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 company has received approval from the National Medical Products Administration for the potassium chloride injection, which will enhance its market competitiveness and sales potential [1][5]. Group 1: Product Approval and Specifications - The potassium chloride injection is approved in a new specification of 10ml:1.5g, in addition to the existing 10ml:1g [1][2]. - The product is indicated for the treatment and prevention of hypokalemia, particularly when oral potassium supplementation is not feasible [1]. Group 2: Research and Development - The company initiated research for the new specification in June 2023 and submitted the application for approval in August 2024, receiving acceptance shortly thereafter [2]. - Cumulative R&D investment for the potassium chloride injection has reached 1.6109 million RMB (approximately 0.24 million USD) [2]. Group 3: Market Landscape - As of 2024, the global sales of potassium chloride injection are projected to be 22.3 million USD [2]. - In the domestic market, the total sales of potassium chloride injection are estimated at 617 million RMB (approximately 93.5 million USD) for 2024, with the top five companies holding significant market shares [3]. - The company reported a sales revenue of 960,000 RMB (approximately 0.14 million USD) for its potassium chloride injection in 2024 [4].