Core Viewpoint - Huahai Pharmaceutical's subsidiary, Zhejiang Huahai Pharmaceutical Technology Co., Ltd., successfully passed an FDA inspection, confirming compliance with current Good Manufacturing Practices (CGMP) for drug production [1] Group 1 - The FDA inspection took place from August 18 to August 22, 2025, covering the overall quality management system and oral solid dosage products of the factory [1] - The inspection report indicates that the production base of Huahai Technology meets the requirements of CGMP [1]

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 2025-115 | | --- | --- | --- | --- | | 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 关于子公司通过美国 FDA 现场检查的公告 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"）子公司浙江华海制药科技有限 公司（以下简称"华海科技"）于 2025 年 8 月 18 日至 2025 年 8 月 22 日接受了美国 食品药品监督管理局（以下简称"FDA"）的现场监督检查，检查范围涵盖工厂整体 质量管理体系及口服固体制剂产品。近日，公司收到现场检查报告，该报告表明华海 科技生产基地符合美国药品 CGMP（现行药品生产质量管理规范）要求，通过了本次 现场检查。现将相关信息公告如下： 由于医药产品具有高科技、高风险、高附加值的特点，各类投产后的产品未来的 具体销售情况可能受到市场环境变化等因素影响，具有较大不确定性，敬请广大投资 1 ...

Core Viewpoint - Huahai Pharmaceutical's subsidiary, Zhejiang Huahai Pharmaceutical Technology Co., Ltd., successfully passed the FDA's on-site inspection, confirming compliance with current Good Manufacturing Practices (CGMP) for drug production [1] Group 1 - The FDA inspection took place from August 18 to August 22, 2025, covering the overall quality management system and oral solid dosage products of the factory [1] - The inspection report indicates that the production base of Huahai Technology meets the requirements of CGMP [1]

Core Viewpoint - Huahai Pharmaceutical's subsidiary, Zhejiang Huahai Pharmaceutical Technology Co., Ltd., successfully passed an FDA inspection, confirming compliance with current Good Manufacturing Practices (CGMP) for drug production [1] Group 1 - The FDA inspection took place from August 18 to August 22, 2025, covering the overall quality management system and oral solid dosage products of Huahai Technology [1] - The inspection report indicates that the production base of Huahai Technology meets the requirements of CGMP [1]

Core Points - Huahai Pharmaceutical announced that as of November 5, 2025, its stock price has fallen below 80% of the current conversion price for at least 15 trading days within any 30 consecutive trading days, triggering the downward adjustment clause for "Huahai Convertible Bonds" [2] - The company's board of directors decided not to exercise the right to adjust the conversion price downwards at this time and will not propose a downward adjustment plan if the clause is triggered again within the next two months [2] - Starting from January 6, 2026, if the downward adjustment clause is triggered again, the board will hold another meeting to decide whether to exercise the right to adjust the conversion price [2]

| | | 浙江华海药业股份有限公司 关于不向下修正"华海转债"转股价格的公告 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 2025 年 11 月 5 日，浙江华海药业股份有限公司（以下简称"公司"） 股价已出现任意三十个连续交易日中至少十五个交易日收盘价格低于当期转股 价格 80%的情形，触及"华海转债"转股价格向下修正条款。 经公司第九届董事会第六次临时会议审议通过，公司董事会决议本次不行使 "华海转债"转股价格向下修正的权利，且在未来 2 个月内（2025 年 11 月 6 日 至 2026 年 1 月 5 日），如再次触及可转债的转股价格向下修正条款，亦不提出向 下修正方案。从 2026 年 1 月 6 日开始重新起算，若再次触发"华海转债"转股 价格向下修正条款，届时公司董事会将再次召开会议审议是否行使"华海转债" 转股价格向下修正的权利。 一、可转换公司债券基本情况 根据中国证券监督管理委员会《关于核准浙江华海药业股份有限公司公开发 行可转换公司债券的批复》（证监许可[2020]22 ...

债券简称：华海转债 债券代码：110076 股票简称：华海药业 股票代码：600521 公告编号：临 2025-113 号 浙江华海药业股份有限公司 董事会 浙江华海药业股份有限公司 第九届董事会第六次临时会议决议公告 表决情况：同意：9 票；反对：0 票；弃权：0 票。 具体内容详见公司于 2025 年 11 月 6 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 份有限公司关于不向下修正"华海转债"转股价格的公告》。 特此公告。 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（以下称"公司"）第九届董事会第六次临时会议于 二零二五年十一月五日下午十五点以通讯方式在公司四楼会议室召开。会议应到会 董事九人，实际到会董事九名，符合召开董事会会议的法定人数。会议由公司董事 长李宏先生主持。会议程序符合《公司法》及《公司章程》的规定，会议合法有效。 会议审议并通过了如下决议： 一、审议通过了《关于不向下修正"华海转债"转股 ...

Core Viewpoint - Huahai Pharmaceutical is a leading vertically integrated enterprise in the domestic specialty API and formulation sector, with strong capabilities in innovative drug research and development [1] Group 1: Business Performance - In Q3 2025, Huahai Pharmaceutical achieved revenue of 6.409 billion yuan, ranking 14th among 110 companies in the industry, with the industry leader, East China Pharmaceutical, generating 32.664 billion yuan [2] - The net profit for the same period was 374 million yuan, placing the company 24th in the industry, while the top performer, Heng Rui Medicine, reported a net profit of 5.76 billion yuan [2] Group 2: Financial Ratios - As of Q3 2025, the company's debt-to-asset ratio was 54.62%, higher than the industry average of 35.26%, indicating relatively high debt pressure [3] - The gross profit margin for Q3 2025 was 61.71%, above the industry average of 57.17%, reflecting strong profitability [3] Group 3: Shareholder Information - As of September 30, 2025, the number of A-share shareholders increased by 1.58% to 68,400, with an average holding of 21,900 circulating A-shares [5] - Notable changes among the top ten circulating shareholders include a decrease in shares held by China Europe Medical Health Mixed A and an increase by Hong Kong Central Clearing Limited [5] Group 4: Research and Development - In H1 2025, the company invested 649 million yuan in R&D, a year-on-year increase of 23.07%, accounting for 14.36% of revenue [6] - Key clinical trials for innovative drugs such as HB0034 and HB0017 are progressing, with HB0034 expected to submit a formal application for market approval soon [6] Group 5: Market Outlook - Current stock price corresponds to a PE ratio of 34.2 for 2025, with a projected increase in net profit for 2025-2027 [6] - The company is expected to benefit from an optimized product structure and new approvals in both domestic and international markets [7]

Group 1 - The core viewpoint of the article highlights Huahai Pharmaceutical's significant decline in both revenue and net profit for the third quarter of 2023 compared to the same period last year [1] Group 2 - Huahai Pharmaceutical reported a revenue of approximately 6.409 billion yuan for the first three quarters of 2025, representing a year-on-year decrease of 11.57% [1] - The net profit attributable to shareholders of the listed company was about 380 million yuan, reflecting a year-on-year decrease of 63.12% [1] - The basic earnings per share stood at 0.26 yuan, which is a decrease of 63.38% compared to the previous year [1]

Core Viewpoint - Huahai Pharmaceutical (600521.SH) reported a decline in revenue and net profit for Q3 2025, indicating potential challenges in its financial performance [1] Financial Performance - The company's operating revenue for Q3 2025 was 1.893 billion yuan, representing a year-on-year decrease of 10.70% [1] - The net profit attributable to shareholders of the listed company was -29.1313 million yuan [1] - The net profit attributable to shareholders after deducting non-recurring gains and losses was -93.3738 million yuan [1]