浙江华海药业股份有限公司（以下简称"公司"）于近日收到国家药品监督管 理局（以下简称"国家药监局"）核准签发的左卡尼汀注射液的《药品注册证书》， 现将相关情况公告如下： 一、药品的基本情况 药品名称：左卡尼汀注射液 剂型：注射剂 规格：5ml:1g 申请事项：药品注册（境内生产） 注册分类：化学药品 4 类 | 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 2026-002 | | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | 浙江华海药业股份有限公司 关于获得药品注册证书的公告 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个别及连带责任。 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符 合药品注册的有关要求，批准注册，发给药品注册证书。 二、药品其他相关情况 左卡尼汀注射液用于慢性肾衰长期血透病人因继发性肉碱缺乏产生的一系列 并发症状，临床表现如心肌病、骨骼肌病、心律失常、高脂血症，以及低血压和透 析中肌痉挛等。左卡尼 ...

Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration of L-carnitine injection, which is intended for patients with chronic renal failure undergoing long-term hemodialysis and suffering from secondary carnitine deficiency-related complications [1] Group 1 - The L-carnitine injection is used to address complications such as cardiomyopathy, skeletal muscle disease, arrhythmias, hyperlipidemia, low blood pressure, and muscle cramps during dialysis [1] - The company has invested approximately 4.69 million yuan in the research and development of the L-carnitine injection project [1]

Core Viewpoint - Huahai Pharmaceutical (600521.SH) has received approval from the National Medical Products Administration for the registration certificate of L-carnitine injection, which is used for complications arising from secondary carnitine deficiency in patients with chronic renal failure undergoing long-term hemodialysis [1] Group 1 - The L-carnitine injection is indicated for symptoms such as cardiomyopathy, skeletal myopathy, arrhythmia, hyperlipidemia, low blood pressure, and muscle cramps during dialysis [1] - The approval of L-carnitine injection enriches the company's product line and enhances its market competitiveness [1] - The product is classified as a chemical drug of category 4, which is considered equivalent to passing the consistency evaluation according to national policies [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of L-Carnitine Injection, which is intended for treating complications arising from secondary carnitine deficiency in patients with chronic renal failure undergoing long-term hemodialysis [1] Group 1 - The L-Carnitine Injection is classified as a Class 4 chemical drug, which is equivalent to passing the consistency evaluation, enhancing the company's market competitiveness [1] - The company has invested approximately 4.69 million yuan in the research and development of the L-Carnitine Injection project [1] - The projected domestic market sales for L-Carnitine Injection are estimated to reach approximately 508 million yuan in the first half of 2025 [1]

Group 1 - The core viewpoint of the news is that Zhejiang Huahai Pharmaceutical Co., Ltd. has undergone a site inspection by its sponsor, Zheshang Securities, which found that the company is operating well in terms of corporate governance, internal control, and compliance with regulations [1][12] Group 2 - The site inspection was conducted on December 30, 2025, and involved reviewing the company's governance documents, internal control systems, and financial practices [3][4] - The inspection confirmed that the company has a complete governance structure and that its internal control systems are effectively implemented [2][4] - The company has maintained independence from its controlling shareholders and has not engaged in any improper transactions with related parties [4][5] Group 3 - The use of raised funds was found to be compliant, with all funds stored in designated accounts and no evidence of misuse or unauthorized changes in fund allocation [5][6] - There were no violations related to external guarantees, related transactions, or significant external investments during the inspection period [5][6] Group 4 - The company's operational status remains stable, with no significant adverse changes in its business model or structure [6][12] - The company is advised to continue enhancing its corporate governance and risk management practices to ensure accurate and complete information disclosure [8]

| 证券代码：600521 | 证券简称：华海药业 | 公告编号：临 号 2026-001 | | --- | --- | --- | | 债券代码：110076 | 债券简称：华海转债 | | 浙江华海药业股份有限公司 可转换公司债券转股结果暨股份变动公告 未转股可转债情况：截至2025年12月31日，尚未转股的华海转债金额为 1,842,382,000元，占华海转债发行总额的99.9882%。 本季度转股情况：自2025年10月1日至2025年12月31日期间，华海转债合 计共有23,000元转为公司股份，因转股形成的股份数量为694股，占华海转债转 股前公司已发行股份总额的0.000048%。 一、可转债发行上市概况 （一）华海转债发行上市情况 经中国证券监督管理委员会证监许可[2020]2261号文核准，浙江华海药业股 份有限公司（以下简称"公司"或"华海药业"）于2020年11月2日公开发行1,842.60 万张可转换公司债券，每张面值100元，发行总额为184,260.00万元，期限为发行 之日起6年。 经上海证券交易所自律监管决定书[2020]376号文同意，公司184,260.00万元 可转换 ...

浙商证券股份有限公司 浙商证券股份有限公司 （二）保荐代表人 浙商证券股份有限公司（以下简称"浙商证券"或"保荐机构"）作为浙江 华海药业股份有限公司（以下简称"华海药业"或"公司"）2025 年向特定对象 发行股票项目的保荐机构，根据《证券发行上市保荐业务管理办法》以及《上海 证券交易所上市公司自律监管指引第 11 号——持续督导》等相关法规规定，于 2025 年 12 月 30 日对公司进行了现场检查。现将本次检查的情况报告如下： 一、本次现场检查的基本情况 （一）保荐机构 关于浙江华海药业股份有限公司 2025 年度持续督导工作现场检查报告 王一鸣、潘洵 （三）现场检查时间 2025 年 12 月 30 日 （四）现场检查人员 （六）现场检查手段 1、查看公司主要生产经营场所，对公司相关人员进行访谈； 2、查阅本持续督导期间公司召开的历次三会文件； 3、查阅本持续督导期间公司的信息披露文件； 4、查阅公司募集资金专户银行对账单、募集资金使用相关重大合同、凭证 1 潘洵 （五）现场检查内容 公司治理和内部控制，信息披露情况，独立性以及与控股股东、实际控制人 及其他关联方资金往来情况，募集资金使用情况，关联 ...

Core Viewpoint - Huahai Pharmaceutical's stock has shown a slight increase of 2.00% recently, with a current price of 17.31 CNY per share and a total market capitalization of 25.917 billion CNY, indicating a mixed performance in the stock market [1]. Financial Performance - For the period from January to September 2025, Huahai Pharmaceutical reported a revenue of 6.409 billion CNY, reflecting a year-on-year decrease of 11.57%. The net profit attributable to shareholders was 380 million CNY, down 63.12% compared to the previous year [2]. - Cumulative cash dividends since the company's A-share listing amount to 2.989 billion CNY, with 1.016 billion CNY distributed over the last three years [3]. Shareholder Information - As of September 30, 2025, the number of shareholders for Huahai Pharmaceutical reached 68,400, an increase of 1.58% from the previous period. The average number of circulating shares per shareholder is 21,889, which is an increase of 1.23% [2]. - The top ten circulating shareholders include notable entities such as China Europe Medical Health Mixed A, which holds 28.785 million shares, and Hong Kong Central Clearing Limited, which increased its holdings by 2.125 million shares [3].

| 证券代码：600521 | 证券简称：华海药业 | 公告编号：临 2025-135 号 | | --- | --- | --- | | 债券代码：110076 | 债券简称：华海转债 | | 近日，公司接到股东周明华先生的通知，其质押给上海农村商业银行股份有 限公司浦东分行的公司股份 510 万股已办理了解除质押手续，具体情况如下: 单位：股 浙江华海药业股份有限公司 关于股东部分股份解除质押的公告 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个别及连带责任。 重要内容提示: 截至本公告披露日，浙江华海药业股份有限公司（以下简称"公司"） 5%以上股东周明华先生持有公司股份总数为 224,418,890 股，占公司总股本的比 例为 14.99%。本次股份解除质押后，周明华先生处于质押状态的股份累计数为 52,400,000 股，占其所持有公司股份总数的 23.35%，占公司总股本的比例为 3.50%。 一、本次股份解除质押情况 二零二五年十二月三十一日 | 股东名称 | 周明华 | | --- | --- | | 本次解除质押股份 ...

Core Viewpoint - Huahai Pharmaceutical announced that major shareholder Zhou Minghua will解除质押 of 5.1 million shares to Shanghai Rural Commercial Bank, representing 2.27% of his holdings and 0.34% of the company's total share capital, with the解除时间 set for December 30, 2025 [1] Summary by Relevant Categories Shareholder Actions - Zhou Minghua currently holds 224 million shares, accounting for 14.99% of the company [1] - After the解除质押, Zhou Minghua will have 52.4 million shares still pledged, which is 23.35% of his holdings and 3.50% of the company's total share capital [1]