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 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].