证券研究报告 2025 年 09 月 07 日 湘财证券研究所 行业研究 体外诊断行业周报 IVD 短期业绩承压，静待拐点 相关研究： 核心要点： 本周医药生物上涨 1.40%，体外诊断下跌 1.97% 根据 Wind 数据，本周申万一级行业医药生物上涨 1.40%，涨幅排名位列申 万 31 个一级行业第 4 位。沪深 300 指数下跌 0.81%，医药跑赢沪深 300 指 数 2.21 个百分点。 申万医药生物二级子行业医疗服务 II 报收 7028.81 点，上涨 1.69%；中药 II报收 6813.50 点，下跌 1.39%；化学制药Ⅱ报收 14482.25 点，上涨 3.92%； 生物制品Ⅱ报收 7051.97 点，上涨 1.93%；医药商业Ⅱ报收 5187.84 点， 下跌 0.77%；医疗器械 II 报收 7065.40 点，下跌 1.26%。三级行业中体外 诊断报收 8769.61 点，下跌 1.97%。 从医疗服务板块公司的表现来看，表现居前的公司有：易瑞生物（+7.1%）、 艾德生物（+5.2%）、浩欧博（+4.9%）、硕世生物（+4.7%）、新产业（+4.1%）； 表现靠后的公司有：透景 ...

Summary of Key Points from the Conference Call Industry Overview - **Industry**: Pharmaceutical Industry - **Key Focus**: Policy outlook for the second half of 2025, emphasizing basic healthcare and innovation support [1][2] Core Insights and Arguments - **Policy Direction**: The government aims to enhance medical accessibility and affordability while strengthening industry regulation. The focus is on supporting pharmaceutical innovation to meet clinical needs and achieve economic and social benefits [1][2] - **Support for Innovative Drugs**: The National Healthcare Security Administration (NHSA) and the National Health Commission (NHC) have introduced measures to support innovative drug development across five areas: R&D, insurance catalog, clinical application, diversified payment, and security measures. The commercial insurance innovation catalog is a highlight, allowing companies to apply concurrently and negotiate settlement prices [1][6][11] - **Separate Payment System Progress**: The separate payment system for innovative drugs is gradually advancing, with an increase in the number of domestic drugs included in Guangdong's separate payment scope. This is expected to enhance market access and coverage for innovative drugs [1][7] - **Drug Procurement Optimization**: The 11th batch of national drug procurement has optimized reporting methods and bidding rules, raising the bidding threshold and clarifying that new drugs will not be included in procurement. This aims to improve quality control and ensure reasonable pricing [1][13][14] Additional Important Content - **Real-Time Settlement**: As of May 2025, real-time settlement has been implemented in 300 regions, covering 77% of the country, with a total of 300 billion yuan allocated from the medical insurance fund. However, the impact on the growth rate of the insurance fund remains limited [3][15][16] - **Regulatory Environment**: The regulatory intensity in the healthcare sector will remain high, with ongoing efforts to address misconduct in medical procurement and retail pharmacy sectors [3][17][28][29] - **Medical Equipment Market**: The bidding scale for medical equipment is gradually increasing, with significant growth in areas such as medical imaging and surgical robots. However, the terminal prices are under pressure due to centralized procurement [3][23][24][25] - **IVD (In Vitro Diagnostics) Sector**: The IVD sector is experiencing slower progress in price adjustments due to different pricing mechanisms in hospitals, but there is a significant potential for domestic substitution as imported products still hold a large market share [20][21] Conclusion The pharmaceutical industry is undergoing significant changes driven by government policies aimed at enhancing healthcare accessibility and supporting innovation. The focus on regulatory compliance and quality control is expected to shape the industry's future landscape, with opportunities for growth in innovative drugs and medical equipment sectors.

Investment Rating - The report does not explicitly state an investment rating for the industry Core Insights - The policy direction focuses on "ensuring basic needs and strengthening innovation," aiming to enhance accessibility and affordability of medical products and services while promoting innovation across the pharmaceutical industry [4][7] - The support for innovative drugs continues to increase, with measures to enhance their quality development and integration into insurance systems [12][13] - The report highlights the ongoing collection and procurement processes for various drug categories, including generic drugs, traditional Chinese medicine, and high-value consumables, indicating a trend towards optimization and expansion [21][24][31] Summary by Sections 1. Top-Level Design Direction - The central government has issued guidelines to enhance social security and improve public services, particularly in the healthcare sector, emphasizing the need for equitable access to medical resources [7][8] 2. Support for Innovative Drugs - The National Healthcare Security Administration (NHSA) and the National Health Commission have released measures to support the high-quality development of innovative drugs, including multi-channel payment systems and international promotion [12][13] - The introduction of a separate payment mechanism for long-term and high-cost drugs is being implemented in various provinces, enhancing accessibility for patients [14][16] 3. Generic Drugs - The report anticipates optimization of the rules for the 11th batch of drug procurement, which is expected to take place in 2025, focusing on quality and price adjustments [21][23] 4. Traditional Chinese Medicine - The procurement rules for traditional Chinese medicine are becoming clearer, with expectations for quality improvements and market expansion [24][26] 5. High-Value Consumables - The report notes that most high-value consumable procurement has been completed, with ongoing attention to key product renewals and the expansion of procurement coverage [31][32] 6. In Vitro Diagnostics (IVD) - The report discusses the dual approach of alliance procurement and service price governance, indicating a comprehensive strategy to enhance the IVD sector [35][38] 7. Industry Regulation - Regulatory measures are being strengthened to guide high-quality development in the healthcare sector, including ongoing efforts to combat corruption and ensure compliance among medical institutions and retail pharmacies [8][9] 8. Real-Time Medical Insurance Settlement - The NHSA plans to implement real-time settlement of basic medical insurance funds by the second half of 2025, which is expected to alleviate cash flow pressures for medical institutions [9][10]

智通财经编辑 | 谢欣 中美贸易摩擦影响延伸到体外诊断（IVD）行业。 体外诊断作为我国现代医疗体系的核心组成部分，广泛应用于疾病筛查、诊断与疗效监测，在整个医疗 服务链条中扮演着基础但关键的角色。 长期以来，IVD产业链高度依赖全球化分工，是受进出口影响最大的医疗器械细分领域之一。这也是我 国唯一进口额大于出口额的医疗细分领域，其余如医用耗材、康复产品、牙科设备等均实现顺差。 智通财经记者 | 李科文 据药智医械数据，2024年，我国IVD试剂与IVD仪器的进口额分别为416.79亿元和154.08亿元，分别占 医疗器械进口总额的17%和6.28%。 在关税摩擦下，国产IVD行业、尤其是在上游原料上，也迎来了一个发展的窗口期。 国产化已有突破 伯杰医学健康X研究院负责人沙海跟智通财经表示，过去十余年间，我国体外诊断领域的国产化进程取 得了不少实质性突破。在生化诊断、血细胞分析、分子PCR检测、NGS（二代基因测序）和POCT（即 时诊断）这些产品领域，国产替代的比例已达到60%–70%。而随着国家政策的持续鼓励以及产业技术 能力的进一步提升，相关技术已逐步趋近于完全自主。 一位不愿具名的体外诊断从业者向智通 ...