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力生制药:氯化钾缓释片国内上市许可申请获批

Core Viewpoint - The company has received approval for its self-developed potassium chloride sustained-release tablets, which are expected to enhance its product portfolio and market share in the pharmaceutical industry [1][3]. Group 1: Product Approval and Characteristics - The potassium chloride sustained-release tablets have been approved by the National Medical Products Administration, with specifications of 0.5g and 0.6g [1]. - This product is classified as a Category 3 generic drug under new chemical drug registration, which is considered equivalent to passing the consistency evaluation [1]. - The sustained-release technology offers advantages such as improved medication adherence, stable blood drug concentration, reduced peak-trough fluctuations, and minimized side effects [1]. Group 2: Research and Development Achievements - The company has developed unique large-scale production technology for the potassium chloride sustained-release tablets, ensuring stable production and high efficiency [2]. - The research institute has successfully demonstrated bioequivalence between the new product and the original formulation, achieving consistent therapeutic effects [2]. - The company has also secured a patent for the preparation method of the potassium chloride sustained-release tablets, marking a breakthrough in core technology [2]. Group 3: Market Potential - The potassium chloride sustained-release tablets are included in the 2024 National Medical Insurance Directory, indicating significant market potential [2]. - Sales figures for the potassium chloride sustained-release tablets are projected to grow from 350 million yuan in 2022 to 400 million yuan in 2024 [2]. Group 4: Strategic Direction - The potassium chloride sustained-release tablets represent an upgrade to the company's existing product line, aimed at capturing a larger market share and generating greater benefits [3]. - The company plans to continue enhancing research and industrial collaboration to provide accessible quality medications for patients while creating long-term value for investors [3].