Workflow
艾曲泊帕乙醇胺片
icon
Search documents
趋势研判!2025年中国ITP药物治疗路径、产业链、市场规模、竞争格局及发展趋势分析:市场规模约28亿元,海曲泊帕探索空间广阔[图]
Chan Ye Xin Xi Wang· 2025-11-26 02:49
Core Insights - The ITP drug treatment market in China is projected to grow, reaching 2.4 billion yuan in 2024, an increase of 200 million yuan from 2023, and is expected to reach approximately 2.8 billion yuan in 2025 [1][3][4] - Eltrombopag, a novel oral small molecule TPO receptor agonist, has shown excellent efficacy in treating ITP, significantly expanding treatment options for patients [1][4][7] - The sales of Eltrombopag in hospitals reached 376 million yuan in 2023, with an estimated 430 million yuan for the entire year of 2024 [1][4] ITP Drug Treatment Industry Pathway - ITP, or Immune Thrombocytopenic Purpura, is primarily treated with corticosteroids as the first-line therapy, while second-line treatments include platelet-stimulating drugs [2][4] - The incidence of ITP in adults in China is estimated at 5 to 10 per 100,000, with a projected 130,400 patients in 2024 [2][3] ITP Drug Treatment Industry Development Status - The ITP drug treatment market has been expanding, with a notable increase in treatment options due to ongoing research into the disease's pathophysiology [4][6] - The market is characterized by a growing number of patients and an increasing demand for effective treatments [2][3] ITP Drug Treatment Industry Chain - The upstream of the ITP drug treatment industry includes active pharmaceutical ingredients (APIs), chemical raw materials, and related equipment, while the midstream focuses on drug manufacturing [4][6] ITP Drug Treatment Competitive Landscape - Major companies in the domestic ITP drug market include Jiangsu Aosaikang Pharmaceutical, Jiangsu Hengrui Medicine, and Shenyang Sanofi Pharmaceutical, among others [2][6] - Several companies have received approval for Eltrombopag, indicating a competitive environment for generic versions of the drug [6][7] ITP Drug Treatment Development Trends - The treatment of ITP is moving towards targeted and precision medicine, with new therapies showing potential in regulating key immune nodes [7] - Future research may explore the combination of Eltrombopag with existing therapies to enhance treatment outcomes and achieve long-term remission for patients [7]
中国仿制药行业市场竞争加剧
Di Yi Cai Jing Zi Xun· 2025-11-24 04:15
Core Insights - The article discusses the impact of the "volume-based procurement" policy on the Chinese generic drug industry, highlighting increased competition and challenges such as product homogeneity and cost-cutting in production [2][3][11] 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 products intensifying market competition [2] - As of 2024, the number of generic drugs that have passed consistency evaluations or are considered equivalent has increased by over two-thirds compared to three years prior, primarily driven by a few companies and previously approved products [2][7] Regulatory Environment - The Chinese government has emphasized improving the quality of generic drugs as a key reform goal since 2015, with consistency evaluations becoming a prerequisite for participation in centralized procurement [4][5] - Despite the increase in evaluated products, a significant proportion of generic drugs have yet to meet the evaluation standards, indicating a low market concentration [5][7] Product Trends - In 2024, the number of evaluated or equivalent generic drug varieties reached 914, a significant increase from 543 in 2021, with 70% of these concentrated in 33% of companies [7] - The report indicates that the market for biosimilars is also experiencing similar trends, with over 50% of the 87 approved biosimilars being antibody biosimilars [11] Production Dynamics - The report notes a significant increase in the participation of contract manufacturing in centralized procurement, with 31% of selected products in the tenth round being produced by contract manufacturers, up from 3% in the second round [13][15] - The need for effective quality management and regulatory oversight in contract manufacturing has become increasingly critical as the industry faces pressures from policy changes and market competition [15][16]
中国仿制药行业市场竞争加剧
第一财经· 2025-11-24 04:06
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].
仿制药发展2.0阶段:“过评”数量大增,同质化加剧
Di Yi Cai Jing· 2025-11-23 13:26
Core Insights - The Chinese generic drug market is experiencing intensified competition due to increased homogeneity of products and cost-cutting production strategies driven by the "volume-based procurement" policy [1][2][3] 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 products intensifying competition [1] - 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 products [1][3] Product Evaluation and Approval - By 2024, the number of approved or equivalent generic drug varieties reached 914, a significant increase from 543 in 2021, with 70% of these concentrated in 33% of companies [5][8] - The concentration of approved products remains low, with the top 10 companies holding about 22% of the market share in the chemical generic drug sector [3][5] Biological Similarity Drugs - As of 2024, 87 biological similar drugs have been approved in China, with over 50% being antibody similar drugs [8] - The application for metabolic drugs, particularly semaglutide, has surged, indicating a trend towards increased competition in this segment [8] Regulatory Environment - The National Medical Products Administration (NMPA) has released 93 batches of reference preparation directories since 2017, covering 2,787 varieties, but the coverage of domestic innovative drugs remains low [9] - The NMPA is implementing a dynamic adjustment mechanism for the reference preparation directory to better meet public medication needs [9] Contract Manufacturing Trends - The participation of contract manufacturers in national drug procurement has significantly increased, with 31% of selected products in the tenth batch being produced by contract enterprises, up from 3% in the second batch [10][13] - The regulatory focus is shifting towards ensuring quality in contract manufacturing, with increased scrutiny on compliance and quality management systems [13][14]
第11批集采结果公布:纳入55种药品
21世纪经济报道· 2025-11-12 05:38
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].
第11批集采结果公布:从降价导向转向质量导向
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]
海正药业董事长:仿制药集采下难有高利润,要靠规模和技术壁垒突破
Di Yi Cai Jing· 2025-10-31 11:54
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]
海正药业:公司及全资子公司3个产品拟中选第十一批全国药品集中采购
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]
海正药业:公司及全资子公司瀚晖制药符合本次集中采购范围的3个产品拟中标本次集中采购
Mei Ri Jing Ji Xin Wen· 2025-10-29 10:14
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]
国家集采药品 成都企业多个产品拟中标
Sou Hu Cai Jing· 2025-10-29 02:54
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]