华润双鹤药业股份有限公司 关于控股子公司双鹤天安药业(贵州)股份有限公司通过GMP符合性检查的公告

Core Viewpoint - The company, through its subsidiary Shuanghe Tianan Pharmaceutical, has received a GMP compliance inspection notice from the Guizhou Provincial Drug Administration, confirming that its production quality management meets GMP requirements, which is crucial for maintaining product quality and production capacity [1][4]. GMP Inspection Information - The inspected entity is Shuanghe Tianan Pharmaceutical, located in Guizhou, with the inspection conducted from October 15 to October 17, 2025, focusing on the production line for Metformin and Empagliflozin Tablets (I) [1][2]. - The production line has a designed capacity of 500 million tablets per year [2]. Product and Market Situation - Metformin and Empagliflozin Tablets (I) are used for improving blood sugar control in adults with type 2 diabetes and were developed by Boehringer Ingelheim, launched in the EU and the US in 2015, and in China in 2019 [2]. - The global sales for Metformin and Empagliflozin Tablets (I) are projected to reach $103 million in 2024, with the product "SYNJARDY" generating sales of approximately $43.31 million [2]. - In the Chinese market, there are 22 approved manufacturers for Metformin and Empagliflozin Tablets (I), with Shuanghe Tianan included, and the total sales in the domestic market are estimated at 341 million RMB in 2024 [3]. Impact on the Company - The successful GMP compliance inspection indicates that the company can maintain stable product quality and production capacity, which is essential for meeting market demand [4]. - The inspection results are not expected to have a significant impact on the company's financial performance [4].