华润双鹤药业股份有限公司关于全资子公司安徽双鹤药业有限责任公司氯化钾注射液获得药品补充申请批准通知书的公告

Core Viewpoint - The announcement highlights that China Resources Double Crane Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, Anhui Double Crane Pharmaceutical Co., Ltd., has received approval for a supplementary application for potassium chloride injection, which is expected to enhance market sales and competitiveness in the future [1][2]. Group 1: Drug Approval and Specifications - Anhui Double Crane received the "Drug Supplementary Application Approval Notice" from the National Medical Products Administration for potassium chloride injection [1]. - The potassium chloride injection is used for the treatment and prevention of hypokalemia, particularly when oral potassium supplementation is not feasible [1]. - The company initiated research for a new specification of potassium chloride injection (10ml:1.5g) in June 2023 and submitted the application for consistency evaluation on August 14, 2024, which was accepted on August 20, 2024, and approved on August 25, 2025 [1]. Group 2: Market Situation - The global sales of potassium chloride injection are projected to reach $223 million in 2024 [2]. - In China, there are 44 companies approved to produce potassium chloride injection (10ml:1.5g), with 26 having passed or deemed to have passed the consistency evaluation [2]. - The total sales revenue for potassium chloride injection in the domestic medical and retail market is estimated at 617 million RMB in 2024, with the top five companies holding significant market shares [2]. Group 3: Financial Investment - The cumulative R&D investment for potassium chloride injection by Anhui Double Crane is 1.6109 million RMB (unaudited) as of the announcement date [2]. - The projected sales revenue for the company's potassium chloride injection in 2024 is 960,000 RMB [2].