证券代码：600267 证券简称：海正药业 公告编号：临 2025-55 号 浙江海正药业股份有限公司 第十届董事会第七次会议决议公告 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"或"海正药业"）第十届 董事会第七次会议于 2025 年 9 月 16 日上午以通讯方式召开，应参加本次会议董 事 9 人，亲自参加会议董事 9 人。本次会议的召开程序符合《公司法》和《公司 章程》的规定，会议合法有效。本次会议由公司董事长肖卫红先生主持，与会董 事以通讯表决方式通过了如下决议： 一、关于公司与深圳艾欣达伟医药科技有限公司签署产品独家许可及战略合 作协议的议案； 为进一步完善公司在创新药领域的战略布局，持续强化创新药开发能力，助 力公司培育新的价值增长点，同意公司引进由深圳艾欣达伟医药科技有限公司 （以下简称"艾欣达伟"）开发的全球首创（FIC）小分子前药 AST-3424（即"合 作标的"，包括其所有规格、剂型及适应症）在合作区域内（指中国大陆、中国 香港特别行政区和中国澳门特别行政区） ...

Core Viewpoint - The company, Haizheng Pharmaceutical (600267.SH), has signed an exclusive licensing and strategic cooperation agreement with Shenzhen Aixin Dawei Pharmaceutical Technology Co., Ltd. to introduce the globally innovative small molecule prodrug AST-3424 in specified regions [1] Group 1 - The company will pay an upfront fee to Aixin Dawei and will also pay milestone payments based on the actual achievement of development milestones, with total costs not exceeding 240 million yuan [1] - The cooperation area includes mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region [1] - The company will also engage in strategic cooperation with Aixin Dawei on the AKR1C3 enzyme activation platform [1]

Core Viewpoint - The article highlights the recognition of Hai Zheng Animal Health's product, Hai Le Miao, as the leading brand in the cat internal deworming market in China, emphasizing its significant market position and consumer acceptance [1][12]. Company Overview - Hai Le Miao is a subsidiary of Zhejiang Hai Zheng Animal Health Products Co., Ltd., which is a holding company of Zhejiang Hai Zheng Pharmaceutical Co., Ltd. (stock code: 600267). The company has invested 800 million to build an international animal health enterprise and has established two major production bases [5][6]. Product Development and Market Position - Hai Le Miao has been awarded certificates for being the "national sales leader in cat internal deworming" and for having "over ten million choices by pet owners," indicating its strong market presence [1][12]. - The product is recognized for its effective formulation, combining Milbemycin Oxime and Praziquantel, which targets eight common internal parasites in cats, making it a preferred choice among cat owners [8][12]. Industry Trends - The demand for cat internal deworming products has evolved from optional to essential, as pet owners increasingly view deworming as a critical aspect of health management, akin to vaccinations and health check-ups [8]. - The regulatory environment for the pet pharmaceutical industry in China is becoming more standardized, leading to increased compliance and quality in production, which benefits leading brands like Hai Le Miao [9][10]. Marketing Strategy - The company employs a dual-channel marketing strategy, focusing on both professional channels (veterinary institutions and large distributors) and consumer channels (e-commerce and social media), enhancing brand recognition and consumer engagement [11]. - Hai Le Miao's marketing efforts have resulted in a strong reputation and consumer loyalty, contributing to its leading market position [11].

Group 1 - The company Zhejiang Haizheng Pharmaceutical Co., Ltd. has received the Certificate of Suitability to Monograph of European Pharmacopoeia (CEP) for the active pharmaceutical ingredient Tigecycline from the European Directorate for the Quality of Medicines & HealthCare (EDQM) [1][2] - The CEP certificate indicates that the quality of Tigecycline is recognized by European standards, allowing the product to enter the EU market and other markets that acknowledge the CEP certificate, which positively impacts the company's international market expansion [2] - The global sales volume of Tigecycline active pharmaceutical ingredient is projected to be approximately 601.30 kilograms in 2024 and around 290.22 kilograms for the first half of 2025, according to IQVIA data [1] Group 2 - The company is the first domestic enterprise to obtain the CEP certificate for Tigecycline active pharmaceutical ingredient, highlighting its competitive position in the market [1] - Tigecycline is primarily used for treating infections caused by specific bacterial strains in patients over 18 years old, including complicated intra-abdominal infections, complicated skin and soft tissue infections, and community-acquired bacterial pneumonia [1] - The international active pharmaceutical ingredient business is subject to changes in overseas market conditions and exchange rate fluctuations, which may impact the company's operations [2]

证券代码：600267 证券简称：海正药业 公告编号：临 2025-54 号 浙江海正药业股份有限公司 关于替加环素原料药获得 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"）收到欧洲药品质量 管理局（European Directorate for the Quality of Medicines & HealthCare，以下简称 "EDQM"）签发的替加环素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 特此公告。 生产地址：浙江省台州市椒江区外沙路46号 发证机构：欧洲药品质量管理局（EDQM） 二、药品的其他相关情况 替加环素主要适用于18岁以上患者在下列情况下由特定细菌的敏感菌株所 致感染的治疗：复杂性腹腔内感染、复杂性皮肤和皮肤软组织感染、社区获得性 细菌 ...

Core Viewpoint - The company, Haizheng Pharmaceutical, has received the Certificate of Suitability to Monograph of European Pharmacopoeia (CEP certificate) from the European Directorate for the Quality of Medicines & HealthCare (EDQM) for its Tigecycline active pharmaceutical ingredient [1] Group 1 - The CEP certificate indicates that Tigecycline is suitable for use in treating infections caused by specific sensitive strains of bacteria in patients aged 18 and above [1] - Tigecycline is primarily indicated for the treatment of complex intra-abdominal infections, complex skin and soft tissue infections, and community-acquired bacterial pneumonia [1]

Core Viewpoint - Haizheng Pharmaceutical has received the CEP certificate for Tigecycline raw materials from the European Medicines Agency, marking it as the first domestic company to achieve this certification, which enhances its qualifications for entering the EU and other markets that recognize the CEP certificate [1] Group 1 - The receipt of the CEP certificate signifies recognition and affirmation of the quality of the raw material by the European regulatory market [1] - This certification allows the company to expand its international market presence positively [1]

Core Viewpoint - The company has received the CEP certificate for tigecycline active pharmaceutical ingredient from the European Directorate for the Quality of Medicines and HealthCare (EDQM), marking a significant achievement as the first domestic enterprise to obtain this certification [1] Group 1 - The global sales volume of tigecycline active pharmaceutical ingredient is approximately 290.22 kilograms for the period from January to June 2025 [1]

Group 1 - The company, Haizheng Pharmaceutical, disclosed information regarding its share repurchase account in the section "Top Ten Shareholders and Share Repurchase Account Status" of its 2025 semi-annual report format [1]

Core Insights - The company emphasizes that research and development (R&D) is the core driving force for its growth, aiming for precise and efficient R&D [1] - The company focuses on key therapeutic areas such as cardiovascular and metabolic diseases, establishing a systematic layout for global patent barrier innovation pipelines [1] - The self-developed Class 1 small molecule innovative drug HS387 has received clinical implied approval from NMPA, officially entering the clinical development stage [1] - The company is accelerating the introduction of clinical-stage pipelines to enrich its product lineup and address more unmet clinical needs [1]