上市企业：恒瑞医药[600276]、奥赛康[002755]、三生国健[688336]、三生制药[01530]、和黄医药 [00013]、科伦药业[002422.SZ]、远大医药[00512]、海正药业[600267] 相关企业：则正医药、正大天晴药业、齐鲁制药、山东京卫药业、常州制药、宏越科技、维健国际控股 集团有限公司、赛诺菲、维健医药 关键词：ITP药物治疗路径、ITP药物治疗产业逻、ITP药物治疗市场规模、ITP药物市场竞争格局、 ITP药物治疗发展趋势 一、ITP药物治疗行业治疗路径 免疫性血小板减少症（ITP），又称特发性血小板减少性紫癜，主要由于机体内免疫功能异常导致的血 小板破坏增多和血小板生成减少所致，是一种常见的获得性自身免疫性出血性疾病，约占出血性疾病总 数的1/3。ITP可分为急性型与慢性型。急性型多见于儿童，多与病毒感染相关，起病急但病程自限；慢 性型多见于成人，病程迁延反复。目前，ITP一线治疗仍以糖皮质激素为主，二线治疗药物包含有如促 血小板生成药物等。 内容概要：ITP是一种血液系统疾病。目药物治疗是ITP的主要治疗手段。近年来，中国ITP药物治疗市 场规模有所增长，2024年中 ...

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 ...

Core Viewpoint - The article discusses the accelerated clinical access and economic substitution of high-quality generic drugs in China due to the "volume-based procurement" policy, alongside the increasing proportion of biological drugs in national negotiations, which facilitates the listing and promotion of biosimilars in hospitals [3][4]. Group 1: Market Overview - The Chinese generic drug market has maintained a scale of approximately 900 billion yuan, with an increase in the number of companies and varieties intensifying market competition [3]. - As of 2024, the number of generic drugs that have passed consistency evaluation or are deemed equivalent has increased by over two-thirds compared to three years ago, primarily driven by a few companies and previously approved varieties [4][9]. - In the chemical generic drug sector, the top 10 companies hold a stable market share of around 22%, indicating a relatively low market concentration [7][9]. Group 2: Drug Evaluation and Approval - The number of approved generic drugs reached 914 in 2024, a significant increase from 543 in 2021, with 70% of these approvals concentrated among 33% of companies [9]. - The phenomenon of "homogenization of varieties" is becoming a defining characteristic of competition in the generic drug market, with a notable increase in the number of similar products [12][13]. Group 3: Biosimilars Market - By 2024, 87 biosimilars have been approved in China, with over 50% being antibody biosimilars, indicating a concentrated market in specific therapeutic areas [13]. - The application for biosimilars has reached a historical high, particularly in the metabolic field, with one drug alone accounting for nearly 40% of applications [13]. Group 4: Contract Manufacturing Trends - The participation of contract manufacturers in national drug procurement has significantly increased, with 31% of selected products in the tenth round of procurement being produced by contract manufacturers, up from 3% in the second round [16][19]. - The article highlights the challenges of ensuring quality control and regulatory compliance in contract manufacturing, especially as the number of B certificate enterprises increases [19][20].

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].

Core Insights - The 11th batch of national organized drug centralized procurement results has been officially announced, set to be implemented in February 2026, involving 55 drugs across various therapeutic areas [1][2] - The procurement aims to stabilize clinical needs, ensure quality, prevent excessive competition, and avoid collusion, marking a shift from a price-oriented approach to a quality-oriented one [1][6] Summary by Sections Procurement Results - A total of 55 drugs were included in the 11th batch, with 4.6 million medical institutions participating and 272 companies winning bids for 453 products [1][2] - The average selection rate increased from 49% in the 10th batch to 57% in the 11th batch, attributed to the introduction of a revival mechanism [2][3] Pricing and Competition - The average price difference for selected drugs narrowed to 1.7 times, with 13 products triggering a price correction mechanism to maintain orderly pricing [2][3] - The competitive landscape saw an increase in the number of participating companies, with an average of 14 companies per product, doubling from previous batches [2][3] Quality Control and Regulatory Changes - New requirements for bidders include production experience and compliance with Good Manufacturing Practices (GMP), enhancing quality control [2][7] - The procurement process emphasizes transparency and fairness, aiming to reduce hidden costs and improve market dynamics [5][7] Industry Impact and Future Trends - The centralized procurement system is evolving towards a more transparent and quality-focused model, which is expected to drive innovation and compliance among pharmaceutical companies [6][8] - The market is witnessing a shift as companies adapt to new competitive dynamics, with some focusing on generic drugs while others invest in innovative drug development [7][8] Overall Development Direction - The drug procurement system has matured, maintaining stable core principles while continuously optimizing implementation measures based on feedback [9]

Group 1 - Company continues to increase investment in high-end generic drug business despite market challenges [1] - Three generic drugs won bids in the latest procurement round, with a decrease in overall selected prices compared to previous bids [1] - The selected drugs include Pravastatin Sodium Tablets, Adenosine Methionine Dihydrochloride, and Eltrombopag Ethanolamine Tablets, with projected sales revenues of 54.2 million, 88.96 million, and 740,000 respectively for the first half of 2025 [1] Group 2 - Company signed a cooperation agreement with Saint Zhao Pharmaceutical to invest up to 700 million in a joint venture focused on complex injectables [2] - The investment aligns with the company's strategic focus on high-end generics and aims to enhance R&D, production, and global commercialization capabilities in this area [2] - Complex injectables are expected to have a higher price point compared to ordinary generics, providing companies with more room for cost control through technological advancements [2] Group 3 - The market for complex injectables is projected to reach 77.9 billion yuan in China by 2030, driven by aging population and increasing chronic disease demands [3] - There are fewer than 10 companies in China capable of producing complex injectables, facing challenges in mass production [3] - The establishment of the joint venture aims to develop large-scale manufacturing capabilities for complex injectables and expand into international markets [3]

Core Viewpoint - Haizheng Pharmaceutical (600267) and its wholly-owned subsidiary, Hanhui Pharmaceutical Co., Ltd., participated in the 11th batch of national centralized drug procurement organized by the Joint Procurement Office, with three products expected to win bids in this procurement process [1] Group 1 - The company announced its participation in the national centralized drug procurement bidding on October 29 [1] - The Joint Procurement Office published the proposed winning results for the procurement on October 28, 2025 [1] - The three products that are expected to win bids include Pravastatin Sodium Tablets, Injection Adenosine Methionine, and Aicuo Bopamine Ethanolamine Tablets [1]

Group 1 - The core point of the article is that Zhejiang Haizheng Pharmaceutical Co., Ltd. and its wholly-owned subsidiary, Hanhui Pharmaceutical Co., Ltd., participated in the 11th national centralized procurement organized by the Joint Procurement Office, with three products expected to win bids [1] - The three products that are likely to be awarded in the centralized procurement include Pravastatin Sodium Tablets, with projected sales revenue of 54.2 million yuan for the first half of 2025, Injection AdoMet, with projected sales revenue of 88.96 million yuan, and Eltrombopag Ethanolamine Tablets, with projected sales revenue of 740,000 yuan [1] - As of the report, Haizheng Pharmaceutical has a market capitalization of 13.2 billion yuan [1] Group 2 - In 2024, the revenue composition of Haizheng Pharmaceutical is expected to be: 58.46% from pharmaceutical manufacturing, 39.29% from drug sales, 1.94% from other industries, 0.23% from other businesses, and 0.08% from CMO/CDMO/CRO services [1]

Core Insights - The latest round of national centralized drug procurement in China has successfully awarded contracts for 55 drugs, with 453 products from 272 companies qualifying for selection, expanding the total number of covered drugs to 490 [1] Group 1: Company Participation - Kelun Pharmaceutical and Yuandong Biological, two listed pharmaceutical companies from Chengdu, announced a total of 14 products that are likely to be selected in the recent procurement round [1] - Kelun Pharmaceutical reported that it and its subsidiaries participated in the 11th national drug procurement, with 12 products likely to be selected across various treatment areas including liver disease, oncology, and mental health [3][4] Group 2: Product Details - The 12 products from Kelun Pharmaceutical cover a range of diseases, including chronic liver disease, ovarian cancer, depression, and chronic obstructive pulmonary disease, showcasing the company's diverse product portfolio [3] - The proposed winning prices for Kelun's products vary significantly, from 2.11 yuan per bag for a specific injection to 195.37 yuan per box for an oncology drug, indicating a wide range of medication price points [3] Group 3: Financial Impact - For the 12 products proposed for selection by Kelun, most had zero sales revenue prior to this procurement, with only a few products generating minimal revenue in 2023 or 2024 [3] - Yuandong Biological announced that its selected products, including a specific injection and a tablet, contributed to a small percentage of the company's total revenue for the first nine months of 2025 [4] Group 4: R&D Investment - Yuandong Biological has maintained an average R&D investment of over 20% of its revenue in the past three years, leading to a high conversion efficiency with at least 10 new formulations approved for market each year [4]