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亚宝药业:ZY-A002获得药物临床试验批准通知书
Xin Lang Cai Jing· 2025-09-23 08:08
Core Viewpoint - The company received approval from the National Medical Products Administration for the clinical trial of ZY-A002, which is aimed at treating cough variant asthma in children [1] Group 1: Product Information - ZY-A002 is indicated for dispelling wind and promoting lung function, as well as relieving spasms and cough [1] - The primary target condition for ZY-A002 is cough variant asthma in children, characterized by symptoms such as paroxysmal cough, throat itching, minimal or no phlegm, and clear nasal discharge [1] - The clinical symptoms associated with the condition include a pale tongue, thin white coating, and a wiry pulse [1]
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]
亚宝药业集团股份有限公司关于研发项目终止临床试验并计提减值准备的公告
Core Viewpoint - The company has decided to terminate the clinical development of the SY-009 project and fully recognize an impairment loss on the capitalized research and development costs due to the project's uncertain future and the need to allocate resources to more promising projects [1][3]. Group 1: Project Termination Details - The drug SY-009 is a Sodium-glucose Cotransporter 1 (SGLT1) inhibitor aimed at treating type 2 diabetes and was approved for clinical trials in July 2018 [1]. - The project has undergone three Phase I clinical studies and one Phase II clinical study from April 2019 to March 2024, with an additional Phase II trial approved for functional constipation in September 2024 [1]. - The decision to terminate was based on the Phase II trial results, which indicated that the primary efficacy endpoint was not met, and further development would require significant time and investment with high uncertainty [1][2]. Group 2: Financial Implications - The total research and development investment in SY-009 amounted to 87.87 million yuan, with 32.08 million yuan expensed and 55.79 million yuan capitalized [1]. - The company will fully recognize an impairment loss of 55.79 million yuan on the capitalized amount, which will reduce the total profit for the year 2025 by the same amount [5]. - This impairment is in accordance with the accounting standards and reflects the company's cautious approach to accurately represent its financial status and asset value [4][5].
亚宝药业:终止SY-009临床试验并计提减值准备 将减少2025年度利润总额5579.33万元
Jing Ji Guan Cha Wang· 2025-09-22 18:28
Core Viewpoint - The company has decided to terminate the clinical research and development of SY-009, a sodium-glucose co-transporter 1 inhibitor intended for the treatment of type 2 diabetes, and will fully recognize an asset impairment provision according to accounting standards [1] Financial Summary - Total R&D investment in SY-009 amounts to 87.87 million yuan, with 32.08 million yuan recognized as expenses and 55.79 million yuan capitalized [1] - The asset impairment provision will reduce the company's total profit for the year 2025 by 55.79 million yuan [1]
亚宝药业:关于研发项目终止临床试验并计提减值准备的公告
Zheng Quan Ri Bao· 2025-09-22 14:04
Core Viewpoint - The company has decided to terminate the clinical research and development of the SY-009 project after a careful evaluation of its progress, investment risks, and future market value [2] Group 1 - The decision to halt the SY-009 project is aimed at rationally allocating the company's research and development resources [2] - The company will fully recognize the impairment of the capitalized amount related to the SY-009 project based on accounting prudence principles [2] - The focus will now shift to the company's advantageous projects within its research pipeline [2]
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]
亚宝药业终止SY-009的临床研究开发工作,将计提5579.33万元资产减值准备
Bei Jing Shang Bao· 2025-09-22 09:27
Core Viewpoint - The company has decided to terminate the clinical research and development of the SY-009 project due to the assessment of its progress, investment risks, and future market value, aiming to allocate resources more effectively to its advantageous projects [1][2] Group 1: Project Termination - The company announced the termination of the SY-009 clinical research project after careful evaluation of its progress and associated risks [1] - The Phase II clinical study results indicated a relationship between dose and effect, but the primary efficacy endpoint was not met, leading to uncertainty in further development [1] - The decision was made following recommendations from the scientific committee and approval from the company's president and chairman [1] Group 2: Financial Implications - The company has fully recognized an asset impairment provision of 55.7933 million yuan for the SY-009 project due to the termination of its clinical research and the lack of potential buyers for related proprietary technology [2]
亚宝药业(600351) - 亚宝药业集团股份有限公司关于研发项目终止临床试验并计提减值准备的公告
2025-09-22 08:30
证券代码:600351 证券简称:亚宝药业 公告编号:2025-033 亚宝药业集团股份有限公司 剂型:胶囊剂 规格:0.5mg、5mg 注册分类:化学药品第 1 类 关于研发项目终止临床试验并计提减值准备的公告 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法律责任。 近日,亚宝药业集团股份有限公司(以下简称"公司")对 SY-009 研发项目 (以下简称"SY-009")进行了审慎评估,综合项目进展情况、继续开发的投入 风险和未来的市场价值等多种因素,为合理配置公司研发资源,聚焦研发管线中 的优势项目,公司决定终止 SY-009 的临床研究开发工作,同时根据《企业会计 准则》等相关规定,基于会计谨慎性原则,将该项目研发资本化金额全额计提资 产减值准备,现将有关情况公告如下: 一、终止临床试验的药物基本信息 药品名称:SY-009 胶囊 批件号:2018L02807、2018L02808、2024LP02207 二、药物研发相关情况及终止原因说明 申请人:亚宝药业集团股份有限公司、苏州亚宝药物研发有限公司 (一)研发相关情况 SY-0 ...
亚宝药业(600351.SH):研发项目终止临床试验并计提减值准备
Ge Long Hui A P P· 2025-09-22 08:27
Core Viewpoint - The company has decided to terminate the clinical research and development of the SY-009 project after a careful evaluation of various factors including project progress, investment risks, and future market value [1] Group 1 - The company will focus its research and development resources on more advantageous projects within its pipeline [1] - The decision to terminate SY-009 is based on a comprehensive assessment of the project's status and associated risks [1] - The company will fully recognize an impairment provision for the capitalized research and development costs of the SY-009 project in accordance with accounting prudence principles [1]