经济观察网山河药辅公告通过美国食品药品监督管理局(FDA)现场检查，核查涵盖质量、生产等六大体 系。该事件标志着公司产品质量体系接轨国际，对拓展美国及全球市场有积极影响。 近期事件 经济观察网山河药辅公告通过美国食品药品监督管理局(FDA)现场检查，核查涵盖质量、生产等六大体 系。该事件标志着公司产品质量体系接轨国际，对拓展美国及全球市场有积极影响。 近期事件 2026年2月4日，山河药辅公告通过美国食品药品监督管理局(FDA)现场检查，核查涵盖质量、生产等六 大体系。该事件标志着公司产品质量体系接轨国际，对拓展美国及全球市场有积极影响。 股票近期走势 近7天(2026年2月4日至11日)，山河药辅股价呈现波动态势。2月5日股价触及阶段高点17.14元，随后回 调；截至2月11日最新收盘价15.98元，单日上涨0.50%，换手率5.12%。资金流向方面，2月10日主力资 金净流出198.98万元，但游资和散户资金分别净流入157.36万元和41.62万元，显示市场活跃度维持。技 术面显示，股价短期处于多头行情，20日压力位16.68元，支撑位14.53元。 以上内容基于公开资料整理，不构成投资建议。 2026 ...

安徽山河药用辅料股份有限公司于2025年12月4日至12月5日接受了美国FDA的现场检查，检查范围包括 质量管理、生产管理、设施与设备管理、实验室质量控制、物料和包装标签管理六大体系。公司已收到 美国FDA出具的现场检查报告（EIR），确认检查结束并顺利通过。此次为公司首次通过美国FDA现场 检查，表明其质量管理体系符合国际标准，有利于拓展美国及其他国际市场，同时对国内药用辅料替代 进口业务产生积极影响。公司提示投资者注意海外业务可能受到市场环境、关税、汇率等因素影响的风 险。 当日关注点 交易信息汇总资金流向 2月4日主力资金净流入1290.58万元；游资资金净流入1183.64万元；散户资金净流出2474.22万元。 公司公告汇总关于通过美国FDA现场检查公告 截至2026年2月4日收盘，山河药辅(300452)报收于15.77元，上涨2.8%，换手率8.84%，成交量17.55万 手，成交额2.75亿元。 以上内容为证券之星据公开信息整理，由AI算法生成（网信算备310104345710301240019号），不构成 投资建议。 来自交易信息汇总：2月4日主力资金净流入1290.58万元，游资资金同步净 ...

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].

山河药辅（300452）(300452.SZ)公告，公司收到美国FDA出具的现场检查报告(EIR),确认本次检查已结 束，公司顺利通过FDA现场检查 ...

智通财经APP讯，山河药辅(300452.SZ)公告，公司收到美国FDA出具的现场检查报告(EIR),确认本次检 查已结束，公司顺利通过FDA现场检查 ...

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].

Market Overview - The chemical pharmaceutical sector experienced a decline of 0.77% on January 20, with Kangzhi Pharmaceutical leading the drop [1] - The Shanghai Composite Index closed at 4113.65, down 0.01%, while the Shenzhen Component Index closed at 14155.63, down 0.97% [1] Stock Performance - Notable gainers in the chemical pharmaceutical sector included: - Hanshang Group (Code: 600774) with a closing price of 11.64, up 10.02% and a trading volume of 438,600 shares, totaling 489 million yuan [1] - Tainkang (Code: 301263) with a closing price of 32.71, up 7.04% and a trading volume of 138,300 shares, totaling 437 million yuan [1] - Sitaili (Code: 603520) with a closing price of 10.58, up 2.52% and a trading volume of 210,900 shares, totaling 225 million yuan [1] - Conversely, significant decliners included: - Kangyi Pharmaceutical (Code: 300086) with a closing price of 10.44, down 5.86% and a trading volume of 447,100 shares [2] - Dizhe Pharmaceutical (Code: 688192) with a closing price of 62.72, down 5.10% and a trading volume of 42,700 shares [2] - Guangji Pharmaceutical (Code: 000952) with a closing price of 7.52, down 4.93% and a trading volume of 292,200 shares [2] Capital Flow - The chemical pharmaceutical sector saw a net outflow of 1.348 billion yuan from institutional investors, while retail investors contributed a net inflow of 1.109 billion yuan [2] - The capital flow for specific stocks indicated: - Huabang Health (Code: 002004) had a net inflow of 88.38 million yuan from institutional investors, but a net outflow of 73.07 million yuan from retail investors [3] - Fuxiang Pharmaceutical (Code: 300497) recorded a net inflow of 57.88 million yuan from institutional investors, with a net outflow of 102 million yuan from retail investors [3] - Xinqiao Pharmaceutical (Code: 000756) had a net inflow of 25.08 million yuan from institutional investors, but also saw a net outflow of 15.54 million yuan from retail investors [3]

Core Viewpoint - The A-share annual report season is in full swing, with significant performance forecasts for 2025 from various companies, leading to notable stock price increases for several firms [1] Group 1: Performance Forecasts - A total of 366 A-share listed companies have released their 2025 annual performance forecasts, with 16 companies expecting a year-on-year net profit increase of over 200% [1] - SAIC Motor Corporation leads with an expected net profit increase of 438% to 558%, projecting a profit of 9 billion to 11 billion yuan due to increased vehicle sales and a low base from asset impairment in 2024 [2][3] - BAW Storage anticipates a net profit of 850 million to 1 billion yuan, representing a year-on-year growth of 427.19% to 520.22%, driven by a recovery in storage prices and strong demand in AI sectors [3] Group 2: Sector Highlights - Longxin Bochuang expects a net profit of 320 million to 370 million yuan, reflecting a growth of 344.01% to 413.39%, supported by increased demand in data communication markets [5] - Lakala forecasts a net profit of 1.06 billion to 1.2 billion yuan, a growth of 202% to 242%, attributed to increased transaction volumes in cross-border payments and stock investment gains [5] - Shanhua Pharmaceutical anticipates a net profit of 165 million to 194 million yuan, with a growth of 38.16% to 62.45%, driven by strong order volumes in both domestic and foreign markets [7] Group 3: Market Reactions - Following the performance forecasts, several companies experienced significant stock price increases, with Lakala and Shanhua Pharmaceutical both hitting the 20% daily limit up [1][5] - BAW Storage's stock rose over 17% after its earnings announcement, reflecting positive market sentiment towards its growth prospects in AI and advanced packaging solutions [3]