证券研究报告 2025 年 12 月 28 日 湘财证券研究所 行业研究 医疗耗材行业周报 第六批耗材集采启动，关注后续开标情况 相关研究： | 1. 《第五批耗材国采即将落地执 | | --- | | 行》 2025.02.18 | | 2.《年报披露密集期，耗材板块关 | | 注创新与业绩修复》 2025.04.01 | 行业评级：增持（维持） 近十二个月行业表现 -50.00% 0.00% 50.00% 沪深300 医疗耗材 | % | 1 个月 | 3 个月 | 12 个月 | | --- | --- | --- | --- | | 相对收益 | -3 | -8 | -9 | | 绝对收益 | -1 | -7 | 8 | 注：相对收益与沪深 300 相比 分析师：聂孟依 证书编号：S0500524040001 Tel：(8621) 50299667 Email：nmy06967@xcsc.com 地址：上海市浦东新区银城路 88 号 中国人寿金融中心 10 楼 核心要点： ❑ 医疗耗材板块上周上涨 0.08% 根据 wind，上周，医药生物报收 8254.26 点，下跌 0.18%，涨幅排名位列 申万 ...

Macroeconomic Overview - The U.S. GDP growth for Q3 exceeded expectations, with an initial annualized rate of 4.3%, compared to a forecast of 3.3% and a previous quarter's final value of 3.8% [4] - Personal consumption expenditures rose from 2.5% in Q2 to 3.5% in Q3, surpassing the expected 2.7% [4] - Exports increased significantly by 8.8%, while imports decreased by 4.7% [4] Industry Insights Precious Metals - International gold and silver prices reached historical highs, with COMEX gold futures at $4,515 per ounce (up 1.02%) and silver at $71.61 per ounce (up 4.44%) [7] - The rise in precious metals prices is attributed to market expectations of continued interest rate cuts by the U.S. government [7] Medical Supplies - The sixth batch of high-value medical consumables procurement has been officially launched, including drug-coated balloons and urological intervention consumables, with bidding set for January 13, 2026 [8] - The introduction of anchor pricing and a multi-repetition mechanism is expected to prevent malicious competition, although significant price declines are anticipated [8] Automotive Industry - Retail data for January-November 2025 shows that major brands like BYD, Volkswagen, and Toyota dominate the market, with the top ten brands holding a combined market share of 51.7% [10] - The competitive landscape remains fragmented, with ongoing price wars likely due to the lack of a dominant market structure [10] - Demand resilience in the battery supply chain is noted, but profitability will depend on product structure and bargaining power [10] Air Conditioning Sector - The air conditioning industry experienced a significant decline in production and sales in November, with production and sales down approximately 37% and 32% year-on-year, respectively [12] - The decline is attributed to high base effects from previous government subsidy policies and abnormal weather conditions [12] - A cautious outlook is maintained for the industry, with production plans for January 2026 indicating a year-on-year increase of about 21% [12]

Core Viewpoint - The article discusses the release of the procurement document for high-value medical consumables, specifically drug-coated balloons and urological intervention materials, by the National Organization for High-Value Medical Consumables Joint Procurement Office, outlining the requirements and timelines for the sixth batch of centralized procurement [4]. Group 1: Procurement Details - The procurement cycle will run from the effective date until December 31, 2028, with products needing to obtain valid medical device registration certificates by December 26, 2025 [4]. - The procurement covers two main categories: drug-coated balloons and urological intervention materials, with a total annual demand exceeding 3.4 million sets across 12 subcategories [4]. - The procurement will be implemented by the Tianjin Pharmaceutical Procurement Center, which will handle daily operations [4]. Group 2: Product Categories and Demand - The drug-coated balloon category includes four subcategories, with an annual demand of 690,000 units, where the coronary drug-coated balloon has the highest demand at 614,800 units [9]. - Major domestic companies such as Yinyi Biological, Lepu Medical, and Shenqi Medical lead in demand for coronary drug-coated balloons, with respective demands of 113,300, 97,100, and 86,900 units [9]. - The urological intervention category focuses on key surgical pathways, with an annual demand exceeding 2.75 million sets, where the ureteral intervention guide wire is the largest single item with a demand of 1,372,400 units [9]. Group 3: Market Share and Domestic Replacement - In the procurement, domestic companies account for approximately 80% of the market share for both coronary and peripheral drug-coated balloons, while foreign companies hold about 20% [10]. - The demand for ureteral intervention guide wires is also dominated by domestic products, indicating a trend towards accelerated domestic replacement [10]. - The introduction of the "anchor price" concept aims to rationalize prices and reduce vicious competition in the industry, benefiting more patients [7][19]. Group 4: Pricing and Competitive Rules - The procurement document introduces an "anchor price" based on the arithmetic average of the effective bidding prices of participating companies, set at 65% of the average price [19]. - The maximum effective bidding prices for various products have been established, with significant reductions compared to previous prices, such as the maximum effective bidding price for a non-target pressure measurement ureteral soft mirror being set at 1,860 yuan [11]. - The rules for selection and competition have been optimized, allowing non-selected companies to adjust their bids for a chance to qualify, which may enhance participation rates [20]. Group 5: Industry Impact - The changes in procurement rules are expected to reshape the competitive landscape, with leading domestic companies likely to benefit the most, while foreign companies may face pressure to localize [20]. - Smaller companies may exit the market, leading to increased industry concentration [22].

12月22日，国家组织高值医用耗材联合采购办公室（简称"联采办"）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）》（简称《采购文件》），明确第六批耗材集采申 报要求及关键时间节点，采购周期自执行日起至2028年12月31日。 申报产品需属采购范围且于2025年12月26日（含）前取得有效医疗器械注册证，申报企业需在2026年1月12 日17:00前确认供应产品。现场递交申报材料及信息公开将于1月13日开展。本次集采由天津市医药采购中 心承担日常工作并负责具体实施。 本轮集采锁定药物涂层球囊、泌尿介入两大高值耗材细分领域，均为临床使用频次高、市场需求刚性的核 心品类，合计覆盖12个细分品种，年度总需求量超340万个（套），基本覆盖临床常规使用产品。 | 品种 序号 | 类别 | 品种 | | --- | --- | --- | | 1 | | 冠状动脉药物涂层球囊 | | 2 | | 外周血管药物涂层球囊(用于动静脉醤透析通路) | | 3 | 药物涂层球囊类 | 外周血管药物涂层球囊(用于膝上部位,包括股浅动脉、股动脉、股 | | | | 胭动脉、近端胭动脉、胭动 ...

2025年12月22日 ， 国家医药耗材联采平台 正式发布 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）》 的公告，标志 着第六批高值医用耗材国家集采的正式启动。 本批集采将 药物涂层球囊类耗材 与 泌尿介入类医用耗材 纳入采购范围，并在竞价方式、分组机制与拟中选规则层面 给出了更为细化、结构化的制度安排。 根据文件披露的时间表，本轮集采拟中选结果预计将于 2026 年 1 月 13 日 公布。相较此前批次，本次文件的关注点不再局限于是否"降价"，而是更集中体现在 如何 通过规则设计引导理性竞争与稳定供给 。 附文件原文： https://www.nhsa.gov.cn/module/download/downfile.jspclassid=0&filename=72254d0fe9da4790a08c55e6f8d01514.pdf # 集采品种与需 求规 模 根据采购文件披露，本次第六批医用耗材集中带量采购的采购范围主要覆盖 药物涂层球囊 与 泌尿介入 两大类耗材。 其中，药物涂层球囊进一步细分为 冠状动脉药物涂层球囊 和 外周血管药物涂层球囊 。外周药物涂 ...

Core Insights - The sixth batch of high-value medical consumables centralized procurement has officially commenced, focusing on drug-coated balloons and urological intervention consumables, which are critical clinical needs [1][2] - The new procurement rules aim to reshape the market landscape, promote domestic substitution, and drive high-quality industry development [1][4] Procurement Details - The procurement covers drug-coated balloons for coronary and peripheral vascular use, and urological intervention consumables have been narrowed down to six essential categories, emphasizing basic needs and strong demand [2] - The procurement volume ratio has been adjusted from 80%-90% to 80%, with new clauses allowing for volume adjustments based on clinical demand, ensuring market supply stability while reserving space for innovative products [2][3] - The introduction of the "anchor price" mechanism aims to mitigate vicious price competition, shifting the focus from low-price selection to reasonable pricing [3][4] Market Impact - The drug-coated balloon market is experiencing rapid growth, with a market size of 4.5 billion yuan in 2023, a year-on-year increase of 22.7%, and expected to exceed 12 billion yuan by 2025 [4] - The urological intervention market, previously dominated by imports, is now presented with opportunities for domestic companies to capture market share, potentially increasing the domestic substitution rate to over 60% [5] Industry Transformation - The centralized procurement process is both a challenge and a catalyst for transformation, pushing companies to focus on technological innovation and high-end product development [6] - The ongoing procurement initiative reflects the government's commitment to regularizing and institutionalizing centralized procurement, emphasizing quality, innovation, and price control [6][7] - The integration of procurement policies with medical insurance is expected to lower patient costs while fostering a sustainable environment for industry innovation [6][7]

Macroeconomic Information and Commentary - In the first three quarters, China's GDP reached 10,150.36 billion yuan, with a year-on-year growth of 5.2%. The quarterly growth rates were 5.4% in Q1, 5.2% in Q2, and 4.8% in Q3 [3] - From January to September, the industrial added value above designated size grew by 6.2% year-on-year, while fixed asset investment (excluding rural households) was 3,715.35 billion yuan, down 0.5% year-on-year. Private investment decreased by 3.1% [3] - The retail sales of consumer goods totaled 4,197.1 billion yuan, with a year-on-year growth of 3.0% [3] Industry and Company Analysis Medical Consumables Industry - The sixth batch of medical consumables national procurement introduced new regulations, including the concept of "anchor price" for price difference calculation, aiming to stabilize expectations and prevent vicious competition [7][8] - The focus of this procurement includes drug-coated balloons and urological intervention materials, with a trend towards quality competition rather than just low prices [7][8] - High-value consumables companies are gradually digesting the performance pressure from procurement, with recent innovations and overseas business developments expected to provide new growth points [9] - The medical consumables industry is rated as "overweight," with recommendations to focus on companies with rich product lines and high innovation levels [11] In Vitro Diagnostics Industry - Samsung has partnered with Grail to enter the multi-cancer early detection market, investing 783 million yuan (110 million USD) [15] - The IVD market is undergoing a transformation, with challenges from price controls and procurement affecting short-term performance, but long-term growth is anticipated [17] - The IVD industry is rated as "overweight," with a focus on immunodiagnostics and molecular diagnostics sectors [17] Traditional Chinese Medicine Industry - The Traditional Chinese Medicine (TCM) sector saw a slight increase of 0.38% amidst an overall decline in the pharmaceutical sector [19] - A pilot program for disease-based payment for TCM is set to begin, which may enhance the reimbursement for TCM services [23] - The TCM industry is rated as "overweight," with investment recommendations focusing on companies with strong R&D capabilities and unique products [24]

Core Insights - The centralized procurement of urological medical consumables in China is advancing, with a new initiative led by Chongqing covering 26 provinces, indicating a shift towards domestic product substitution and market restructuring [1][6]. Group 1: Market Dynamics - The market for urological consumables has been historically dominated by imported brands like Boston Scientific and Cook, particularly in high-end products such as alloy stents [1]. - The ongoing centralized procurement aims to stabilize prices and reduce excessive competition by shifting the focus from "low-price selection" to "reasonable price selection" [1][2]. - The urological device market is projected to grow significantly, with the global market expected to reach $65.9 billion by 2032, up from $40.8 billion in 2024, highlighting substantial growth potential [7]. Group 2: Procurement Initiatives - The new procurement initiative will categorize stents based on material and features, allowing for competitive bidding among manufacturers [6]. - Previous regional procurement efforts, such as those in Fujian and Hebei, have already demonstrated significant price reductions for urological consumables [2][3]. - The sixth batch of national procurement will include drug-coated balloons and urological intervention products, indicating a comprehensive approach to cost control and quality assurance [4]. Group 3: Domestic Companies' Positioning - Domestic companies like Weili Medical, Huitai Medical, and Ruibang Medical are increasingly gaining market share through innovation and product diversification in the urological sector [7][8]. - Huitai Medical reported a 135.05% year-on-year revenue increase in its non-vascular intervention products, emphasizing the growing importance of the urological segment [7]. - Weili Medical's urological product revenue reached 216 million yuan in 2024, marking a 6.22% increase, showcasing the rising domestic brand influence [8].

Core Viewpoint - The centralized procurement of urological medical consumables in China is entering a new phase, with a focus on reasonable pricing and the promotion of domestic products, which may lead to significant market changes and opportunities for local manufacturers [3][8][10]. Group 1: Centralized Procurement Initiatives - The Chongqing Medical Security Bureau has initiated a public consultation for the centralized procurement of ureteral stents, covering 26 provinces including Chongqing, Tianjin, and Hebei [3][4]. - The procurement process is part of a broader trend towards institutionalized centralized purchasing of medical consumables in China, aiming to stabilize market expectations and reduce excessive competition [3][6]. - The procurement will categorize products based on material and features, with a focus on ensuring fair competition and preventing price wars [7][8]. Group 2: Market Dynamics and Trends - The urological medical consumables market is expected to undergo structural adjustments, with a shift from imported brands to domestic alternatives, particularly in high-end products like alloy stents [3][10]. - The global urology device market is projected to grow from $40.8 billion in 2024 to $65.9 billion by 2032, indicating significant market potential for domestic companies [9]. - Domestic companies such as Weili Medical, Huitai Medical, and Ruibang Medical are increasingly gaining market share through innovation and product development, with notable revenue growth reported [10][11]. Group 3: Impact on Domestic Companies - Huitai Medical reported a 135.05% year-on-year increase in revenue from non-vascular interventional products, highlighting the growing demand for domestic urological products [10][11]. - Weili Medical's urological product revenue reached 216 million yuan in 2024, marking a 6.22% increase, indicating a strong performance in the domestic market [10][11]. - Ruibang Medical has achieved significant technological advancements, with 42 product registration certificates and 12 CE certifications, showcasing its competitive edge in high-value consumables [11][12].

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].