Core Viewpoint - The company, Yabao Pharmaceutical, has decided to terminate the clinical research and development of its diabetes drug SY-009, which may negatively impact its financial performance for the year [1][2]. Group 1: Project Termination - Yabao Pharmaceutical announced the termination of the clinical research for SY-009, a sodium-glucose co-transporter 1 (SGLT1) inhibitor aimed at treating type 2 diabetes [1]. - The company has invested a total of 87.87 million yuan in the development of SY-009, with 32.08 million yuan expensed and 55.79 million yuan capitalized [1]. - The decision to terminate was based on the Phase II clinical trial results, which indicated that the primary efficacy endpoint was not met, leading to significant uncertainty regarding future development and resource allocation [1][2]. Group 2: Financial Impact - The termination of SY-009 will result in a full impairment of the capitalized development costs amounting to 55.79 million yuan, which will reduce Yabao Pharmaceutical's total profit for 2025 by the same amount [2]. - In 2024, Yabao Pharmaceutical reported a revenue of 2.686 billion yuan, a decrease of 7.69% year-on-year, primarily due to a decline in pharmaceutical production revenue [2]. - The company's revenue for the first half of 2025 was 1.139 billion yuan, reflecting a year-on-year decrease of 21.08%, with a net profit of 174 million yuan, down 2.99% [3].

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: Drug Information - Drug Name: SY-009 Capsule - Dosage Form: Capsule - Specifications: 0.5mg, 5mg - Registration Category: Class 1 Chemical Drug - Applicants: Yabao Pharmaceutical Group Co., Ltd., Suzhou Yabao Pharmaceutical Research Co., Ltd. - Approval Numbers: 2018L02807, 2018L02808, 2024LP02207 [1]. Group 2: R&D Status and Termination Reasons - SY-009 is a Sodium-glucose Cotransporter 1 (SGLT1) inhibitor aimed at reducing postprandial glucose absorption for treating type 2 diabetes. It received clinical trial approval in July 2018 and completed three Phase I and one Phase II clinical studies by March 2024 [1]. - The Phase II clinical study results indicated that while there was a dose-response relationship, the primary efficacy endpoint was not met. The uncertainty and significant investment required for further development led to the decision to terminate the project [1][2]. Group 3: R&D Investment - Total R&D investment for SY-009 amounted to 87.87 million yuan, with 32.08 million yuan expensed and 55.79 million yuan capitalized [2]. Group 4: Asset Impairment Provision - The company has fully recognized an asset impairment provision for the capitalized amount of SY-009, amounting to 55.79 million yuan, based on the project's termination and the absence of potential buyers for the related proprietary technology [3][5][6]. - This impairment provision will reduce the company's total profit for the year 2025 by 55.79 million yuan, with the final accounting treatment to be confirmed in the 2025 annual report [6].

证券代码：600351 证券简称：亚宝药业 公告编号：2025-034 亚宝药业集团股份有限公司 关于 ZY-A002 获得药物临床试验批准通知书的公告 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法律责任。 近日，亚宝药业集团股份有限公司（以下简称"公司"）收到了国家药品监 督管理局（以下简称"国家药监局"）核准签发的 ZY-A002 的《药物临床试验批 准通知书》（通知书编号：2025LP02459），现将相关情况公告如下： 一、药品的基本情况 1、药品名称：ZY-A002 2、剂型：颗粒剂 3、注册分类：中药 1.1 类 4、申请人：亚宝药业集团股份有限公司 5、受理号：CXZL2500046 二、药物研发及相关情况 ZY-A002 的适应症为祛风宣肺、解痉止咳，主要用于儿童咳嗽变异性哮喘（风 邪恋肺证），症见咳嗽阵作，咽痒即咳，无痰或痰少，或鼻流清涕，舌淡，苔薄 白，脉弦。根据米内网的数据显示，2024 年国内儿科止咳祛痰类中药的销售金 额约为 60.67 亿元人民币，其中公立医疗市场销售金额约为 41.59 亿元人民币， 零 ...

人民财讯9月23日电，亚宝药业（600351）9月23日公告，近日，公司收到国家药监局核准签发的ZY- A002的《药物临床试验批准通知书》。ZY-A002的适应症为祛风宣肺、解痉止咳，主要用于儿童咳嗽变 异性哮喘(风邪恋肺证)，症见咳嗽阵作，咽痒即咳，无痰或痰少，或鼻流清涕，舌淡，苔薄白，脉弦。 目前国内外尚未有专用于儿童的同适应症产品上市。 ...

Core Viewpoint - The company, Yabao Pharmaceutical (600351.SH), has received approval from the National Medical Products Administration for the clinical trial of ZY-A002, aimed at treating children with cough variant asthma [1] Group 1: Company Information - Yabao Pharmaceutical has been granted a clinical trial approval notice (No. 2025LP02459) for ZY-A002 [1] - ZY-A002 is indicated for the treatment of cough variant asthma in children, characterized by symptoms such as coughing, throat itching, and minimal sputum production [1] Group 2: Industry Context - The approval of ZY-A002 represents a significant step in addressing pediatric respiratory conditions, particularly cough variant asthma, which is a growing concern in the healthcare sector [1]

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]

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]

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].

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]