Core Viewpoint - The recent acceptance of the market application for Mirabegron extended-release tablets by Wuhan Renfu Pharmaceutical has sparked renewed interest in the urology generic drug sector, indicating a competitive landscape with multiple companies vying for market share [1][15]. Group 1: Market Potential - Mirabegron is projected to exceed $1.1 billion in global sales by 2024, establishing itself as a leading treatment for overactive bladder (OAB) [2]. - The drug, developed by Astellas Pharma, is the first selective β3-adrenergic agonist for OAB treatment, addressing a market that has lacked new mechanisms for nearly 30 years [5][6]. Group 2: Competitive Landscape - As of now, 16 domestic pharmaceutical companies have received approval for Mirabegron, indicating a crowded market with significant competition [12]. - Astellas maintains a dominant position in the domestic market, holding a 39.53% market share in hospitals as of the first three quarters of 2025, making it difficult for competitors to disrupt its lead [9]. Group 3: Company Strategies - Wuhan Renfu's application for Mirabegron is part of a broader strategy to enhance its portfolio in the urology specialty and expand its non-anesthesia product line [19]. - The company has over 100 approved products, with 25 being the first in the domestic market, showcasing its commitment to building a strong presence in the generic drug sector [16]. Group 4: Industry Trends - The increasing interest in Mirabegron reflects a shift towards high-potential products that combine new mechanisms, strong demand, and insurance coverage, which are becoming attractive targets for pharmaceutical companies [20]. - The ongoing competition in the generic drug market, particularly for Mirabegron, suggests a potential for value reassessment as companies seek to capitalize on cash flow opportunities in a transforming industry [20].

证券代码：600079 证券简称：ST 人福 公告编号：2026-003 人福医药集团股份公司 关于参与设立私募基金暨关联交易的进展公告 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。 重要内容提示： | 投资标的名称 | 武汉睿成新药科技成果转化创业投资基金中心 | | | | | --- | --- | --- | --- | --- | | | （有限合伙） | | | | | 投资金额（万元） | 7,500 | | | | | 投资进展阶段 | 完成 | 终止 | 交易要素变更 | √进展 | | | 募集失败 未能完成备案登记 | | | | | | 提前终止 | | | | | | 发生重大变更 | | | | | | √其他：本基金后续运作受到经济环境、监管政 | | | | | 特别风险提示 | 策、行业周期、投资标的经营管理等多种因素影 | | | | | | 响，可能面临投资收益不确定性风险、操作或技 | | | | | | 术风险等。公司将密切关注标的基金运作及管理 | | | | | | ...

登录新浪财经APP 搜索【信披】查看更多考评等级 受损股民可至新浪股民维权平台登记该公司维权：http://wq.finance.sina.com.cn/ 关注@新浪证券、微信关注新浪券商基金、百度搜索新浪股民维权、访问新浪财经客户端、 新浪财经首页都能找到我 一、索赔递交立案 上海沪紫律师事务所刘鹏律师团队代理的案件已递交法院立案审理，目前还在时效内。（刘鹏律师专 栏） 回溯此案，2025年12月29日，ST人福（维权）公告，公司及控股股东收到湖北监管局的《行政处罚事 先告知书》，公司及相关主体涉嫌多项信息披露违法违规行为，涉及非经营性资金占用、关联交易未披 露、年报虚假记载等多方面问题。 长期以来，财务造假一直是资本市场的一大顽疾，它不仅严重损害了投资者的利益，也破坏了市场的公 平性和透明度。 依据相关法律法规符合于2021年4月27日-2024年10月22日（含当日）期间买入，并在2024年10月23 日之后卖出或仍持有而亏损的还可加入维权。（人福医药维权入口） 责任编辑：韦子蓉 登录新浪财经APP 搜索【信披】查看更多考评等级 受损股民可至新浪股民维权平台登记该公司维权：http://wq.finan ...

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].

Group 1 - The application for Hydromorphone Tartrate Extended-Release Tablets by Humanwell Pharmaceutical US, Inc. has been accepted by the National Medical Products Administration on January 13, 2026, with acceptance number JYHL2600002 [1] - The drug type is classified as a chemical drug, and the application type is for import registration under category 5.2 [1] - The companies involved in this application include Humanwell Pharmaceutical US, Inc. and Yichang Humanwell Pharmaceutical Co., Ltd. [1]

关于子公司药品上市许可申请获受理的提示性公告 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。 人福医药集团股份公司（以下简称"公司"）控股子公司宜昌人福药业有限责任 公司（以下简称"宜昌人福"，公司持有其80%的股权）近日收到国家药品监督管理 局核准签发的盐酸纳布啡注射液的药品注册上市许可申请《受理通知书》， 现将相关情况公告如下： 一、药品名称：盐酸纳布啡注射液 二、剂型：注射剂 证券代码：600079 证券简称：ST 人福 编号：临 2026-002 人福医药集团股份公司 六、审查结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。受理号：CXHS2600011、CXHS2600012、CXHS2600013。 宜昌人福盐酸纳布啡注射液于2013年获批上市，目前已获批上市的适应症为"作 为镇痛药用于复合麻醉时的麻醉诱导，术后镇痛"。宜昌人福于2022年9月按化学药 品2.4类取得"用于重症监护病房患者的镇痛(ICU镇痛)"的临床试验批准通知书，截 至目前，在该项目上的累计研发投入约1,600万元 ...

Core Viewpoint - ST Renfu's subsidiary, Yichang Renfu Pharmaceutical Co., Ltd., has received the approval notice from the National Medical Products Administration for the drug registration application of Buprenorphine Hydrochloride Injection, indicating a significant step in expanding its product portfolio in the analgesic market [1] Group 1 - The approved indication for Buprenorphine Hydrochloride Injection includes its use as an analgesic during anesthesia induction and postoperative pain management [1] - Yichang Renfu obtained clinical trial approval for the use of Buprenorphine Hydrochloride Injection in ICU pain management in September 2022, classified as a chemical drug of category 2.4 [1] - The total R&D investment in this project has reached approximately 16 million RMB [1]

Group 1 - The core point of the article is that ST Renfu (600079.SH) announced that its subsidiary, Yichang Renfu Pharmaceutical Co., Ltd., has received the acceptance notice for the drug registration application of Nalbuphine Hydrochloride Injection from the National Medical Products Administration [1] - The approved indication for this drug is as an analgesic for anesthesia induction during combined anesthesia and postoperative analgesia [1] - Yichang Renfu obtained clinical trial approval for the drug in September 2022, specifically for its use in pain management for patients in intensive care units (ICU) [1]

Core Insights - The article highlights that as of January 9, a total of 146 stocks in the Shanghai and Shenzhen markets have experienced net buying from major funds for five consecutive days or more [1] - The stock with the longest streak of net buying is ST Renfu, which has seen net purchases for 12 consecutive trading days [1] - Other notable stocks with significant net buying days include *ST Yedao, Yibai Pharmaceutical, Fenglong Co., Ningbo United, Xingdesheng, Zhongchen Technology, Jinzong Co., and Funeng Co. [1] Summary by Category - **Market Activity** - A total of 146 stocks have recorded net buying from major funds for five days or more [1] - ST Renfu leads with 12 consecutive days of net buying [1] - **Notable Stocks** - Other stocks with considerable net buying include *ST Yedao, Yibai Pharmaceutical, Fenglong Co., Ningbo United, Xingdesheng, Zhongchen Technology, Jinzong Co., and Funeng Co. [1]

Group 1 - The core adjustment of the indices reflects a shift towards high-quality stocks and market representation, with specific companies being added or removed based on their market capitalization and operational stability [1][2] - The inclusion of companies like Chip Source Microelectronics and Huada Gene reflects a trend towards innovation-driven economic transformation, focusing on high-end manufacturing and technological innovation [2][3] - The adjustments serve as a "vote" from the capital market on industry trends, indicating that long-term growth sectors are favored over short-term market fluctuations [3] Group 2 - The adjustments lead to structural reallocation of funds, with passive funds needing to buy newly included stocks and sell those that are removed, creating short-term liquidity premiums for the new entrants [4] - Investors are advised to focus on the underlying fundamentals of companies rather than short-term market movements, as long-term valuations depend on the companies' growth potential [4] - The adjustments are not isolated events but part of a broader market trend, emphasizing the importance of understanding the underlying rules of index composition and industry transformation [4]