21世纪经济报道记者 唐唯珂 报道 第六批耗材国采拉开帷幕。 11月7日，北京市医保局发布《关于开展药物涂层球囊类、泌尿介入类医用耗材采购需求填报工作的通 知》，标志着第六批国家组织高值医用耗材集中采购正式进入采购需求量填报阶段。作为继人工关节、 冠脉支架等品类之后的又一重要集采动作，此次聚焦两大临床刚需领域，叠加创新采购规则的落地，将 对百亿级市场版图重构、国产替代进程及行业高质量发展产生深远影响。 对于企业而言，需求填报的启动意味着集采竞争进入倒计时。"近期的工作集中在结合各省份的临床需 求数据、过往集采中标情况，测算合理的报价区间。" 国内某头部医疗器械企业销售负责人向21世纪经 济报道记者表示，"目前业内开始认可，逐渐集采不是'价格战'，而是'性价比战'，企业端需要在保证利 润空间的前提下，报出有竞争力的价格，同时通过规模效应降低生产成本。" "稳临床、保创新" 本次集采明确锁定药物涂层球囊与泌尿介入两大类高值医用耗材，覆盖范围与筛选逻辑充分贴合临床实 际需求。 其中，药物涂层球囊细分为冠状动脉及外周血管用等多个细分品种，全面覆盖心血管疾病介入治疗核心 场景；泌尿介入类则从前期规划的25类精简至输尿管 ...

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].

Core Viewpoint - The National Organization for High-Value Medical Consumables Joint Procurement Office has initiated the centralized procurement of drug-coated balloons and urological intervention medical consumables, marking a shift towards quality competition rather than price competition in the industry [1][3]. Group 1: Procurement Details - The sixth batch of procurement will cover two main categories: drug-coated balloons and urological intervention consumables, with specific subcategories defined for each [3][4]. - The procurement volume is set at 80% of the total reported demand from medical institutions, a slight adjustment from previous batches which had a higher percentage [5][6]. - The procurement process is becoming more refined, allowing for adjustments in reported demand based on clinical needs [5][6]. Group 2: Pricing Mechanisms - The "maximum effective bid price" has been clearly defined, with standards based on provincial procurement prices and other market data [6][9]. - The introduction of the "anchor price" concept aims to stabilize expectations and ensure that bids are reasonable, requiring companies to justify any bids below this price [9][11]. - The procurement rules allow for a multi-round revival mechanism, ensuring that companies can remain competitive as long as they maintain quality and adjust pricing [9][12]. Group 3: Market Dynamics - The price of drug-coated balloons has significantly decreased from around 20,000 yuan to approximately 6,000 yuan due to previous rounds of procurement [7][8]. - Domestic companies have gained market share in the drug-coated balloon sector, previously dominated by foreign firms, due to competitive pricing and rapid product iteration [8]. - The urological intervention consumables market is still largely controlled by foreign brands, but the upcoming national procurement may provide opportunities for domestic brands to increase their market presence [8].

Core Viewpoint - The approval of AcoArt Verbena® marks a significant breakthrough in the treatment of vertebral artery stenosis, ushering in a new era of "intervention without implantation" [2][4]. Group 1: "Intervention Without Implantation" Concept - The "intervention without implantation" concept aims to restore the health of blood vessels while avoiding the long-term issues associated with permanent implants, such as in-stent restenosis and chronic inflammation [4]. - This approach addresses the limitations of traditional metal stents, which can lead to complications over time [4]. Group 2: AcoArt Verbena® Overview - AcoArt Verbena® is the world's first drug-coated balloon (DCB) specifically designed for vertebral artery origin stenosis (VAOS), suitable for patients with ≥70% stenosis and ineffective drug therapy [9][10]. - The product utilizes advanced drug coating technology with magnesium stearate as a carrier for paclitaxel, enhancing drug stability and delivery efficiency [10]. Group 3: Clinical Trial Results - AcoArt Verbena® demonstrated a significant reduction in target lesion restenosis rates, with the trial group showing a 12-month restenosis rate of 13.04% compared to 37.31% in the control group, a decrease of 67% [16][13]. - The product avoids serious adverse events related to devices, mitigating risks associated with long-term metal stent implantation [16]. Group 4: Market Landscape and Competitive Position - The global peripheral DCB market was valued at 4.91 billion yuan in 2023, with a projected compound annual growth rate (CAGR) of 14.1%, reaching 12.28 billion yuan by 2030 [15]. - Xianruida holds an 86.9% market share in China's peripheral DCB market, indicating a strong competitive position [15]. - The collaboration with Boston Scientific is expected to enhance market penetration and revenue growth, with potential sales exceeding 1.2 billion yuan in the next three years [18][19]. Group 5: Company Background - Xianruida, founded in 2008 and listed on the Hong Kong Stock Exchange in 2021, focuses on innovative medical technologies in vascular intervention [20][21]. - The company has developed a diverse product pipeline, including several DCB products and other interventional devices, addressing unmet clinical needs across various medical fields [21].