| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 2025-072 | | --- | --- | --- | --- | | 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 浙江华海药业股份有限公司（以下简称"公司"）于 2025 年 4 月 28 日、2025 年 5 月 23 日分别召开第八届董事会第三次会议和 2024 年年度股东大会，会议审议 通过了《关于注销部分回购股份并减少注册资本的议案》，同意公司对回购专用证券 账户中的 10,656,753 股股份予以注销，并相应减少公司注册资本。本次注销完成后， 公司总股本将由 1,507,907,834 股变更为 1,497,251,081 股，公司注册资本将由 1,507,907,834 元变更为 1,497,251,081 元。 股份注销日：2025 年 6 月 16 日。 一、回购股份情况概述 公司分别于 2021 年 4 月 23 日、2021 年 5 月 18 日召开第七届董事会第二次会 议、2020 年年度股东大会，审议通过《关于以集中竞价交易方式回购公司股份方案 的议案》；2 ...

证券代码：600521 证券简称：华海药业 债券代码：110076 债券简称：华海转债 浙商证券股份有限公司 关于 浙江华海药业股份有限公司 可转换公司债券转股价格调整的 临时受托管理事务报告 债券受托管理人： （浙江省杭州市五星路 201 号） 二〇二五年六月 1 重要声明 浙商证券股份有限公司（以下简称"浙商证券"）编制本报告的内容及信息 来源于浙江华海药业股份有限公司（以下简称"华海药业"、"公司"或"发行人"） 对外公布的公开信息披露文件及发行人向浙商证券提供的资料。 浙商证券按照《公司债券发行与交易管理办法》《公司债券受托管理人执业 行为准则》等相关规定及与华海药业签订的《浙江华海药业股份有限公司公开发 行可转换公司债券之受托管理协议》（以下简称"《受托管理协议》"）的约定编制 本报告。 本报告不构成对投资者进行或不进行某项行为的推荐意见，投资者应对相关 事宜做出独立判断，而不应将本报告中的任何内容据以作为浙商证券所作的承诺 或声明。请投资者独立征询专业机构意见，在任何情况下，投资者不能将本报告 作为投资行为依据。 浙商证券提请投资者及时关注发行人的信息披露文件，并已督促发行人及时 履行信息披露义务 ...

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2025-074 号 | | --- | --- | --- | --- | | 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 富马酸喹硫平缓释片用于治疗精神分裂症和双相情感障碍的抑郁发作。富马酸 喹硫平缓释片最早由阿斯利康（AstraZeneca）公司研发，于 2007 年 5 月在美国上 市，国内于 2013 年 10 月批准上市。目前国内获得该药品注册证书的主要有吉林天 衡药业有限公司、丽珠集团丽珠制药厂等。根据米内网数据预测，富马酸喹硫平缓 释片 2024 年国内市场销售金额约人民币 4.51 亿元。 截止目前，公司在富马酸喹硫平缓释片研发项目上已投入研发费用约人民币 1,693 万元。 三、对公司的影响 1 本次富马酸喹硫平缓释片获得国家药监局的《药品注册证书》，进一步丰富了 公司的产品线，有助于提升公司产品的市场竞争力，对公司的经营发展具有一定积 极的作用。 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 ...

证券代码：600521 证券简称：华海药业 公告编号：临 2025-073 号 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 关于因回购股份注销调整"华海转债"转股价格 因授予限制性股票增发股份，华海转债的转股价格由 34.46 元/股调整为 33.85 元/股，具体内容详见公司于 2021 年 7 月 10 日刊登在中国证券报、上海证券报、 证券时报、证券日报及上海证券交易所网站（www.sse.com.cn）上的《浙江华海药 业股份有限公司关于授予限制性股票增发股份调整可转债转股价格的公告》（公告 编号：临 2021-065 号）。 因向激励对象授予预留部分限制性股票，华海转债的转股价格由 33.85 元/股 调整至 33.79 元/股，具体内容详见公司于 2022 年 5 月 27 日刊登在中国证券报、 上海证券报、证券时报、证券日报及上海证券交易所网站（www.sse.com.cn）上的 《浙江华海药业股份有限公司关于授予限制性股票增发股份调整可转债转股价格 的公告》（公告编号：临 2022-064 号）。 暨转股停复牌的公告 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 ...

Core Viewpoint - Huahai Pharmaceutical (600521.SH) has received approval from the National Medical Products Administration for the registration of Fumaric Acid Quetiapine Extended-Release Tablets, which are used to treat schizophrenia and depressive episodes of bipolar disorder [1] Summary by Relevant Categories Product Approval - The approved drug was originally developed by AstraZeneca and was launched in the United States in 2007 [1] - The approval of this drug enhances the company's product line and improves its market competitiveness [1] Market Potential - According to data from Minet, the projected domestic market sales for this drug are approximately 451 million yuan in 2024 [1] R&D Investment - The company has invested approximately 16.93 million yuan in the research and development of this project [1]

Policy Developments - The Central Committee and State Council issued an opinion to improve the adjustment mechanism for the basic medical insurance drug catalog and to establish an innovative drug catalog for commercial health insurance [2] - The opinion aims to promote the sharing of high-quality medical resources and enhance the capacity of grassroots medical institutions [2] - The commercial health insurance sector is becoming a crucial lever for the high-quality development of commercial health insurance, helping to address the payment challenges for innovative drugs [3] Medical Device Approvals - DaAn Gene obtained a medical device registration certificate for six nucleic acid test kits for respiratory pathogens, expanding its product portfolio [5] - BGI Innovation received a medical device registration certificate for a human papillomavirus genotyping test kit, classified as Class III [6] - Shanghai Pharmaceuticals received approval for the production of Formoterol Fumarate inhalation solution, which is used for the maintenance treatment of chronic obstructive pulmonary disease [7] Corporate Transactions - Pilin Bio announced the resumption of trading after China National Pharmaceutical Group acquired 21.03% of its shares, changing the controlling shareholder [8] - China General Nuclear Power Corporation plans to inject 500 million yuan into its subsidiary for proton medical research and development [9] - Zhonghui Pharmaceutical completed two rounds of financing totaling nearly 50 million yuan, which will be used for the construction of a hollow microneedle medical device production base [10] Industry Developments - Dongxing Medical's subsidiary signed two contracts with Shanghai Jiao Tong University for synthetic biology technology development, totaling 6 million yuan [11] Regulatory Alerts - Huahai Pharmaceutical received a warning letter from the FDA regarding its production facility, which may affect future ANDA applications but will not significantly impact current performance [12]

Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. received a warning letter from the FDA based on an inspection conducted from January 16 to January 24, 2025, at its production facility in Xunqiao Town, Linhai City, which raised concerns regarding the management of cleaning for solid oral production equipment, maintenance of sterile production areas, and the adequacy of parameters for tablet rejection studies [1][2]. Group 1 - The warning letter specifically affects the approval of ANDA new applications or supplemental applications related to the Xunqiao production facility, but it will not have a significant impact on the company's current performance [2]. - The company is taking the FDA's suggestions seriously and has begun to implement optimization measures while maintaining active communication with the FDA [1][2]. - The company is committed to continuously improving its quality management system to ensure compliance with operational standards [1].

Core Viewpoint - Huahai Pharmaceutical received a warning letter from the FDA due to issues found during an inspection of its Linhai Xunqiao production base, which may affect future ANDA applications but will not significantly impact current performance [2][3]. Group 1: FDA Warning Letter - The warning letter was issued following an FDA inspection from January 16 to January 24, 2025, which identified problems related to cleaning management of oral solid production equipment, maintenance of sterile production areas, and the adequacy of tablet rejection parameter studies [2]. - The company has acknowledged the FDA's suggestions and is taking measures to optimize its operations while maintaining active communication with the FDA [2]. Group 2: Historical Context and Previous Performance - The Linhai Xunqiao production base previously passed FDA inspections with zero defects, highlighting its compliance history [3]. - In 2020, the sales revenue from formulation products produced at the Linhai Xunqiao base in the U.S. was 780 million yuan, while the revenue from active pharmaceutical ingredients (APIs) was 27.6651 million yuan [3]. - For 2024, the U.S. formulation business is projected to generate approximately 1.279 billion yuan in sales, reflecting a year-on-year decline of 6.51%, although the average gross margin of products has been improving [3]. Group 3: Previous Warnings and Compliance - In 2018, the company received a warning letter from the FDA regarding its Chuan Nan plant, citing issues such as failure to ensure quality-related complaint investigations and not assessing the impact of process changes on API quality [4]. - The 2018 warning was linked to the detection of a potential carcinogen in an API, which raised concerns about the company's production methods [5]. - The FDA lifted the warning for the Chuan Nan production base by the end of 2021, allowing products from this facility to re-enter the U.S. market [5].

浙江华海药业股份有限公司（以下简称"公司"）于近日收到美国食品药品监 督管理局（以下简称"FDA"）发出的警告信，该警告信系基于 2025 年 1 月 16 日 至 1 月 24 日期间 FDA 对公司位于临海市汛桥镇的药品生产基地（以下简称"汛桥 生产基地"）进行的现场检查。警告信针对汛桥生产基地的制剂产品提出了相关检 查意见和改进建议，主要涉及部分口服固体生产设备清洁管理、无菌生产区域维护 和压片剔废参数研究的充分性。 公司高度重视 FDA 的建议，已积极采取措施进行优化，并持续与 FDA 保持积 极沟通。公司将持续提升质量管理体系，确保合规运营。 | | | 股票简称：华海药业 股票代码：600521 公告编号：临 2025-071 号 浙江华海药业股份有限公司 关于公司收到 FDA 警告信的公告 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。 浙江华海药业股份有限公司 董 事 会 二零二五年六月九日 1 公司制剂生产基地主要有汛桥制剂生产基地（位于浙江省临海市汛桥镇）和子 公司浙江华海制药科技有限公司（位于临海市 ...

| | | 股票简称：华海药业 股票代码：600521 公告编号：临 2025-071 号 浙江华海药业股份有限公司 关于公司收到 FDA 警告信的公告 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。 浙江华海药业股份有限公司（以下简称"公司"）于近日收到美国食品药品监 督管理局（以下简称"FDA"）发出的警告信，该警告信系基于 2025 年 1 月 16 日 至 1 月 24 日期间 FDA 对公司位于临海市汛桥镇的药品生产基地（以下简称"汛桥 生产基地"）进行的现场检查。警告信针对汛桥生产基地的制剂产品提出了相关检 查意见和改进建议，主要涉及部分口服固体生产设备清洁管理、无菌生产区域维护 和压片剔废参数研究的充分性。 公司高度重视 FDA 的建议，已积极采取措施进行优化，并持续与 FDA 保持积 极沟通。公司将持续提升质量管理体系，确保合规运营。 公司制剂生产基地主要有汛桥制剂生产基地（位于浙江省临海市汛桥镇）和子 公司浙江华海制药科技有限公司（位于临海市江南街道）。本次警告信仅对涉及汛 桥生产基地的 ANDA 新申 ...