证券代码：000566 证券简称：海南海药 公告编号：2025-036 海南海药股份有限公司关于 控股子公司获得化学原料药上市申请批准通知书的公告 本公司董事会及全体董事保证公告内容的真实、准确和完整，没有虚假记载、 误导性陈述或者重大遗漏。 海南海药股份有限公司（以下简称"公司"或"海南海药"）控股子公司重 庆天地药业有限责任公司近日获得国家药品监督管理局核准签发的富马酸伏诺 拉生《化学原料药上市申请批准通知书》（通知书编号：2025YS00357）。现将 相关情况公告如下： 一、产品基本情况 | 化学原料药名称 | 通用名称 ：富马酸伏诺拉生 | | --- | --- | | | 英文名/拉丁名：Vonoprazan Fumarate | | 化学原料药注册 标准编号 | YBY64172025 有效期 18 个月 | | 包装规格 | 25kg/桶 | | 申请事项 | 境内生产化学原料药上市申请 | | 审批结论 | 根据《中华人民共和国药品管理法》及有关规定，经审查，本品符 | | | 合药品注册的有关要求，批准注册。质量标准、标签及生产工艺照 | | | 所附执行。 | | 生产企业 | 重庆天 ...

Group 1: Drug Development and Clinical Trials - Pinegabine is being developed using a stepwise approach, first assessing its efficacy in combination therapy before evaluating its effectiveness as a monotherapy [2] - The company is currently conducting Phase IIa clinical trials for Pinegabine, with low-dose cohort enrollment completed and mid-dose cohort enrollment ongoing [2] - Pinegabine is positioned as a me-better drug compared to Retigabine, which was withdrawn from the market due to safety concerns [3] Group 2: Market Analysis and Product Characteristics - Epilepsy is the second most common neurological disorder after stroke, with a significant portion of patients experiencing treatment-resistant epilepsy [4] - There is a lack of innovative antiepileptic drugs in recent years, particularly for special types of epilepsy and acute seizures [4] - Pinegabine demonstrates superior chemical stability and higher brain distribution compared to Retigabine, enhancing its efficacy and safety profile [4] Group 3: Patent and Market Strategy - The patent for Pinegabine is held by the Shanghai Institute of Materia Medica, with exclusive rights for clinical development and commercialization in mainland China [5] - The company plans to explore international rights transfer and partnerships based on the outcomes of Phase II clinical trials [5] Group 4: Future Prospects and Expansion - Pinegabine may expand its indications based on Phase II clinical results and market needs, potentially targeting conditions like severe depression due to KCNQ mutations [4] - Fluorofenone, another drug in development, is expected to enter Phase III clinical trials in the second half of 2025, having been included in the breakthrough therapy list by the National Medical Products Administration [6] - The company aims to focus on anti-fibrosis indications initially, with potential future expansions depending on clinical trial outcomes [6]

证券代码：000566 证券简称：海南海药 公告编号：2025-033 海南海药股份有限公司 第十一届董事会第二十五次会议决议公告 本公司董事会及全体董事保证公告内容的真实、准确和完整，没有虚假记载、 误导性陈述或者重大遗漏。 海南海药股份有限公司（以下简称"公司"）第十一届董事会第二十五次会 议于 2025 年 4 月 28 日以通讯表决方式召开。本次会议于 2025 年 4 月 25 日以 电子邮件等方式送达了会议通知及文件。会议应到董事 9 人，实到董事 9 人，会 议的召开符合《公司法》和《公司章程》有关规定。经与会董事认真审议，表决 通过了如下议案： 一、 审议通过了《2025 年第一季度报告的议案》 具体内容详见同日刊载于巨潮资讯网（http//www.cninfo.com.cn）的《海 南海药股份有限公司 2025 年第一季度报告》。 表决结果：9 票同意，0 票反对，0 票弃权 二、审议通过了《关于调整第十一届董事会专门委员会委员的议案》 鉴于王俊红女士因到龄退休申请辞去公司董事、总经理及提名委员会委员职 务，为保障公司董事会的正常运行，2025 年 4 月 16 日公司召开的 2025 年第 ...

Financial Performance - The company's operating revenue for Q1 2025 was ¥206,597,801.19, a decrease of 43.09% compared to ¥363,023,438.22 in the same period last year[5]. - The net loss attributable to shareholders was ¥68,365,454.56, compared to a loss of ¥15,842,321.07 in the previous year[5]. - The net cash flow from operating activities was negative at ¥4,050,243.96, a significant decline from a positive cash flow of ¥21,998,961.19 in the same period last year[5]. - Total operating revenue decreased to ¥206,597,801.19 from ¥363,023,438.22, representing a decline of approximately 43.2%[22]. - Operating profit turned negative at -¥76,570,411.86 compared to -¥19,908,640.89 in the previous period[23]. - Net profit also declined to -¥76,284,917.68 from -¥24,451,294.07, indicating a worsening loss situation[23]. - The net profit attributable to the parent company was -68,365,454.56, compared to -15,842,321.07 in the previous period, indicating a significant decline[24]. - The total comprehensive income attributable to the parent company was -68,507,804.74, down from -15,814,817.61 in the previous period[24]. - The basic and diluted earnings per share were both -0.0527, compared to -0.0122 in the previous period[24]. Assets and Liabilities - The company's total assets decreased by 0.99% to ¥6,053,293,977.22 from ¥6,113,528,499.69 at the end of the previous year[5]. - Current assets totaled ¥1,355,205,305.67, down from ¥1,401,755,463.26, a decrease of approximately 3.3%[20]. - Non-current assets slightly decreased to ¥4,698,088,671.55 from ¥4,711,773,036.43, a reduction of about 0.3%[20]. - Total liabilities increased to ¥5,539,344,277.34 from ¥5,523,151,531.94, reflecting a rise of approximately 0.3%[20]. - The company's equity attributable to shareholders decreased by 13.04% to ¥456,779,178.09 from ¥525,286,982.84 at the end of the previous year[5]. Cash Flow - Cash inflows from operating activities totaled 397,862,931.92, an increase from 282,004,095.46 in the previous period[26]. - The net cash flow from investing activities was -25,603,318.25, an improvement from -58,676,823.84 in the previous period[26]. - Cash inflows from financing activities were 756,200,000.00, down from 946,572,741.84 in the previous period[26]. - The net cash flow from financing activities was -8,522,852.55, compared to 37,485,073.32 in the previous period[26]. - The ending cash and cash equivalents balance was 222,769,322.57, down from 304,717,701.02 in the previous period[27]. Shareholder Information - The number of ordinary shareholders at the end of the reporting period was 64,032[10]. - The largest shareholder, Hainan Huadong Industrial Co., Ltd., held 22.89% of the shares, amounting to 296,989,889 shares, with 148,494,944 shares pledged[10]. - The company reported a total of 107,216,412 shares held by Yunnan International Trust Co., Ltd. under the single fund trust No. 36[11]. - The top shareholder, Hainan Huatong Industrial Co., Ltd., holds 296,989,889 shares, representing a significant portion of the company's equity[11]. Legal and Debt Matters - The company is pursuing legal action against Southern Tongzheng and Haiyao Real Estate for outstanding debts totaling 311,169,942.04 yuan, along with additional interest and penalties[15]. - The company has collateralized properties, including 110 sets of commercial housing, to secure debts owed by Haiyao Real Estate[14]. - The company has established a debt transfer agreement with Southern Tongzheng, with a net value of 446,362,578.91 yuan for receivables[13]. - The company has disclosed multiple announcements regarding debt agreements and legal proceedings to keep stakeholders informed[16]. Research and Development - Research and development expenses were ¥14,505,089.72, down 36.93% from ¥22,999,618.72 in the previous year[8]. - Research and development expenses decreased to ¥14,505,089.72 from ¥22,999,618.72, a reduction of approximately 37.0%[23]. Other Income - Other income increased by 134.50% to ¥6,114,690.92, compared to ¥2,607,514.61 in the same period last year, mainly due to increased government subsidies[8]. - The company reported a significant increase in other income to ¥6,114,690.92 from ¥2,607,514.61, an increase of about 134.0%[23].

海南海药（000566）公告，2025年第一季度营业收入2.07亿元，同比下降43.09%。净亏损6836.55万 元，去年同期净亏损1584.23万元。 ...

Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical industry [4] Core Views - The pharmaceutical sector is expected to experience positive growth factors in 2025, driven by innovation, international expansion, and an aging population [4][5] - The report highlights the significant unmet demand for new drugs in the epilepsy and depression markets, suggesting potential investment opportunities in companies like Hainan Haiyao and Warner Pharmaceuticals [3][4] Summary by Sections Epilepsy Market Potential - Approximately 9 million epilepsy patients in China, with about 30% unresponsive to current treatments, indicating a substantial market opportunity [10][11] - The anti-epileptic drug market in China is projected to exceed 10 billion yuan, with significant growth potential for innovative drugs targeting KCNQ channels [4][10][12] Depression Treatment Demand - Depression poses a major public health threat, with a global market for antidepressants expected to reach $17.6 billion by 2030 [39] - The report emphasizes the urgent need for rapid-acting and effective treatments for major depressive disorder with suicidal ideation (MDSI), highlighting the limitations of traditional antidepressants [41][43] Key Companies and Products - Warner Pharmaceuticals' ZG001, a modified version of ketamine, shows promise in treating depression without addiction risks, currently in clinical trials [47] - Johnson & Johnson's Spravato (esketamine) is the only approved treatment for MDSI, with projected sales reaching $3 billion by 2027 [44][45] Industry Trends - The report notes a successful transition from generic to innovative drug development in China, with companies like Heng Rui Medicine and Kelun Pharmaceutical leading the way [5] - The aging population is driving demand for treatments related to chronic diseases, further enhancing the growth prospects for the pharmaceutical sector [5]

Core Viewpoint - Hainan Haiyao has reported significant financial losses in its 2024 annual report, with a revenue decline of 33% and a net profit loss of approximately 1.53 billion yuan, marking a troubling trend of negative net profits for eight consecutive years [2][10][11]. Financial Performance - The company achieved a revenue of approximately 990.7 million yuan in 2024, down from 1.48 billion yuan in 2023, representing a 33% decrease [5][10]. - The net profit attributable to shareholders was approximately -1.53 billion yuan, a substantial increase in losses compared to -106.5 million yuan in 2023 [5][10]. - The company's cash flow from operating activities was -17.55 million yuan, a decline of 116.95% year-on-year [11]. - The asset-liability ratio reached 90.34%, an increase of 28.83% compared to the previous year, indicating worsening financial health [11]. Business Overview - Hainan Haiyao's main business focuses on the health industry, including intermediates, raw materials, chemical preparations, modern traditional Chinese medicine, and medical services [6]. - The company has three production bases located in Jiangsu, Chongqing, and Hainan, and has a full industrial chain production capability for its anti-infection drugs [6]. Challenges and Issues - The company has faced continuous revenue decline since 2018, with revenues dropping from a peak of 2.47 billion yuan in 2018 to 990.7 million yuan in 2024 [6][10]. - Hainan Haiyao has reported significant asset impairment and credit impairment losses totaling 7.49 billion yuan, raising concerns about asset quality [10]. - The company has been under regulatory scrutiny due to compliance issues, leading to fines and required corrections [14][15]. Future Prospects - Hainan Haiyao is attempting to accelerate its R&D efforts, with ongoing clinical trials for innovative drugs and plans for new product registrations [12]. - The company has also engaged in asset disposals to improve cash flow, but these measures are seen as insufficient to address the broader financial challenges [13]. - The management changes and ongoing compliance issues pose additional risks to the company's recovery efforts [14][15].

北京大成（海口）律师事务所 关于海南海药股份有限公司2025年第二次临时股东大会的 法 律 意 见 书 大成 is Dentons' Preferred Law Firm in China. 北京大成（海口）律师事务所 1 / 7 北京大成（海口）律师事务所 关于海南海药股份有限公司2025年第二次临时股东大会 的法律意见书 致：海南海药股份有限公司 根据《中华人民共和国证券法》（以下简称"《证券法》"）、《中华人民 共和国公司法》（以下简称"《公司法》"）和中国证券监督管理委员会《上市 公司股东会规则》（以下简称"《股东会规则》"）等法律、 法规和其他有关规范 性文件的要求，北京大成（海口）律师事务所（以下简称"本 所"）接受海南海 药股份有限公司（以下简称"公司"）的委托，指派律师参加公司2025 年第二次 临时股东大会（以下简称"本次股东大会"）。 本所声明：本所律师仅对本次股东大会的召集程序、召开程序、出席会议人员 资格、召集人资格、表决程序、表决结果及会议决议发表法律意见，并不对本次股 东大会所审议的议案、议案所涉及的事项及内容发表意见。本所律师同意将本法 律意见书随本次股东大会其他信息披露资料一并 ...

证券代码：000566 证券简称：海南海药 公告编号：2025-032 海南海药股份有限公司 2025 年第二次临时股东大会决议公告 本公司及董事会全体成员保证信息披露的内容真实、准确和完整，没有虚假记载、 误导性陈述或重大遗漏。 一、特别提示： 1、本次股东大会无否决议案的情形； 2、本次股东大会不涉及变更前次股东大会决议的情形。 二、会议召开的情况 1、召开时间： 现场会议召开时间：2025年4月16日下午15：00 网络投票时间：2025年4月16日 （1）通过深圳证券交易所交易系统进行网络投票的时间为：2025年4月16日9：15～ 9：25，9：30～11：30和13：00～15：00； （2）通过深圳证券交易所互联网投票系统投票的时间为：2025年4月16日9:15～ 15:00期间的任意时间。 2、召开地点：海南省海口市秀英区南海大道 192 号海药工业园公司会议室 3、召开方式：采用现场表决与网络投票相结合的方式召开 4、召集人：公司第十一届董事会 5、现场会议主持人：公司第十一届董事会董事长王建平先生 6、公司部分董事、监事和高级管理人员现场或通过视频方式出席了本次股东大会， 北京大成(海口 ...

Core Points - Hainan Haiyao reported a significant decline in revenue and a substantial increase in losses for 2024, with a net profit loss of approximately 1.525 billion yuan, marking a year-on-year increase in losses of 1332.27% [1][2] - The company has faced continuous operational challenges, including a decline in sales across its pharmaceutical and medical service segments, attributed to industry policy changes and reduced demand for certain medications [1][2] - Hainan Haiyao's financial health is deteriorating, with an asset-liability ratio reaching 90.34%, indicating increasing financial risk [3] Revenue Performance - The total revenue for Hainan Haiyao in 2024 was approximately 991 million yuan, a decrease of 33% year-on-year [1] - The pharmaceutical segment generated 794 million yuan, down 38.06%, while medical services brought in 168 million yuan, a decline of 2.57% [1] - The company has experienced a continuous decline in revenue since 2019, with a peak revenue of 2.472 billion yuan in 2018, now reduced to less than 1 billion yuan in 2024 [2] Financial Condition - The company recorded a total of 749 million yuan in impairment provisions for the year, alongside a fair value loss of approximately 400 million yuan [2] - Total expenses, including sales, management, and financial costs, reached 678 million yuan, accounting for 68% of total revenue, with management expenses increasing by 37.14% [2] - The net cash flow from operating activities was negative at -17.55 million yuan, primarily due to increased payment methods and reduced tax refunds [2] Regulatory Issues - Hainan Haiyao has faced multiple regulatory actions due to financial misconduct, including a fine of 2 million yuan for significant disclosure violations [4] - The company was also ordered to rectify issues related to inaccurate financial reporting and improper revenue recognition practices [5] - Despite changes in control and management, ongoing compliance issues indicate persistent internal control weaknesses [4][5]