格隆汇2月2日丨海正药业(600267.SH)公布，截至2026年1月月底，公司已累计回购股份7,216,100股，占 公司总股本的比例为0.60%，购买的最高价为10.55元/股、最低价为8.92元/股，已支付的总金额为 67,992,848.98元（不含交易费用）。 ...

Group 1 - The core point of the article is that Haizheng Pharmaceutical (600267) has filed an international patent application for "Aryl Tricyclic Derivatives and Their Preparation Methods and Uses" with the application number PCT/CN2025/099565, which is set to be published internationally on January 29, 2026 [1] - In 2023, Haizheng Pharmaceutical has announced a total of 2 international patent applications [1] - The company invested 202 million yuan in research and development in the first half of 2025, representing a year-on-year increase of 13.98% [1]

Core Insights - The Chinese generic drug industry is undergoing significant changes due to policy factors, including the implementation of the drug marketing authorization holder system and early resolution mechanisms for patent disputes, which are reshaping the competitive landscape [1][11]. Industry Overview - The number of generic drug products that have passed or are deemed to have passed evaluations in China reached 2,998 in 2024, an increase of 1,008 from 2023, representing a year-on-year growth of 50.65% [1][11]. - The proportion of contract manufacturing among these evaluated generic drug products reached 33% in 2024, up from 12% in 2020, indicating a trend towards deeper industry collaboration and resource allocation [1][11]. Generic Drug Consistency Evaluation - The consistency evaluation of generic drugs ensures that they meet the same quality and efficacy standards as original drugs, which is crucial for patient safety and effective treatment [2][3]. - The evaluation process includes determining reference formulations, conducting pharmaceutical research, and ongoing monitoring to ensure compliance with quality and safety standards [2][3]. Industry Policies - Recent policies have been introduced to enhance the quality of generic drugs and promote their market acceptance, including the 2025 guidelines for deepening drug regulation reforms [5][6]. - The establishment of a reference formulation directory is essential for conducting consistency evaluations, with 87 batches published by the National Medical Products Administration by the end of 2024 [9]. Market Dynamics - The market for chemical generic drugs in China is projected to be 868.3 billion yuan in 2024, showing a decline of 3% year-on-year, with the market share of chemical generics in the overall drug market decreasing from 60% in 2018 to 50% in 2024 [7][8]. - The competitive landscape is becoming increasingly polarized, with leading pharmaceutical companies gaining significant market share while smaller firms face challenges due to funding and research limitations [11]. Key Companies - Notable companies in the generic drug consistency evaluation sector include Tigermed Pharmaceutical Technology Co., Ltd., Huahai Pharmaceutical Co., Ltd., and Hengrui Medicine Co., Ltd., among others [1][11]. - Tigermed reported a revenue of 1.71 billion yuan in clinical trial services for the first half of 2025, reflecting a 3.07% increase year-on-year, while Hengrui Medicine achieved a revenue of 13.693 billion yuan, up 12.85% [12][14]. Future Trends - The focus of generic drug evaluations is expected to shift towards high-tech barrier products, such as controlled-release formulations and complex injectables, requiring enhanced reverse engineering and pharmaceutical research capabilities [15][16]. - The production model is transitioning from batch production to continuous manufacturing, which aims to ensure consistent quality and compliance with evaluation standards [15][16]. - Companies are encouraged to adopt a full lifecycle management approach for their products, emphasizing ongoing research and optimization post-evaluation to maintain market leadership [16].

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（以下简 称"海正杭州公司"）收到美国食品药品监督管理局（以下简称"美国FDA"）的通知，海正杭州公司向美 国FDA申报的注射用米卡芬净的新药简略申请（ANDA，即美国仿制药申请）已获得批准，意味着海正 杭州公司可以生产并在美国市场销售该产品。现就相关情况公告如下： 一、药品基本情况 药品名称：注射用米卡芬净 ANDA号：219712 剂型：注射剂 规格：50mg和100mg 申请事项：ANDA（美国新药简略申请） 申请人：海正药业（杭州）有限公司 二、药品的其他相关情况 注射用米卡芬净适用于治疗：（1）成人和4个月及以上儿科患者的念珠菌血症、急性播散性念珠菌病、 念珠菌性腹膜炎及脓肿；（2）4个月以下儿科患者的念珠菌血症、急性播散性念珠菌病、念珠菌性腹膜 炎及脓肿（不伴有脑膜脑炎和/或眼部播散）；（3）成人和4个月及以上儿科患者的食管念珠菌病； （4）预防成人和4个月及以上儿科患者造血干细胞移植 ...

Core Viewpoint - The approval of the abbreviated new drug application (ANDA) for injectable micafungin by the U.S. FDA allows the company to produce and sell the product in the U.S. market [1] Group 1: Company Announcement - The company’s wholly-owned subsidiary, Zhejiang Hisun Pharmaceutical Co., Ltd. (referred to as "Hisun Hangzhou"), has received notification from the U.S. FDA regarding the approval of its ANDA for injectable micafungin [1] - This approval signifies a significant milestone for Hisun Hangzhou, enabling it to enter the U.S. market with this product [1] Group 2: Product Indications - Injectable micafungin is indicated for the treatment of: 1. Candidemia, acute disseminated candidiasis, candidal peritonitis, and abscesses in adults and pediatric patients aged 4 months and older 2. Candidemia, acute disseminated candidiasis, candidal peritonitis, and abscesses in pediatric patients under 4 months (without meningitis and/or ocular dissemination) 3. Esophageal candidiasis in adults and pediatric patients aged 4 months and older 4. Prevention of candidal infections in adults and pediatric patients aged 4 months and older following hematopoietic stem cell transplantation [1]

格隆汇1月23日丨海正药业(600267.SH)公布，公司全资子公司海正药业（杭州）有限公司（称"海正杭 州公司"）收到美国食品药品监督管理局（称"美国FDA"）的通知，海正杭州公司向美国FDA申报的注 射用米卡芬净的新药简略申请（ANDA，即美国仿制药申请）已获得批准，意味着海正杭州公司可以生 产并在美国市场销售该产品。 注射用米卡芬净适用于治疗：（1）成人和4个月及以上儿科患者的念珠菌血症、急性播散性念珠菌病、 念珠菌性腹膜炎及脓肿；（2）4个月以下儿科患者的念珠菌血症、急性播散性念珠菌病、念珠菌性腹膜 炎及脓肿（不伴有脑膜脑炎和/或眼部播散）；（3）成人和4个月及以上儿科患者的食管念珠菌病； （4）预防成人和4个月及以上儿科患者造血干细胞移植后的念珠菌感染。 ...

Core Viewpoint - Haizheng Pharmaceutical's wholly-owned subsidiary, Haizheng Hangzhou, has received FDA approval for the abbreviated new drug application of injectable micafungin, allowing production and sales in the U.S. [1] Group 1: Product Details - The approved drug is available in two specifications: 50mg and 100mg, and is indicated for the treatment and prevention of various candidiasis infections [1] - The global sales forecast for 2024 is approximately $208 million, with the U.S. market contributing about $67.57 million [1] - For the period from January to September 2025, global sales are projected to be around $143 million, with U.S. sales estimated at $46.23 million [1] Group 2: Investment and Financials - The company has invested approximately 17.94 million yuan in this project [1]

证券代码：600267 证券简称：海正药业 公告编号：临 2026-07 号 注射用米卡芬净适用于治疗：（1）成人和 4 个月及以上儿科患者的念珠菌血 症、急性播散性念珠菌病、念珠菌性腹膜炎及脓肿；（2）4 个月以下儿科患者的 念珠菌血症、急性播散性念珠菌病、念珠菌性腹膜炎及脓肿（不伴有脑膜脑炎和 /或眼部播散）；（3）成人和 4 个月及以上儿科患者的食管念珠菌病；（4）预防成 人和 4 个月及以上儿科患者造血干细胞移植后的念珠菌感染。原研药 Mycamine for Injection 由 Astellas Pharma US，Inc.公司研发，国内外生产、销售厂商主要有 SANDOZ、FRESENIUS、HIKMA PHARMA、浙江海正药业股份有限公司等。 据统计，注射用米卡芬净 2024 年全球销售额约 20,833.43 万美元，其中美国市场 销售额约 6,757.14 万美元；2025 年 1-9 月全球销售额约 14,340.18 万美元，其中 美国市场销售额约 4,623.39 万美元（数据来源于 IQVIA 数据库）。 海正杭州公司于 2024 年 9 月就注射用米卡芬净（50mg 和 10 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 来源：环球网 【环球网综合报道】2026年1月16日，上海证券交易所对浙江海正药业股份有限公司（简称：海正药 业）及6名相关责任人进行了通报批评，原因是该公司在2021年至2024年的年度报告中存在财务信息不 真实、不准确的问题。与此同时，浙江证监局也向海正药业出具了警示函，并将相关责任人记入证券期 货市场诚信档案。 上海证券交易所《纪律处分决定书》指出，经查明，海正药业于2025年8月26日披露《关于前期会计差 错更正的公告》，对2021—2024年年度报告的部分财务数据进行更正，其中涉及营业收入、营业成本以 及投资收益等科目。上述事项反映出海正药业此前披露的相关报告财务信息不真实、不准确。 《关于前期会计差错更正的公告》显示，2021—2023年，海正药业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"）部分原料贸易业务缺乏充分的商业实质及商业合理性，不满足收入确定的条 件，相应形成的重要前期差错更正涉及合计调减2021—2023年合并财务报表营业收入94882.64万元，调 减营业成本93002.88万元，调增投资收益1879.77万元；调增2 ...

Core Viewpoint - Recently, Zhejiang Hai Zheng Pharmaceutical Co., Ltd. announced corrections to its financial data for the years 2021 to 2024, indicating that previously disclosed financial information was inaccurate and untruthful [1] Group 1: Financial Corrections - The company corrected financial data related to operating revenue, operating costs, and investment income for the years 2021 to 2024 [1] - The announcement was made on August 26, 2025, highlighting the discrepancies in the annual reports [1] Group 2: Accountability and Penalties - The Shanghai Stock Exchange decided to publicly criticize the company and the responsible individuals, including the former chairman and other executives [1] - The penalties will be reported to the China Securities Regulatory Commission and recorded in the securities and futures market integrity database [1] - The company is required to submit a rectification report signed by all directors and senior management within one month of receiving the decision [1]