证券代码：688799 证券简称：华纳药厂 公告编号：2026-006 湖南华纳大药厂股份有限公司 自愿披露关于子公司通过巴西国家卫生监督局GMP认证的公告 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、准确性和完整性依法承担法律责任。 认证范围：化学原料药：磷霉素氨丁三醇 有效期限：2028年1月19日 发证机关：巴西国家卫生监督局（ANVISA） 二、药品相关情况 磷霉素氨丁三醇是磷霉素氨丁三醇散等制剂产品的原料药，制剂产品主要用于治疗敏感的大肠埃希氏 菌、粪肠球菌、肺炎克雷伯菌、枸橼酸杆菌属、肠杆菌属、奇异变形杆菌引起的急性单纯性尿路感染、 无症状菌尿症等。 近日，湖南华纳大药厂股份有限公司（以下简称"公司"）全资子公司湖南华纳大药厂手性药物有限公司 （以下简称"手性药物公司"）收到巴西国家卫生监督局（ANVISA）签发的药品生产质量管理规范 （GMP）认证证书。现将相关情况公告如下： 一、证书基本信息 生产企业：湖南华纳大药厂手性药物有限公司 生产地址：湖南省长沙市望城区铜官循环经济工业基地铜官大道139号 认证编号：1435341/23-6 湖南 ...

格隆汇2月27日｜华纳药厂(688799.SH)公告称，公司全资子公司湖南华纳大药厂手性药物有限公司收到 巴西国家卫生监督局签发的药品生产质量管理规范（GMP）认证证书，认证范围为化学原料药：磷霉 素氨丁三醇，有效期至2028年1月19日。该认证为该产品成功进入巴西市场创造了条件，有利于提升公 司的国际竞争力。但医药产品的国际原料药业务易受国家政策、海外市场环境变化等因素影响，具有一 定的不确定性。 ...

华纳药厂公告称，其全资子公司手性药物公司收到巴西国家卫生监督局签发的药品生产质量管理规范 （GMP）认证证书，认证范围为化学原料药磷霉素氨丁三醇，有效期至2028年1月19日。磷霉素氨丁三 醇是治疗尿路感染等制剂产品的原料药。此次认证为产品进入巴西市场创造条件，利于拓展国际市场、 提升国际竞争力，但国际原料药业务受政策和市场环境影响，有不确定性。 ...

Core Viewpoint - Northeast Pharmaceutical is implementing a "one body, two wings" development strategy to enhance resilience and profitability amid industry challenges and market competition [1] Group 1: Operational Efficiency and Market Strategy - The company is focusing on improving operational quality and market expansion, with a steady increase in core business foundations [2] - By 2025, the company aims for multiple breakthroughs in market layout, with core products achieving historical sales highs and brand influence steadily increasing [2] - The raw materials segment is adapting to market fluctuations by optimizing sales structures and expanding into emerging fields, solidifying its market position [2] Group 2: Production and Quality Control - Northeast Pharmaceutical has achieved cost reduction and efficiency improvements while maintaining a 100% product pass rate for factory output and inspections [3] - The company is enhancing production efficiency through process optimization, equipment upgrades, and management improvements [3] Group 3: Research and Innovation - The company is driving growth through both generic and innovative drugs, with three new generic products approved for market by March 2025 [3] - Ongoing projects in biopharmaceuticals and health products are being developed, including new health-oriented products like functional skincare items [3] Group 4: Strategic Development Framework - The "one body, two wings" strategy aims to strengthen the core business of chemical generics while expanding into biopharmaceuticals and traditional Chinese medicine [4] - The company plans to enhance its competitive advantage and market influence across all business segments, focusing on key product sales and overseas promotion of certified products [4] Group 5: Support Systems for Strategy Implementation - To ensure the effective implementation of the "one body, two wings" strategy, the company is optimizing management mechanisms and enhancing operational efficiency [5] - The focus is on risk management, cost control, and digital transformation to improve overall business quality [5] Group 6: Future Growth Drivers - The core growth drivers for the company include the successful transformation of innovative research results and the internationalization of the raw materials business [6] - Digital management and efficiency improvements are also seen as positive factors for driving performance growth [6]

● 本报记者 宋维东 东北制药相关负责人日前在接受中国证券报记者采访时表示，面对行业调整、市场竞争加剧等多重挑 战，公司将锚定"一体两翼"发展战略，坚持稳健经营与创新突破并举，深耕医药核心主业，拓展多元赛 道，打造更多盈利增长点，持续增强发展韧性。 运营质效持续提升 "在药品集采常态化、医保改革持续深化、行业竞争日趋激烈的背景下，东北制药紧扣'变、干、实'工 作总要求，主动适应行业变革，在经营提质、市场拓展、生产增效、研发创新等方面协同发力，发展质 效稳步提升，核心业务根基持续夯实。"该负责人说。 2025年，公司市场布局多点突破，营销效能持续释放。其中，制剂板块聚焦核心产品，深耕终端市场， 渠道覆盖与市场渗透力不断增强，多款主导产品销量创历史新高，新开发终端与主要品种覆盖率均同比 增长，品牌影响力稳步提升。此外，原料药板块积极应对国内外市场波动，通过优化产品销售结构、拓 展新兴领域等举措，核心产品市场地位不断稳固，海外市场持续拓展。该负责人表示，公司各子公司协 同发力，部分子公司成功扭亏为盈，构筑起多元协同、稳健向好的发展格局。 在生产运营方面，东北制药实现降本增效与质量管控双线提升。公司构建了"产销协同、 ...

Core Viewpoint - Northeast Pharmaceutical is currently in a critical period of deep adjustment and transformation in the pharmaceutical industry, emphasizing the importance of each step in its development [1] Group 1: R&D and Strategic Transformation - Northeast Pharmaceutical is a significant drug production and export base in China, focusing on innovation-driven strategies and core business enhancement, achieving important results in R&D breakthroughs and quality improvement [2] - The company has increased R&D investment, aiming to accelerate the transition of innovative results from the laboratory to clinical applications [2] - The DCTY0801 injection, developed by its subsidiary, is set to undergo clinical trials for specific types of high-grade brain gliomas, marking a substantial breakthrough in cancer treatment innovation [2] - The acquisition of a 70% stake in DCTY0801's developer allows Northeast Pharmaceutical to quickly enter the cell therapy field, positioning it as a key platform for innovative drug development [3] - The company is committed to building a systematic and scalable talent cultivation system to enhance its R&D capabilities and facilitate its strategic shift from chemical pharmaceuticals to biological innovative drugs [3] Group 2: Quality Assurance and Market Expansion - Strong R&D capabilities provide essential support for product quality enhancement, which is crucial for global market competition [4] - The company’s core raw material product, Phosphomycin Amide, received the European Pharmacopoeia suitability certificate (CEP) in 2025, becoming the first domestic company to achieve this certification, enhancing its brand image and competitiveness in the international high-end market [4] - Northeast Pharmaceutical successfully passed a surprise inspection by the FDA, demonstrating its leading quality control system across the entire production and management chain [4] - The company is enhancing its quality management capabilities to support its expansion in both domestic and international markets [4] Group 3: Business Diversification and Value Enhancement - Northeast Pharmaceutical is expanding into related business areas, developing health food products based on the concept of "medicinal food homology" and launching a skincare brand, "Qifangyuan," to enter the beauty market [6] - The company’s diversification efforts are based on professional technology and aim to extend the value chain around the core of "health" [6] - The "Qifangyuan" brand integrates pharmaceutical technology and standards into skincare product development, showcasing the company's innovative approach [6] - Northeast Pharmaceutical is committed to optimizing its health product matrix and exploring comprehensive health services to create additional growth points [6] Group 4: Recognition and Achievements - The company’s improved business layout and solid operational results have enhanced its overall strength, leading to recognition from various sectors [7] - In 2025, Northeast Pharmaceutical was included in the list of recommended "National Intellectual Property Demonstration Enterprises" in Liaoning Province and re-certified as a national high-tech enterprise [7] - The company received the title of "Top 100 Pharmaceutical Industrial Enterprises by Revenue" for the 2024-2025 period in industry evaluations [7]

Core Viewpoint - The company is undergoing a critical period of deep adjustment and transformation in the pharmaceutical industry, emphasizing the importance of each step in its development and focusing on innovation, quality, talent strategy, and diversified layout to drive transformation and upgrade [1] R&D-Driven Strategic Transformation - Northeast Pharmaceutical is a significant drug production and export base in China, focusing on innovation and core business development, achieving important results in R&D breakthroughs and quality improvement [1] - The company has increased R&D investment, accelerating the transition of innovative results from the laboratory to clinical applications [2] - The DCTY0801 injection, developed by its subsidiary Dingcheng Peptide Source, received approval for clinical trials targeting specific types of high-grade brain gliomas, marking a substantial breakthrough in innovative drug development for tumor treatment [1][2] Quality Assurance for Market Expansion - Strong R&D capabilities have provided essential support for product quality enhancement, with quality being described as the lifeline for pharmaceutical companies [2] - The company's core raw material product, phosphomycin aminobutyric acid, received the European Pharmacopoeia suitability certificate (CEP) in 2025, becoming the first domestic company to obtain this certification, enhancing the brand image and competitiveness of Chinese raw materials in the international high-end market [3] - The company passed a surprise inspection by the FDA with a "zero defect" score, demonstrating its leading quality control system across the entire production and management chain [3] Comprehensive Value Enhancement through Layout - While deepening its core business, the company is actively expanding into related fields based on its professional advantages in pharmaceutical R&D and production [4] - The company has developed four health biscuits based on the concept of "food and medicine homology," enriching its existing product matrix in food and health products [4] - The launch of the skincare brand "Qifangyuan" represents the company's entry into the beauty sector, integrating pharmaceutical technology with skincare product development [4] Recognition and Achievements - The company's comprehensive business layout and solid operational results have enhanced its overall strength, leading to recognition from various sectors [5] - In 2025, Northeast Pharmaceutical was included in the list of "National Intellectual Property Demonstration Enterprises" recommended by Liaoning Province and re-certified as a national high-tech enterprise [5] - The company was awarded the title of "Top 100 Pharmaceutical Industrial Enterprises by Revenue for 2024-2025" in industry evaluations [5]

Core Viewpoint - The recent shareholding increase by Jiangxi Fangda Steel Group, a concerted action party of the controlling shareholder Fangda Group, in Northeast Pharmaceutical Group signifies a strong confidence in the company's intrinsic value and future prospects, marking a new chapter of high-quality development for the company [1][2][9] Group 1: Shareholding Increase - Fangda Steel has completed its shareholding increase plan, raising its stake in Northeast Pharmaceutical to nearly 56%, indicating a significant commitment beyond mere financial investment [1][2] - This action reflects a belief that the current market valuation does not accurately represent the company's true value and future potential, presenting an attractive opportunity for further investment [2][9] Group 2: Protection of Minority Investors - The controlling shareholder's investment serves as a protective measure for minority investors, reinforcing market expectations and demonstrating a commitment to long-term development [3][9] - The increase in shareholding does not alter the company's control structure, aiming to enhance investor confidence and promote sustainable growth [3] Group 3: Internal Growth Drivers - Northeast Pharmaceutical is focusing on "R&D innovation" and "international expansion" as dual engines for growth, transitioning from traditional to modern development models [4][5] - The recent achievement of obtaining the European Pharmacopoeia Certificate (CEP) for its active pharmaceutical ingredient signifies a major milestone, allowing the company to access high-value European markets [4] Group 4: Strategic Investments - The company has significantly increased its investment in R&D in the first quarter of 2025, reflecting a long-term vision amidst a cost-cutting trend in the pharmaceutical industry [5] - This strategic focus on R&D is expected to yield new products and establish competitive advantages, supporting the company's long-term value growth [5] Group 5: External Expansion - Northeast Pharmaceutical is also pursuing external growth through strategic acquisitions, such as the recent purchase of Beijing Dingcheng Peptide Source Biopharmaceutical Company, which enhances its product offerings and market reach [6][8] - The acquisition aims to create synergies in product lines and R&D capabilities, thereby increasing overall market penetration and brand influence [7][8] Group 6: Future Outlook - The combination of internal growth, strategic acquisitions, and strong support from the controlling shareholder positions Northeast Pharmaceutical for a significant value return and operational success [9] - The current developments suggest a pivotal moment for the company, indicating a successful transformation and potential for renewed market recognition [9]

Core Insights - Northeast Pharmaceutical has officially obtained the CEP certificate for its core raw material product, fosfomycin trometamol, from the European Directorate for the Quality of Medicines (EDQM), marking a significant milestone as the first domestic pharmaceutical company to achieve this certification [1][2] - The CEP certificate serves as a "golden key" for entering the European and American markets, indicating that the product meets stringent quality standards that exceed typical international registration requirements [2] - The certification enhances Northeast Pharmaceutical's international brand value and strengthens China's position in the global antibiotic sector [2][3] Market Potential - Fosfomycin trometamol is recognized for its low resistance characteristics and is suitable for treating various infections, making it highly relevant in the context of the global antibiotic resistance crisis [3] - The demand for high-quality antibiotic raw materials in the European market is on the rise, and the CEP certification is expected to boost the market penetration of Northeast Pharmaceutical's products in Europe [3] Competitive Position - Northeast Pharmaceutical has established a robust international registration matrix, with approximately 20 raw material products having passed high-end registrations in various countries, including the EU, Japan, and Russia [4] - The company is a major supplier of vitamin C and holds significant positions in the global supply of fosfomycin and chloramphenicol, maintaining a competitive edge in the international market [4] - The company aims to leverage its CEP registration to enhance its global market share and transition from "product export" to "brand export," thereby gaining greater international respect for Chinese pharmaceuticals [5]

Group 1 - The fourth China (Nanchang) International Health Industry Conference and Expo was inaugurated, showcasing the achievements of Liaoning Fangda Group in the health sector [1] - Liaoning Fangda Group is a diversified large enterprise group with multiple listed companies across various sectors, including pharmaceuticals, and is focusing on enhancing its pharmaceutical business [1][2] - Northeast Pharmaceutical, a subsidiary of Liaoning Fangda Group, is a major supplier of vitamin C and has made significant progress in international certifications, including receiving the CEP certificate for its raw material phosphomycin [2] Group 2 - Liaoning Fangda Group is investing nearly 10 billion yuan to establish Liaoning Fangda General Hospital, which will feature advanced medical technologies and a capacity of 5,000 beds [3] - The hospital aims to set a new benchmark for private hospitals in China by integrating public welfare attributes with private mechanisms and has formed strategic partnerships with top medical institutions [3] - The health industry is identified as a future growth sector, with Liaoning Fangda Group planning to develop a comprehensive health ecosystem through the Fangda Health City project [4]