2025.11.24 本文字数：2412，阅读时长大约4分钟 作者 |第一财经 吴斯旻 近年来，"带量采购"政策让优质优价的仿制药加速临床准入与经济性替代。与此同时，随着"国谈"中生 物药占比增加，"谈判药品同通用名仿制药上市自动属于目录范围"的医保政策则为生物类似药挂网入院 及院内推广提供便利。 双重趋势下，中国仿制药行业的市场竞争加剧——仿制药的研发水平和一致性评价通过率明显提升，却 也面临"品种同质化"和"生产拼成本"等发展困境。 近日，中国医学科学院药物研究所、中国医药工业信息中心和中国食品药品检定研究院联合发布的《中 国仿制药发展报告（2025）》（下称"报告"）显示，中国仿制药市场规模多年维持在9000亿元水平，企 业与品种数量的增加正进一步加剧市场存量竞争。 第一财经梳理报告发现，在化学仿制药领域，2024年，通过一致性评价或视同过评的品种数较三年前增 加了超过2/3，但当年增长主要由少数企业和既往过评品种的持续获批推动；而在生物类似药领域，截 至2024年，我国已有41家制药企业的87款生物类似药（包含胰岛素）获批上市，但仅涉及23个药品通用 名。 此外，有业界观点认为，在中国仿制药行业市场集 ...

2025.11. 24 本文字数：2412，阅读时长大约4分钟 作者 | 第一财经 吴斯旻 近年来，"带量采购"政策让优质优价的仿制药加速临床准入与经济性替代。与此同时，随着"国谈"中 生物药占比增加，"谈判药品同通用名仿制药上市自动属于目录范围"的医保政策则为生物类似药挂网 入院及院内推广提供便利。 双重趋势下，中国仿制药行业的市场竞争加剧——仿制药的研发水平和一致性评价通过率明显提升， 却也面临"品种同质化"和"生产拼成本"等发展困境。 近日，中国医学科学院药物研究所、中国医药工业信息中心和中国食品药品检定研究院联合发布的 《中国仿制药发展报告（2025）》（下称"报告"）显示，中国仿制药市场规模多年维持在9000亿元 水平，企业与品种数量的增加正进一步加剧市场存量竞争。 第一财经梳理报告发现，在化学仿制药领域，2024年，通过一致性评价或视同过评的品种数较三年 前增加了超过2/3，但当年增长主要由少数企业和既往过评品种的持续获批推动；而在生物类似药领 域，截至2024年，我国已有41家制药企业的87款生物类似药（包含胰岛素）获批上市，但仅涉及23 个药品通用名。 此外，有业界观点认为，在中国仿制药行业市 ...

品种同质化加剧，成为仿制药市场竞争的底色。 近年来，"带量采购"政策让优质优价的仿制药加速临床准入与经济性替代。与此同时，随着"国谈"中生物药占比增加，"谈判药品同通用名仿制药上市自动 属于目录范围"的医保政策则为生物类似药挂网入院及院内推广提供便利。 双重趋势下，中国仿制药行业的市场竞争加剧——仿制药的研发水平和一致性评价通过率明显提升，却也面临"品种同质化"和"生产拼成本"等发展困境。 近日，中国医学科学院药物研究所、中国医药工业信息中心和中国食品药品检定研究院联合发布的《中国仿制药发展报告（2025）》（下称"报告"）显示， 中国仿制药市场规模多年维持在9000亿元水平，企业与品种数量的增加正进一步加剧市场存量竞争。 第一财经梳理报告发现，在化学仿制药领域，2024年，通过一致性评价或视同过评的品种数较三年前增加了超过2/3，但当年增长主要由少数企业和既往过 评品种的持续获批推动；而在生物类似药领域，截至2024年，我国已有41家制药企业的87款生物类似药（包含胰岛素）获批上市，但仅涉及23个药品通用 名。 此外，有业界观点认为，在中国仿制药行业市场集中度较低的背景下，不仅要审慎看待仿制研发"扎堆"现象 ...

Core Viewpoint - The 11th batch of national organized drug centralized procurement results has been announced, with implementation set for February 2026, focusing on maintaining clinical stability, ensuring quality, and preventing excessive competition [3][10]. Summary by Sections Procurement Results - A total of 55 drugs were included in the 11th batch of procurement, covering various therapeutic areas such as anti-infection, anti-allergy, anti-tumor, and more [3][4]. - Approximately 46,000 medical institutions participated, with 445 companies submitting bids for 794 products, resulting in 272 companies winning bids for 453 products [3][5]. Market Dynamics - The overall selection rate increased from 49% in the 10th batch to 57% in the 11th batch, attributed to the introduction of a revival mechanism allowing about 25% of companies to regain eligibility [6][10]. - The average price difference for selected drugs narrowed to 1.7 times, with 13 products triggering a price correction mechanism to maintain orderly pricing [6][7]. Competitive Landscape - The average number of companies competing per product doubled to 14 compared to 7.5 in previous batches, indicating heightened competition while maintaining a high selection rate [6][7]. - Major domestic companies like Qilu Pharmaceutical and international firms like Germany's B. Braun secured multiple selections, reflecting a balanced competitive environment [7][12]. Regulatory Improvements - The procurement rules have been continuously optimized, focusing on fairness and transparency, with new mechanisms such as anchor pricing and revival processes introduced [10][11]. - Quality control measures have been strengthened, requiring bidders to have relevant production experience and compliance with Good Manufacturing Practices (GMP) [11][12]. Industry Transformation - The centralized procurement system is pushing companies to adapt, with some focusing on compliant generic drugs while others accelerate innovation in drug development [12][14]. - The market is witnessing a shift towards high-quality, innovative products, with a significant increase in the number of approved innovative drugs and medical devices [14][15]. Future Outlook - The drug procurement system is evolving towards a more transparent and quality-focused approach, with ongoing adjustments based on feedback and practical conditions [15]. - The core principles of the procurement system remain stable, ensuring a balance between public welfare, corporate development, and high-quality industry transformation [15].

21世纪经济报道记者 闫硕 日前，第11批国家组织药品集中带量采购（简称"集采"）结果正式公布，将于2026年2月实施。 据了解，此次集采共纳入55种药品，覆盖抗感染、抗过敏、抗肿瘤、降血糖、降血压、降血脂、消炎镇 痛等领域常用药品，全部采购成功。全国共4.6万家医药机构参加报量，445家企业的794个产品参与投 标，其中272家企业的453个产品中选。 第11批集采总体实现了"稳临床、保质量、反内卷、防围标"预期目标。比如，复活环节的设置，进一步 提高了厂牌与临床实际需求的匹配度，也有利于引导企业科学研判、理性报价。 在业内专家看来，新增未入围复活机制及锚点价后，企业报价整体趋稳，既为维护市场竞争秩序提供有 力支撑，也彰显了医保部门在平衡药品降价与履约保障方面的积极探索。总体来看，本次集采更注重可 持续性与执行效能平衡，彰显政策正从"降价导向"向"质量导向"稳步转型。 截至目前，国家医保局共开展11批国家组织药品集采，成功采购490种药品，集采惠民覆盖面持续扩 大。"十五五"规划建议明确部署"优化药品集采"，国家医保局后续将加强评估、总结经验、补齐短板， 持续推动集采工作规范化、制度化、常态化开展。 以竞争 ...

Core Insights - The National Medical Products Administration has approved the sodium hyaluronate eye drops submitted by Yangzhou Zhongbao Pharmaceutical Co., Ltd, enhancing the company's product pipeline in the ophthalmology sector [1][2] - Sodium hyaluronate is a natural polysaccharide known for its excellent moisture retention and lubrication properties, addressing the increasing prevalence of dry eye symptoms due to heightened screen time and electronic device usage [1] - The approval of this product not only provides a reliable solution for the domestic eye medication market but also offers consumers a convenient and safe option for self-medication [1] Company Overview - Yangzhou Zhongbao Pharmaceutical is a comprehensive pharmaceutical enterprise engaged in research and development, production, and marketing, with a product range covering cardiovascular, respiratory, ophthalmology, and health sectors [1] - The company has established a diversified R&D system, including innovative drug development, inhalation formulation technology platforms, and ophthalmic drug research platforms, showcasing its continuous innovation capabilities [1] - The company has received over 20 invention patent authorizations and has more than 30 ongoing projects, reflecting its robust innovation vitality [1] Recent Developments - In the past two years, Yangzhou Zhongbao Pharmaceutical has entered a concentrated harvest period for R&D achievements, with multiple new products successfully launched or passing the consistency evaluation for generic drugs [2] - The sodium hyaluronate eye drops are not the only product approved this year; the company has also received approvals for six other products, including inhalation solutions and injection liquids, demonstrating strong product pipeline development and continuous innovation [2] - Looking ahead, the company plans to leverage this product approval to increase R&D investment, optimize product structure, and develop more high-quality drugs that meet clinical and market needs, contributing to the "Healthy China" initiative [2]

Core Viewpoint - Tianjin Pharmaceutical Industry (津药药业) announced that its subsidiaries, Tianjin Peace Pharmaceutical Co., Ltd. and Hubei Tian Pharmaceutical Co., Ltd., participated in the 11th national centralized drug procurement organized by the National Organization for Drug Procurement Office, with seven products expected to be selected for this procurement [1] Group 1 - The subsidiaries involved in the procurement are Tianjin Peace Pharmaceutical and Hubei Tian Pharmaceutical [1] - The seven products proposed for selection include Betamethasone Sodium Phosphate Injection, Ambroxol Hydrochloride Injection, Metoclopramide Hydrochloride Injection, Theophylline Injection, Isoniazid Injection, Adrenaline Hydrochloride Injection, and Famotidine Injection [1]

Core Viewpoint - The company announced that its subsidiaries participated in the 11th national centralized drug procurement organized by the National Organization for Drug Procurement Office, with seven products expected to be selected for this procurement [1] Group 1: Procurement Participation - The subsidiaries of the company, Tianjin Pharmaceutical Peace Pharmaceutical Co., Ltd. and Hubei Tianjin Pharmaceutical Co., Ltd., are involved in the national centralized drug procurement [1] - The seven products proposed for selection include Betamethasone Sodium Phosphate Injection, Ambroxol Hydrochloride Injection, Metoclopramide Hydrochloride Injection, Theophylline Injection, Isoniazid Injection, Adrenaline Hydrochloride Injection, and Famotidine Injection [1] Group 2: Financial Impact - The total projected sales revenue from the selected products for the year 2024 is approximately 95.16 million yuan, accounting for 2.96% of the company's total revenue for that year [1] - For the first three quarters of 2025, the projected sales revenue from these products is approximately 22.08 million yuan, representing 0.99% of the company's revenue for that period [1]

Group 1 - The company Shanghai Pharmaceutical Group Co., Ltd. announced that its subsidiary, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration approving the supplementary application for the drug Dihydroxypropyl Theophylline Injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1][2] - The drug Dihydroxypropyl Theophylline Injection is indicated for bronchial asthma, wheezing bronchitis, and obstructive pulmonary emphysema, and it was developed by Eisai Co., Ltd. and launched in Japan in October 1952 [2] - As of the announcement date, the company has invested approximately RMB 3.05 million in research and development for this drug [2] Group 2 - The approval of the drug's consistency evaluation is expected to enhance its market share and competitiveness, as products that pass this evaluation will receive greater support in medical insurance payments and procurement by medical institutions [2] - The total procurement amount for Dihydroxypropyl Theophylline Injection (2ml:0.3g) in hospitals in mainland China for 2024 is reported to be RMB 9.737 million [2]

Group 1 - The core point of the article is that Shanghai Pharmaceuticals announced the approval of its dihydroxypropyl theophylline injection by the National Medical Products Administration, indicating that the drug has passed the consistency evaluation of quality and efficacy for generic drugs [2] Group 2 - The drug is produced by Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd., a subsidiary of Shanghai Pharmaceuticals [2] - The approval signifies a significant milestone for the company in expanding its product portfolio in the pharmaceutical market [2] - The consistency evaluation is crucial for ensuring that generic drugs meet the same standards as their branded counterparts, which can enhance market competitiveness [2]