| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2025-010 | 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 关于制剂产品多西环素胶囊获得美国 FDA 批准文号 的公告 4、规格：40 mg 5、申请事项：ANDA（美国新药简略申请） 6、申请人：普霖斯通制药有限公司（Prinston Pharmaceutical, Inc.） 二、药物的其他相关情况 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。 近日，浙江华海药业股份有限公司（以下简称"公司"）收到美国食品药品 监督管理局（以下简称"美国 FDA"）的通知，公司向美国 FDA 申报的多西环 素胶囊的新药简略申请（ANDA，即美国仿制药申请）已获得批准，现将相关情 况公告如下： 一、药品的基本情况 1、药物名称：多西环素胶囊 2、ANDA 号：217098 3、剂型：胶囊 多西环素胶囊主要用于治疗丘疹脓疱型红斑痤疮。多 ...

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 2025-011 号 浙江华海药业股份有限公司 关于下属子公司获得药物临床试验许可的公告 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。 近日，浙江华海药业股份有限公司（以下简称"华海药业"或"公司"）的下 属子公司上海华奥泰生物药业股份有限公司（以下简称"华奥泰"）及华博生物医 药技术（上海）有限公司（以下简称"华博生物"，华奥泰下属全资子公司）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 HB0017 注射液项目 新增适应症的《药物临床试验批准通知书》，现将相关情况公告如下： 一、药物基本情况 二、药物的其他相关情况 2024 年 11 月 5 日，华奥泰和华博生物就 HB0017 注射液项目新增的化脓性汗 腺炎适应症向国家药监局提交临床试验申请并获得受理；近日，国家药监局同意该 药物进行上述新增适应症的临床试验。截至目前，公司 HB0017 注射液项目共有 5 个适应症（银屑病、银屑病关节炎、强直性 ...

Core Viewpoint - Huahai Pharmaceutical has received regulatory approvals for new drug indications and applications, indicating progress in its product pipeline and potential market expansion [1] Group 1: Regulatory Approvals - Huahai Pharmaceutical's subsidiary Huao Tai and Huabo Biotech received approval from the National Medical Products Administration for clinical trials of HB0017 injection for the new indication of suppurative hidradenitis [1] - The company has also received notification from the U.S. Food and Drug Administration (FDA) that its abbreviated new drug application for doxycycline capsules has been approved, which are primarily used for treating papulopustular rosacea [1]

Investment Rating - The investment rating for Huahai Pharmaceutical is "Sell" with a target price adjusted to RMB 14 from RMB 15, reflecting an 8.3% downside from the current price of RMB 15.26 [1][7][6]. Core Insights - The company reported a net profit forecast for 2024 in the range of RMB 11.40 billion to RMB 12.40 billion, representing a year-on-year growth of 37% to 49%, which exceeds previous estimates of RMB 10.52 billion. This positive outlook is attributed to lower-than-expected sales management expense ratios [1][5]. - The report indicates that the company has successfully transitioned from a raw material manufacturer to a leading exporter of generic drugs, primarily serving the US and Chinese markets. However, profitability remains challenged due to increasing pressure on generic products in the US market, rising R&D costs, and ongoing patent litigation [5][6]. Summary by Relevant Sections Financial Forecasts - Revenue and net profit forecasts for 2024 to 2027 have been adjusted, with 2024 revenue expected to be RMB 9.568 billion and net profit at RMB 1.198 billion, reflecting a 13.9% increase from previous estimates. The EPS for 2024 is projected at RMB 0.80, up 12.7% from earlier predictions [4][6]. Market Position and Challenges - Huahai Pharmaceutical faces challenges in maintaining profitability due to increasing competition in the US market, rising R&D costs, and legal issues related to patent disputes. The current expected P/E ratio is above the five-year average, indicating a potentially overvalued stock [5][6]. Valuation Methodology - The target price of RMB 14 is based on a 16x five-year exit P/E valuation method, assuming an 8% CAGR in expected EPS over the next five years. The report highlights potential upside risks, including better-than-expected product pipeline deliveries and sales, as well as a recovery in the US market [6][7].

Financial Performance Forecast - The estimated net profit attributable to shareholders for 2024 is expected to be between 1,140 million and 1,240 million CNY, representing a year-on-year increase of approximately 30.953 million to 40.953 million CNY, or a growth rate of about 37.3% to 49.3%[3] - The estimated net profit attributable to shareholders after deducting non-recurring gains and losses for 2024 is expected to be between 1,150 million and 1,250 million CNY, with a year-on-year increase of approximately 26.148 million to 36.148 million CNY, corresponding to a growth rate of about 29.4% to 40.7%[3] - The net profit for the same period last year was 830.466 million CNY, and the net profit after deducting non-recurring gains and losses was 888.522 million CNY[6] Factors Contributing to Profit Growth - The company attributes the significant profit growth to expanded sales scale, improved sales team structure, and effective market penetration strategies, along with the introduction of new products[7] - Continuous optimization of lean management and enhanced technical capabilities have contributed to improved cost control and increased gross margin, further strengthening the company's profitability[7] Performance Forecast Reliability - There are no major uncertainties affecting the accuracy of this performance forecast[8] - The performance forecast data is preliminary and has not been audited by an accounting firm; the final figures will be disclosed in the official 2024 annual report[9]

Company and Industry Summary Company Overview - The company has been involved in the pharmaceutical industry, focusing on both chemical and biological drugs, with significant investments in expanding its biological drug portfolio [1][2][15]. Key Points and Arguments Market Share and Growth - The company has successfully captured market share through its optimized manufacturing processes and cost control, achieving stable growth despite pressure on mid-range prices [1]. - Domestic pharmaceutical business has been a key growth driver, with revenue reaching 3.5 billion in 2023 and a compound annual growth rate (CAGR) of 25% from 2019 [4][5]. Financial Performance - The company experienced a recovery in financial performance post-2021 after a period of decline due to regulatory issues, with a notable increase in revenue and profit margins [3][12]. - The raw material business generated 3.16 billion in revenue in 2023, with a gross margin of 47.8%, reflecting strong cost management [8]. Product Development and Pipeline - The company has expanded its product pipeline significantly, with 20 new raw material products approved in 2023, indicating a robust development strategy [9][10]. - The biological drug segment is gaining traction, with the company establishing subsidiaries like HuAoTai and HuaBo Bio to enhance its capabilities in this area [2][15]. Clinical Trials and Innovations - The company is conducting multiple clinical trials for its biological products, including HB0125, which shows promising results in various cancers [16][17]. - The company aims to leverage its strong R&D capabilities to focus on high-difficulty products with favorable market conditions [7]. Future Outlook - The company anticipates significant reductions in losses from its U.S. operations by 2024 and expects overall profitability in overseas business by 2025 [2]. - The company projects a gross profit growth rate of 15% to 20% for 2025 and 2026, indicating a positive long-term outlook [18]. Additional Important Insights - The company has strategically targeted high-value products with substantial market potential, such as those exceeding $5 billion in sales [14]. - The competitive landscape is evolving, with increasing pressure on pricing due to supply dynamics and international competition [11][10]. This summary encapsulates the company's strategic positioning, financial performance, product development, and future outlook, highlighting its resilience and growth potential in the pharmaceutical industry.

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 2025-004 号 浙江华海药业股份有限公司 第八届董事会第三十二次临时会议决议公告 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"）第八届董事会第三十二次临时会 议于二零二五年一月三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"转股价格的议案》 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 2024 年 1 月 4 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》。 浙江华海药业股份有限公司 董 ...

经公司第八届董事会第三十二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 3 个月内（2025 年 1 月 4 日至 2025 年 4 月 3 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 2025 年 4 月 4 日开始重新起算，若再次触发"华海转债"的 转股价格向下修正条款，届时公司董事会将再次召开会议决定是否行使"华海转 债"的转股价格向下修正权利。 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： | 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2025-005 | 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 截至 2025 年 1 月 3 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 ...

本公司董事会及全体董事保证本公告内容不存在虚假记载、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： 累计转股情况：浙江华海药业股份有限公司可转换公司债券（以下简称 "华海转债"）于2021年5月6日开始转股，截至2024年12月31日，累计共有178,000 元华海转债转为公司股份，因转股形成的股份数量为5,187股，占华海转债转股 前公司已发行股份总额的0.00036%。 未转股可转债情况：截至2024年12月31日，除已回售的可转债外（期间 公司可转债回售金额为1,000元），尚未转股的华海转债金额为1,842,421,000元， 占华海转债发行总额的99.9903%。 本季度转股情况：自2024年10月1日至2024年12月31日期间，华海转债 未发生转股情况。 一、可转债发行上市概况 （一）华海转债发行上市情况 | 证券代码：600521 | 证券简称：华海药业 | 公告编号：临 | 2025-002 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 可 ...

浙江华海药业股份有限公司（以下简称"公司"）于 2024 年 12 月 16 日披露了 《浙江华海药业股份有限公司关于"华海转债"可选择回售的公告》（公告编号： 临 2024-123 号），并分别于 2024 年 12 月 17 日、2024 年 12 月 18 日、2024 年 12 月 19 日、2024 年 12 月 20 日、2024 年 12 月 21 日、2024 年 12 月 24 日、2024 年 12 月 25 日、2024 年 12 月 26 日、2024 年 12 月 27 日披露了关于"华海转债"回 售的提示性公告（公告编号分别为：临 2024-124 号、临 2024-125 号、临 2024-126 号、临 2024-127 号、临 2024-128 号、临 2024-129 号、临 2024-130 号、临 2024-131 号、临 2024-134 号），具体内容详见公司刊登在中国证券报、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 上的相关公告。 本次回售的"华海转债"代码为"110076"，回售价格为人民币 100.27 元/张 （含当 ...