Core Viewpoint - A domestic pharmaceutical company, Yabao Pharmaceutical, has halted the clinical research of its oral drug SY-009, an SGLT1 inhibitor, due to unsatisfactory results from its Phase II clinical trial, marking the second failure in diabetes drug development for the company [1][2]. Group 1: Company Overview - Yabao Pharmaceutical, originally focused on pediatric drugs, is transitioning towards innovative drugs, aiming to reduce its reliance on generic drugs from 90% to 40% by 2024 [1]. - The company has invested a total of 87.87 million yuan in the development of SY-009, which will be written off as a loss due to the termination of the project [2]. Group 2: Drug Development Details - SY-009 was approved for clinical trials in July 2018 and underwent three Phase I and one Phase II clinical trials over nearly six years [2]. - The Phase II trial results indicated a lack of achievement in primary efficacy endpoints, leading to the decision to terminate further development [2][3]. Group 3: Market Context - The global diabetes treatment market is projected to reach nearly $80 billion by 2024, with China's market exceeding 70 billion yuan [3]. - The competition in diabetes treatment is intense, with various classes of oral medications available, but SGLT1 inhibitors have limited presence in the market [3][4]. - The rise of GLP-1 class drugs has shifted the competitive landscape in diabetes treatment, with significant market potential and ongoing exploration of new indications [5].

Group 1 - The company has received approval from the National Medical Products Administration for the clinical trial of ZY-A002, which is intended for the treatment of cough variant asthma in children [1][3] - ZY-A002 is classified as a traditional Chinese medicine and is in the granule form, with a registration classification of Category 1.1 [5] - The total sales amount for pediatric cough and phlegm relief traditional Chinese medicine in China is projected to be approximately 6.067 billion RMB in 2024, with public medical market sales accounting for about 4.159 billion RMB and retail pharmacy sales around 1.908 billion RMB [2] Group 2 - The clinical trial application for ZY-A002 was accepted on July 7, 2025, and it is required to conduct Phase III clinical trials before it can be produced and marketed [3] - The company has invested approximately 12.5682 million RMB in the research and development of the ZY-A002 project to date [3]

Core Viewpoint - The company, Yabao Pharmaceutical, has decided to terminate the SY-009 innovative drug project after seven years of development, leading to a significant financial impact due to asset impairment provisions [2][5][6]. Group 1: Project Termination - The SY-009 project, aimed at developing an oral formulation for treating type 2 diabetes, has been officially terminated due to unmet efficacy endpoints in clinical trials [3][4]. - The total investment in the SY-009 project amounted to 87.87 million yuan, with 55.79 million yuan capitalized and subject to impairment [6][9]. - The decision to terminate the project was made after careful consideration of the risks and future market value, focusing on reallocating resources to more promising projects [4][6]. Group 2: Financial Impact - The termination of the SY-009 project will result in a reduction of 55.79 million yuan in the company's profit for the fiscal year 2025 [5][6]. - In the first half of 2025, Yabao Pharmaceutical reported a revenue of 1.139 billion yuan, a year-on-year decline of 21.08%, and a net profit of 174 million yuan, down 2.99% [9]. - The decline in revenue is attributed to decreased sales of several products, including pain relief patches and pediatric medications [9]. Group 3: R&D Investment - From 2017 to mid-2025, Yabao Pharmaceutical's total R&D expenses reached 1.129 billion yuan, reflecting the high costs associated with innovative drug development [7][9]. - The company has also invested approximately 127 million yuan in another innovative drug project, SY-005, which has completed its first phase of clinical trials [8][9]. - The pharmaceutical industry is characterized by high investment and risk, with long development cycles and various uncertainties affecting project outcomes [7].

Core Viewpoint - ZY-A002, a new drug developed by Yabao Pharmaceutical, has received approval for clinical trials targeting cough variant asthma in children, marking a significant step in addressing a gap in the pediatric market for this condition [1][2]. Drug Information - Drug Name: ZY-A002 - Dosage Form: Granule - Registration Category: Traditional Chinese Medicine Class 1.1 - Applicant: Yabao Pharmaceutical Group Co., Ltd. - Acceptance Number: CXZL2500046 - Approval Conclusion: The clinical trial application for ZY-A002 was accepted on July 7, 2025, and is approved to conduct confirmatory clinical trials for cough variant asthma in children [1][3]. Market Context - The indication for ZY-A002 includes relieving wind and clearing the lungs, as well as stopping spasms and coughs, specifically for cough variant asthma in children, which is characterized by chronic, irritating cough [2]. - According to data from Minet, the sales amount for pediatric cough and phlegm-relieving traditional Chinese medicine in China is approximately 6.067 billion RMB in 2024, with public medical market sales around 4.159 billion RMB and retail pharmacy sales about 1.908 billion RMB [2]. R&D Investment - As of the announcement date, the company has invested approximately 12.5682 million RMB in the R&D of the ZY-A002 project [3].

Group 1 - The core point of the article is that Yabao Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of ZY-A002 [2] Group 2 - The approval notification number for the clinical trial is 2025LP02459 [2]

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]