Core Viewpoint - The European Union has revoked the GMP non-compliance declaration for Haizheng Pharmaceutical's Taizhou factory, positively impacting the company's product sales in the EU and other markets [1] Summary by Relevant Sections - **Regulatory Update** - The EU's revocation of the GMP non-compliance declaration for the Taizhou factory occurred on October 17, 2025 [1] - The official EU database no longer shows the GMP non-compliance status for the Taizhou factory, indicating a return to compliance [1] - **Market Impact** - The lifting of the non-compliance status is expected to have a positive effect on the company's ability to sell products in the EU market and potentially other markets [1]

Core Viewpoint - The announcement from Haizheng Pharmaceutical indicates that the EU has lifted the GMP non-compliance status for the company's Taizhou factory, which is expected to positively impact the company's product sales in the EU and other markets [1] Group 1: Company Impact - The lifting of the GMP non-compliance status is a significant development for Haizheng Pharmaceutical, as it allows for the resumption of product sales to the EU market [1] - The company may experience an increase in market opportunities due to the restored compliance status, although the recovery may be influenced by various factors such as market environment and sales channels [1] Group 2: Industry Context - The pharmaceutical industry is characterized by strict regulatory compliance, and the EU market's recovery may face uncertainties despite the positive news regarding GMP compliance [1]

关于欧盟撤销台州工厂《GMP 不符合声明》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。 2016年9月20日，欧盟药品管理局（EMA）网站发布了关于浙江海正药业股 份有限公司（以下简称"公司"）台州工厂的《GMP不符合声明》。2019年3月 18日至3月26日，以西班牙药品和医疗设备局牵头的欧盟官方对公司台州工厂进 行了GMP检查，本次检查是欧盟官方针对2016年检查的跟踪检查。2019年7月30 日，欧盟药品管理局（EMA）网站发布了关于公司台州工厂的《GMP不符合声 明》。2021年4月19日至30日，以西班牙药品和医疗设备局牵头的欧盟官方对公 司台州工厂进行了远程审计；2022年2月，欧盟官方就该次检查正式下发最终检 查报告，决定部分撤销公司台州工厂的《GMP不符合声明》项，但公司台州工 厂岩头厂区二期工程（Y20、Y36、Y37、Y38和Y39厂房）生产的细胞毒及有害 活性药物成分（原料药）产品仍处于不符合状态。具体内容详见公司于2016年9 月22日、2019年8月1日和2022年3月1日披露的"临2016 ...

格隆汇10月19日｜海正药业(600267.SH)公告称，公司收到欧盟官方邮件，公司二期工程（Y20、Y36、 Y37、Y38和Y39号厂房）的违规声明已于2025年10月17日被撤销。这意味着欧盟已解除公司台州工厂 GMP不符合状态，对公司产品销往欧盟市场及其他市场带来一定的积极影响。 ...

Core Viewpoint - The report by Zhiyan Consulting highlights the growth trends in China's chemical pharmaceutical industry, projecting a production increase in raw chemical drugs by 3.4% year-on-year in April 2025, with a cumulative growth of 3.9% from January to April 2025 [1] Industry Summary - In April 2025, China's production of raw chemical drugs reached 332,000 tons, marking a year-on-year increase of 3.4% [1] - The cumulative production of raw chemical drugs from January to April 2025 totaled 1,257,000 tons, reflecting a cumulative growth of 3.9% [1] - The report provides insights into the supply and demand dynamics of the chemical pharmaceutical industry in China from 2025 to 2031 [1] Company Summary - Listed companies in the report include Heng Rui Medicine, East China Pharmaceutical, Lijun Group, Baiyunshan, North China Pharmaceutical, Haizheng Pharmaceutical, Fosun Pharmaceutical, Kelun Pharmaceutical, Enhua Pharmaceutical, and Xianju Pharmaceutical [1] - Zhiyan Consulting is recognized as a leading industry consulting firm in China, specializing in in-depth industry research and providing comprehensive consulting services for investment decisions [1]

据行业分析机构IQVIA数据，2025年上半年，中国制药企业对外授权与战略合作交易总额已高达 485亿美元，创下历史新高。在国际化加速、创新技术突破、企业战略转型等因素的推动下，中国医药 企业出海正成为大势所趋。 目前，海正美国已从单一市场触点升级为支撑集团全球销售一体化战略的关键节点。依托本地化团 队的专业优势，海正美国不仅推动制剂产品在美商业化，更全面赋能母公司在海外的人用原料和制剂、 兽药原料和制剂、CMO、非药营养品板块以及跨境保健品电商等多类业务，形成"以点带面、全域协 同"的国际化运营网络。 赋能行业：打造中国药企出海"基础设施" 凭借在质量管理体系、市场拓展和海外本地化运营等方面积累的优势，海正药业正逐步转型为中国 药企出海的综合服务平台。2024年，海正美国与三家国内大型药企签署了4个产品的独家授权及合作开 发协议。2025年，其代理的首个引进产品，第二季度在美国市场实现市占率21%，充分印证了其成熟的 平台服务能力和高效的商业化落地能力。 作为深耕国际化领域30余年的先行者，浙江海正药业股份有限公司（以下简称"海正药业"）主动求 变，推动国际化战略向纵深发展，迈入深度国际化2.0时代，构建起 ...

Core Insights - The animal vaccine sector has seen a rise of 1.93%, ranking fourth among concept sectors in terms of growth, with 17 stocks increasing in value, led by TianKang Biological, BioShares, and Hengtong Holdings, which rose by 7.52%, 4.42%, and 4.24% respectively [1][2] - The sector experienced a net inflow of 178 million yuan from main funds, with 14 stocks receiving net inflows, and 6 stocks exceeding 10 million yuan in net inflows, with BioShares leading at 64.02 million yuan [2][3] - The top three stocks by net inflow ratio were HaiZheng Pharmaceutical, KeQian Biological, and TianKang Biological, with net inflow ratios of 13.58%, 10.61%, and 8.79% respectively [3][4] Sector Performance - The animal vaccine sector's performance is highlighted by the significant gains of key stocks, with TianKang Biological showing the highest increase at 7.52% and BioShares following closely at 4.42% [1][2] - The overall market sentiment for the animal vaccine sector appears positive, as indicated by the net inflow of funds and the number of stocks experiencing gains [2][3] Fund Flow Analysis - The main funds have shown a strong interest in the animal vaccine sector, with a total net inflow of 178 million yuan, indicating robust investor confidence [2][3] - The stocks with the highest net inflow include BioShares, TianKang Biological, and HaiZheng Pharmaceutical, suggesting these companies are currently favored by investors [3][4]

每经AI快讯，有投资者在投资者互动平台提问：国家药监局5月6日公告，辉瑞主动注销了注射用哌拉 西林钠他唑巴坦钠的药品注册证书。是否会对公司特治星地产化产品的销量带来利好？ （记者 王晓波） 海正药业（600267.SH）10月10日在投资者互动平台表示，注射用哌拉西林钠他唑巴坦钠（特治星）作 为辉瑞与海正药业早年合资时注入的核心品种，技术与权益归属已完成转移，瀚晖制药已成为该药品在 中国市场上的合法上市许可持有人。瀚晖制药的特治星在辉瑞指导下实现本地化生产，经验证其产品质 量与原研完全一致，产品已具备持续供应能力，早已完成对原研进口产品的市场替代；此外，公司特治 星二期扩产项目预计将于明年上半年可以实现商业化生产。 ...

Investment Rating - The report maintains a "Market Weight" rating for the pharmaceutical and biotechnology industry [2][24]. Core Viewpoints - The SW pharmaceutical and biotechnology industry underperformed the Shanghai and Shenzhen 300 index, declining by 0.23% from September 26, 2025, to October 9, 2025, lagging behind the index by approximately 2.76 percentage points [9][24]. - Most sub-sectors within the industry recorded negative returns during the same period, with the medical research outsourcing and in vitro diagnostics sectors showing gains of 1.99% and 0.55%, respectively, while the raw materials and chemical preparations sectors fell by 2.23% and 1.73% [10][24]. - Approximately 54% of stocks in the industry achieved positive returns, with the top performer, Zhendemedical, increasing by 21.43%, while the largest decline was seen in Guangshentang, which fell by 21.86% [11][14]. - The overall price-to-earnings (PE) ratio for the SW pharmaceutical and biotechnology industry was approximately 55.04 times as of October 9, 2025, indicating a decrease in industry valuation [15][24]. Summary by Sections 1. Market Review - The SW pharmaceutical and biotechnology industry underperformed the Shanghai and Shenzhen 300 index, with a decline of 0.23% from September 26, 2025, to October 9, 2025 [9]. - Most sub-sectors recorded negative returns, with medical research outsourcing and in vitro diagnostics performing better than others [10]. - About 54% of stocks in the industry recorded positive returns, with significant variations in individual stock performance [11]. 2. Industry News - The 11th batch of national procurement will begin accepting applications on October 21, 2025, with 55 major varieties included [22]. - The National Medical Products Administration issued guidelines for the quality management of medical device online sales [20][21]. 3. Company Announcements - Zhejiang Haizheng Pharmaceutical announced that its product achieved Self-GRAS certification in the U.S., allowing it to enter the U.S. market [23]. 4. Weekly Industry Perspective - The report suggests focusing on investment opportunities in innovative drugs and sectors with expected business development catalysts, including medical devices and pharmaceutical commerce [24][26].

截至2025年9月月底，公司已累计回购股份553.5万股，占公司总股本的比例为0.46% 。实际回购价格区 间在8.92元/股至9.40元/股之间，已支付的总金额为50891385元（不含交易费用）。值得注意的是， 2025年9月，公司当月未进行股份回购。 从数据来看，此次回购进展符合既定的回购股份方案。公司表示，将严格按照相关规定，在回购期限内 根据市场情况择机做出回购决策并予以实施，同时及时履行信息披露义务。广大投资者需注意投资风 险。 登录新浪财经APP 搜索【信披】查看更多考评等级 浙江海正药业股份有限公司于2025年10月10日发布关于第四次以集中竞价交易方式回购公司股份的进展 公告，披露了回购相关重要信息。 回购方案关键信息 2025年5月12日，浙江海正药业第十届董事会第二次会议和第十届监事会第二次会议，审议通过以集中 竞价交易方式回购公司股份的议案。回购资金总额不低于5000万元且不超过1亿元，回购股份价格不超 过13元/股，回购期限自董事会审议通过之日起12个月，即2025年5月12日至2026年5月11日。该回购方 案首次披露日为2025年5月13日，回购用途主要为用于员工持股计划或股权激 ...