华海药业公告，公司下属子公司上海华奥泰生物药业股份有限公司收到国家药品监督管理局签发的瑞西 奇拜单抗（研发代号为：HB0034）注射液境内生产药品注册上市许可申请的《受理通知书》。该药品 用于治疗成人泛发性脓疱型银屑病（GPP）发作。目前全球范围内，尚未有国内企业自研的靶向IL-36R 抗体获批上市。HB0034作为国内首个自研创新抗IL-36R抗体，可通过抑制IL-36通路发挥抗炎的生物学 效应。根据研究分析结果显示，相比于安慰剂，HB0034单次静脉给药后的第1周GPP发作患者的皮肤脓 疱得到明显清除，达到方案预设的主要研究终点，安全性方面表现良好，未发现新的安全性信号。 ...

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。 证券代码：600521 证券简称：华海药业 公告编号：临 2025-106 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 可转换公司债券转股结果暨股份变动公告 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2025年9月30日，累计共有194,000 元华海转债转为公司股份，因转股形成的股份数量为5,665股，占华海转债转股 前公司已发行股份总额的0.00039%。 未转股可转债情况：截至2025年9月30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1,842,405,000元， 占华海转债发行总额的99.9894%。 本季度转股情况：自2025年7月1日至2025年9月30日期间，华海转债合计 共有12,000元转为公司股份，因转股形成的股份数量为361股，占华海转债转股 前公司已发行股份总额的0.000025%。 一、可 ...

| 股票简称：华海药业 股票代码：600521 | 公告编号：临 | 号 2025-105 | | --- | --- | --- | | 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 关于子公司药品上市许可申请获得受理的提示性公告 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"）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"）收到国家药品监督管 理局（以下简称"国家药监局"）签发的瑞西奇拜单抗（研发代号为：HB0034）注射 液境内生产药品注册上市许可申请的《受理通知书》。现将相关情况公告如下： 一、药物基本情况 受理号：CXSS2500106 申请事项：境内生产药品注册上市许可 申请人：上海华奥泰生物药业股份有限公司 药物名称：瑞西奇拜单抗注射液 剂型：注射剂 规格：120mg（2ml）/瓶 申报适应症：用于治疗成人泛发性脓疱型银屑病（GPP）发作 注册分类：治疗用生物制品 1 类 申请人：上海华奥泰生 ...

Core Viewpoint - Huahai Pharmaceutical (600521) announced that its subsidiary, Huaotai, received the acceptance notice for the drug registration application of HB0034 injection from the National Medical Products Administration, which is intended for the treatment of adult generalized pustular psoriasis (GPP) flare-ups [1] Company Summary - Huahai Pharmaceutical's subsidiary, Huaotai, is advancing in the pharmaceutical market with the development of HB0034 injection [1] - The drug is specifically aimed at treating a significant dermatological condition, indicating potential market demand and therapeutic relevance [1] Industry Summary - The approval process for new drug applications is critical in the pharmaceutical industry, reflecting regulatory compliance and the potential for market entry [1] - The treatment of generalized pustular psoriasis represents a niche but important segment within dermatological therapies, highlighting ongoing innovation in this area [1]

Core Viewpoint - Huahai Pharmaceutical's stock has experienced fluctuations, with a year-to-date increase of 15.77% but a recent decline over various trading periods, indicating potential volatility in the market [1][2]. Financial Performance - For the first half of 2025, Huahai Pharmaceutical reported revenue of 4.516 billion yuan, a year-on-year decrease of 11.93%, and a net profit attributable to shareholders of 409 million yuan, down 45.30% year-on-year [2]. - Cumulative cash dividends since the company's A-share listing amount to 2.989 billion yuan, with 1.016 billion yuan distributed over the past three years [3]. Stock Market Activity - As of September 29, Huahai Pharmaceutical's stock price was 20.40 yuan per share, with a market capitalization of 30.544 billion yuan [1]. - The stock has seen significant trading activity, with a net inflow of 363,300 yuan from main funds and notable buying and selling volumes over recent days [1]. Shareholder Information - As of September 19, the number of shareholders increased by 28.47% to 67,300, while the average circulating shares per person decreased by 22.16% to 21,624 shares [2]. - Major shareholders include China Europe Medical Health Mixed A, which increased its holdings by 12.234 million shares, and Southern CSI 500 ETF, which also saw an increase in holdings [3].

Core Viewpoint - The article discusses the announcement by President Trump regarding a new round of high tariffs on various imported products, particularly focusing on the pharmaceutical industry, which will see a 100% tariff on patented and branded drugs starting October 1, 2023, significantly higher than the previous 15% agreement with Europe [1][2]. Group 1: Tariff Details and Market Reaction - The new tariffs include a 50% tariff on kitchen cabinets and bathroom sinks, a 30% tariff on imported furniture, and a 100% tariff on patented and branded drugs, with exemptions for companies that have manufacturing facilities "under construction" in the U.S. [1][2] - Following the announcement, the innovation drug index and various biotech ETFs saw declines of over 1%, with specific companies like Huahai Pharmaceutical and Baiyue Shenzhou experiencing stock price drops [2][3]. Group 2: Company Responses and Strategies - Many domestic pharmaceutical companies are assessing the impact of the new tariffs, with some indicating that their production capabilities in the U.S. may mitigate the effects. For instance, Huahai Pharmaceutical is evaluating whether its facilities meet the criteria for exemption [4][5]. - Major U.S. pharmaceutical companies like Johnson & Johnson and Eli Lilly have already invested significantly in expanding their domestic production capabilities, with Johnson & Johnson planning to invest approximately $20 billion in North Carolina and Eli Lilly announcing a $270 billion investment for new factories [3][4]. Group 3: Expert Opinions and Future Outlook - Industry experts suggest that the 100% tariff is politically motivated and may not significantly impact domestic innovative drug companies, as many already have manufacturing in the U.S. and the majority of their sales are through partnerships with multinational corporations [6][7]. - The anticipated implementation of a global drug pricing model by the U.S. government could further influence drug pricing and market dynamics, but experts believe that the overall impact on the domestic pharmaceutical industry will be limited [6][7].

Core Viewpoint - Huahai Pharmaceutical's stock has experienced fluctuations, with a recent decline of 2.02% and a year-to-date increase of 24.17%, indicating volatility in market performance [1][2]. Financial Performance - For the first half of 2025, Huahai Pharmaceutical reported revenue of 4.516 billion yuan, a year-on-year decrease of 11.93%, and a net profit attributable to shareholders of 409 million yuan, down 45.30% year-on-year [2]. - Cumulative cash dividends since the company's A-share listing amount to 2.989 billion yuan, with 1.016 billion yuan distributed over the past three years [3]. Shareholder Information - As of September 19, 2025, the number of shareholders increased by 28.47% to 67,300, while the average circulating shares per person decreased by 22.16% to 21,624 shares [2]. - The top ten circulating shareholders include notable entities such as China Europe Medical Health Mixed A and Hong Kong Central Clearing Limited, with varying changes in their holdings [3]. Market Activity - The stock's trading volume on September 25 was 532 million yuan, with a turnover rate of 1.61% and a total market capitalization of 32.76 billion yuan [1]. - Huahai Pharmaceutical has appeared on the "Dragon and Tiger List" twice this year, with the most recent instance on September 9, where it recorded a net buy of -53.101 million yuan [1]. Business Overview - Huahai Pharmaceutical, established on February 28, 2001, and listed on March 4, 2003, specializes in the research, production, and sales of various dosage forms of generic drugs, biological drugs, innovative drugs, and specialty raw materials [1]. - The company's revenue composition includes finished drug sales (61.86%), raw materials and intermediates sales (36.75%), and other services [1]. Industry Classification - Huahai Pharmaceutical is classified under the pharmaceutical and biological industry, specifically in chemical pharmaceuticals and chemical preparations, with involvement in AI medicine, generic drugs, innovative drugs, cell therapy, and biomedicine [2].

Summary of Key Points Core Viewpoint - On September 25, a total of 12 companies had their restricted shares unlocked, with a total unlocking volume of 131 million shares, amounting to a market value of 4.428 billion yuan based on the latest closing price [1] Unlocking Volume - Two companies had unlocking shares exceeding 10 million: Enwei Pharmaceutical with 69.79 million shares and Huahai Pharmaceutical with 41.15 million shares, followed by Lierda with 9.28 million shares [1] Unlocking Market Value - The market value of unlocked shares exceeded 100 million yuan for two companies: Enwei Pharmaceutical at 2.323 billion yuan, Huahai Pharmaceutical at 919 million yuan, and Wancheng Group at 762 million yuan [1] Unlocking Ratio - One company had an unlocking ratio exceeding 10%: Enwei Pharmaceutical at 67.83%, followed by Huahai Pharmaceutical at 2.75% and Wancheng Group at 2.36% [1]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" (maintained) [1] Core Insights - The industry is entering a new development phase driven by optimized procurement and innovation [3] - The raw material pharmaceutical sector is at a cyclical bottom, with companies actively transitioning to innovative drug development [5][8] - The vaccine sector is experiencing a decline in performance but is accelerating the layout of new technologies and products [6] - The medical services sector is leveraging AI technology to enhance efficiency and quality [7] Summary by Sections Raw Material Pharmaceutical Sector - The raw material pharmaceutical industry has faced a downturn for nearly four years, with prices of various products, such as sartans and heparins, reaching historical lows [5] - Revenue and net profit in the raw material pharmaceutical sector showed a downward trend in the first half of 2025 due to significant price drops in anti-infective products and increased R&D investments [5] - Companies like Huahai Pharmaceutical and Borui Pharmaceutical are focusing on innovative drug development, with several products in various clinical trial phases [5][68] Vaccine and Blood Products Sector - The vaccine industry is facing continuous performance decline due to a decrease in newborn numbers and changing competitive dynamics, although some companies are introducing new technologies and products [6] - The blood products sector is also experiencing a downturn, with revenue and net profit declining due to high inventory levels and suppressed demand from medical insurance [6][75] - The industry is expected to see increased consolidation as leading companies accelerate mergers and acquisitions [6][8] Medical Services Sector - The medical services sector's performance has declined due to DRGs and the consumption environment, but the application of AI technology is expected to enhance service quality and efficiency [7] - The core competitiveness of the medical services industry lies in acquiring and training quality doctors and hospital management [7] Investment Recommendations - The report suggests that companies in the raw material pharmaceutical sector are likely to enter a harvest period as they transition to innovative drugs [8] - The blood products sector is anticipated to accelerate consolidation, with significant mergers expected in the near future [8] - Recommended stocks include Federal Pharmaceutical, Pro Pharmaceutical, Guobang Pharmaceutical, and others, while benefiting stocks include Tianyu Co., Meinuo Pharma, and others [8]

Core Viewpoint - Huahai Pharmaceutical's stock has shown a year-to-date increase of 25.65%, despite a recent decline of 6.27% over the past five trading days, indicating volatility in its performance [1]. Financial Performance - For the first half of 2025, Huahai Pharmaceutical reported a revenue of 4.516 billion yuan, a year-on-year decrease of 11.93%, and a net profit attributable to shareholders of 409 million yuan, down 45.30% year-on-year [2]. - The company has distributed a total of 2.989 billion yuan in dividends since its A-share listing, with 1.016 billion yuan distributed over the past three years [3]. Stock Market Activity - As of September 24, Huahai Pharmaceutical's stock price was 22.14 yuan per share, with a market capitalization of 33.149 billion yuan and a trading volume of 308 million yuan [1]. - The stock has appeared on the "龙虎榜" (Dragon and Tiger List) twice this year, with the most recent appearance on September 9, where it recorded a net buy of -531 million yuan [1]. Shareholder Structure - As of June 30, 2025, the number of shareholders decreased by 16.37% to 52,400, while the average number of tradable shares per shareholder increased by 18.71% to 27,781 shares [2]. - Notable institutional shareholders include China Europe Medical Health Mixed Fund, which increased its holdings by 12.234 million shares, and Southern CSI 500 ETF, which also increased its holdings by 2.158 million shares [3].