12月22日，国家组织高值医用耗材联合采购办公室发布《国家组织药物涂层球囊类、泌尿介入类医用耗 材集中带量采购文件（GH-HD2025-1）》（以下简称"《采购文件》"）的公告，采购范围涵盖药物涂层 球囊类和泌尿介入类两大品类，这意味着第六批国家组织高值医用耗材集中带量采购正式开启。2026年 1月13日，第六批国家组织高值医用耗材集中带量采购将在天津开标。 12个核心品种需求规模可观 《采购文件》显示，本次第六批国家组织高值医用耗材集中带量采购明确纳入12个重点品种。其中，药 物涂层球囊类耗材包含冠状动脉药物涂层球囊、外周血管药物涂层球囊（用于动静脉瘘透析通路、膝上 部位、膝下部位）4个品种；泌尿介入类则涵盖输尿管介入导丝、输尿管介入鞘、输尿管球囊扩张导管 （含测压与非测压功能）、泌尿取石网篮、一次性输尿管软镜导管（含测压与非测压功能）、肾造瘘套 件等8个品种。对输尿管介入导丝、泌尿取石网篮的芯丝材质明确要求为钛合金。 依据《采购文件》，本次集采中选规则设置了A、B两个竞价单元，实行分单元竞价的中选机制。 在单元划分上，同一品种内，累计需求量前85%且具备全国供应能力的企业，将进入A竞价单元；若该 单元企业 ...

Core Viewpoint - The eleventh batch of national organized drug procurement is set to officially announce its selection results, with new rules focusing on stabilizing clinical use, ensuring quality, preventing excessive competition, and avoiding collusion, thereby fostering a healthy environment for the pharmaceutical industry [1] Group 1: Selection Results and Impact - The results of the eleventh batch of drug procurement will be officially announced, with patients expected to access a new batch of quality and affordable drugs by February 2026 [1] - A total of 272 companies with 55 varieties and 453 products have obtained proposed selection qualifications, increasing the total number of drug varieties included in national procurement to 490 [1] - Over 70% of the reported quantities were successful, with mainstream companies that have strong supply capabilities and quality assurance mostly selected [2] Group 2: New Rules and Quality Control - The new procurement rules emphasize quality control, raising the quality threshold for companies and requiring that selected drugs have no quality issues in the past two years [2][3] - The introduction of a "reference price" mechanism aims to prevent extreme low pricing and encourages rational bidding among companies [4][5] - The procurement process has seen a significant increase in competition, with some products having up to 48 companies competing, indicating a robust supply capacity in the pharmaceutical industry [7] Group 3: Industry Challenges and Future Directions - The industry faces challenges related to low profit margins for selected drugs, which may lead to concerns about quality and sustainability in the long term [6] - Experts suggest that the "anti-involution" measures should not only focus on procurement but also guide companies in scientific project initiation to avoid excessive competition in the same drug category [8]

Core Viewpoint - The sixth batch of high-value medical consumables national procurement is shifting towards a focus on quality and stability rather than just price competition, as indicated by the draft proposal that emphasizes "stabilizing clinical use, ensuring quality, preventing collusion, and countering internal competition" [1][10]. Group 1: Procurement Framework - The draft proposal highlights the selection of consumables that are "clinically essential," particularly focusing on drug-coated balloon catheters and urological intervention products, which cover over 90% of mainstream clinical usage [3]. - The proposal introduces a "price ceiling" for bids, with drug-coated balloon catheters' maximum bid based on previous provincial procurement prices, averaging around 6,300 yuan in Jiangsu and 6,000 yuan in the Beijing-Tianjin-Hebei region [4]. - A "price anchor" mechanism is established to prevent low-price bidding, requiring companies to justify costs if their bids fall below a certain threshold, addressing previous issues of unsustainable low pricing [5]. Group 2: Market Dynamics - The adjustments in procurement rules are seen as a means to facilitate industry restructuring rather than merely a price war, with a shift from price competition to value competition [7]. - The domestic market for drug-coated balloon catheters is expected to strengthen, with local brands increasing their market share from 20% to over 70% due to competitive pricing and improved technology [7][8]. - The proposal allows for a 20% market reserve to support innovative products, ensuring that the procurement process does not hinder innovation while maintaining quality standards [10]. Group 3: Quality Control Measures - Stringent quality control measures are included, with all selected companies subject to on-site inspections, and low-priced products will be prioritized for quality checks [9]. - Companies found to have quality issues or supply violations will face disqualification from future procurement opportunities for 1 to 3 years, reinforcing the importance of maintaining product standards [9].