证券代码：300452 证券简称：山河药辅 公告编号：2026-006 债券代码：123199 债券简称：山河转债 安徽山河药用辅料股份有限公司 关于 5%以上股东减持股份计划实施完毕的公告 公司 5%以上股东上海复星医药产业发展有限公司保证向本公司提 供的信息内容真实、准确、完整，没有虚假记载、误导性陈述或重大遗 漏。 本公司及董事会全体成员保证公告内容与信息披露义务人提供的 信息一致。 安徽山河药用辅料股份有限公司（以下简称"公司"）于 2025 年 10 月 31 日发布了《关于 5%以上股东减持股份计划的预披露公告》 （公告编号：2025-059），披露了持股 5%以上股东上海复星医药产 业发展有限公司（以下简称"复星医药"）计划在减持计划预披露公 告日起 15 个交易日后三个月内（2025 年 11 月 24 日至 2026 年 2 月 21 日）以集中竞价交易方式和大宗交易方式合计减持本公司股份 不超过 6,978,729 股，即不超过公司总股本（扣除公司回购股份 182.55 万股）的 3%。 近日，公司收到复星医药出具的《关于减持股份计划实施完毕的 通知函》，前述减持计划已于 2026 年 2 ...

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical excipients industry, indicating a positive outlook compared to the broader market [4]. Core Insights - The pharmaceutical excipients industry is undergoing an upgrade, with increasing specialization and scale as the regulatory framework and standards improve. The industry is expected to mature gradually [6][30]. - The implementation of the 2025 edition of the Chinese Pharmacopoeia, effective from October 1, 2025, introduces 52 new standards for pharmaceutical excipients, a 15.5% increase from the 2020 edition, totaling 387 standards. This is anticipated to enhance product quality and competitiveness in international markets, facilitating import substitution [6][28]. - The report highlights the strong performance of leading companies in the sector, such as Shanhe Pharmaceutical Excipients, which is positioned well to support pharmaceutical companies amid international changes. The company has shown steady growth and impressive export performance [6][30]. Summary by Sections 1. Importance of Pharmaceutical Excipients - Pharmaceutical excipients are essential components in drug production, influencing drug efficacy and manufacturing processes. They account for approximately 70% of the entire drug formulation [14][23]. 2. Development of the Pharmaceutical Excipients Industry - The industry is experiencing high-quality development, driven by improved regulatory environments and growing domestic demand. The market is expected to expand significantly, with a focus on high-end excipients and new formulations [30][31]. - The report notes that the domestic pharmaceutical excipients market is projected to reach approximately 48.28 billion yuan in 2024, with solid dosage form excipients accounting for about 33.8 billion yuan [32]. 3. Key Companies to Watch - Shanhe Pharmaceutical Excipients is highlighted as a leading player in the solid dosage excipients sector, with a robust product matrix and core technological advantages [6][30]. - Shandong Heda, a key player in the plant capsule market, is also recommended for investment due to its growth potential driven by the expanding health supplement market [2][6]. 4. Market Trends and Projections - The global health supplement market is expected to grow at a CAGR of approximately 5.4% from 2023 to 2028, potentially reaching nearly 1.4 trillion USD by 2028. The Chinese health supplement market is projected to reach 423.7 billion yuan by 2027 [6][30]. - The plant capsule market is anticipated to grow significantly, with global revenues expected to rise from approximately 1.535 billion USD in 2024 to 2.568 billion USD by 2031, driven by demand in both health supplements and pharmaceutical applications [6][30].

Recent Events - The company announced on February 4, 2026, that it passed the on-site inspection by the U.S. Food and Drug Administration (FDA), covering six major systems including quality and production [1][3]. Stock Performance - Over the past 7 days (February 4 to February 11, 2026), the company's stock price exhibited volatility, reaching a peak of 17.14 yuan on February 5, followed by a correction. The latest closing price as of February 11 is 15.98 yuan, with a daily increase of 0.50% and a turnover rate of 5.12% [2][4]. - On February 10, there was a net outflow of 1.9898 million yuan from main funds, while retail and speculative funds saw net inflows of 1.5736 million yuan and 416,200 yuan, respectively, indicating sustained market activity [2][4]. - The technical analysis suggests that the stock is currently in a bullish trend, with a resistance level at 16.68 yuan and a support level at 14.53 yuan [2][4].

Group 1 - The stock price of Shanhe Pharmaceutical Excipients Co., Ltd. closed at 15.77 yuan on February 4, 2026, with an increase of 2.8% and a trading volume of 175,500 shares, amounting to a transaction value of 275 million yuan [1] - On February 4, the net inflow of main funds was 12.91 million yuan, while retail investors experienced a net outflow of 24.74 million yuan, indicating a mixed sentiment among different investor groups [2] - The company successfully passed its first on-site inspection by the U.S. FDA from December 4 to December 5, 2025, confirming that its quality management system meets international standards, which is expected to facilitate expansion into the U.S. and other international markets [1][2] Group 2 - The successful FDA inspection is anticipated to positively impact the company's ability to replace imported pharmaceutical excipients in the domestic market [1] - The company has received the Establishment Inspection Report (EIR) from the FDA, marking a significant milestone in its quality management recognition [1]

Core Viewpoint - The company, Anhui Shanhe Pharmaceutical Excipients Co., Ltd., successfully passed its first on-site inspection by the U.S. FDA, indicating that its quality management system meets international standards, which is expected to facilitate the expansion into U.S. and other international markets [1]. Group 1: Stock Performance - As of February 4, 2026, the stock price of Shanhe Pharmaceutical Excipients closed at 15.77 yuan, reflecting a 2.8% increase from the previous trading day [1]. - The stock opened at 15.35 yuan, reached a high of 16.01 yuan, and a low of 15.28 yuan, with a trading volume of 2.75 billion yuan and a turnover rate of 8.84% [1]. Group 2: FDA Inspection - The company underwent an on-site inspection by the U.S. FDA from December 4 to December 5, 2025, covering six major systems: quality management, production management, facility and equipment management, laboratory quality control, material and packaging label management [1]. - The company received the FDA's Establishment Inspection Report (EIR), confirming that the inspection was completed successfully [1]. Group 3: Market Implications - The successful FDA inspection is expected to positively impact the company's domestic pharmaceutical excipients business by reducing reliance on imports [1]. - The company cautions investors about potential risks to overseas business due to market conditions, tariffs, and exchange rates [1].

Group 1 - The company, Shanhe Pharmaceutical (300452.SZ), has successfully passed the FDA on-site inspection as confirmed by the issued Establishment Inspection Report (EIR) [1] - The completion of the inspection marks a significant milestone for the company in its compliance with U.S. regulatory standards [1] - This successful inspection may enhance the company's credibility and potential for market expansion in the U.S. pharmaceutical sector [1]

Core Viewpoint - The company, Shanhe Pharmaceutical (300452.SZ), has successfully passed the FDA on-site inspection as confirmed by the issued Establishment Inspection Report (EIR) [1] Group 1 - The company received the EIR from the US FDA, indicating the completion of the on-site inspection [1] - The successful passing of the FDA inspection is a significant milestone for the company [1]

证券代码：300452 证券简称：山河药辅 公告编号：2026-005 债券代码：123199 债券简称：山河转债 安徽山河药用辅料股份有限公司 关于通过美国 FDA 现场检查公告 本公司及董事会全体成员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。 一、基本情况 二、对上市公司的影响及风险提示 本次是公司首次接受并通过美国 FDA 的现场检查，标志着公司 产品质量体系接轨国际，具备持续为美国乃至全球市场提供高品质药 用辅料产品的资质。此次通过美国 FDA 现场检查是公司严格贯彻执 行高标准质量管理规范的成果，是对公司管理体系有效运行的肯定， 对公司进一步拓展美国市场和其他国际市场有着积极的作用，同时也 将对公司国内药用辅料替代进口业务产生积极的影响。 公司海外业务近几年虽然增速较快，但总体上美国业务占比较小， 由于医药行业的特点，相应产品在国际市场的销售情况易受到市场环 境变化、关税、汇率等不确定性因素影响，敬请广大投资者谨慎决策， 注意防范投资风险。 特此公告。 安徽山河药用辅料股份有限公司董事会 二〇二六年二月四日 安徽山河药用辅料股份有限公司（以下简称"公司"）于 2025 年 12 月 ...

证券代码：300452 证券简称：山河药辅 公告编号：2026-004 债券代码：123199 债券简称：山河转债 安徽山河药用辅料股份有限公司 二、风险控制措施 1、董事会授权财务部负责具体经办事宜。财务部负责根据公司 财务状况、现金流状况及利率变动等情况，对理财产品业务进行内容 审核和风险评估，一旦发现存在可能影响公司资金安全的风险因素， 将及时采取保全措施，控制投资风险。 2、公司审计部对闲置募集资金使用与保管情况进行监督与审计， 对可能存在的风险进行评价。 3、独立董事对募集资金使用情况进行监督与检查，必要时可以 聘请专业机构进行审计。 4、公司将根据深圳证券交易所的相关规定及时履行披露义务。 关于使用部分暂时闲置募集资金购买的理财产品到期赎回 的进展公告 本公司及董事会全体成员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。 安徽山河药用辅料股份有限公司（以下简称"公司"）于 2025 年 4 月 21 日召开公司第六届董事会第五次会议、第六届监事会第五 次会议，审议通过了《关于使用部分闲置募集资金进行现金管理和部 分闲置自有资金进行委托理财的议案》，在不影响募集资金投资项目 正常进行及 ...

Core Insights - The Chinese generic drug industry is undergoing significant changes due to policy factors, including the implementation of the drug marketing authorization holder system and early resolution mechanisms for patent disputes, which are reshaping the competitive landscape [1][11]. Industry Overview - The number of generic drug products that have passed or are deemed to have passed evaluations in China reached 2,998 in 2024, an increase of 1,008 from 2023, representing a year-on-year growth of 50.65% [1][11]. - The proportion of contract manufacturing among these evaluated generic drug products reached 33% in 2024, up from 12% in 2020, indicating a trend towards deeper industry collaboration and resource allocation [1][11]. Generic Drug Consistency Evaluation - The consistency evaluation of generic drugs ensures that they meet the same quality and efficacy standards as original drugs, which is crucial for patient safety and effective treatment [2][3]. - The evaluation process includes determining reference formulations, conducting pharmaceutical research, and ongoing monitoring to ensure compliance with quality and safety standards [2][3]. Industry Policies - Recent policies have been introduced to enhance the quality of generic drugs and promote their market acceptance, including the 2025 guidelines for deepening drug regulation reforms [5][6]. - The establishment of a reference formulation directory is essential for conducting consistency evaluations, with 87 batches published by the National Medical Products Administration by the end of 2024 [9]. Market Dynamics - The market for chemical generic drugs in China is projected to be 868.3 billion yuan in 2024, showing a decline of 3% year-on-year, with the market share of chemical generics in the overall drug market decreasing from 60% in 2018 to 50% in 2024 [7][8]. - The competitive landscape is becoming increasingly polarized, with leading pharmaceutical companies gaining significant market share while smaller firms face challenges due to funding and research limitations [11]. Key Companies - Notable companies in the generic drug consistency evaluation sector include Tigermed Pharmaceutical Technology Co., Ltd., Huahai Pharmaceutical Co., Ltd., and Hengrui Medicine Co., Ltd., among others [1][11]. - Tigermed reported a revenue of 1.71 billion yuan in clinical trial services for the first half of 2025, reflecting a 3.07% increase year-on-year, while Hengrui Medicine achieved a revenue of 13.693 billion yuan, up 12.85% [12][14]. Future Trends - The focus of generic drug evaluations is expected to shift towards high-tech barrier products, such as controlled-release formulations and complex injectables, requiring enhanced reverse engineering and pharmaceutical research capabilities [15][16]. - The production model is transitioning from batch production to continuous manufacturing, which aims to ensure consistent quality and compliance with evaluation standards [15][16]. - Companies are encouraged to adopt a full lifecycle management approach for their products, emphasizing ongoing research and optimization post-evaluation to maintain market leadership [16].