药品名称药品通用名称：氯化钾注射液 英文名/拉丁名：Potassium ChlorideInjection 剂型注射剂注册分类化学药品规格10ml:1.5g证书编号2025B03884药品批准文号国药准字H20258168申请 事项增加10ml:1.5g规格，同时申请仿制药质量和疗效一致性评价审批结论根据《中华人民共和国药品 管理法》、《国务院关于改革药品医疗器械审评审批制度的意见》(国发〔2015〕44号)、《关于仿制药 质量和疗效一致性评价工作有关事项的公告》(2017年第100号)和《国家药监局关于开展化学药品注射 剂仿制药质量和疗效一致性评价工作的公告》(2020年第62号)的规定，经审查，批准本品增加10ml:1.5g 规格的补充申请，核发药品批准文号。本品通过仿制药质量和疗效一致性评价。上市许可持有人名称： 安徽双鹤药业有限责任公司生产企业名称：安徽双鹤药业有限责任公司 二、药品相关情况 氯化钾注射液用于治疗和预防低钾血症，适用于无法口服补钾时。 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 近日，华润双鹤药业股 ...

证券代码：600062 证券简称：华润双鹤 公告编号：临2025－077 氯化钾注射液获得药品补充申请批准通知书的公告 华润双鹤药业股份有限公司 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 关于全资子公司安徽双鹤药业有限责任公司 近日，华润双鹤药业股份有限公司(以下简称"公司")全资子公司安徽双鹤药业有限责任公司(以下简 称"安徽双鹤")收到了国家药品监督管理局(以下简称"国家药监局")颁发的氯化钾注射液(以下简称"该药 品")《药品补充申请批准通知书》。现将相关情况公告如下： 一、通知书主要内容 ■ 二、药品相关情况 国内市场，根据国家药监局网站信息显示，中国大陆境内已批准上市的氯化钾注射液(10ml:1.5g)生产企 业有44家(含安徽双鹤)，其中通过或视同通过一致性评价的生产企业有26家(含安徽双鹤)。根据米内网 数据显示，2024年国内医疗市场和零售市场氯化钾注射液销售总额(终端价)为6.17亿元人民币，其中排 名前5名的企业及其市场份额分别为大冢制药43.44%，湖北科伦药业17.87%，山西诺成制药9.99%， ...

每经AI快讯，华润双鹤（600062）公告，公司全资子公司安徽双鹤药业有限责任公司近日收到国家药 品监督管理局颁发的氯化钾注射液《药品补充申请批准通知书》。氯化钾注射液用于治疗和预防低钾血 症，适用于无法口服补钾时。截至本公告日，安徽双鹤针对氯化钾注射液累计研发投入为161.09万元人 民币(未经审计)。 ...

格隆汇8月31日丨华润双鹤(600062.SH)公布，近日，公司全资子公司安徽双鹤药业有限责任公司(以下 简称"安徽双鹤")收到了国家药品监督管理局(以下简称"国家药监局")颁发的氯化钾注射液(以下简称"该 药品")《药品补充申请批准通知书》。 ...

氯化钾注射液用于治疗和预防低钾血症，适用于无法口服补钾时。氯化钾注射液获得《药品补充申请批 准通知书》将有利于未来的市场销售和市场竞争，并为后续开展仿制药一致性评价积累了宝贵的经验。 智通财经APP讯，华润双鹤(600062.SH)发布公告，近日，公司全资子公司安徽双鹤药业有限责任公司 (简称"安徽双鹤")收到了国家药品监督管理局(简称"国家药监局")颁发的氯化钾注射液《药品补充申请 批准通知书》。经审查，批准本品增加10ml:1.5g规格的补充申请，核发药品批准文号。本品通过仿制 药质量和疗效一致性评价。 ...

华润双鹤（600062）(600062.SH)发布公告，近日，公司全资子公司安徽双鹤药业有限责任公司(简称"安 徽双鹤")收到了国家药品监督管理局(简称"国家药监局")颁发的氯化钾注射液《药品补充申请批准通知 书》。经审查，批准本品增加10ml:1.5g规格的补充申请，核发药品批准文号。本品通过仿制药质量和 疗效一致性评价。 氯化钾注射液用于治疗和预防低钾血症，适用于无法口服补钾时。氯化钾注射液获得《药品补充申请批 准通知书》将有利于未来的市场销售和市场竞争，并为后续开展仿制药一致性评价积累了宝贵的经验。 ...

华润双鹤公告，全资子公司安徽双鹤药业有限责任公司收到国家药监局颁发的氯化钾注射液《药品补充 申请批准通知书》。该药品用于治疗和预防低钾血症，安徽双鹤现有氯化钾注射液(10ml:1g)，此次获批 增加10ml:1.5g规格，累计研发投入为161.09万元人民币。2024年氯化钾注射液全球销售额为2.23亿美 元，国内医疗市场和零售市场销售总额为6.17亿元人民币。公司氯化钾注射液2024年销售收入为96万 元。 ...

Core Viewpoint - Tianjin Pharmaceutical Industry is recognized as a leading domestic manufacturer of steroid hormone drugs and a global leader in amino acid raw materials, showcasing its advanced position and demonstration effect in the industry for the year 2024 [1] Product Matrix - The company has a diverse product matrix with over 70 types of raw materials, including dexamethasone series, prednisone series, methylprednisolone series, betamethasone series, and amino acids, as well as more than 10 dosage forms such as injections, ointments, and tablets, catering to various patient treatment needs [2] R&D Innovation - In recent years, the company has significantly enhanced its product R&D and scientific research system, focusing on steroid hormones and amino acids, and implementing a "raw materials + formulations" full industry chain layout, with R&D investment reaching 248 million yuan in 2024, accounting for 7.7% of revenue, reflecting its strong R&D capabilities [3] Dual-Track Strategy - The company employs a dual-track strategy of "innovation line" and "generic line" to accelerate the new drug approval process, with 11 specifications of 10 products recently receiving approval, including the first domestic approval for a specific injection by its subsidiary [4] Market Performance - Among its products, the injection of isopropyl methochloride has shown strong market performance, with sales increasing from 756 million yuan in 2022 to 821 million yuan in 2023, and is expected to expand further due to its inclusion in the national medical insurance [5] - The inhalation solution of acetylcysteine is also a national medical insurance drug, with significant market potential in treating respiratory diseases, indicating a stable growth outlook as the patient population expands [5] Future Outlook - The company plans to continue its commitment to innovation, increasing investment in technology R&D, and focusing on new product development and consistency evaluation to provide high-quality, efficient drugs for patients and deliver substantial value returns to shareholders [6]

Core Viewpoint - The company, Shanghai Modern Pharmaceutical Co., Ltd., announced that its wholly-owned subsidiary, National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd., has received approval for potassium chloride injection to pass the consistency evaluation of generic drug quality and efficacy, which is expected to enhance market expansion and sales potential for the product [6][7]. Financial Data - The quarterly financial report for the first quarter of 2025 has not been audited [3]. - The company has invested approximately RMB 1.6354 million in the research and development of potassium chloride injection [8]. Drug Information - Potassium chloride injection is a commonly used medication for supplementing potassium in the body, primarily used to treat and prevent hypokalemia, especially when oral supplementation is not possible [7]. - The sales revenue of potassium chloride injection in public medical institutions across China was RMB 619 million in 2023 [7]. Regulatory Approval - The approval was granted based on various regulations, including the Drug Administration Law of the People's Republic of China and related announcements regarding the consistency evaluation of generic drugs [6].