Investment Rating - The report maintains a "Strong Buy" rating for Huahai Pharmaceutical with a target price of 24.6 CNY [2][9]. Core Insights - The company's main business is under pressure, but significant progress has been made in innovative drug research and development [2][9]. - For the first three quarters of 2025, the company reported revenue of 6.409 billion CNY, a year-on-year decrease of 11.57%, and a net profit attributable to shareholders of 380 million CNY, down 63.12% year-on-year [2][9]. - The third quarter alone saw revenue of 1.893 billion CNY, a decline of 10.70% year-on-year, with a net loss of 29 million CNY, marking a year-on-year decline of 110.30% [2][9]. Financial Performance Summary - Revenue projections for 2024A, 2025E, 2026E, and 2027E are 9.547 billion CNY, 8.367 billion CNY, 9.101 billion CNY, and 10.100 billion CNY respectively, with a year-on-year growth rate of 14.9%, -12.4%, 8.8%, and 11.0% [4]. - Net profit attributable to shareholders is forecasted to be 1.119 billion CNY in 2024A, 375 million CNY in 2025E, 668 million CNY in 2026E, and 810 million CNY in 2027E, reflecting growth rates of 34.7%, -66.5%, 78.1%, and 21.1% respectively [4]. - The company’s gross margin for the first three quarters of 2025 was 61.71%, a decrease of 0.95 percentage points year-on-year [9]. Business Development and Innovation - The company is accelerating its transformation and upgrading efforts, with a focus on innovative drug pipelines entering a harvest period [9]. - In the first three quarters of 2025, the company registered 16 new domestic formulation products, received 3 ANDA approvals in the U.S., and obtained 4 clinical trial approvals for biological drugs [9]. - Key innovative drugs are progressing through critical stages, including the domestic first self-developed IL-36R monoclonal antibody HB0034, which is expected to be approved in the second quarter of next year [9].

Corporate Announcements - China Aluminum announced the election of He Wenjian as chairman and the appointment of Zhang Ruizhong as general manager, with Zhang holding 147,100 shares of A-shares [4] - Jiangbolong reported that its self-developed main control chip deployment exceeded 100 million units by the end of Q3, with ongoing rapid growth [5] - Asia-Pacific Pharmaceutical received a notice of disapproval for the consistency evaluation application of Diltiazem Hydrochloride Tablets, which will not significantly impact current performance [6] - Fuxiang Pharmaceutical successfully passed the FDA's cGMP inspection, marking the third successful inspection, enhancing its qualification for international market supply [7] - Biaobang Co. terminated its control change planning due to failure to reach consensus on core terms, leading to stock resumption [8] - Jingjin Equipment announced the release of its actual controller and chairman from detention, allowing normal operations [9] - Sand Membrane reported that part of its fundraising account was frozen, amounting to 11.74 million yuan, related to a contract dispute [10] - Renfu Pharmaceutical's subsidiary received approval for clinical trials of HWH217 tablets for treating pulmonary arterial hypertension [12] - Wanye Enterprises will change its stock name to "Xian Dao Ji Dian" effective November 12 [13] - Huahai Pharmaceutical's subsidiary passed the FDA inspection, ensuring compliance with international standards [14] Performance Metrics - Daqin Railway reported a cargo transport volume of 32.51 million tons in October, a decrease of 4.7% year-on-year [19] - Jingji Agriculture announced sales of 233,300 pigs in October, generating revenue of 317 million yuan [20] - Baiyun Airport reported a passenger throughput of 7.64 million in October, a year-on-year increase of 12.04% [21] - Dongfeng Motor's total vehicle production decreased by 23.4% year-on-year in October, with significant declines in commercial vehicle categories [22] - Hongyang Real Estate reported a contract sales amount of 202 million yuan in October [23][24] Shareholding Changes - Xintonglian announced that a shareholder plans to reduce its stake by up to 3% [25] - Tonghua Dongbao conducted its first share buyback, acquiring 0.01% of its shares for 1.29 million yuan [26] - Guoci Materials plans to repurchase shares worth 100 million to 200 million yuan at a price not exceeding 30 yuan per share [27] - Xili Technology announced multiple shareholders plan to reduce their stakes [28] Major Contracts - Dayu Water announced a pre-bid win for a 310 million yuan water conservancy project in Hainan [29] - Zhongjian Technology signed a significant sales contract worth 563 million yuan [30] - Longjian Co. won a bid for a 441 million yuan project for road construction in Heilongjiang [31] - Chongqing Construction's subsidiary won a bid for a 781 million yuan project in Chongqing [32]

Core Viewpoint - Huahai Pharmaceutical's subsidiary, Zhejiang Huahai Pharmaceutical Technology Co., has successfully passed an FDA inspection, confirming compliance with CGMP standards for its production facility [2]. Group 1 - The FDA conducted an on-site inspection from August 18 to August 22, 2025, focusing on the overall quality management system and oral solid dosage products of Huahai Technology [2]. - The inspection report indicates that Huahai Technology's production base meets the requirements of current Good Manufacturing Practice (CGMP) for pharmaceuticals [2].

Corporate Governance - China Aluminum announced the election of He Wenjian as chairman and the appointment of Zhang Ruizhong as general manager, effective immediately [3] - Jiang Guiting, the actual controller and chairman of Jingjin Equipment, has had his detention lifted, allowing him to resume his duties [8] - Biao Bang Co. has terminated its plans for a change in control, with stock resuming trading [7] Industry Developments - Jiangbolong reported that its self-developed main control chip deployment has exceeded 100 million units, with rapid growth expected [4] - Asia Pacific Pharmaceutical received a notice of disapproval for its consistency evaluation application for a drug, which will not significantly impact its current performance [5] - Fuxiang Pharmaceutical successfully passed a cGMP inspection by the FDA, marking its third successful inspection [6] - Huahai Pharmaceutical's subsidiary passed an FDA inspection, enhancing its international market capabilities [13] Financial Performance - Daqin Railway reported a cargo transport volume of 32.51 million tons in October 2025, a year-on-year decrease of 4.7% [18] - Jingji Zhino achieved sales revenue of 317 million yuan from selling 233,300 pigs in October 2025 [19] - Baiyun Airport reported a passenger throughput of 7.64 million in October 2025, a year-on-year increase of 12.04% [20] - Dongfeng Motor's total vehicle production in October 2025 was 6,536 units, a year-on-year decrease of 23.40% [21] - Hongyang Real Estate reported a contract sales amount of 202 million yuan in October 2025 [22] Shareholder Actions - Xintonglian announced that a shareholder plans to reduce its stake by up to 3% [24] - Tonghua Dongbao conducted its first share buyback, acquiring 143,500 shares for 1.29 million yuan [25] - Guoci Materials plans to repurchase shares worth 100 million to 200 million yuan at a price not exceeding 30 yuan per share [26] Project Wins - Dayu Water-saving announced a pre-bid win for a 310 million yuan water conservancy project in Hainan [28] - Zhongjian Technology signed a significant sales contract worth 563 million yuan [29] - Longjian Co. won a project bid worth 441 million yuan for road construction in Heilongjiang [30] - Chongqing Construction's subsidiary won a project bid worth 781 million yuan for a residential project in Chongqing [31]

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 ...