以下文章来源于21新健康 ，作者唐唯珂 21新健康 . 政策密集落地 本轮价格治理以"全域覆盖、动态调整"为核心特征，各地政策形成互补协同的治理体系。宁夏 聚焦采购金额靠前的高风险挂网耗材，要求企业在2026年1月28日前确认全国最低有效价并上 传证明材料，未按期调价或弄虚作假的产品将被暂停挂网，涉及一次性心电电极、医用胶片等 临床高频使用品类。 21世纪传媒 · 公众号矩阵成员。 记者丨 唐唯珂 编辑丨季媛媛 2026年初，医用耗材价格治理进入"全域覆盖、动态联动"的新阶段，多地开始耗材降价落地。 宁夏医保局近期发布的价格风险治理通知，与江西、黑龙江此前推出的常态化联动政策形成呼 应，多地密集出台的治理措施直指耗材价格虚高问题。从部分产品超97%的惊人降幅，到全国 最低价成为挂网"硬门槛"，这场覆盖临床常用耗材与高值产品的价格革命，正重塑医药产业竞 争格局。 "全国价格已经联网了，躲也躲不过，企业必须赶紧梳理产品线，该降的就及时降。"一位医药 经销商向21世纪经济报道记者坦言，低价竞争终非长久之计，未来企业需绑定SPD管理、DRG 控费方案等服务才能持续发展。 价格"地板价"的出现，正在加速医用耗材行业的洗 ...

《科创板日报》12月31日讯（记者 史士云）2025年，科创板医药板块展现出更具说服力的市场叙事能力，也获得了资本市场的更多垂青。 数据显示，截至2025年12月26日，科创板医药板块上市的企业共有118家，其中98家企业的股价实现了年内的整体上涨，仅有不到20家企业（剔除近期上市 的新股）股价下跌。 从上市情况看，2025年科创板医药板块新增上市企业5家，而2024年为1家，另有包括汉诺医疗、信诺维、同心医疗等企业的科创板IPO也于近日获得受理。 此外，2025年，科创板生物医药企业IPO终止数量也显著下降，全年仅有天星医疗1家企业终止审核。而2024年同类企业终止数量超过10家。 相较于2024年市场的清冷，2025年的科创板生物医药板暖意已显。 ▌政策加持，年内新增5家生物医药企业 2025年6月18日，是一个再平凡不过的周四，但对于科创板而言，却迎来了市场改革的重要节点。 在当日召开的"2025陆家嘴论坛"上，中国证监会主席吴清宣布，证监会将推出进一步深化科创板改革"1+6"政策措施，包括设置科创板科创成长层，且重启 未盈利企业适用科创板第五套上市标准，以及面向优质科技企业试点IPO预先审阅机制等。同 ...

Core Viewpoint - Sino Medical (688108.SH) has received approval from the Korean Ministry of Food and Drug Safety for its self-developed TRADENTTM coronary artery balloon dilation catheter, marking a significant milestone in its product portfolio expansion in overseas markets [1] Product Approval and Features - The TRADENTTM catheter is designed for the treatment of vascular stenosis during PTCA, featuring a unique "spiral" layout of thorn wires on the balloon surface, which enhances embedding capability while maintaining good passability [1] - Compared to existing plaque-modifying balloons in the market, this product offers more comprehensive plaque coverage and effectively reduces the incidence of dissection [1] Regulatory Approvals and Market Potential - The product has already obtained medical device registration certificates from the National Medical Products Administration of China, as well as from Thailand and Korea [1] - Following its launch in Korea, the product is expected to complement the company's coronary stents and balloons, potentially boosting overseas sales [1] Market Challenges - Sales in international markets may be influenced by uncertainties related to foreign regulations, market environment changes, and exchange rate fluctuations [1]

Core Viewpoint - Sino Medical (688108.SH) has received approval from the Korean Ministry of Food and Drug Safety (MFDS) for its TRADENT TM coronary stent balloon dilation catheter, enhancing its product offerings in overseas markets [1] Group 1: Product Approval - The TRADENT TM coronary stent balloon dilation catheter is designed for the dilation of narrowed coronary arteries [1] - The product has obtained a medical device registration certificate in South Korea, marking a significant milestone for the company [1] Group 2: Market Impact - The registration of the TRADENT TM catheter will effectively increase the variety of products available for sale in the overseas market [1] - Upon its launch in South Korea, the product will complement the company's existing offerings, such as coronary stents and balloons, creating a robust product portfolio [1] - The utilization of the company's overseas channel resources is expected to drive sales growth for its products in international markets [1]

Financial Performance - Boston Scientific reported Q3 net sales of $5.065 billion, representing a 20.3% increase year-over-year, with organic growth of 15.3% [4][6] - Adjusted EPS for the quarter was $0.75, up from $0.63 in the same period last year, exceeding market expectations [4][6] - The company raised its full-year sales and profit guidance, projecting approximately 20% growth in reported sales and 15.5% organic growth, with adjusted EPS guidance increased to a range of $3.02–$3.04 [6] Product and Clinical Drivers - The left atrial appendage occluder, Watchman, saw a sales increase of approximately 35%, becoming one of the company's highest-margin products [9] - The electrophysiology (EP) business experienced explosive growth, with sales up about 63%, driven by increasing atrial fibrillation ablation volumes and advancements in ablation technologies [9] - The cardiovascular segment achieved an organic growth rate of 19%, reflecting strong market demand in structural heart disease and electrophysiology [9] Regional and Strategic Expansion - North America remains the primary market for Boston Scientific, with a 27% increase in sales, while the Asia-Pacific and Latin America regions showed strong double-digit organic growth [11] - The company’s strategic focus on "complementing the supply chain and accelerating" through acquisitions has enhanced market efficiency and resource sharing [12] - The emphasis on digitalization and AI in clinical practices is creating a competitive edge in the cardiovascular field [12] Industry Trends - The global cardiovascular intervention and electrophysiology markets are entering a phase of structural expansion, with increased penetration rates for structural heart disease and atrial fibrillation procedures [13] - Improved payment and policy environments are facilitating the adoption of high-value procedures in both developed and emerging markets [13] - Technological innovations are shortening learning curves, enhancing the replicability of procedures, and accelerating acceptance among healthcare providers [13] Competitive Landscape - Boston Scientific maintains a leading position in the structural heart disease market with its Watchman product, while competition in the electrophysiology space is intensifying [14] - The company's integrated approach combining procedures, products, and education is proving effective in maintaining market share [14] Insights for Domestic Manufacturers - Domestic cardiovascular and electrophysiology companies should focus on building comprehensive solutions around procedural scenarios, enhancing hospital engagement through education and post-operative management [16] - Attention should be directed towards rapidly growing segments such as atrial fibrillation ablation and left atrial appendage occlusion, creating a synergistic matrix of devices and imaging navigation [16] - Emphasizing policy, payment, and real-world evidence is crucial for gaining early market access and competitive advantage [16]

Investment Rating - The industry rating is "Overweight" [4] Core Insights - The Chinese neurointerventional medical device market is expected to grow from CNY 4.9 billion in 2019 to CNY 37.1 billion by 2030, with a compound annual growth rate (CAGR) of 20.2% from 2019 to 2030 [16][22] - The number of ischemic stroke treatment surgeries in China is projected to increase from 45,800 in 2019 to 881,300 by 2030, representing a CAGR of 30.8% [22] - The market for neurointerventional devices in China is growing at a faster rate compared to the U.S., with a surgical penetration rate of only 9.1% in 2020, compared to 62.3% in the U.S. [22][24] Summary by Sections 1. Market Outlook for Vascular Diseases - Neurovascular diseases are a leading cause of death in China, accounting for over 20% of total deaths in 2019, and the prevalence of peripheral vascular diseases is increasing due to aging [14] - The interventional treatment market is in an emerging stage in China, driven by increased health awareness, rising cardiovascular disease rates, and supportive government policies [14] 1.1 Neurovascular Disease Market Outlook - The neurointerventional medical device market in China is projected to grow significantly, with a market size increase from CNY 2.6 billion in 2015 to CNY 4.9 billion in 2019, and expected to reach CNY 37.1 billion by 2030 [16] - The number of neurointerventional surgeries is expected to rise from 46,200 in 2015 to 740,500 by 2026, with a CAGR of 28.9% [17] 1.1.1 Neurointerventional Market Outlook - The market for neurointerventional devices is expected to grow significantly, with a projected CAGR of 20.2% from 2019 to 2030 [16] 1.1.2 Ischemic Neurovascular Disease Market Outlook - The number of ischemic stroke cases in China is expected to rise from 2.8 million in 2015 to 5.8 million by 2030, with a CAGR of 5.0% [22] 1.1.3 Hemorrhagic Neurovascular Disease Market Outlook - The penetration rate for hemorrhagic stroke neurointerventional surgeries in China is expected to increase from 9.1% in 2020 to 31.7% by 2026 [24] 1.2 Peripheral Vascular Disease Surgery Market Outlook - The number of peripheral artery disease patients in China is projected to grow from 53.05 million in 2022 to 62.92 million by 2030 [30] - The number of peripheral vascular interventions is expected to increase from 178,000 in 2022 to 623,000 by 2030, with a CAGR of 13.7% from 2026 to 2030 [31] 1.2.1 Peripheral Artery Disease Market Outlook - The prevalence of peripheral artery disease is increasing, with a projected growth in patient numbers due to aging [29] 1.2.2 Peripheral Venous Market Outlook - The market for peripheral venous intervention devices in China is expected to grow from CNY 1.01 billion in 2021 to CNY 4.99 billion by 2030, with a CAGR of 19.5% [35] 2. Companies Related to Neurovascular Diseases - MicroPort NeuroScience (02172.HK) is a leading company in neurointerventional consumables in China [2] - Guichuang Tongqiao (02190.HK) focuses on peripheral and neurovascular intervention devices [2] - Sino Medical (688108.SH) covers key areas in cardiovascular and neurovascular interventions [2] - Xinwei Medical (06609.HK) provides comprehensive solutions for stroke treatment and prevention [2]

Group 1 - The core stock price of Sino Medical reached 33.38 yuan as of August 25, 2025, with an increase of 0.68 yuan, representing a rise of 2.08% [1] - The trading volume on that day was 2.307 billion yuan, with a turnover rate of 16.47% [1] - Sino Medical operates in the medical device industry, focusing on the research, production, and sales of high-end interventional medical devices, including coronary stents and balloon catheters [1] Group 2 - The company's subsidiary, Sino Shenchang Medical Technology Co., Ltd., recently received a registration certificate from the National Medical Products Administration for a disposable microcatheter, which is suitable for neurovascular operations [1] - The registration certificate for the microcatheter is valid until August 21, 2030 [1] - For the first half of 2025, the company reported revenue of 240 million yuan and a net profit attributable to the parent company of 13.84 million yuan [1] Group 3 - On August 25, 2025, the net outflow of main funds was 107 million yuan, with a cumulative net outflow of 1.454 billion yuan over the past five days [2]

Group 1 - The stock price of Sino Medical reached 30.40 yuan as of August 14, 2025, marking a 3.05% increase from the previous trading day [1] - The trading volume on that day was 2.26 billion yuan, with a turnover rate of 18.55% [1] - Sino Medical specializes in the research, production, and sales of cardiovascular interventional medical devices, including coronary stents and balloon catheters [1] Group 2 - A subsidiary of Sino Medical recently received recognition from the U.S. Food and Drug Administration (FDA), which has generated market interest in its potential applications in the field of neurovascular intervention [1] - On August 14, the net inflow of main funds was 164 million yuan, accounting for 1.3% of the circulating market value [1] - Over the past five trading days, the cumulative net outflow of main funds was 143 million yuan [1]

Market Overview - On August 7, the medical device sector experienced a significant surge, with companies such as Kehua Bio-engineering, Sainuo Medical, and Dabo Medical reaching their daily price limits [1] Stock Performance - Various stocks in the medical device sector showed notable price increases, including: - Baonuo Medical (688108.SS) with a price of 17.03, up by 20.01% [2] - Shangrong Medical (002551.SZ) at 4.22, up by 9.90% [2] - Kehua Bio-engineering (002022.SZ) at 7.95, up by 9.96% [2] - Zhonghong Medical (300981.SZ) at 16.21, up by 19.99% [2] - Lidman (300289.SZ) at 9.77, up by 20.02% [2] Key Events - On August 6, Sainuo Medical announced that its subsidiary received breakthrough medical device designation from the FDA for its COMETIU self-expanding intracranial drug-coated stent system and COMEX balloon microcatheter [3] - The State Council's news office clarified that the selection of centralized procurement will no longer solely rely on the lowest price, requiring the lowest bidders to justify their pricing [3] - The National Medical Products Administration released measures to support the innovation and development of high-end medical devices [3] - Several Hong Kong-listed medical device companies are expected to turn profitable or see rapid performance releases, with some companies experiencing over 100% growth year-to-date due to innovative product launches and technological breakthroughs [3] Institutional Insights - For high-value consumables, centralized procurement is a key variable, with most categories already included. As procurement rules are optimized, price competition is expected to ease, leading to a potential turning point for the fundamentals of domestic products [4] - The A-share Shenwan Medical Device Index has rebounded since early 2025 after four years of decline, with expectations of performance and valuation recovery for many companies due to policy easing and strategic transformations [5] - National-level policy support for innovative medical devices is comprehensive, covering all stages from research and development to production and payment, which is expected to stimulate industry innovation and upgrade [5]

Summary of Key Points from Medical Device Industry and Companies Industry Overview - The medical device sector has faced challenges due to centralized procurement and anti-corruption measures, leading to concerns about earnings certainty. However, with policy optimization and growth in international business, opportunities are increasing within the sector [1][2] - The medical device index has rebounded by 12% since the beginning of the year, following a period of decline due to significant events and policy factors [2] Company Performance and Outlook - **Mindray Medical**: Experienced revenue and profit pressure due to delayed domestic equipment tenders, but is expected to see a performance turnaround in Q3. The company has significant international growth potential [3][11] - **MicroPort Medical**: Currently has a low valuation, with a projected valuation of only 11 times earnings next year. The company is expected to benefit from the approval of its coronary stent application in the U.S. and potential domestic approval [5] - **Sino Medical**: Recent approval of its intracranial self-expanding drug stent is expected to drive growth, with strong clinical results anticipated to facilitate commercialization [19] - **HuiTai Medical**: In the electrophysiology sector, the company is expected to see rapid growth due to innovative products like PFA ablation catheters, which are anticipated to gain market traction [14][13] Sector-Specific Insights - **High-Value Consumables**: The sector is seeing valuation recovery and improved earnings certainty due to policy optimization. Surgical volumes are expected to grow steadily, with specific segments like electrophysiology and peripheral nerve intervention showing high growth potential [7][8] - **IVD Sector**: The IVD industry is facing challenges from price adjustments in testing services, but companies with strong innovation capabilities and international expansion potential are still expected to grow [9][28] Investment Opportunities - Companies like **Xinmai Medical** and **Nanwei Medical** have shown significant stock price increases, with some companies in the medical device sector experiencing substantial gains [4] - Low-valuation growth potential stocks such as **Chunli Medical** and **Yingke Medical** have seen price increases of up to 60% since Q2 [4][5] - The orthopedic sector is stabilizing, with companies like **Chunli** and **Aikang** showing potential for international market expansion [12] Future Trends - The medical device sector is expected to see a performance turnaround starting in Q3, driven by improved tender data and reduced channel inventory pressure [6][10] - The overall medical industry is projected to face volume and price pressures in the first half of 2025, but improvements are expected in the second half, potentially leading to a growth inflection point by year-end [10] Conclusion - The medical device industry is on the cusp of recovery, with several companies poised for growth due to policy changes and international expansion. Investors are encouraged to focus on undervalued companies with strong growth potential, particularly in high-value consumables and innovative medical technologies [29]