医疗设备见底了么行业有哪些看点 20250909 摘要 医疗设备集采难全国推行，因资金来源多样、采购决策分散，与药品、 耗材由医保直接支付不同。未来或以省级或区域单位对成熟产品集采， 高端设备价格维持受压价措施影响。 医疗设备采购周期长（6 个月至 1 年），决策权在卫健委领导或医院院 长手中，与药品耗材由科室主任决定不同，导致设备公司业绩与终端招 采节奏不一致。 国内医疗器械公司营收现分化，联影影像类设备需求直接反映终端，迈 瑞、澳华受渠道库存调节影响，开立业绩受海外市场主导，整体面临去 库存压力。 国内品牌在超声及内窥镜软镜领域市占率提升前景良好，即使市场波动， 国产品牌仍具竞争力，预计随招投标恢复将保持增长势头。 国内医疗设备市场 2025 下半年有望恢复正增长，但迈瑞上半年国内市 场下滑 33%，因大监护设备需求下降，未来增长取决于十五规划医院建 设。 Q&A 医疗设备与耗材及药品的主要区别是什么？ 医疗设备、耗材和药品之间存在显著区别。首先，医疗设备包括超声监护、 CT、核磁共振等用于医院检查或检验的设备，而耗材则如心脏支架、关节等产 品。药品和耗材通常由医保直接支付，而医疗设备的采购则由医院自行承 ...

Summary of the Conference Call on the Pharmaceutical Industry Industry Overview - The pharmaceutical industry experienced a profit decline in 2019 due to centralized procurement policies, but demand growth during the pandemic provided some relief. By the first half of 2025, segments such as innovative drugs, pharmaceutical commerce, and CXO showed positive growth, although overall profit levels continued to decline [1][2]. Key Insights and Arguments - **Centralized Procurement Impact**: The centralized procurement of medical consumables began in 2020, leading to negative revenue growth for two consecutive quarters by Q4 2023. However, Q1 2024 saw a return to positive revenue growth, indicating a stabilization in high-value consumables [3][4]. - **Sector Performance**: The chemical preparations sector saw significant revenue declines in Q3 and Q4 of 2023, directly linked to centralized procurement policies. The medical consumables sector has faced revenue and profit pressures since 2022, with in vitro diagnostics (IVD) expected to face challenges starting Q4 2024 [5][6]. - **Future Outlook**: The worst period for the pharmaceutical industry is believed to be over, with price issues being resolved. The price levels are relatively low compared to international markets, and a return to positive growth is anticipated in Q2 2025, potentially leading to an overall positive growth for the year [6][7]. Segment-Specific Insights - **CXO Sector**: The CXO sector is divided into demand-driven and supply-driven enterprises. The latter has benefited from the recovery of overseas markets, while domestic demand-driven companies are beginning to show signs of recovery, as evidenced by the performance of companies like Tigermed and Northstar [7][8]. - **IVD Sector**: The IVD sector is under significant pressure due to policy impacts, with a notable 20% decline in Roche's domestic luminescence business. The overall industry growth rate is approximately -15% [12][13]. - **Medical Equipment**: The medical equipment sector has faced continuous declines since Q4 2023, but signs of recovery were noted in the first half of 2025, with companies like United Imaging and Mindray showing varying degrees of recovery [17][18]. Additional Important Points - **High-Value Consumables**: The high-value consumables sector has undergone multiple rounds of centralized procurement, leading to stable or improved performance for many companies. The gross margin levels for high-value consumables have reached a bottom, with certain products like artificial crystals beginning to see the effects of procurement policies [19][20]. - **Internationalization of Domestic Companies**: Domestic high-value consumables companies are enhancing their international capabilities, with significant clinical data published and FDA certifications obtained for products aimed at the U.S. market [23]. - **Market Competition**: The competition in the luminescence industry is intense, particularly among companies outside the top three, which are resorting to price cuts to gain market share, resulting in significant declines in gross margins [13][14]. This summary encapsulates the key points discussed in the conference call regarding the pharmaceutical industry, highlighting the challenges and opportunities within various segments.

Group 1 - The stock price of Sino Medical reported at 14.19 yuan as of August 6, 2025, down by 2.54% from the previous trading day [1] - The trading volume on that day was 119,538 hands, with a transaction amount of 171 million yuan [1] - Sino Medical operates in the medical device industry, focusing on the research, production, and sales of high-end interventional medical devices, including cardiovascular interventional devices like stents and balloon catheters [1] Group 2 - The company's subsidiary, Sino Shenchang, specializes in the development of products in the neurointerventional field [1] - Sino Shenchang's COMETIU self-expanding intracranial drug-coated stent system and COMEX balloon microcatheter have received breakthrough medical device designation from the FDA [1] - This product is the first in FDA history for the treatment of intracranial atherosclerotic stenosis and the first domestically produced neurointerventional device to receive such designation [1] Group 3 - On the funding flow side, there was a net outflow of 28.91 million yuan from main funds on that day, accounting for 0.49% of the circulating market value [1] - Over the past five trading days, the cumulative net outflow of main funds reached 33.18 million yuan, representing 0.56% of the circulating market value [1]

Core Insights - Weihai has emerged as a significant hub for the medical device industry, with 216 medical and healthcare enterprises and 75 large-scale enterprises contributing to its growth [1] - Key players include Weigao Group, which leads in medical consumables, and Dain Pharmaceutical, which holds over 60% of the children's vitamin A&D market [1][2] - The city has established a robust ecosystem for innovation and industry support, including a strong focus on standard-setting and technological advancement [3][4] Group 1: Industry Growth and Key Players - Weihai's medical device industry is rapidly expanding, with notable companies like Weigao Group, Dain Pharmaceutical, and Jive Medical leading in various segments [1][2] - Weigao Group has developed a diverse brand portfolio across multiple product categories, emphasizing a "zero defect" quality standard [2] - Dain Pharmaceutical specializes in children's medication, achieving a market share exceeding 60% with its product "Yikexin" [2] Group 2: Innovation and Standards - Weihai has established a "1+4+N" innovation platform system, comprising 104 innovation platforms, with 39 at the provincial level or above [3] - Weigao Group has taken the lead in setting national technical standards for medical devices, participating in the formulation of 28 national standards and 72 industry standards [3] - Collaborative efforts among 12 companies in the orthopedic implant sector have resulted in unified material parameters, enhancing industry standards [3] Group 3: Supportive Ecosystem and Policies - The city has implemented 12 special support policies that have generated an additional revenue of 5.3 billion yuan for enterprises [4] - A 26 billion yuan industrial fund has been established, offering 205 financial products and a total credit of 115.2 billion yuan [4] - Regulatory reforms have significantly expedited the medical device registration process, reducing approval times by over 95% [4]

Core Viewpoint - The definition of "medical devices" is crucial as it delineates industry boundaries, research paths, capital logic, pricing strategies, and even the starting point for industry reshuffling [1][2][4]. Group 1: Definition and Importance - The definition of medical devices affects product marketability, profitability, and industry regulation [2][4]. - Understanding what constitutes a medical device is fundamental for companies to strategize product development and market entry [3][5]. Group 2: Regulatory Implications - Medical AI software must undergo registration and approval processes if classified as medical devices, impacting their commercialization and revenue generation [4][5]. - Medical beauty products face stricter regulations once classified as medical devices, leading to industry consolidation and increased barriers to entry [4][5]. Group 3: Global Perspective - The official definition of medical devices in China is derived from the "Medical Device Supervision and Administration Regulations," emphasizing non-pharmacological efficacy [7][9]. - Globally, while definitions may vary, a common understanding is that medical devices do not achieve their effects through pharmacological, immunological, or metabolic means [9][10]. Group 4: Misconceptions and Clarifications - Not all software qualifies as a medical device; it depends on whether it serves a medical function [12][16]. - Devices used for animal treatment are not classified as medical devices under Chinese regulations, presenting unique challenges for the pet medical equipment market [13][16]. Group 5: Future Directions - Understanding the classification of medical devices is essential for determining project viability, hospital integration, financing, and revenue potential [17]. - The upcoming series "MedTech Base" will explore medical device classification, registration pathways, regulatory systems, and representative products [17][18].

Core Viewpoint - The company, BluFan Medical Co., Ltd. (stock code: 002382), is expected to report a narrowed net loss for the first half of 2025 compared to the same period last year, indicating a potential recovery in its financial performance [2]. Financial Performance Summary - The company anticipates a net loss attributable to shareholders of between 100 million to 150 million yuan, an improvement from a loss of 160.21 million yuan in the same period last year, reflecting a year-on-year growth of 6.38% to 37.58% [2]. - The net loss after deducting non-recurring gains and losses is expected to be between 170 million to 230 million yuan, with a year-on-year change of -17.11% to 13.44% [2]. - Basic earnings per share are projected to be a loss of 0.15 yuan to 0.10 yuan, compared to a loss of 0.16 yuan per share in the previous year [2]. Reasons for Performance Changes - Investment Loss: The company recognized a fair value change loss of approximately 120 million yuan due to the valuation change of its investment in Suzhou Tongxin Medical Technology Co., Ltd., which negatively impacted the cardiovascular business segment [5]. - Cardiovascular Business Improvement: Excluding the Suzhou Tongxin matter, the cardiovascular division's operating performance improved, with sales revenue exceeding 690 million yuan, a year-on-year increase of over 20% [5]. - Financial Expense Pressure: Financial expenses of 25 million yuan were accrued in the second quarter of 2025 due to strategic investments made in 2024, further affecting profits [5]. - Pressure on Protective Business: The health protection division faced losses due to fluctuations in overseas orders and declining sales prices [5]. Company Overview - BluFan Medical Co., Ltd. was established in 2002 and is a leading medical device company listed on the Shenzhen Stock Exchange since 2010, covering both low-value and high-value consumables [5]. - The company operates in four major segments: Cardiovascular, Health Protection, Surgical, and Nursing [6]. - The cardiovascular division focuses on interventional devices, while the health protection division centers on medical gloves and related products [6]. Key Products - BioFreedom® Drug-Coated Coronary Stent System: This product has been validated for safety and efficacy in high bleeding risk populations, significantly reducing the duration of dual antiplatelet therapy [10]. - The first domestic drug balloon, featuring a new generation of rapamycin derivatives, addresses previous limitations in drug absorption and retention [12]. - The Xinyue® Drug-Coated Stent System has been upgraded to improve patient outcomes while maintaining effective anti-proliferation effects [13].

Group 1 - The core point of the news is the change in the indirect controlling shareholder of Bluestar Medical, with Langhui Petrochemical acquiring a 52.0395% stake, diluting Bluestar Group's stake from 98% to 47.0013% [1] - The company emphasizes that this equity change does not trigger a mandatory takeover, nor does it lead to a change in the controlling shareholder or actual controller, and it will not adversely affect the company's business structure or financial status [1][2] - Langhui Petrochemical, previously a subsidiary of Bluestar Medical, has maintained a close cooperative relationship with the company, being its largest supplier for three consecutive years from 2022 to 2024 [2][3] Group 2 - Langhui Petrochemical initiated its listing guidance in September 2021, with the latest guidance period set from January 1 to March 31, 2025, but faces challenges in internal control and independent director appointments [3] - Bluestar Medical has experienced continuous pressure on its performance over the past three years, with revenues of 4.9 billion, 4.93 billion, and 6.25 billion from 2022 to 2024, and net profits of -372 million, -568 million, and -445 million during the same period [4] - As of May 28, Bluestar Investment holds 235 million shares of Bluestar Medical, accounting for 23.31%, with 183 million shares pledged, representing 18.2% of the total share capital [4]

Core Viewpoint - The pharmaceutical industry is experiencing a significant divide, with some representatives thriving while others face severe challenges due to policy changes and market dynamics [3][8]. Group 1: Industry Challenges - The introduction of centralized procurement and anti-corruption measures has drastically reduced profit margins for pharmaceutical companies, leading to a stark contrast in the experiences of industry representatives [4][17]. - In 2024, nearly half of listed pharmaceutical companies are expected to report rising performance, while the other half will see declines, indicating a bifurcation in the industry [8][19]. - The marketing expense ratios of pharmaceutical companies have significantly decreased, with some companies experiencing reductions of over 70% from 2019 to 2024 [20]. Group 2: Impact of Centralized Procurement - Centralized procurement has led to drastic price reductions for drugs, with some products seeing profit margins drop from 1000% to just 10% overnight [22][25]. - The frequency of centralized procurement announcements has increased, affecting a wide range of drugs and medical devices, leading to widespread layoffs among pharmaceutical representatives [23][26]. - Major pharmaceutical companies have significantly reduced their sales teams, with some companies cutting their workforce by over 50% since 2020 [26]. Group 3: Changing Dynamics for Representatives - The role of pharmaceutical representatives is evolving, with a greater emphasis on professionalism and knowledge as traditional sales tactics become less effective [32][34]. - Despite the challenges, some representatives still see potential in the industry, citing opportunities in online sales and the growing acceptance of e-commerce for pharmaceuticals [36][38]. - The industry remains a relatively high-income sector compared to other traditional industries, with starting salaries for representatives still competitive [34].

Core Viewpoint - The pharmaceutical industry is experiencing a significant transformation due to policy changes such as centralized procurement and anti-corruption measures, leading to a stark divide in the fortunes of pharmaceutical representatives and companies, with some thriving while others struggle [6][7][15]. Group 1: Industry Challenges - The pharmaceutical industry is facing a "big earthquake" with half of the listed pharmaceutical companies expected to see their performance rise while the other half declines in 2024 [7]. - The implementation of centralized procurement has drastically reduced profit margins, with some products seeing profit drop from 10 times to just 10% [18][21]. - The anti-corruption campaign has led to a significant reduction in marketing expenses for pharmaceutical companies, with many companies cutting their sales expense ratios by over 70% from 2019 to 2024 [16][17]. Group 2: Impact on Pharmaceutical Representatives - Pharmaceutical representatives are experiencing a "frozen and fiery" situation, with some enjoying salary increases while others face layoffs and reduced income [6][8]. - The number of pharmaceutical representatives has been drastically reduced, with companies like 恒瑞医药 and 石药集团 cutting their sales teams by 42.7% and 54% respectively from 2019 to 2023 [22]. - The once lucrative profession is now fraught with uncertainty, as representatives face increased pressure to meet performance targets amid tightening regulations and market conditions [25][26]. Group 3: Future Opportunities - Despite the challenges, some representatives believe that the pharmaceutical industry remains a sunrise industry, with opportunities for growth in areas like online pharmaceutical sales [31][32]. - The importance of professionalism and knowledge in the role of pharmaceutical representatives is increasing, as they must now rely on clinical data and research to engage with healthcare professionals [29][30]. - The shift towards a more transparent and regulated environment may lead to the elimination of unethical practices, allowing for a more sustainable industry in the long run [29][34].

Core Insights - The pharmaceutical industry is experiencing a significant divide, with some companies thriving while others struggle due to recent policy changes and market dynamics [2][3][8]. Group 1: Industry Challenges - The introduction of centralized procurement and anti-corruption measures has drastically reduced profit margins for pharmaceutical representatives, leading to a challenging job market [1][8][12]. - The sales expense ratios of listed pharmaceutical companies have seen a significant decline, indicating a tightening of marketing budgets in response to regulatory pressures [9][12]. - The industry is witnessing a substantial reduction in the number of pharmaceutical representatives, with some companies cutting their sales teams by over 50% [13][12]. Group 2: Market Dynamics - The market is characterized by a stark contrast in performance, with nearly half of the listed pharmaceutical companies expected to report increased earnings in 2024, while the other half may see declines [2][3]. - The shift towards more transparent and ethical practices is reshaping the role of pharmaceutical representatives, emphasizing the need for professionalism and knowledge [18][19]. - The ongoing trend of centralized procurement is expected to continue, further impacting the profitability of pharmaceutical products and the viability of traditional sales methods [14][12]. Group 3: Opportunities and Adaptations - Despite the challenges, some representatives are finding new opportunities in online pharmaceutical sales, capitalizing on the increased public awareness of medication options [25][26][24]. - The industry still offers competitive salaries compared to other sectors, with entry-level positions in foreign pharmaceutical companies starting at 8,000 yuan, which is higher than many other sales roles [20][19]. - Representatives who adapt to the changing landscape by focusing on building relationships and providing value through education are likely to succeed in the evolving market [18][19].