Core Viewpoint - Huahai Pharmaceutical has received the drug registration certificate for injectable Nicorandil from the National Medical Products Administration, which enhances its product line and market competitiveness [1] Group 1 - Huahai Pharmaceutical announced the approval of injectable Nicorandil on November 17 [1] - The approval allows the product to be considered as having passed the consistency evaluation under the relevant national policies [1] - This new product approval is expected to enrich the company's product offerings [1]

Group 1 - The core point of the article is that Huahai Pharmaceutical has received approval from the National Medical Products Administration for the injection of Nicorandil, which is a significant development for the company [1] - Huahai Pharmaceutical's revenue composition for the year 2024 is as follows: finished drug sales account for 60.32%, raw materials and intermediates sales account for 38.19%, technical services account for 0.66%, other businesses account for 0.55%, and other industries account for 0.28% [1] - As of the report, Huahai Pharmaceutical has a market capitalization of 27.8 billion yuan [1]

注射用尼可地尔用于不稳定型心绞痛。注射用尼可地尔最早由中外製薬株式会社研发，于1993年9月在 日本上市，国内未进口原研。目前国内获得该药品注册证书的生产厂家主要有北京四环科宝制药股份有 限公司、扬子江药业集团有限公司、天津天士力之骄药业有限公司等。根据米内网数据预测，注射用尼 可地尔2024年国内市场销售金额约人民币6.2亿元。 智通财经APP讯，华海药业(600521.SH)发布公告，公司于近日收到国家药品监督管理局(以下简称"国家 药监局")核准签发的注射用尼可地尔的《药品注册证书》。 ...

申请事项：药品注册（境内生产） | 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 2025-118 | | --- | --- | --- | --- | | 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、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"）于近日收到国家药品监督管 理局（以下简称"国家药监局"）核准签发的注射用尼可地尔的《药品注册证书》， 现将相关情况公告如下： 一、药品的基本情况 药品名称：注射用尼可地尔 剂型：注射剂 规格：12mg 1 根据国家相关政策，公司注射用尼可地尔按化学药品 3 类批准生产可视同通过 一致性评价。该产品的获批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。 四、风险提示 注册分类：化学药品 3 类 申请人：浙江华海药业股份有限公司 药品批准文号：国药准字 H20255924 审批结论：根据《中华人民共和国药品管理法》及有关规定， ...

Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the injection of Nicorandil, which is classified as a Class 3 chemical drug for unstable angina, indicating a significant development in its product portfolio [1] Group 1: Product Approval - The injection of Nicorandil is approved with a specification of 12mg [1] - This drug was first launched in Japan in September 1993 and has not been imported as an original research product in China [1] Group 2: Market Potential - According to Mi Nei Network, the projected domestic market sales for Nicorandil in 2024 are approximately 620 million yuan [1] Group 3: R&D Investment - The company has invested around 6.78 million yuan in the research and development of this product [1] Group 4: Competitive Advantage - The approval of this product is seen as a means to enhance the company's product line and competitiveness, as it is considered to have passed the consistency evaluation [1] Group 5: Market Challenges - The production and sales of the drug may be influenced by various factors, indicating potential challenges in the market [1]

Core Viewpoint - Huahai Pharmaceutical's stock has shown fluctuations in recent trading, with a year-to-date increase of 7.20% and a recent decline over the past 20 and 60 days [1][2]. Financial Performance - For the period from January to September 2025, Huahai Pharmaceutical reported a revenue of 6.409 billion yuan, a year-on-year decrease of 11.57%, and a net profit attributable to shareholders of 380 million yuan, down 63.12% year-on-year [2]. - The company has cumulatively distributed 2.989 billion yuan in dividends since its A-share listing, with 1.016 billion yuan distributed in the last three years [3]. Stock Market Activity - As of November 13, Huahai Pharmaceutical's stock price was 18.89 yuan per share, with a market capitalization of 28.283 billion yuan [1]. - The stock experienced a net inflow of 6.4475 million yuan from main funds, with significant buying and selling activity noted [1]. Shareholder Information - As of September 30, 2025, the number of shareholders increased to 68,400, with an average of 21,889 circulating shares per person [2]. - Notable changes in institutional holdings include a decrease in shares held by China Europe Medical Health Mixed A and an increase by Hong Kong Central Clearing Limited [3].

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2025-117 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 关于公司及下属子公司涉及诉讼的进展公告 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: 案件所处的诉讼阶段：Gaston Roberts（以下简称"原告"）人身损害赔 偿案件（以下简称"Gaston Roberts 案件"）一审驳回原告诉讼请求 是否会对上市公司损益产生负面影响：本次涉及的 Gaston Roberts 案件 判决系法院针对领头羊 Gaston Roberts 案件作出的一审判决，原告有权在收到判 决后 30 日内决定是否提起上诉，公司暂无法判断上述诉讼事项对公司损益产生 的影响，最终实际影响需以后续案件情况、法院生效判决或执行结果为准。 浙江华海药业股份有限公司（以下简称"公司"）近日收到美国新泽西州联邦 法院作出的判决书，涉及公司及下属控股子公司普 ...

| 股票简称：华海药业 股票代码：600521 | 公告编号：临 | 号 2025-116 | | --- | --- | --- | | 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 关于召开 2025 年第三季度业绩说明会的公告 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法律责任。 重要内容提示： 浙江华海药业股份有限公司（以下简称"公司"）已于 2025 年 10 月 31 日发 布公司 2025 年第三季度报告，为便于广大投资者更全面深入地了解公司 2025 年第三季度经营成果、财务状况，公司计划于 2025 年 11 月 18 日（星期二） 15:00-16:00 举行 2025 年第三季度业绩说明会，就投资者关心的问题进行交流。 一、说明会类型 本次投资者说明会以网络互动形式召开，公司将针对 2025 年第三季度的经 营成果及财务指标的具体情况与投资者进行互动交流和沟通，在信息披露允许的 范围内就投资者普遍关注的问题进行回答。 二、说明会召开的时间、地点 （一）会议召开时间：2025 ...

Market Overview - As of 10:30 AM today, the Shanghai Composite Index is at 3998.79 points, with a slight increase of 0.03% and total A-share trading volume reaching 1,083.642 billion yuan [1] Stocks Breaking Through Annual Line - A total of 76 A-shares have surpassed their annual line today, with notable stocks showing significant deviation rates including Binhai Energy at 8.36%, Overseas Chinese Town A at 6.04%, and Peking University Pharmaceutical at 5.58% [1] - The stocks with the largest deviation rates are as follows: - Binhai Energy: 9.96% increase, turnover rate of 4.54%, annual line at 11.51 yuan, latest price at 12.47 yuan [1] - Overseas Chinese Town A: 9.92% increase, turnover rate of 3.53%, annual line at 2.51 yuan, latest price at 2.66 yuan [1] - Peking University Pharmaceutical: 10.02% increase, turnover rate of 6.51%, annual line at 6.14 yuan, latest price at 6.48 yuan [1] Additional Stocks with Minor Deviations - Other stocks that have just crossed the annual line with smaller deviation rates include: - Shifeng Culture: 7.28% increase, turnover rate of 9.18%, annual line at 20.09 yuan, latest price at 20.92 yuan [1] - Shede Liquor: 3.72% increase, turnover rate of 2.05%, annual line at 59.70 yuan, latest price at 61.88 yuan [1] - Times Energy: 3.05% increase, turnover rate of 1.39%, annual line at 16.45 yuan, latest price at 16.92 yuan [1]

Core Viewpoint - The company reported a significant decline in revenue and net profit for the first three quarters of 2025, indicating challenges in traditional business segments while awaiting the results of its transformation efforts [1][2]. Financial Performance - For the first three quarters of 2025, the company achieved revenue of 6.409 billion yuan, a year-on-year decrease of 11.57%, and a net profit attributable to shareholders of 380 million yuan, down 63.12% year-on-year [1]. - In Q3 2025, the company recorded revenue of 1.893 billion yuan, a decline of 10.70% year-on-year, and a net loss of 29 million yuan, marking a year-on-year decline of 110.30% [1]. Business Segment Analysis - The decline in raw material drug revenue in Q3 2025 was primarily due to price wars stemming from overcapacity and slower-than-expected commercialization of new projects [2]. - Domestic formulation revenue also fell due to intensified competition and the impact of centralized procurement policies, with new products taking time to ramp up [2]. - U.S. formulation revenue experienced a slight decline due to tariffs and low-price competition [2]. Profitability and R&D Investment - 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, with the raw material drug gross margin remaining stable at approximately 48.45% [3]. - R&D expenses reached 829 million yuan, an increase of 20.66% year-on-year, focusing on biopharmaceutical projects in clinical phases II/III [3]. - The non-GAAP net profit margin dropped to 4.21%, down 10.03 percentage points year-on-year, reflecting the impact of declining high-margin formulation business revenue [3]. Innovation and Pipeline Development - The company made progress in its transformation, with 16 new domestic formulation products approved and 3 ANDA approvals in the U.S. during the first three quarters of 2025 [4]. - Key innovative drug developments are advancing, including the domestic first self-developed IL-36R monoclonal antibody HB0034, which has recently been accepted for listing application [4]. - The global first anti-PD-L1/VEGF fusion protein HB0025 has shown significant efficacy in phase II clinical trials and is set to enter phase III trials within the year [4]. Investment Outlook - The company is at a critical turning point, with expected net profits of 375 million yuan, 668 million yuan, and 810 million yuan for 2025-2027, reflecting a recovery trajectory [4]. - Given the competitive advantage of the "raw material drug-formulation integration" model and the long-term growth potential from innovation, a target price of 24.6 yuan is set based on a 55 times PE for 2026 [4].