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药盒里的潮汐进退:进口原研药高溢价神话崩塌与国产药逆袭
Hua Xia Shi Bao· 2025-08-12 11:07
Core Insights - The shift from imported original research drugs to domestic generics and innovative drugs is significant, with the market share of imported original cancer drugs in top-tier hospitals dropping from 68% in 2021 to 34% in 2024, while domestic generics and innovative drugs now account for 66% [1][5][10] - The decline of imported original drugs is attributed to aggressive pricing strategies by multinational pharmaceutical companies and the cost advantages of domestic generics [1][6][10] - Patients are increasingly accepting domestic drugs, with many reporting satisfactory treatment outcomes and reduced financial burdens [4][12] Industry Dynamics - Multinational pharmaceutical companies are accelerating localization efforts, expanding production bases, and upgrading R&D centers to balance cost and innovation [2][13] - The Chinese government's policies, including centralized drug procurement and price negotiations, are effectively reducing drug prices and reshaping the market landscape [10][16] - The acceptance of domestic drugs is growing among patients, driven by improved quality and increased awareness [5][12] Market Trends - The usage of imported original cancer drugs has significantly decreased, with one hospital reporting a drop from over 200 units per month to around 50 units, while the usage of domestic innovative drugs has more than doubled [4][5] - The market for imported original drugs is facing challenges, with a low bid success rate in centralized procurement, leading to many companies withdrawing from public hospital markets [6][10] - The trend of patients preferring cost-effective domestic drugs is supported by studies showing equivalent efficacy and safety compared to original drugs [12][16] Future Outlook - The pharmaceutical industry is expected to continue evolving, with multinational companies adapting their strategies to maintain market presence through innovation and collaboration with local firms [13][14] - The Chinese market is becoming increasingly competitive, with domestic companies focusing on differentiated innovation to capture market share [11][14] - Ongoing reforms in the healthcare system aim to ensure that patients have access to a wider range of affordable and high-quality medications [16]
特稿 | 药盒里的潮汐进退:进口原研药高溢价神话崩塌与国产药逆袭
Hua Xia Shi Bao· 2025-08-12 04:19
Core Viewpoint - The article highlights a significant shift in the pharmaceutical market in China, where the market share of imported original research cancer drugs in top-tier hospitals is projected to drop from 68% in 2021 to 34% in 2024, while the combined share of domestic generic and innovative drugs is expected to rise to 66% [5][10]. Group 1: Market Dynamics - The transition from imported original drugs to domestic alternatives reflects deeper changes in the pharmaceutical market, driven by cost advantages of domestic generics and innovations [1][6]. - In the first half of 2025, over 30 original research drugs from multinational companies are expected to withdraw from the market, including those from Takeda, Pfizer, and GlaxoSmithKline [1]. - The declining market share of imported drugs is attributed to multinational companies' pricing strategies and the competitive pricing of domestic generics [6][10]. Group 2: Patient Perspectives - Many patients are initially hesitant to switch from imported to domestic drugs due to concerns about efficacy and safety, as illustrated by the experiences of patients like Ms. Zhou and an elderly male patient [3][4]. - However, some patients have reported positive outcomes after switching to domestic drugs, noting both cost savings and effective treatment [4][12]. Group 3: Policy and Regulatory Environment - The article discusses the impact of national drug procurement policies, which have significantly reduced the market presence of imported original drugs, with a low winning rate of 3.7% in recent procurement rounds [6][10]. - The ongoing reforms in the healthcare payment system, including DRG and DIP models, are pushing hospitals to prioritize lower-cost drugs, further squeezing the space for imported original drugs [10][12]. Group 4: Industry Adjustments - Multinational pharmaceutical companies are adapting by localizing their operations, including expanding production bases and upgrading research centers in China [13][14]. - Companies like Sanofi and Roche are shifting their focus towards innovative drugs and adjusting their product portfolios in response to market changes [8][14]. Group 5: Future Outlook - The article emphasizes the need for a transparent and competitive market environment to foster the development of high-quality, reasonably priced drugs, whether domestic or imported [16]. - The ongoing evolution in the pharmaceutical landscape suggests that both multinational and domestic companies will continue to adapt their strategies to meet changing patient needs and regulatory requirements [9][16].
为老百姓提供“质优价宜”用药清单!三“问”第十一批国家组织药品集采→
Sou Hu Cai Jing· 2025-08-07 15:18
Group 1 - The core idea of the new centralized drug procurement policy emphasizes "no procurement for new drugs, and new drugs are not included in procurement" to protect industry innovation and ensure reasonable returns for innovative drugs during their initial market period [1][2] - The new procurement rules will not use the lowest price as a reference, which aims to avoid the elimination of normal-priced companies and is expected to increase the average price level of selected drugs [2] - The procurement process respects clinical needs by allowing pharmacies to participate, thus broadening the sales channels for procured drugs and enhancing accessibility for patients [3] Group 2 - The selection of drugs for procurement focuses on those with procurement amounts exceeding 100 million yuan in 2024, allowing companies more time to develop and cultivate the market [1] - A mechanism has been introduced to allow non-selected companies to "revive" their bids by lowering prices, promoting rational competition among enterprises [2] - Special consideration has been given to children's medications by creating an independent grouping, which aims to improve the accessibility of these essential drugs [3]
第十一批国家组织药品集采报量正式启动
证券时报· 2025-08-07 04:39
Core Viewpoint - The article discusses the recent announcement by the National Organization for Drug Procurement regarding the 11th batch of centralized drug procurement, highlighting the new reporting requirements and rules for medical institutions [1]. Group 1: Reporting Characteristics - Medical institutions can report demand by brand name or by generic name, allowing for greater flexibility in participation [1]. - Accurate reporting is emphasized, with a requirement that each institution's reported annual demand for each product should not be less than 80% of the average usage for 2023-2024 [1]. - The reporting system is designed to align with policies on essential medicines and pediatric medications, allowing institutions to report based on actual needs if certain conditions are met [1]. Group 2: Brand Selection and Reporting Process - The selection of brands available for reporting is based on prior submissions from companies that have provided relevant drug information [3]. - Institutions can choose to report demand either by product type or by brand, with no limit on the number of brands selected [4]. - The reporting system automatically calculates whether the reported demand meets the historical procurement volume requirement of 80% [5]. Group 3: Special Considerations - Institutions facing challenges in meeting the 80% requirement due to special circumstances can submit explanations for reduced reporting [6]. - For unapproved specifications and essential medicines, institutions can determine their own reporting ratios based on clinical needs [7]. - Special considerations are made for pediatric formulations, allowing institutions to report based on actual needs if certain formulations have not passed consistency evaluations [8]. Group 4: Participation and Compliance - The procurement process allows for participation from private medical institutions and retail pharmacies, promoting access to quality medicines [12]. - Institutions are encouraged to prioritize the use of selected drugs while still having the option to procure non-selected products for remaining needs [10][11]. - The article outlines the process for new users to register and for existing users to recover their accounts [13].
45进10?第十一批集采竞争激烈,国家医保局提示企业理性报价
Di Yi Cai Jing· 2025-08-05 06:21
Group 1 - The eleventh batch of centralized procurement has seen an increase in competition, with an average of 15 companies per product and a record 45 companies for the most competitive product [1][2] - A total of 480 companies submitted information for the procurement, indicating a high level of interest and participation in the process [1][3] - The top three products with the most applicants are Dihydrocodeine Injection (45 companies), Cefazolin Injection (43 companies), and Famotidine Injection (40 companies) [1][2] Group 2 - The new procurement rules aim to prevent excessive competition and ensure quality, with a focus on rational pricing and integrity in bidding [2][3] - The procurement process has been optimized to allow medical institutions to report demand based on specific brands, enhancing respect for clinical choices [5][6] - The National Healthcare Security Administration encourages qualified companies to participate and emphasizes the importance of rational pricing and ethical practices [2][6]
确保百姓用药质优价宜
Jing Ji Ri Bao· 2025-08-04 01:21
"新药不集采、集采非新药"是国家药品集采多年来坚持的原则。自2018年以来,国家已成功开展10 批药品集采,覆盖435种药品。第十一批集采继续聚焦上市多年、临床使用成熟的"老药",更加关注群 众多层次、多元化用药需求。国家医保局相关司负责人说,本次集采与医保目录谈判相衔接,首次在品 种遴选时排除了通过谈判新进入医保且仍在协议期内的品种,旨在保护行业创新积极性。 在合理确定约定采购量方面,集采原则上要求报量总数不低于实际使用量的80%,但对于医疗机构 反映临床需求量减少,或因季节性、流行性疾病等需求量不稳定的,可由医疗机构作出说明后下调报 量。今年,将根据市场竞争格局、实际中选企业数等因素,把医疗机构报量的60%至80%作为约定采购 量,剩余部分仍由医疗机构自主选择品牌。对于抗菌药物、重点监控药品等特殊品种还会适当降低带量 比例,为临床用药留出更大选择空间。 在品种遴选上,此次集采以今年3月31日为品种遴选截止时间,沿用第十批集采的以"参比制剂和通 过质量和疗效一致性评价"的企业数量合计达到7家作为门槛,并进一步优化筛选条件。"截至今年3月31 日,共有122种药品满足初选条件。"国家组织药品联合采购办公室主任 ...
55种药品纳入第十一批集采 确保百姓用药质优价宜
Jing Ji Ri Bao· 2025-08-04 00:20
近期,第十一批国家组织药品集中采购工作启动,初步确定将对55种药品进行采购。国家医保局相关司 负责人介绍,此次集采即将进入医疗机构报量阶段,采购规则总体将坚持"稳临床、保质量、防围标、 反内卷"的原则,持续优化中选规则,完善集采机制,保障药品供应和价格合理性,让广大患者用上"质 优价宜"的药品,促进医药产业健康发展。 "新药不集采、集采非新药"是国家药品集采多年来坚持的原则。自2018年以来,国家已成功开展10批药 品集采,覆盖435种药品。第十一批集采继续聚焦上市多年、临床使用成熟的"老药",更加关注群众多 层次、多元化用药需求。国家医保局相关司负责人说,本次集采与医保目录谈判相衔接,首次在品种遴 选时排除了通过谈判新进入医保且仍在协议期内的品种,旨在保护行业创新积极性。 在品种遴选上,此次集采以今年3月31日为品种遴选截止时间,沿用第十批集采的以"参比制剂和通过质 量和疗效一致性评价"的企业数量合计达到7家作为门槛,并进一步优化筛选条件。"截至今年3月31日, 共有122种药品满足初选条件。"国家组织药品联合采购办公室主任郑颐说,这些药品还需要满足医保和 自费分组后达到"7家及以上"竞争格局、2024年采 ...
55种药品纳入第十一批集采—— 确保百姓用药质优价宜
Jing Ji Ri Bao· 2025-08-03 21:56
Core Viewpoint - The eleventh batch of national organized drug procurement has been initiated, focusing on 55 types of drugs, with an emphasis on ensuring quality, reasonable pricing, and meeting diverse patient needs while promoting healthy development in the pharmaceutical industry [1][2]. Group 1: Procurement Process - The procurement process will enter the reporting phase for medical institutions, adhering to principles of "stabilizing clinical use, ensuring quality, preventing collusion, and avoiding excessive competition" [1]. - The selection of drugs for this batch will exclude newly negotiated drugs that are still under agreement, aiming to protect industry innovation [1][2]. - A total of 122 drugs met the initial selection criteria as of March 31, 2023, with 55 drugs ultimately selected for procurement after further screening [2]. Group 2: Quality Assurance - Stricter quality requirements have been established, mandating that participating companies must have at least two years of production experience for similar formulations, and their production lines must not have violated quality management standards in the past two years [2][3]. - The procurement office will support real-world studies on the clinical efficacy of selected drugs to enhance patient confidence in medication [2]. Group 3: Pricing and Competition - The procurement rules have been optimized to limit excessively low bids, requiring the lowest bidders to justify their pricing and ensure it does not fall below cost [3]. - The procurement will allow medical institutions to report specific brand quantities, aligning their needs with the selected results, thus enhancing the diversity of medication options available [3][4]. Group 4: Procurement Volume - The total reported quantity must not be less than 80% of actual usage, with allowances for adjustments based on clinical demand fluctuations [4]. - The procurement volume will be set between 60% to 80% based on market competition and the number of selected companies, allowing for greater flexibility in brand selection [4]. Group 5: Industry Impact - The ongoing optimization of procurement rules is expected to shift the industry focus from "low-price competition" to "quality competition, cost control, and reasonable profits," thereby enhancing the overall quality and accessibility of medications for the public [4].
第十一批国采最新规则!N-3竞价入围,引入复活机制,实行带量封顶
Core Viewpoint - The National Federation of Industry and Commerce Pharmaceutical Industry Chamber has released a notice regarding the solicitation of opinions on the "Draft of the Eleventh Batch of National Organization Drug Centralized Procurement Main Rules," indicating a refinement of drug procurement rules in line with government directives [1] Group 1: Key Aspects of the Draft - The draft includes five main areas: coverage scope, medical institution reporting and agreed procurement volume, bidding and selection rules, volume-based and quantity-based rules, and supporting policies [1] - New rules proposed in the draft include the implementation of an "N-3" bidding entry mechanism, the introduction of two types of revival mechanisms, and a requirement for a single enterprise to have a volume cap [1]
集采重磅消息!生物药爆拉,智飞生物20cm涨停,生物药ETF(159839)暴涨超4%
Xin Lang Cai Jing· 2025-07-24 06:31
Group 1 - The National Medical Insurance Administration announced that the basic medical insurance coverage rate will remain stable at around 95% during the 14th Five-Year Plan, with the number of insured individuals reaching 1.327 billion by 2024 [2] - The 11th batch of centralized procurement for drugs has been initiated, with new principles established to protect innovative drugs from price pressure, thereby encouraging R&D in the pharmaceutical industry [2] - Recent statistics show a significant increase in the number of new drug approvals globally, with 106 new drugs approved in June 2025, indicating a vibrant pharmaceutical research and development environment [3] Group 2 - The Biopharmaceutical ETF (159839) has seen a strong performance, with a 3.82% increase in the National Biopharmaceutical Index and notable gains in constituent stocks such as Zhifei Biological Products and Watson Bio [1] - The Biopharmaceutical ETF has experienced a substantial growth in scale, increasing by 13.76 million in the past six months, ranking in the top third among comparable funds [1] - Leveraged funds have been actively investing in the Biopharmaceutical ETF, with net purchases reaching 1.2935 million in recent days, indicating strong market interest [1]