [7][10]
中纪委推进医药领域纠风治乱;体外类胃囊模型构建成功
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-23 00:16
Policy Developments - The Central Commission for Discipline Inspection and the National Supervisory Commission are intensifying efforts to rectify issues in the pharmaceutical sector, focusing on eliminating practices such as medical staff accepting "red envelopes" and improper benefits through academic exchanges [1] Drug and Device Approvals - YKYY013 injection from Yuyuan Pharmaceutical has received FDA approval for clinical trials aimed at treating chronic hepatitis B virus infection, which utilizes a dual-stranded siRNA mechanism to silence the virus [2] - *ST Suwu's hydrochloride lincomycin injection has passed the consistency evaluation for generic drugs, receiving approval from the National Medical Products Administration [3] - Tianjin Pharmaceutical's recombinant human urokinase (Puyouke) has been granted approval for a new indication for thrombolytic treatment of acute ischemic stroke, expanding its product line in the neurological field [4] Capital Market - Lepu Medical has entered into a strategic cooperation agreement with Hanhai Information Technology, aiming to enhance its medical aesthetics business through shared resources and a comprehensive sales network [5] Industry Events - The National Medical Insurance Administration has published the first batch of typical cases involving violations by designated medical institutions, highlighting issues such as falsifying medical records and duplicate charges [6] - Starting January 1, 2025, a new management system for medical insurance payment qualifications will be implemented, introducing a point-based system for violations to ensure the safety of medical insurance funds [7] Research and Development - Researchers at Kunming University of Science and Technology have successfully constructed an in vitro model of the stomach, providing a new platform for studying human gastric organ development [8] Public Sentiment Alerts - Zhejiang Pharmaceutical announced that its shareholder, Guotou Gaoke, plans to reduce its stake by up to 1% within three months, which will not affect the company's control [9]
华东医药ADC创新药临床试验获FDA批准;亚宝药业终止一药品研发
Mei Ri Jing Ji Xin Wen· 2025-09-22 23:17
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]
华东医药ADC创新药临床试验获FDA批准;亚宝药业终止一药品研发丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-09-22 23:12
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]
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
Shang Hai Zheng Quan Bao· 2025-09-22 18:51
Core Viewpoint - Tian Shi Li Pharmaceutical Group's subsidiary has received approval for a new indication of its recombinant human urokinase for the treatment of acute ischemic stroke, enhancing its product line and market competitiveness [1][3]. Group 1: Drug Information - The drug, recombinant human urokinase (brand name: Pu You Ke), is now approved for thrombolytic treatment of acute ischemic stroke [1]. - It is a first-class biological innovative drug supported by the national "Major New Drug Creation" project during the "11th Five-Year Plan" [1]. - The drug has a specific mechanism that preferentially activates plasminogen on the surface of fibrin, targeting occlusive thrombus while minimizing the risk of bleeding [2]. Group 2: Clinical and Market Impact - The drug's Phase III clinical results indicate that it is non-inferior to the control group for patients with acute ischemic stroke when administered within 4.5 hours of onset, while significantly reducing the risk of intracranial hemorrhage [2]. - The total R&D investment for the acute ischemic stroke indication has reached approximately 32.93 million RMB [3]. - The approval of this new indication expands the company's product offerings in the neurological and psychiatric fields, potentially increasing its market share and competitiveness [3].
5连板杭电股份:光通信业务亏损;天士力:普佑克新增适应症获批丨公告精选
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-22 14:29
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]
9月22日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-22 11:58
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]
天士力加入生物创新药国家队 普佑克脑梗适应症获批
Zheng Quan Ri Bao Zhi Sheng· 2025-09-22 10:09
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]
天士力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批
Bei Jing Shang Bao· 2025-09-22 09:27
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]
天士力:注射用重组人尿激酶原新适应症获药品注册证书
Zheng Quan Shi Bao Wang· 2025-09-22 08:52
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]