钠 - 葡萄糖协同转运蛋白1(SGLT1)抑制剂
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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
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-09-23 09:00
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].
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
Shang Hai Zheng Quan Bao· 2025-09-22 20:41
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].