格隆汇10月9日丨海正药业(600267.SH)公布，公司产品1,4-丁二磺酸腺苷蛋氨酸，按照美国FDA GRAS 准则完成Self-GRAS（Self-affirmed Generallyrecognized as safe）科学评价并获得专家组一致批准，正式 通过美国Self-GRAS认证。 ...

本次公司1,4-丁二磺酸腺苷蛋氨酸通过Self-GRAS认证，意味着该产品经过科学评估程序，正式获得美 国市场准入资格，可以作为安全的膳食原料在美国市场以及认可美国GRAS认证的其他国际市场进行销 售并使用，进一步丰富公司盈利结构，为公司膳食类业务全球化布局奠定关键基础。 海正药业(600267.SH)发布公告，近日，公司产品1,4-丁二磺酸腺苷蛋氨酸，按照美国FDA GRAS准则完 成Self-GRAS(Self-affirmed Generallyrecognized as safe)科学评价并获得专家组一致批准，正式通过美国 Self-GRAS认证。 ...

海正药业（600267）(600267.SH)发布公告，近日，公司产品1,4-丁二磺酸腺苷蛋氨酸，按照美国FDA GRAS准则完成Self-GRAS(Self-affirmed Generallyrecognized as safe)科学评价并获得专家组一致批准，正 式通过美国Self-GRAS认证。 本次公司1,4-丁二磺酸腺苷蛋氨酸通过Self-GRAS认证，意味着该产品经过科学评估程序，正式获得美 国市场准入资格，可以作为安全的膳食原料在美国市场以及认可美国GRAS认证的其他国际市场进行销 售并使用，进一步丰富公司盈利结构，为公司膳食类业务全球化布局奠定关键基础。 ...

证券代码：600267 证券简称：海正药业 公告编号：临 2025-58 号 产品特性与应用：腺苷蛋氨酸是一种安全的高价值食品营养强化剂，具有调 节生理机能的重要作用，在营养补充、食品加工等领域应用广泛。在美国市场， 公司该产品可作为膳食原料，在预期使用条件下应用于特定食品、特殊膳食代餐 产品等多个品类，适配现代消费者对健康营养的需求。 二、对上市公司的影响 近日，浙江海正药业股份有限公司（以下简称"公司"）产品1,4-丁二磺酸 腺苷蛋氨酸，按照美国FDA GRAS准则完成Self-GRAS（Self-affirmed Generally recognized as safe）科学评价并获得专家组一致批准，正式通过美国Self-GRAS 认证。现就相关情况公告如下： 一、产品基本情况 中文名称：1,4-丁二磺酸腺苷蛋氨酸 英文名称：SAMe-1,4-butanedisulfonate 浙江海正药业股份有限公司 关于公司产品通过美国 Self-GRAS 认证的公告 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。 本次公司1,4- ...

Core Viewpoint - The company Haizheng Pharmaceutical has successfully obtained Self-GRAS certification for its product 1,4-butanedisulfonic acid adenosylmethionine, allowing it to enter the U.S. market [1] Group 1: Product and Certification - The product 1,4-butanedisulfonic acid adenosylmethionine is recognized as a safe and high-value food nutritional supplement [1] - The product plays a significant role in regulating physiological functions and has wide applications in nutritional supplementation and food processing [1] - The successful completion of the Self-GRAS scientific evaluation and unanimous approval by the expert panel signifies the product's formal market entry qualification in the U.S. [1]

一、 回购股份的基本情况 浙江海正药业股份有限公司（以下简称"公司"）于 2025 年 5 月 12 日召开的 第十届董事会第二次会议和第十届监事会第二次会议，审议通过了《关于第四次 以集中竞价交易方式回购公司股份的议案》，同意公司通过自有资金以集中竞价交 易方式回购公司股份，回购的资金总额不低于人民币 5 千万元且不超过人民币 1 亿元（均包含本数），回购股份价格不超过人民币 13 元/股（含），回购期限自公司 董事会审议通过回购股份方案之日起 12 个月内。具体内容详见《浙江海正药业股 份有限公司关于第四次以集中竞价交易方式回购股份方案暨回购报告书》（公告编 号：临 2025-29 号），已登载于 2025 年 5 月 13 日的《中国证券报》《上海证券报》 《证券时报》和上海证券交易所网站（www.sse.com.cn）上。 二、 回购股份的进展情况 证券代码：600267 证券简称：海正药业 公告编号：临 2025-57 号 浙江海正药业股份有限公司 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 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 ...

浙江海正药业股份有限公司发布第四次以集中竞价交易方式回购公司股份的进展公告。该回购方案于 2025年5月12日经董事会和监事会审议通过，实施期限为2025年5月12日至2026年5月11日，预计回购金 额5000万元至1亿元，用于员工持股计划或股权激励。截至2025年9月底，公司累计回购股份5,535,000 股，占总股本0.46%，支付总金额50,891,385元，实际回购价格区间为8.92元/股至9.40元/股。 ...

Core Points - Zhejiang Haizheng Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the tacrolimus capsule, which has passed the consistency evaluation of generic drug quality and efficacy [1][2] Group 1: Drug Information - The drug name is tacrolimus capsule, available in dosages of 0.5mg and 1mg, classified as a chemical drug [1] - The original drug was developed by Astellas Pharma Co., Limited, and is primarily used to prevent organ rejection after liver or kidney transplants [2] - The global sales of tacrolimus capsules are projected to be approximately $138.73 million in 2024, with domestic sales around $46.16 million [2] Group 2: Company Impact - The approval of tacrolimus capsules for consistency evaluation is expected to enhance the company's market share and competitiveness in the pharmaceutical industry [3] - The company has invested approximately 61.44 million RMB in the consistency evaluation of this drug [2]

Core Viewpoint - The Chinese beauty industry is undergoing a deep upgrade driven by technology and consumer demand, with pharmaceutical companies emerging as key players due to their strong R&D capabilities and quality systems [3][4]. Industry Overview - Over 400 pharmaceutical companies in China are venturing into the cosmetics sector, aiming to transform pharmaceutical technology into effective skincare and health aesthetic products [3]. - The market for cosmetics in China reached approximately 1,073.82 billion yuan in 2024, continuing to exceed the trillion yuan mark for two consecutive years [8]. Company Profile: Zhejiang Haizheng Pharmaceutical Co., Ltd. - Established in 1956, Haizheng Pharmaceutical has a long history in chemical and pharmaceutical production, with a diversified business matrix focusing on various therapeutic areas [5][6]. - The company reported a revenue of 9.787 billion yuan and a net profit of 600 million yuan in 2024, with R&D investment reaching 420 million yuan [6]. Strategic Moves - Haizheng Pharmaceutical is actively engaging in the "pharmaceutical + aesthetics" trend, leveraging its industrial strength and R&D foundation to innovate in synthetic biology and health aesthetic products [4][9]. - The establishment of Haizheng Weilan and Luan Sheng Synthetic Biology marks the company's strategic entry into health aesthetics and synthetic biology, respectively [9][13]. Product Development and Innovation - Luan Sheng Synthetic Biology has developed over 30 raw material varieties, focusing on high-tech and high-value products to avoid low-level price competition [13][14]. - The company plans to create a product pyramid structure, including "road lamp products" for quick commercialization and "lighthouse products" for mid-term development [14]. Market Strategy - Haizheng Weilan aims to build a comprehensive health aesthetic platform, integrating pharmaceutical e-commerce and innovative business models [15][16]. - The company is focusing on nutrition, functional skincare, and medical beauty, utilizing its raw material advantages to develop products that address joint health and liver protection [18]. Future Outlook - The ultimate goal for Haizheng Pharmaceutical is to establish a complete value chain from synthetic biology raw material innovation to health aesthetic brand products, ensuring each link maintains pharmaceutical-grade quality [21][22]. - The company emphasizes a long-term approach to development, prioritizing solid R&D and reliable quality over quick market gains [22].

Core Viewpoint - Recently, the company received approval from the National Medical Products Administration for its Tacrolimus capsules, which have passed the consistency evaluation of quality and efficacy for generic drugs [2] Group 1 - The company announced the receipt of the "Drug Supplement Application Approval Notice" for Tacrolimus capsules [2] - The approval indicates that the company's Tacrolimus capsules have met the standards for quality and efficacy consistency as a generic drug [2]