产品剂型：原料药 证书编号：No. CEP 2024-314 - Rev 00 证券代码：600267 证券简称：海正药业 公告编号：临 2025-75 号 浙江海正药业股份有限公司 关于全资子公司依维莫司原料药获得 CEP 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，浙江海正药业股份有限公司（以下简称"公司"）全资子公司海正药 业杭州有限公司（简称"海正杭州公司"）收到欧洲药品质量管理局（European Directorate for the Quality of Medicines & HealthCare，以下简称"EDQM"）签发 的 依 维莫 司 原 料 药欧 洲 药 典 适用 性 认 证证 书 （ Certificate of Suitability to Monograph of European Pharmacopoeia，以下简称"CEP 证书"），现就相关情 况公告如下： 一、CEP证书相关信息 药品名称：EVEROLIMUS/依维莫司 生产地址：浙江省杭州市富阳区胥口镇海正路1号 ...

Core Viewpoint - Haizheng Pharmaceutical's subsidiary, Haizheng Hangzhou Company, has received the Certificate of Suitability to Monograph of European Pharmacopoeia (CEP) for its active pharmaceutical ingredient, Everolimus, indicating recognition of its quality in the European market and enhancing its qualifications for international market expansion [1] Group 1 - Haizheng Hangzhou Company has been awarded the CEP certificate by the European Directorate for the Quality of Medicines & HealthCare (EDQM) [1] - The CEP certification signifies that the quality of Everolimus meets European standards, allowing the product to enter the EU and other markets that recognize the CEP certificate [1] - This certification is expected to have a positive impact on the company's efforts to expand its international market presence [1]

Core Viewpoint - Zhejiang Haizheng Pharmaceutical Co., Ltd. has signed a project agreement with Zhejiang University for the development and industrialization of bio-synthesized anticoagulant heparin, with a total project amount of 120 million yuan, aiming to provide green innovative solutions for the global anticoagulant drug market [1][3]. Group 1: Market Context - The domestic heparin market has nearly reached 30 billion yuan, while the global market has surpassed 10 billion USD [3]. - The demand for heparin drugs is increasing due to factors such as an aging population, rising surgical procedures, and increasing chronic disease prevalence [3]. Group 2: Challenges in Traditional Production - Traditional heparin production relies on pig intestinal mucosa, leading to supply instability, quality fluctuations, and environmental pressures [3]. - The bio-synthesis method using microbial fermentation technology offers a sustainable supply of raw materials and significantly improves quality control [3]. Group 3: Company Expertise and Strategy - Haizheng Pharmaceutical has 69 years of experience in the pharmaceutical field and over 55 years of expertise in microbial technology [3]. - The collaboration will enhance Haizheng's product matrix in the anticoagulant drug sector, optimize existing industrial resources, and improve competitiveness in the high-end biopharmaceutical market [3][4]. Group 4: Project Significance - The bio-engineered heparin project is a core initiative of the research institute, marking a significant transition from laboratory research to industrial application [4]. - The partnership aims to disrupt traditional animal extraction methods for heparin production, facilitating a comprehensive process from laboratory research to mass production [4]. Group 5: Future Aspirations - The collaboration seeks to establish a globally leading research and production platform for anticoagulant drugs, filling the clinical application gap for bio-engineered heparin and providing safer and more effective treatment options for patients worldwide [5].

Core Viewpoint - Qianjin Pharmaceutical (600479.SH) has received the drug registration certificate for Lurasidone Hydrochloride Tablets from the National Medical Products Administration, which is used for the treatment of schizophrenia, enhancing the company's product pipeline and supporting sustainable development [1] Company Summary - Qianjin Xiangjiang Pharmaceutical, a subsidiary of Qianjin Pharmaceutical, has invested a total of 6.3294 million yuan in the research and development of Lurasidone Hydrochloride Tablets [1] - The approval of Lurasidone Hydrochloride Tablets signifies that the product has passed the consistency evaluation, which is a positive development for the company's product offerings [1] Industry Summary - Other companies that have received the drug registration certificate for Lurasidone Hydrochloride Tablets include Jiangsu Hengrui Medicine Co., Ltd., Zhengda Tianqing Pharmaceutical Group Co., Ltd., and Zhejiang Haizheng Pharmaceutical Co., Ltd. [1] - The production and sales of the drug are subject to significant uncertainties due to factors such as national policies and market environment changes [1]

Core Viewpoint - Haizheng Pharmaceutical's wholly-owned subsidiary, Haizheng Hangzhou, has received a CEP certificate for Everolimus active pharmaceutical ingredient from EDQM, indicating the product's qualification for entry into the EU market, which will positively impact the company's international market expansion [1] Group 1 - Everolimus is applicable for various cancers and diseases related to tuberous sclerosis, and it can also prevent transplant rejection [1] - The global sales volume for Everolimus is projected to be approximately 128.81 kilograms in 2024, with an estimated 66.01 kilograms for the first half of 2025 [1] - The application for the CEP certificate was submitted on June 29, 2024, by Haizheng Hangzhou [1] Group 2 - The certification signifies the product's capability to enter international markets, which is expected to enhance the company's international business development [1] - However, there are risks associated with international business operations [1]

Core Viewpoint - Qianjin Pharmaceutical's subsidiary, Qianjin Xiangjiang Pharmaceutical, has received the drug registration certificate for Lurasidone Hydrochloride Tablets from the National Medical Products Administration, indicating a significant milestone in the company's product pipeline and potential for sustainable development [1] Group 1: Drug Registration and Development - The drug is indicated for the treatment of schizophrenia, with other companies such as Jiangsu Hengrui Medicine Co., Ltd., Zhengda Tianqing Pharmaceutical Group Co., Ltd., and Zhejiang Hisun Pharmaceutical Co., Ltd. also having obtained registration for the same drug [1] - Qianjin Xiangjiang Pharmaceutical has invested a total of 6.3294 million yuan in the research and development of Lurasidone Hydrochloride Tablets [1] Group 2: Market and Regulatory Environment - The approval of the drug registration certificate is considered equivalent to passing the consistency evaluation, which enhances the company's product offerings [1] - The production and sales of the drug are subject to significant uncertainties due to potential changes in national policies and market conditions [1]

Group 1 - Guangzhou Pharmaceutical Co., Ltd. announced a 500 million yuan acquisition of its wholly-owned subsidiary Zhejiang Pharmaceutical Industry Co., Ltd., marking the second major cross-province merger in the pharmaceutical distribution sector within a few days [1] - In 2024, Guangzhou Pharmaceutical is projected to achieve a main business revenue of 54.524 billion yuan, ranking 6th among national pharmaceutical wholesale companies, while Zhejiang Pharmaceutical is expected to generate 4.777 billion yuan, placing it 32nd [1] - The acquisition of Zhejiang Pharmaceutical is part of a broader trend where pharmaceutical distribution companies are expanding their business footprint beyond their home provinces through mergers and acquisitions [1][2] Group 2 - Zhejiang Pharmaceutical has a nationwide sales network covering 26 provinces, with a strong presence in Zhejiang, reaching 90% of county-level hospitals and hundreds of community health service centers [2] - Tailong Pharmaceutical's business includes drug formulation, traditional Chinese medicine, drug research services, and drug material distribution, with its subsidiary Tongquntang having a sales network across all 31 provinces and over 1 million acres of medicinal herb cultivation [2] - The top five companies in China's pharmaceutical wholesale industry, including China National Pharmaceutical Group and Shanghai Pharmaceuticals, have annual revenues exceeding 100 billion yuan, creating significant competitive pressure on smaller regional companies [2][4] Group 3 - Prior to the acquisition of Zhejiang Pharmaceutical, Guangzhou Pharmaceutical had already invested 749 million yuan to acquire 11.04% of Nanjing Pharmaceutical, becoming its second-largest shareholder [3] - Guangzhou Pharmaceutical is actively pursuing a strategy to "recreate a new Guangzhou Pharmaceutical," focusing on capital operations and expanding its industrial footprint through various acquisitions and partnerships [3] - The 2024 report on the pharmaceutical distribution industry indicates that as market growth slows, resource integration and scale advantages are becoming crucial for development [4]

Core Viewpoint - Haizheng Pharmaceutical (600267.SH) has confirmed Guangzhou Medicine as the buyer in a property rights transaction, with a deposit of RMB 86 million paid for the acquisition of 100% equity in Zhejiang Pharmaceutical Industry Co., Ltd. [1] Group 1 - The company received a notification from the Taiwan Stock Exchange regarding the property rights transaction on December 10, 2025 [1] - The transaction is governed by the "Entrusted Transfer Service Agreement," "Bidding and Commitment," and "Online Bidding Transaction Guidelines" [1] - Guangzhou Medicine has submitted a total deposit of RMB 86 million for the equity transfer project [1]

浙江海正药业股份有限公司 关于全资子公司浙江省医药工业有限公司 100%股权 转让公开挂牌的进展公告 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。 浙江海正药业股份有限公司（以下简称"公司"）于 2025 年 8 月 22 日召开 的第十届董事会第六次会议审议通过了《关于公开转让全资子公司浙江省医药工 业有限公司 100%股权的议案》，同意公司通过公开挂牌方式对外转让全资子公 司浙江省医药工业有限公司（以下简称"省医药公司"）100%股权。公司已于 2025 年 11 月 10 日向台州市产权交易所有限公司（以下简称"台交所"）提交 了省医药公司 100%股权转让的挂牌申请，由台交所组织实施交易。具体详见公 司于 2025 年 8 月 26 日、2025 年 11 月 12 日披露的"临 2025-47 号"、"临 2025-68 号"公告。 2025 年 12 月 10 日，公司收到台交所出具的《产权交易签约通知函》（以 下简称"《通知函》"），根据《委托转让服务协议》、《竞买及承诺》和《网 络竞价交易须知》的规定，确认广 ...

Core Viewpoint - Haizheng Pharmaceutical (600267.SH) has confirmed that Guangzhou Medicine is the buyer in a property rights transaction, with a deposit of RMB 86 million paid for the acquisition of 100% equity in Zhejiang Pharmaceutical Industry Co., Ltd [1] Group 1 - The transaction is based on the "Entrusted Transfer Service Agreement," "Bidding and Commitment," and "Online Bidding Trading Instructions" [1] - The transaction notification was issued by the Taiwan Stock Exchange on December 10, 2025 [1]