近日，浙江海正药业股份有限公司（以下简称"海正药业"）迎来了其国际化战略的重大突破。根据公 告，经查询欧盟官方数据库，海正药业台州工厂的《GMP不符合声明》已经被移除，意味着欧盟已解 除公司台州工厂GMP不符合状态。 欧盟禁令全面解除，对海正药业巩固欧盟市场地位，重建并深化国际客户合作关系具有重大意义。这也 是海正药业国际化2.0战略升级的关键里程碑，标志着公司国际化进入高质量协同发展的全新阶段。 此次解禁也证明了海正药业质量体系兼具国际普适性和可持续性。海正药业副总裁兼质量管理总部总经 理周臻弘表示，品质是医药企业的生命线，更是海正药业近70年发展历程中始终坚守的核心价值观和不 懈追求。公司始终将产品质量置于企业发展的战略首位，对标国际最高质量标准持续投入，不断完善质 量管理体系。正因如此，近年来，海正药业在FDA、EDQM等国际质量认证方面捷报频传，印证了公司 数十年如一日狠抓质量、全员追求卓越的扎实成果，未来，该体系将持续赋能创新药研发与全球化布 局，巩固海正在国际医药产业链的品质领先地位。 海正药业的国际化发展，不仅是其30年质量长跑的里程碑，更是中国医药产业从"制造"向"智造""质 造"转型升级的生 ...

对此，海正药业开启了全方位的质量攻坚战。公司制定了"分步走"的破局策略，在一期整改阶段，优先 选择基础条件较好的车间作为先行试点，在人、机、料、法、环等各个方面进行系统性优化，从厂房设 计布局、空调系统管控、人流物流管控、设备选型到工艺设计等进行全面革新。一期整改工作很快得到 了欧盟官方的认可，2021年4月公司接受了以西班牙药品和医疗设备局牵头的欧盟官方的远程审计，最 终欧盟决定部分撤销台州工厂的《GMP不符合声明》项。 海正药业指出，这种极致投入也在去年美国食品药品监督管理局(FDA)和今年欧洲药品质量管理局 (EDQM)的现场检查中获得了认可，海正药业cGMP管理体系获得FDA审计组"已达国际一流水平"的高 度赞誉，公司专业协作与完善的生产质量管理体系也获得EDQM检查官的高度肯定。基于前期持续努力 及一系列正面检查结果，海正药业委托律师再次向西班牙药品和医疗设备局提出申请，请求撤销此前针 对台州工厂岩头厂区抗肿瘤二期工程厂房内生产的细胞毒及有害活性药物原料药所出具的不符合声明， 最终于近日获其同意全面撤销决定。 海正药业董事长兼总裁肖卫红表示，公司正全面推进"全球市场一体化"战略，依托原料药出口传统优 ...

近日海正药业（600267）发布公告称收到欧盟官方关于公司台州工厂的《GMP不符合声明》已于2025 年10月17日撤销的通知。 根据公告显示，经查询欧盟官方数据库，海正药业台州工厂的《GMP不符合声明》已经被移除，意味 着欧盟已解除海正药业台州工厂GMP不符合状态，对该公司产品销往欧盟市场及其他市场将带来积极 影响。此次撤销是基于2025年3月公司接受的欧洲药品质量管理局与德国官方联合审计结果。 对此海正药业表示，欧盟禁令全面解除，对海正药业巩固欧盟市场地位，重建并深化国际客户合作关系 具有重大意义。这也是海正药业国际化2.0战略升级的关键里程碑，标志着该公司国际化进入高质量协 同发展的全新阶段。 海正药业董事长兼总裁肖卫红表示，海正药业正全面推进"全球市场一体化"战略，依托原料药出口传统 优势，重点布局巴西、中东+北非、独联体+东欧三大区域，同步筹备日本、东南亚市场。欧盟市场的 全面恢复，一方面显著降低公司对单一市场的依赖，另一方面，与海正美国、巴西等市场形成深度战略 协同，共同构建"多区域、多板块"协同出海的新格局，进一步巩固全球价值链稳定性。 欧盟作为全球药品监管最严格的地区之一，其GMP认证素以"行 ...

Group 1 - Xuedilong plans to invest no more than 400 million yuan to build an innovation industrial base in Changping District, Beijing, focusing on chromatography and mass spectrometry production lines [1] - The project aims to enhance research and production capabilities in carbon monitoring and measurement systems [1] Group 2 - Zejing Pharmaceutical's tri-specific antibody drug ZGGS34 has received clinical trial approval from the National Medical Products Administration for treating MUC17 positive advanced solid tumors [2] - The drug shows strong anti-tumor activity and good safety in preclinical studies [2] Group 3 - Aosaikang's new cMET inhibitor ASK202 will present clinical research data at the 2025 ESMO annual meeting, showing an objective response rate of 68.8% and a disease control rate of 93.8% in advanced non-small cell lung cancer patients [2][3] Group 4 - China Life expects a net profit of 156.785 billion to 177.689 billion yuan for the first three quarters of 2025, representing a year-on-year increase of 50% to 70% [4] Group 5 - Silan Microelectronics plans to jointly invest 5.1 billion yuan to build a 12-inch high-end analog chip production line, with a total project investment of 20 billion yuan [5][6] Group 6 - New City intends to use 156.65 million yuan of remaining fundraising to invest in a "Building Green Energy and Zero Carbon Park" project, with a total investment of 257 million yuan [8] Group 7 - Yidao Information plans to acquire control of Guangzhou Langguo Electronic Technology and Shenzhen Chengwei Information through a combination of share issuance and cash payment [9] Group 8 - Xiling Information's controlling shareholder has received a notice of lifting restrictions, allowing normal business operations to resume [10] Group 9 - Dongpeng Holdings' first batch of rock slab products has passed the highest level 5A quality inspection, becoming one of the first companies to meet the new national standard [11] Group 10 - Aonlikang's levofloxacin tablets have received approval from the National Medical Products Administration, classified as a chemical drug of category 4 [15] Group 11 - Haizheng Pharmaceutical's Taizhou factory has had its GMP non-compliance declaration revoked by the EU, confirming compliance with EU GMP requirements [17][18] Group 12 - Hongfuhan's shareholder plans to reduce its stake by up to 1.5% through various trading methods due to asset integration and funding needs [19] Group 13 - Purang Co. plans to establish a wholly-owned subsidiary in Hong Kong to enhance its international competitiveness and service levels [20] Group 14 - Tianhe Magnetic Materials' subsidiary has signed an investment agreement for a project worth 850 million yuan focused on high-performance rare earth permanent magnets [22] Group 15 - Xiangfenghua reported a 64.64% year-on-year decline in net profit for the first three quarters, despite an 8.16% increase in revenue [23] Group 16 - Darui Electronics reported a 26.84% year-on-year increase in net profit for the first three quarters, with total revenue growing by 28.59% [24] Group 17 - Xiangsheng Medical reported a 4.56% year-on-year decline in net profit for the first three quarters, despite a 41.95% increase in net profit for the third quarter [25]

Core Viewpoint - The report by Zhiyan Consulting highlights the growth and future trends in China's chemical pharmaceutical industry, indicating a steady increase in production and market dynamics from 2025 to 2031 [1]. Industry Summary - According to the National Bureau of Statistics, the production of chemical pharmaceutical raw materials in China reached 263,000 tons in August 2025, with a cumulative production of 2,477,000 tons from January to August 2025, reflecting a growth of 3.1% [1]. - The report provides insights into the supply and demand situation in the chemical pharmaceutical industry, projecting future trends and market conditions [1]. Company Summary - Listed companies in the report include Heng Rui Medicine, East China Medicine, Lizhu Group, Baiyunshan, North China Pharmaceutical, Haizheng Pharmaceutical, Fosun Pharmaceutical, Kelun Pharmaceutical, Enhua Pharmaceutical, and Xianju Pharmaceutical, indicating a diverse range of players in the market [1]. - The report emphasizes the importance of industry research and consulting services in aiding investment decisions, showcasing Zhiyan Consulting's expertise in providing comprehensive industry solutions [1].

登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：600267 证券简称：海正药业 公告编号：临2025-59号 浙江海正药业股份有限公司 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 ...

Core Viewpoint - Multiple companies in the Shanghai and Shenzhen stock markets have announced significant developments, including investments in semiconductor manufacturing, clinical research advancements, and changes in corporate governance, which may present investment opportunities and insights for stakeholders [3]. Investment Announcements - Silan Microelectronics plans to invest 20 billion yuan to establish a 12-inch high-end analog integrated circuit chip manufacturing line, aiming for a production capacity of 54 million chips annually after completion [4]. - Xidilong intends to invest no more than 400 million yuan to purchase land use rights and build an innovation industrial base, adding chromatography and mass spectrometry production lines [8]. - Tianhe Magnetic Materials' subsidiary plans to invest 850 million yuan in high-performance rare earth permanent magnets and component manufacturing [9]. - New City plans to allocate 157 million yuan of remaining fundraising to a green energy and zero-carbon park planning project [10]. - Yanguang Nuohuo proposes to invest 15 million yuan to increase the registered capital of Yuanma Zhiyao, focusing on innovative CAR-T cell therapies [15]. Corporate Governance Changes - Xiling Information's controlling shareholder and general manager has had their detention lifted, allowing them to resume normal duties [5][6]. Regulatory Developments - Haizheng Pharmaceutical's Taizhou factory has had its GMP non-compliance status revoked by the EU, positively impacting its product sales in the EU market [7]. - Zhonghe Titanium White will change its stock name to "Titanium Energy Chemical" starting October 20, 2025, while retaining its stock code [14]. Performance Reports - China Life expects a net profit increase of approximately 50% to 70% for the first three quarters of 2025, estimating profits between 156.785 billion yuan and 177.689 billion yuan [20]. - Yangjie Technology reported a 52.4% increase in net profit for Q3 2025, driven by growth in the semiconductor sector [21]. - Xiangsheng Medical's Q3 net profit grew by 41.95%, despite a decline in revenue [22]. - Zhuhai Guanyu anticipates a net profit increase of 36.88% to 55.54% for the first three quarters of 2025 [23]. - Huiquan Beer reported a 23.7% increase in net profit for Q3 2025 [24]. - Darui Electronics' net profit grew by 26.84% in the first three quarters of 2025 [25]. - Xingwang Yuda turned a profit in Q3 2025, reporting a net profit of 38.3749 million yuan [27]. - Tongyou Technology reported a net profit of 27.6683 million yuan in Q3 2025, marking a turnaround from losses [28]. Shareholding Changes - Hongfuhan's shareholder, Hengmei International, plans to reduce its stake by up to 1.5% [30]. - Intelligent Control's controlling shareholder's associate plans to reduce its stake by up to 1% [31].

Core Viewpoint - The company, Haizheng Pharmaceutical, has successfully revoked its non-compliance statement regarding GMP for its Taizhou factory, which is expected to positively impact its product sales in the EU and other markets [1] Group 1 - On October 19, Haizheng Pharmaceutical announced the withdrawal of its non-compliance statement for its Phase II project (Y20, Y36, Y37, Y38, and Y39 buildings) [1] - The company confirmed that a search of the EU official database revealed no current non-compliance statements for its Taizhou factory [1] - The revocation of the non-compliance status by the EU is anticipated to have a positive effect on the company's product sales in the EU market and other markets [1]

经查询欧盟官方数据库，目前已无法查询到公司台州工厂的《GMP不符合声明》，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。 海正药业(600267.SH)公告，欧盟撤销公司台州工厂《GMP不符合声明》，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日撤销。 ...

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]