Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. received a warning letter from the FDA based on an inspection conducted from January 16 to January 24, 2025, at its production facility in Xunqiao Town, Linhai City, which raised concerns regarding the management of cleaning for solid oral production equipment, maintenance of sterile production areas, and the adequacy of parameters for tablet rejection studies [1][2]. Group 1 - The warning letter specifically affects the approval of ANDA new applications or supplemental applications related to the Xunqiao production facility, but it will not have a significant impact on the company's current performance [2]. - The company is taking the FDA's suggestions seriously and has begun to implement optimization measures while maintaining active communication with the FDA [1][2]. - The company is committed to continuously improving its quality management system to ensure compliance with operational standards [1].

Core Viewpoint - Huahai Pharmaceutical received a warning letter from the FDA due to issues found during an inspection of its Linhai Xunqiao production base, which may affect future ANDA applications but will not significantly impact current performance [2][3]. Group 1: FDA Warning Letter - The warning letter was issued following an FDA inspection from January 16 to January 24, 2025, which identified problems related to cleaning management of oral solid production equipment, maintenance of sterile production areas, and the adequacy of tablet rejection parameter studies [2]. - The company has acknowledged the FDA's suggestions and is taking measures to optimize its operations while maintaining active communication with the FDA [2]. Group 2: Historical Context and Previous Performance - The Linhai Xunqiao production base previously passed FDA inspections with zero defects, highlighting its compliance history [3]. - In 2020, the sales revenue from formulation products produced at the Linhai Xunqiao base in the U.S. was 780 million yuan, while the revenue from active pharmaceutical ingredients (APIs) was 27.6651 million yuan [3]. - For 2024, the U.S. formulation business is projected to generate approximately 1.279 billion yuan in sales, reflecting a year-on-year decline of 6.51%, although the average gross margin of products has been improving [3]. Group 3: Previous Warnings and Compliance - In 2018, the company received a warning letter from the FDA regarding its Chuan Nan plant, citing issues such as failure to ensure quality-related complaint investigations and not assessing the impact of process changes on API quality [4]. - The 2018 warning was linked to the detection of a potential carcinogen in an API, which raised concerns about the company's production methods [5]. - The FDA lifted the warning for the Chuan Nan production base by the end of 2021, allowing products from this facility to re-enter the U.S. market [5].

浙江华海药业股份有限公司（以下简称"公司"）于近日收到美国食品药品监 督管理局（以下简称"FDA"）发出的警告信，该警告信系基于 2025 年 1 月 16 日 至 1 月 24 日期间 FDA 对公司位于临海市汛桥镇的药品生产基地（以下简称"汛桥 生产基地"）进行的现场检查。警告信针对汛桥生产基地的制剂产品提出了相关检 查意见和改进建议，主要涉及部分口服固体生产设备清洁管理、无菌生产区域维护 和压片剔废参数研究的充分性。 公司高度重视 FDA 的建议，已积极采取措施进行优化，并持续与 FDA 保持积 极沟通。公司将持续提升质量管理体系，确保合规运营。 | | | 股票简称：华海药业 股票代码：600521 公告编号：临 2025-071 号 浙江华海药业股份有限公司 关于公司收到 FDA 警告信的公告 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个别及连带责任。 浙江华海药业股份有限公司 董 事 会 二零二五年六月九日 1 公司制剂生产基地主要有汛桥制剂生产基地（位于浙江省临海市汛桥镇）和子 公司浙江华海制药科技有限公司（位于临海市 ...

| | | 股票简称：华海药业 股票代码：600521 公告编号：临 2025-071 号 浙江华海药业股份有限公司 关于公司收到 FDA 警告信的公告 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个别及连带责任。 浙江华海药业股份有限公司（以下简称"公司"）于近日收到美国食品药品监 督管理局（以下简称"FDA"）发出的警告信，该警告信系基于 2025 年 1 月 16 日 至 1 月 24 日期间 FDA 对公司位于临海市汛桥镇的药品生产基地（以下简称"汛桥 生产基地"）进行的现场检查。警告信针对汛桥生产基地的制剂产品提出了相关检 查意见和改进建议，主要涉及部分口服固体生产设备清洁管理、无菌生产区域维护 和压片剔废参数研究的充分性。 公司高度重视 FDA 的建议，已积极采取措施进行优化，并持续与 FDA 保持积 极沟通。公司将持续提升质量管理体系，确保合规运营。 公司制剂生产基地主要有汛桥制剂生产基地（位于浙江省临海市汛桥镇）和子 公司浙江华海制药科技有限公司（位于临海市江南街道）。本次警告信仅对涉及汛 桥生产基地的 ANDA 新申 ...

华海药业(600521.SH)公告称，公司于近日收到美国食品药品监督管理局（FDA）发出的警告信，该警 告信系基于2025年1月16日至1月24日期间FDA对公司位于临海市汛桥镇的药品生产基地进行的现场检 查。警告信针对汛桥生产基地的制剂产品提出了相关检查意见和改进建议，主要涉及部分口服固体生产 设备清洁管理、无菌生产区域维护和压片剔废参数研究的充分性。本次警告信仅对涉及汛桥生产基地的 ANDA新申请或补充申请的批准产生影响，不会对公司当期业绩产生重大影响。 ...

沪指6月9日上涨0.43%，申万所属行业中，今日上涨的有30个，涨幅居前的行业为医药生物、农林牧 渔，涨幅分别为2.30%、1.72%。医药生物行业位居今日涨幅榜首位。跌幅居前的行业为食品饮料，跌 幅分别为0.43%。 资金面上看，两市主力资金全天净流入35.37亿元，今日有16个行业主力资金净流入，非银金融行业主 力资金净流入规模居首，该行业今日上涨1.20%，全天净流入资金27.81亿元，其次是医药生物行业，日 涨幅为2.30%，净流入资金为20.27亿元。 医药生物行业今日上涨2.30%，全天主力资金净流入20.27亿元，该行业所属的个股共475只，今日上涨 的有435只，涨停的有16只；下跌的有36只。以资金流向数据进行统计，该行业资金净流入的个股有251 只，其中，净流入资金超亿元的有5只，净流入资金居首的是华海药业，今日净流入资金2.78亿元，紧 随其后的是睿智医药、众生药业，净流入资金分别为2.48亿元、2.47亿元。医药生物行业资金净流出个 股中，资金净流出超亿元的有5只，净流出资金居前的有恒瑞医药、千红制药、博瑞医药，净流出资金 分别为2.88亿元、1.18亿元、1.07亿元。（数据宝） | ...

Group 1 - The Alzheimer's concept sector increased by 3.80%, ranking 6th among concept sectors, with 29 stocks rising, including Hotgen Biotech, Jinkai Biotechnology, and Wohua Pharmaceutical, which rose by 18.15%, 9.25%, and 7.55% respectively [1] - The Alzheimer's concept sector saw a net inflow of 414 million yuan from main funds today, with 18 stocks receiving net inflows, and 5 stocks exceeding 30 million yuan in net inflow. Huahai Pharmaceutical led with a net inflow of 278 million yuan, followed by Kanghong Pharmaceutical, Meinian Health, and Hotgen Biotech [2][3] Group 2 - The top stocks in the Alzheimer's concept sector by net inflow ratio include Huahai Pharmaceutical, Dongya Pharmaceutical, and Kanghong Pharmaceutical, with net inflow ratios of 15.84%, 10.28%, and 9.61% respectively [3] - The trading performance of various stocks in the Alzheimer's concept sector shows significant activity, with Huahai Pharmaceutical and Kanghong Pharmaceutical leading in both net inflow and trading volume [4][5]

截至6月9日收盘，仿制药一致性评价概念上涨3.37%，位居概念板块涨幅第9，板块内，120股上涨，海 辰药业20%涨停，罗欣药业、昂利康、众生药业等涨停，星昊医药、一品红、万邦医药等涨幅居前，分 别上涨27.29%、9.95%、8.99%。跌幅居前的有奥赛康、海思科、复旦复华等，分别下跌1.85%、 1.16%、0.96%。 今日涨跌幅居前的概念板块 | 概念 | 今日涨跌幅（%） | 概念 | 今日涨跌幅（%） | | --- | --- | --- | --- | | CRO概念 | 4.73 | 金属铅 | -0.30 | | 减肥药 | 4.66 | 供销社 | -0.05 | | 足球概念 | 4.44 | 金属铜 | 0.07 | | 创新药 | 3.91 | 金属锌 | 0.10 | | 毛发医疗 | 3.82 | 小米汽车 | 0.15 | | 阿尔茨海默概念 | 3.80 | 黄金概念 | 0.21 | | 染料 | 3.71 | 同花顺中特估100 | 0.23 | | 稀土永磁 | 3.45 | 海南自贸区 | 0.25 | | 仿制药一致性评价 | 3.37 | 低辐射玻璃(Low-E ...

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 2025-070 | | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | 浙江华海药业股份有限公司 关于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个别及连带责任。 浙江华海药业股份有限公司（以下简称"公司"）于近日收到国家药品监督管 理局（以下简称"国家药监局"）核准签发的托伐普坦片的《药品注册证书》，现将 相关情况公告如下： 一、药品的基本情况 药品名称：托伐普坦片 剂型：片剂 规格：15mg 申请事项：药品注册（境内生产） 注册分类：化学药品 4 类 申请人：浙江华海药业股份有限公司 药品批准文号：国药准字 H20254289 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，发给药品注册证书。 二、药品其他相关情况 三、对公司的影响 1 本次托伐普坦片获得国家药监局的《药品注册证书》，进一步丰富了公司的产 品线， ...

Core Insights - Huahai Pharmaceutical (600521) has received the drug registration certificate for tolvaptan tablets from the National Medical Products Administration [1] - Tolvaptan tablets are indicated for the treatment of hyponatremia and fluid retention caused by heart failure, with an estimated domestic market sales amount of approximately 497 million yuan [1] - The company has invested around 9.51 million yuan in research and development for this product [1] - The approval of the registration certificate will enhance the product line and improve market competitiveness [1]