证券代码：601089 证券简称：福元医药 公告编号：临 2025-048 北京福元医药股份有限公司 由协和发酵麒麟研制的盐酸贝尼地平片，最早于 1991 年 10 月获 日本批准上市，2004 年 3 月，经国家药品监督管理局批准，盐酸贝尼 地平片在国内获批上市，用于原发性高血压，心绞痛。 关于盐酸贝尼地平片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 担法律责任。 近日，北京福元医药股份有限公司（以下简称"公司"）收到了 国家药品监督管理局(以下简称"国家药监局")颁发的盐酸贝尼地平 片（规格：8mg）(以下简称"该药品")《药品注册证书》(证书编号： 2025S01906)，批准该药品生产。现将相关情况公告如下： 药品名称 药品通用名称：盐酸贝尼地平片 英文名/拉丁名：Benidipine Hydrochloride Tablets 剂型 片剂 注册分类 化学药品4类 规格 8mg 药品批准文号 国药准字H20254631 药品注册标准编号 YBH13712025 申请事项 药品注册（境内生产） 审批结论 ...

| 一、药品注册证书主要内容 | | --- | | | 批准注册，发给药品注册证书。质量标准、说 明书、标签及生产工艺照所附执行。药品生产 | | --- | --- | | | 企业应当符合药品生产质量管理规范要求方可 | | | 生产销售。 | | 上市许可持有人 | 北京福元医药股份有限公司 | | 生产企业 | 北京福元医药股份有限公司 | 二、药品相关信息 由默克研制的比索洛尔氨氯地平片，最早于 2010 年 10 月通过互 认程序获批上市，参照成员国为匈牙利，2021 年 5 月，经国家药品监 督管理局批准，比索洛尔氨氯地平片在国内获批上市。本品作为高血 压治疗的替代疗法，用于目前同时服用与复方制剂剂量相同的单药且 血压控制良好的患者。 公司于 2024 年 2 月 26 日获得申报受理通知书，并于近日获得国 家药监局批准。根据国家相关政策规定，本次获得《药品注册证书》， 视同通过一致性评价。 证券代码：601089 证券简称：福元医药 公告编号：临 2025-047 北京福元医药股份有限公司 关于比索洛尔氨氯地平片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、 ...

Core Viewpoint - The company has received the drug registration certificate for Benidipine Hydrochloride Tablets (8mg) from the National Medical Products Administration, which will enhance its product line and market competitiveness [1] Group 1: Drug Approval and Market Impact - The drug was first approved in Japan in 1991 and received domestic approval in 2004 for the treatment of primary hypertension and angina [1] - The company received the acceptance notice for the application on March 5, 2024, and has recently been granted approval [1] - The estimated sales revenue for Benidipine Hydrochloride Tablets in China's three major terminal markets is approximately 1.007 billion yuan in 2024 [1] Group 2: R&D Investment - The total research and development investment for this drug by the company amounts to 5.2737 million yuan [1]

Investment Rating - The report maintains a "Recommended" investment rating for the healthcare sector [7]. Core Insights - The healthcare sector has shown a mixed performance, with the Shenyin Wanguo Pharmaceutical Bio Index rising by 1.60% from June 23 to June 27, 2025, underperforming the CSI 300 Index by 0.35 percentage points [2][12]. - Year-to-date, the pharmaceutical sector has increased by 6.24%, outperforming the CSI 300 Index by 6.57 percentage points, ranking 11th among 31 sectors [2][14]. - As of June 27, 2025, the valuation of the pharmaceutical sector stands at 27.54 times (TTM overall method, excluding negative values), with a premium of 140.94% compared to the CSI 300 [2][17]. Summary by Sections 1. Market Performance - The pharmaceutical sector's performance from June 23 to June 27, 2025, was a 1.60% increase, ranking 23rd among 31 sectors [12]. - The year-to-date performance shows a 6.24% increase, ranking 11th among 31 sectors [14]. 2. Important Events - The National Healthcare Security Administration released the "2025 Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory Adjustment Application Guidelines," marking a significant step for commercial health insurance in the multi-level medical security system [4][21]. 3. Industry Perspective - The inclusion of the commercial insurance innovative drug directory indicates an enhanced role for commercial insurance in the multi-level medical security system, providing greater opportunities for the industry [5][22]. - The report expresses optimism for innovative drugs, overseas expansion, and the clearing of procurement in specific segments, suggesting a focus on companies involved in these areas [22].

Core Viewpoint - On June 30, a total of 31 listed companies had their restricted shares unlocked, with a total market value of approximately 31.50 billion yuan [1]. Group 1: Unlocking Details - The specific details of the restricted share unlocks include: - Meili Ecology (000010): 239 million shares from A-share issuance to original shareholders - Xingrong Environment (000598): 4.926 million shares from equity incentive lock-up - Yueyang Xinchang (000819): 526,800 shares from equity incentive lock-up - Gaohong Co., Ltd. (000851): 4.944 million shares from equity incentive lock-up - Zhongyan Chemical (600328): 470,460 shares from equity incentive lock-up - Yangnong Chemical (600486): 115,480 shares from equity incentive lock-up - Kangyuan Pharmaceutical (600557): 2.6093 million shares from equity incentive lock-up - Keda Technology (002518): 1.3953 million shares from equity incentive lock-up - Longci Technology (300835): 562,700 shares from equity incentive lock-up - Weiming Environmental Protection (603568): 3.129 million shares from equity incentive lock-up - Dongrui Co., Ltd. (001201): 486,400 shares from A-share issuance to original shareholders - Sanwei Co., Ltd. (603033): 1.183 million shares from equity incentive lock-up - Naer Co., Ltd. (002825): 140,000 shares from equity incentive lock-up - Jinyinhe (300619): 1.6248 million shares from A-share issuance to legal persons - Tianyuan Environmental Protection (301127): 14.6 million shares with extended lock-up period - Youningwei (301166): 40.6188 million shares with extended lock-up period - Xutian Salt Industry (600929): 3.033 million shares from equity incentive lock-up - Keli Sensor (603662): 722,800 shares from equity incentive lock-up - Gongniu Group (603195): 641,200 shares from equity incentive lock-up - Fuyuan Pharmaceutical (601089): 27.5 million shares from pre-issue lock-up - Xinbang Intelligent (301112): 7.4097 million shares from pre-issue lock-up - Shanghai Port Bay (605598): 29,400 shares from equity incentive lock-up - Dingjide (603255): 507,500 shares from equity incentive lock-up - United Precision (001268): 6.154 million shares from pre-issue lock-up - Pinggao Co., Ltd. (688227): 48.9585 million shares - Chunli Medical (688236): 20.9 million shares - Zhongwulian (688297): 40.3 million shares - Lais Information (688631): 163,480 shares - Shichuang Energy (688429): 200,000 shares - Xindong Link (688582): 220,840 shares - Aike Saibo (688719): 100,000 shares [2].

Investment Rating - The report maintains a "Buy" rating for multiple companies in the pharmaceutical sector, including Junshi Bioscience, Hualing Pharmaceutical-B, and others [2]. Core Insights - The report emphasizes the broad market for lipid-lowering treatments, particularly focusing on the competitive landscape of PCSK9-targeted drugs, with approximately 500 million adults in China suffering from dyslipidemia, including 120 million with high cholesterol [3][15]. - The pharmaceutical sector saw a 1.60% increase this week, underperforming the CSI 300 index by 0.35 percentage points, with sub-sectors like medical infrastructure and life sciences performing better than generics and innovative drugs [4][31]. Summary by Sections 1. Industry Perspective and Investment Recommendations - The lipid-lowering market is vast, with intense competition in PCSK9-targeted drugs [15]. - Investment strategies should focus on innovative drugs, particularly in the context of increased liquidity and risk appetite in the market [4][31]. 2. Pharmaceutical Sector Performance - The pharmaceutical sector's performance was mixed, with medical infrastructure and life sciences leading, while generics and innovative drugs lagged [4][37]. - The overall P/E ratio for the pharmaceutical industry is 27.69, with a premium of 35.26% compared to the broader A-share market [37]. 3. Company Dynamics - Notable company announcements include Baiyoutai's licensing agreement for BAT2406 in Latin America and Yifan Pharmaceutical's approval for clinical trials of a growth hormone injection [38][40]. - Companies like WuXi AppTec and Lijun Group have made significant moves, including share buybacks and new product approvals [39][41]. 4. Industry Trends - The report highlights the upcoming patent expirations for major small molecule drugs, which could lead to increased demand for raw materials [5][32]. - The report also notes the expected recovery in overseas demand, which may improve the performance of CXO companies [34]. 5. Research and Development Focus - The report discusses the clinical progress of various PCSK9-targeted therapies, including monoclonal antibodies and gene editing approaches, indicating a strong pipeline in this area [3][23][25]. - The competitive landscape for PCSK9 drugs in China is characterized by pricing and adherence challenges, with several products already on the market [27].

证券代码：601089 证券简称：福元医药 公告编号：2025-046 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、准确性和完整性依法承担法律责任。 重要内容提示： ? 本次股票上市类型为首发股份；股票认购方式为网下，上市股 数为274,653,587股。 本次限售股上市流通数量为274,653,587股。（均为首次公开发行 限售股，无战略配售股份。） ? 本次限售股上市流通日期为2025 年 6 月 30 日。 一、本次限售股上市类型 北京福元医药股份有限公司（以下简称 "公司"）经中国证券监 督管理委员会（以下简称"中国证监会"）《关于核准北京福元医药 股份有限公司首次公开发行股票的批复》（证监许可〔2022〕974 号） 核准，首次公开发行人民币普通股（A 股）股票 120,000,000 股，并于 总股本由 360,000,000 股增至 480,000,000 股，其中，有限售条件股 份数量为 360,000,000 股，无限售条件股份数量为 120,000,000 股。 本次上市流通的限售股属于首次公开发行限售股，涉及股东数量为 2 名，分 ...

证券代码：601089 证券简称：福元医药 公告编号：2025-046 北京福元医药股份有限公司 首次公开发行限售股上市流通公告 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、准确性和完整性依法承担法律责任。 重要内容提示： 本次股票上市类型为首发股份；股票认购方式为网下，上市股 数为274,653,587股。 本次限售股上市流通数量为274,653,587股。（均为首次公开发行 限售股，无战略配售股份。） 本次限售股上市流通日期为2025 年 6 月 30 日。 三、本次限售股上市流通的有关承诺 （一）发行前股东股份流通限制及自愿锁定股份的承诺 新和成控股承诺： "1、自发行人股票上市之日起 36 个月内，不转让或者委托他人 管理本公司直接或者间接持有的发行人首次公开发行股票前已发行的 股份，也不由发行人回购该部分股份。 一、本次限售股上市类型 北京福元医药股份有限公司（以下简称 "公司"）经中国证券监 督管理委员会（以下简称"中国证监会"）《关于核准北京福元医药 股份有限公司首次公开发行股票的批复》（证监许可〔2022〕974 号） 核准，首次公开发 ...

首次公开发行限售股上市流通的核查意见 中信建投证券股份有限公司（以下简称"中信建投证券"或"保荐人"）作 为北京福元医药股份有限公司（以下简称"福元医药"、"公司"）首次公开发 行股票并上市项目的保荐人，根据《证券发行上市保荐业务管理办法》《上海证 券交易所上市公司自律监管指引第 1 号——规范运作》等相关规定履行持续督导 职责，对福元医药首次公开发行限售股上市流通的情况进行了审慎核查，核查情 况如下： 一、本次限售股上市流通类型 北京福元医药股份有限公司（以下简称"福元医药"或"公司"）经中国 证券监督管理委员会（以下简称"中国证监会"）《关于核准北京福元医药股 份有限公司首次公开发行股票的批复》（证监许可〔2022〕974号）核准，首次 公开发行人民币普通股（A股）股票120,000,000股，并于2022年6月30日在上海 证券交易所上市。首次公开发行完成后，公司总股本由360,000,000股增至 480,000,000股，其中，有限售条件股份数量为360,000,000股，无限售条件股份 数量为120,000,000股。本次上市流通的限售股属于首次公开发行限售股，涉及 股东数量为2名，分别为新和成控 ...

Industry Overview - The constipation issue is becoming increasingly common due to aging population, fast-paced lifestyle, and changing dietary habits, driving the consumption of laxative products like glycerin enemas [1][10] - The Chinese glycerin enema market is projected to reach a sales revenue of 1.157 billion yuan in 2024, representing a year-on-year growth of 9.36% [1][10] - Glycerin enemas are classified into glycerin-based and mannitol/magnesium sulfate formulations, acting directly on the rectum to stimulate bowel movements [4] Industry Development History - The industry has evolved through three main stages: initial growth in the 1980s-90s, rapid development in the early 2000s to 2010s, and innovation and diversification from the 2020s onwards [4] - The early stage saw limited product variety and reliance on chemical ingredients, while the later stages shifted towards plant extracts and herbal components to reduce side effects [4] - Recent trends include the introduction of high-end product lines and stricter regulatory requirements, enhancing product safety and efficacy [4] Industry Supply Chain - The upstream of the glycerin enema industry includes raw materials like glycerin and production equipment [6] - The midstream involves the manufacturing of glycerin enemas, while the downstream encompasses sales channels such as medical institutions, retail pharmacies, and e-commerce platforms [6] Current Industry Status - The market is experiencing a shift towards natural and effective products, with innovations in dosage forms like gel and granule types to meet consumer demands for convenience and lower residue [10] - Companies are increasingly incorporating plant extracts and herbal ingredients to enhance product appeal and reduce irritation [10] Key Companies' Performance - Shanghai Xiaofang Pharmaceutical Co., Ltd. leads the market with a 38.3% share in 2024, leveraging its "Xinlong" brand and innovative W-type enema design to enhance user experience [12][14] - Beijing Fuyuan Pharmaceutical Co., Ltd. focuses on cost-effective strategies, achieving a production volume of 640 million units in 2024, with a year-on-year increase of 12% [12][16] - The competitive landscape is characterized by a few dominant players and numerous smaller firms employing differentiation strategies to capture niche markets [12] Industry Development Trends 1. **Growing Market Demand**: The demand for glycerin enemas is expected to continue rising, driven by an aging population and increasing health awareness, particularly among the elderly and younger demographics facing lifestyle-related constipation [18] 2. **Accelerated Competitive Differentiation**: The industry is witnessing a shift towards higher concentration, with leading companies solidifying their market positions through brand strength and innovative products [19] 3. **Technological and Product Innovation**: The industry is moving towards diversification and high-end formulations, with a focus on optimizing dosage forms and incorporating beneficial ingredients like prebiotics and probiotics [20]