本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗 漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 赛诺医疗科学技术股份有限公司（以下简称"赛诺医疗"或"公司"） 控股子公司赛诺神畅 医疗科技有限公司（以下简称"赛诺神畅"或"子公司"）于近日收到美国食品药品监督管理局（以 下简称"FDA"）通知，公司控股子公司赛诺神畅自主研发的 COMETIU 自膨式颅内药物涂层支 架系统（以下简称"COMETIU 支架"）及 COMEX 球囊微导管获得美国 FDA 突破性医疗器械 认定。现将具体情况公告如下： 一、"FDA 突破性医疗器械认定"介绍 FDA 突破性器械认定是美国食品药品监督管理局（FDA）为加速创新医疗器械开发和审 评进程而设立的"绿色通道"，旨在让患者能更快的获得用于治疗或诊断威胁生命或不可逆衰弱 疾病或病症的安全、有效的医疗器械。获得 FDA 突破性医疗器械认定的产品必须满足以下关 键条件："在全球范围内的原创技术，且可以更有效的治疗或诊断危及生命或不可逆地使人衰 竭的人类疾病或状况，没有已获批方案或替代方案，或者与现有已获批或替代方案相比具有显 著临 ...

赛诺医疗公告，控股子公司赛诺神畅研发的COMETIU自膨式颅内药物涂层支架系统及COMEX球囊微 导管已获得美国FDA突破性医疗器械认定。该产品是美国FDA历史上全球首个颅内动脉粥样硬化狭窄治 疗产品，也是首个获得美国FDA突破性医疗器械认定的国产神经介入器械产品。此次认定的获得，是公 司在神经介入缺血性卒中治疗创新产品战略进程的又一重大里程碑，标志着公司在研产品COMETIU自 膨式颅内药物涂层支架系统的技术创新及显著临床优势进一步获得国际权威监管机构认可。同时，该认 定将有力推动公司神经介入创新产品的国际化布局，加速公司全球化战略进程，显著提升公司品牌的国 际知名度，进一步夯实公司的核心竞争力。 ...

Core Insights - Stryker reported Q2 2025 financial results with net sales of $6.0 billion, exceeding analyst expectations of $5.94 billion, and adjusted earnings per share of $3.13, surpassing the consensus of $3.07, reflecting double-digit growth in sales and profits year-over-year [1][2][5] - The company raised its full-year 2025 guidance for organic net sales growth to 9.5% to 10.0% and adjusted earnings per share to a range of $13.40 to $13.60, indicating strong momentum in product lines [1][13] Financial Performance - Q2 2025 non-GAAP EPS was $3.13, an 11.4% increase from $2.81 in Q2 2024 [2] - GAAP revenue for Q2 2025 was $6.0 billion, up 11.1% from $5.4 billion in Q2 2024 [2] - U.S. sales increased by 12.5%, while international sales rose by 6.8%, with organic sales growth at 10.2% [5][6] Segment Performance - The MedSurg and Neurotechnology segment generated $3.77 billion in net sales, reflecting a 17.3% year-over-year increase [6] - The Orthopaedics segment recorded $2.25 billion in GAAP sales, with a reported growth of 2.0%, which would have been 10.7% excluding the divestiture of the Spinal Implants business [7] Cost and Margin Analysis - Adjusted operating margin improved to 25.7%, a 1.1 percentage point increase year-over-year, driven by a stronger sales mix and pricing [9] - Increased selling, general, and administrative expenses, along with higher impairment charges, impacted operating margins [8][10] Strategic Initiatives - Stryker's success is attributed to innovation, acquisitions, and effective integration, with recent focus on robotics-assisted devices and vascular offerings [3][4] - The acquisition of Inari significantly contributed to the growth of the vascular devices product family [10] Future Outlook - Management anticipates costs from tariffs to be around $175 million for 2025, alongside ongoing integration of recent acquisitions [13] - Investors are encouraged to monitor the Mako Spine product launch, adoption of AI solutions, and international expansion efforts [14]

Core Insights - In the first half of this year, China approved 43 innovative drugs and 45 innovative medical devices, representing year-on-year increases of 59% and 87% respectively, indicating that reform policy dividends are transforming into industrial development momentum [1] Regulatory Reforms - Since last year, the National Medical Products Administration (NMPA) has conducted pilot reforms in 11 provincial-level bureaus to optimize the supplementary application process for drugs, reducing the review time for supplementary applications that require inspection from 200 working days to 60 working days [1] - The NMPA is also exploring the completion of clinical trial reviews and approvals for key innovative drugs within 30 working days [1] Product Approvals - In the first half of the year, 70 new pediatric drugs and 21 rare disease drugs were approved [1] Innovation Initiatives - The Ministry of Industry and Information Technology and the NMPA jointly launched an initiative to promote innovation in artificial intelligence medical devices and biomedical materials [1] - The NMPA introduced 10 measures to optimize the full lifecycle supervision to support the innovative development of high-end medical devices, facilitating the market entry of complex and high-difficulty innovative medical devices such as multifocal intraocular lenses and cardiac pulsed field ablation devices [1]

Group 1 - The core business of the company is the research, manufacturing, sales, and service of medical devices, with main products including blood purification, drug delivery devices, and thoracic surgery products [2] - As of the end of 2024, the company has obtained 203 authorized patents, 121 accepted patents, and holds 102 medical device product registration certificates, demonstrating a strong focus on technological innovation and R&D [2] - The company has received various governmental support for its projects, including recognition as a "National Intellectual Property Advantage Enterprise" and awards for its key technologies in blood dialysis membrane production [2] Group 2 - The company's latest financial performance for Q1 2025 shows revenue of 361 million yuan, an increase of 8.88% year-on-year, and a net profit of 53.73 million yuan, with a slight increase of 0.20% year-on-year [2] - The company's current rolling P/E ratio is 19.93, which is significantly lower than the industry average of 55.41 and the industry median of 37.94 [1][3] - The total market capitalization of the company is 4.534 billion yuan, ranking it 41st in the medical device industry [1][3]

欧盟批准向企业提供4.03亿欧元资金，以促进医疗器械创新。 ...

Group 1 - The core viewpoint of the article highlights the increasing role of commercial insurance in supporting high-priced innovative drugs and medical devices, as indicated by the measures proposed in "Several Measures to Support the High-Quality Development of Innovative Drugs" [1] - The innovative drug industry is expected to continue its rapid development, leading to a recovery in the upstream supply chain, including research reagents and the CXO industry, with performance expected to improve starting from the 2025 mid-year report [1] - The policy-driven phase of innovative drug results is anticipated, with significant research and development progress acting as a catalyst, making it a key investment theme in the pharmaceutical sector [1] Group 2 - The article expresses optimism about the overseas market and the clearing of centralized procurement sectors, particularly in niche areas such as insulin and orthopedics [1] - The concentration of the pharmaceutical market is accelerating, and an increase in mergers and acquisitions is expected [1] - In the medical device sector, measures to support the innovation and development of high-end medical devices are likely to be introduced, benefiting from policy support and enhanced payment capabilities [1] Group 3 - The medical ETF tracks the CSI Medical Index, which is compiled by the China Securities Index Co., selecting representative listed companies in the pharmaceutical manufacturing, medical services, and medical device sectors from the A-share market [1] - The index constituents exhibit significant industry concentration and market representation, serving as a barometer for observing the development trends in the medical industry and often used as a benchmark for developing medical-themed investment products [1]

Core Viewpoint - The article discusses the implications of the EU's recent ban on Chinese medical device participation in its procurement processes, highlighting the rapid growth of China's medical device industry and the potential for retaliatory measures from China [3][4]. Summary by Sections EU-China Medical Trade Dynamics - In 2024, the trade scale of medical devices between China and the EU is projected to be $37.04 billion, with China importing $28.04 billion (a 6.09% decrease year-on-year) and exporting $9 billion (a 12% increase) [5]. Product Composition and Market Trends - China's exports of high-end medical equipment to the EU have seen significant growth, with endoscopes increasing by 294% over four years. Advanced models like 7.0T MRI and 640-slice CT are gaining market share in Germany and France due to competitive pricing [6]. - Despite the EU being China's largest source of medical device imports, the market share of foreign brands is declining as domestic brands gain traction [6]. Rise of Domestic Brands - The domestic market for MRI machines has reached a localization rate of 35.1% in 2024, with CT machines seeing significant increases in installation rates in tertiary hospitals. Domestic brands have reduced PET-CT examination costs by approximately 25% [8]. - By early 2025, about 70% of medical linear accelerators approved by the National Medical Products Administration are domestically produced, showcasing the rapid advancement of local manufacturing capabilities [8]. Factors Supporting Domestic Growth - The rise of domestic brands is attributed to favorable policies like "Made in China 2025," which mandates the application of domestic medical devices in public hospitals. Regulatory support for emerging technologies has also accelerated domestic innovation [11]. - Domestic medical devices are iterating faster than imports, with significant advancements in technology and design tailored to local needs [12]. Innovations and Future Prospects - China is leading in brain-computer interface technology and surgical robotics, with unique innovations such as five-arm robots and non-inflated surgery techniques [13]. - The article emphasizes the potential for Chinese medical devices to become a global benchmark, driven by a large domestic market and rapid technological advancements [14].

Group 1 - Chengdu High-tech Zone Medical Device Innovation and Transformation Association facilitated Qinglan Jichuang Medical Equipment to obtain a credit line of tens of millions from Chengdu Bank, specifically for production line expansion and technology research and development [1] - Anbiping announced that its HPV nucleic acid test kit received a medical device registration certificate from the National Medical Products Administration, capable of detecting 18 high-risk HPV types and further expanding its layout in the tumor screening field [1] - In the first half of 2025, China approved 45 innovative medical devices, a year-on-year increase of 87%, reflecting the continuous policy dividends driving industry technological upgrades [1] Group 2 - The domestic nuclear medicine industry has a high dependence on imported radionuclide raw materials, but domestic technological breakthroughs and capacity releases are expected to enhance the self-supply capability of major isotopes [2] - The nuclear medicine regulatory environment is strict, creating high barriers to entry, with companies like China Radiopharmaceuticals and Dongcheng Pharmaceutical holding a first-mover advantage in the midstream production and distribution sectors [2] - The nuclear medicine market is projected to grow at a compound annual growth rate of over 20% over the next five years, reaching 26 billion yuan by 2030, driven by policy support and increasing medical resource allocation [2] Group 3 - The ChiNext Medical ETF tracks the Chuangyi Medicine Index, which can experience daily fluctuations of up to 20%, reflecting the overall performance of listed companies in the medical manufacturing, medical devices, and medical services sectors on the ChiNext market [2] - The index consists of companies with innovative characteristics and high growth potential, generally characterized by high research and development investment and industry development potential [2]

Group 1: Market Performance - The biopharmaceutical, innovative drug, and pharmaceutical outsourcing sectors are experiencing strong performance, with WuXi AppTec rising over 9% and WuXi Biologics also increasing by over 9%, contributing to a 1.5% rise in the Hang Seng Biotechnology Index [1] - The Hang Seng Medical ETF (513060) opened high and fluctuated throughout the morning, nearing a 1% increase with a trading volume of nearly 1 billion yuan, indicating active trading [1] Group 2: Policy and Industry Growth - In the first half of 2025, China's innovative medical device sector achieved a milestone with 45 innovative medical devices approved for market, a year-on-year increase of 87%, marking the highest growth rate in history [2] - The approval of innovative drugs also saw a significant increase, with 43 new drugs approved, reflecting a 59% year-on-year growth, driven by ten regulatory optimization measures from the National Medical Products Administration [2] Group 3: Domestic Innovations - The approved innovative medical devices exhibit characteristics of high-end, precision, and platform-based technologies, achieving significant breakthroughs in three areas: precision intervention, structural heart disease, and energy ablation [3] - The domestic IVUS catheter has broken the monopoly of international giants, receiving EU certification and entering the European market, showcasing China's capability in high-end interventional devices [3] - The domestic transcatheter tricuspid valve repair system is the first of its kind approved in China, addressing a significant clinical need for over 1 million patients with severe tricuspid regurgitation [3] Group 4: Robotics and AI Integration - The integration of medical robotics and artificial intelligence is transforming clinical operations, with domestic surgical robots successfully performing complex minimally invasive surgeries [4] - A new business model combining "robot leasing + industry platform" is emerging to lower the cost barriers for hospitals, facilitating the adoption of advanced robotic technologies [4] Group 5: Future Outlook - The combination of AI models and robotic technology is expected to reshape the entire chain from auxiliary diagnosis to surgical execution, with regulatory bodies accelerating clinical transitions [5] - The Hang Seng Medical ETF (513060) is positioned to benefit from the robust growth of the medical device industry, supported by favorable policies and increasing demand due to an aging population [6][7]