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 盐酸吡格列酮分散片获得药品补充申请批准通知书的公告

Core Viewpoint - The company has received approval from the National Medical Products Administration for the drug Pioglitazone Hydrochloride Dispersible Tablets, which is expected to enhance market competitiveness and sales potential in the future [1][2]. Group 1: Drug Approval and Development - The company’s subsidiary, Shuanghe Tianan Pharmaceutical, received the approval notice for Pioglitazone Hydrochloride Dispersible Tablets from the National Medical Products Administration [1]. - The consistency evaluation for this drug began in 2017, with the application submitted in December 2024 and approval received in November 2025 [2]. - The total R&D investment for this drug's consistency evaluation has reached RMB 8.8227 million (unaudited) [2]. Group 2: Market Situation of Similar Drugs - Pioglitazone tablets, developed by Takeda Pharmaceutical, were approved in the U.S. in July 1999 and in China in 2004, but have since been withdrawn from the market [3]. - The global sales of Pioglitazone tablets are projected to be USD 254 million in 2024, with "ACTOS" contributing USD 41.6958 million [3]. - In China, the total sales of Pioglitazone tablets in the medical and retail markets are estimated at RMB 349 million in 2024, with Shuanghe Tianan holding a market share of 10.46% [3].