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 - Zhejiang Hisun Pharmaceutical Co., Ltd. reported a slight increase in revenue but a significant decrease in net profit for the first half of 2025, indicating challenges in profitability despite stable sales performance [2][3]. Company Overview and Key Financial Indicators - The company generated revenue of approximately 5.25 billion RMB, a marginal increase of 0.13% compared to the same period last year [2]. - Total profit decreased by 16.74% to approximately 404.3 million RMB, while net profit attributable to shareholders fell by 31.29% to about 299.07 million RMB [2]. - The net cash flow from operating activities increased by 54.98% to approximately 1.21 billion RMB, reflecting improved efficiency in accounts receivable turnover [2]. - As of June 30, 2025, the company's total assets were approximately 15.56 billion RMB, a decrease of 2.56% from the end of the previous year [2]. Industry and Main Business Situation - The pharmaceutical industry is a crucial part of China's economy, with growing market demand driven by an aging population and increasing health awareness [3]. - In the first half of 2025, the pharmaceutical manufacturing industry reported a revenue of approximately 1.23 trillion RMB, a decrease of 1.2% year-on-year, and total profit of about 176.69 billion RMB, down 2.8% [3]. Main Business Segments - The company operates in various segments, including pharmaceutical formulations, active pharmaceutical ingredients (APIs), and animal health products [4][9]. - The pharmaceutical formulation business focuses on hospital sales, with specialized divisions for cardiovascular, infectious diseases, and oncology [5][6][7]. - The API business leverages over 50 years of fermentation technology, with a diverse product line and significant export capabilities [9]. - The animal health segment has established a strong market presence with over 50 products and partnerships with major livestock groups [10]. Market Position and Performance Drivers - The company has been recognized as a leading comprehensive pharmaceutical enterprise in China, with a focus on innovation and quality [11]. - Key performance drivers include structural optimization, business expansion, and management innovation, leading to a 23.92% increase in net profit excluding non-recurring items [12]. - The company has successfully expanded its market presence through a multi-channel strategy, including e-commerce and international markets, achieving significant growth in sales and market share [12].

Core Viewpoint - Haizheng Pharmaceutical reported a slight increase in revenue but a significant decline in net profit, primarily due to non-recurring factors, while core business segments showed growth and operational efficiency improvements [2][3]. Financial Performance - The company achieved a revenue of 5.25 billion yuan, a year-on-year increase of 0.13% [2]. - Net profit attributable to shareholders decreased by 31.29% to 299 million yuan, influenced by reduced convertible bond repurchase income; however, after excluding this factor, the net profit grew by 23.92% to 321 million yuan [2]. Business Segments - The formulation sales business maintained steady growth, with core products such as Saismei, Mitomycin, and Hailemao contributing to revenue increases [2]. - The pet segment performed exceptionally well, with sales reaching a historical high and a 60% overall growth, including over 100 million yuan in pet e-commerce sales [2]. Market Strategy - The company expanded its domestic business through county hospital coverage, accelerated e-commerce platform development, and implemented an AI-driven marketing system, achieving a 100% success rate in national procurement and a 90% success rate in provincial procurement [2]. - Internationally, Haizheng's first introduced product in the U.S. reached a 21% market share in Q2, and its animal health product "Hailiwang" gained market access in Vietnam [3]. R&D and Innovation - The company continues to focus on R&D and industrial upgrades, employing a dual-driven approach of "self-research + introduction" to enhance its global patent pipeline, particularly in cardiovascular and metabolic disease areas [3]. - A new small molecule innovative drug, HS387, has entered clinical development, and the company is actively introducing clinical-stage pipelines [3]. Future Growth Areas - Key growth drivers identified include the ramp-up of innovative drug Saismei, growth in consumer-oriented pharmaceuticals, advancements in synthetic biology, and the expansion of the pet medicine sector [5]. - The company aims to launch new products in the medical aesthetics sector and is focused on introducing new products to enhance market competitiveness [5].