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"）于 2021 年 12 月向美国食品药品监督管理局（以下简称"FDA"）递交了公司新型药物洗脱支架系 统的注册申报资料。公司于近日收到美国 FDA 通知，公司新型药物洗脱支架系统 PMA 申请获 FDA 附条件批准，美国 FDA 将在公司按其要求完成相关针对性完善工作后，为 公司签发正式批准令。现将本次获得美国 FDA 附条件批准情况公告如下： 证券代码：688108 证券简称：赛诺医疗 公告编号：2025-029 赛诺医疗科学技术股份有限公司 关于公司新型药物洗脱支架系统 获得美国 FDA 附条件批准的自愿性披露公告 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。 本次获得美国 FDA 附条件批准的新型药物洗脱支架系统是我国三类高端植入医疗 器械领域首个在美国 FDA 申请上市前批准（PMA）审批的国产原研产品。该产品拥有全 球专利布局，在中国、美国、日本、欧洲等多个国家和地区超过 100 家顶尖临床机构 同步进行了以国际公认金标准的雅培 Xience 系列、 ...

Group 1 - The core viewpoint of the articles highlights the performance and valuation of Sino Medical, noting its significant increase in stock price and high PE ratio compared to industry averages [1][2] - As of July 18, Sino Medical's stock closed at 12.12 yuan, up 7.73%, with a rolling PE ratio of 821.26, marking a new low in 285 days and a total market capitalization of 5.043 billion yuan [1] - The average PE ratio for the medical device industry is 52.34, with a median of 36.99, placing Sino Medical at the 121st position in the industry ranking [1][2] Group 2 - For Q1 2025, Sino Medical reported revenue of 101 million yuan, a year-on-year increase of 10.75%, and a net profit of 2.9693 million yuan, reflecting a substantial year-on-year growth of 277.50% [2] - The company's gross profit margin stands at 59.66%, indicating strong profitability relative to its revenue [2] - As of March 31, 2025, Sino Medical had 11,044 shareholders, an increase of 381 from the previous count, with an average holding value of 352,800 yuan and an average shareholding of 27,600 shares per shareholder [1]

Summary of Key Points Core Viewpoint - The announcement details the shareholding reduction by directors and executives of Sino Medical Science Technology Co., Ltd., indicating a planned divestment of shares due to personal financial needs, with specific details on the number of shares held and reduced by each individual [1][4][12]. Shareholding Information - Director and core technical personnel Kang Xiaoran held a total of 1,756,399 shares, representing 0.4248% of the total shares before the reduction [1]. - Vice President Cui Liye held 1,794,692 shares, accounting for 0.4341% of the total shares before the reduction [2]. - Director Cai Wenbin held 1,252,414 shares, which is 0.3029% of the total shares before the reduction [2]. - Financial Director Shen Lihua held 237,840 shares, representing 0.0575% of the total shares before the reduction [2]. - Secretary of the Board Huang Kai held 268,981 shares, accounting for 0.0651% of the total shares before the reduction [3]. - Director Chen Lin held 168,000 shares, which is 0.0406% of the total shares before the reduction [3]. Reduction Plan Implementation - The reduction plan was announced to take place over a three-month period from April 17, 2025, to July 16, 2025, following a 15-day trading window after the announcement [4]. - As of July 16, 2025, Kang Xiaoran reduced his holdings by 168,000 shares, leaving him with 1,588,399 shares, or 0.3818% of the total shares [4]. - Cui Liye reduced his holdings by 42,000 shares, resulting in a total of 1,752,692 shares, or 0.4213% of the total shares [4][9]. - Cai Wenbin also reduced his holdings by 42,000 shares, leaving him with 1,210,414 shares, or 0.2909% of the total shares [4][9]. - Shen Lihua and Chen Lin each reduced their holdings by 42,000 shares, with Shen holding 195,840 shares (0.0471%) and Chen holding 126,000 shares (0.0303%) after the reduction [5][10]. Financial Details of Reductions - The reduction prices for Kang Xiaoran ranged from 9.77 to 10.13 CNY per share, totaling approximately 1,660,378.49 CNY [8]. - Cui Liye's shares were sold at prices between 10.66 and 10.86 CNY per share, totaling around 453,760 CNY [9]. - Shen Lihua's shares were sold at prices between 9.77 and 11.12 CNY per share, totaling approximately 429,950 CNY [9]. - Chen Lin's shares were sold at prices between 10.00 and 11.30 CNY per share, totaling around 468,350 CNY [9].

证券代码：688108 证券简称：赛诺医疗 公告编号：2025-028 赛诺医疗科学技术股份有限公司 董事、高管减持股份结果公告 本公司董事会、全体董事及相关股东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： 董事高管持有股份的基本情况 本次减持计划实施前，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"） 董事、副总经理、核心技术人员康小然先生合计持有公司 1,756,399 股，占减持前公司股份总 数的 0.4248%。其中，通过持股平台天津阳光福业企业管理合伙企业（有限合伙）间接持有公 司 1,084,399 股，占减持前公司股份总数的 0.2623%，该部分股票来源为公司首次公开发行前 取得的股份；通过个人股票账户直接持有公司 672,000 股（股权激励归属股份），占减持前公 司股份总数的 0.1625%，该部分股份来源为股权激励计划归属的股份。 公司董事陈琳女士合计持有公司 168,000 股（股权激励归属股份），占减持前公司股份总 数的 0.0406%，均为个人股票账户直接持有，该部分股份来源为股权激励 ...

在eLum的实验室里，Quang曾用一个简单实验展示技术突破：Quang左手拿起像精密弹簧一样的密网支 架，右手将杯子中的水倒入支架，倒进去的水没有像我们想像中的从支架中漏出来。Quang又拿起一支 铅笔轻轻碰触支架，这时有水漏出来了。这种特性，让支架既能阻断动脉瘤血流使其萎缩，又不影响周 边细小血管供血。 更关键的是，eLum帮助改进后的AUCURA血流导向密网支架可通过0.017"微导管抵达更深、更小的血 管中，且能100%顺利打开，这一性能同类产品很难做到。 技术优势源于材料与工艺的双重创新。AUCURA采用了新型合金材料，使用赛诺独有的电子涂层接枝 技术和编制技术，拥有全球最小的通过外径，能够在X光下实现全显影，具有更优的支架贴壁及更高效 封闭血管瘤能力，临床应用更加安全。而eLum并未止步于此，目前正针对支架显影不佳的行业通病， 研发全新的合金材料，未来有望让支架显影更好、支撑力更强。 宣武医院神经外科副主任何川在2025东方脑血管病会议上曾评价，该支架为远端动脉瘤提供了更安全到 达、更高效愈合、更可靠防护的解决方案，有望开启动脉瘤密网治疗的远近双轨时代。 从技术到产能的协同，是赛诺医疗快速崛起的关 ...

Core Viewpoint - The PTCA balloon industry in China is experiencing steady growth due to the increasing prevalence of cardiovascular diseases, the expansion of coronary intervention treatments, and the rise of domestic medical device manufacturers. The market size is projected to grow from 1.059 billion yuan in 2021 to 1.366 billion yuan in 2024, with expectations to exceed 2.274 billion yuan by 2030 [1][11]. Industry Overview - PTCA balloons are medical devices used in cardiovascular interventions to dilate narrowed or blocked coronary arteries, improving blood flow and myocardial supply [1]. - The industry chain consists of upstream raw materials and equipment supply, midstream production, and downstream application in various medical institutions for treating cardiovascular diseases [2]. Industry Environment - The incidence of coronary artery disease (CAD) is rising in China, with the number of patients increasing from 25.272 million in 2020 to 27.953 million in 2024, and projected to exceed 30 million by 2030 [4]. - The mortality rate for CAD has also increased significantly, indicating a growing demand for treatment options [4]. Industry Status - Percutaneous coronary intervention (PCI) is a key treatment method for CAD, with a record of 1.63 million PCI procedures performed in 2023, marking a growth rate of 26.44% [7]. - Despite the increasing number of PCI procedures, the market penetration rate in China remains low at 690.9 procedures per million people, compared to 3022.1 in the U.S., suggesting significant growth potential [9]. Competitive Landscape - The global PTCA balloon market is dominated by international giants like Boston Scientific and Medtronic, which hold over 60% market share, particularly in high-end drug-eluting balloons [13]. - Domestic companies account for 60% of the number of firms but only 40% of the market share, indicating a competitive landscape where local firms are striving to catch up through innovation [13]. Future Trends - The industry is witnessing significant technological innovation and product upgrades, with new polymer materials enhancing balloon performance and the introduction of drug-coated balloons reducing the risk of restenosis [19]. - The trend towards domestic substitution is accelerating, with local companies like MicroPort and Lepu Medical increasing their market share due to improved product quality and performance [20]. - The demand for PTCA balloons is expected to grow as their application expands beyond traditional coronary disease treatment to include peripheral and intracranial vascular diseases [21].

Group 1 - The core viewpoint of the articles highlights the financial performance and market position of Sainuo Medical, indicating a high PE ratio compared to industry averages [1][2] - As of the first quarter of 2025, Sainuo Medical reported a revenue of 101 million yuan, representing a year-on-year increase of 10.75%, and a net profit of 2.97 million yuan, showing a significant year-on-year growth of 277.50% [2] - The company's gross profit margin stands at 59.66%, indicating strong profitability relative to its revenue [2] Group 2 - Sainuo Medical's current PE ratio is 739.95, significantly higher than the industry average of 51.42 and the median of 37.44, placing it at the 121st position in the industry ranking [1][2] - The total market capitalization of Sainuo Medical is 4.543 billion yuan, reflecting its valuation in the medical device sector [1] - The company specializes in high-end interventional medical devices, with key products including biodegradable drug-coated coronary stent systems and various types of balloon catheters [1]

Summary of Key Points from Conference Call Records Industry Overview - The conference call discusses the **domestic medical device industry**, highlighting advancements in various companies and their innovative products. Key Companies and Their Innovations 1. **Peijia Medical** - The shockwave balloon technology shows a **30%-50% efficacy** in early clinical trials for treating aortic valve calcification [1] - The transcatheter aortic valve replacement product **Mona Q** has enrolled **9 patients** in the global Fame clinical trial, with no deaths or strokes reported during long-term follow-up. It has received **IDE clinical approval** in the U.S. and is expected to advance to U.S. clinical trials within the year [2][4] 2. **Jianxi Technology** - The tricuspid valve replacement product has completed clinical registration trials in Europe with a **97% success rate** and is expected to receive CE certification by **2025** [1][3] 3. **Xenon Medical** - The self-expanding intracranial drug-eluting stent has a **restenosis rate of only 1.7%-1.87%** and a **100% surgical success rate**. Approval is anticipated this year, with a market exclusivity period of **1.5 to 2 years** [1][6][7] 4. **HeartTech Medical** - Leading market share in domestic occluder products with a series of **four generations of biodegradable occluders**. The aortic valve product has been approved for commercialization since Q1 [1][8] 5. **Qiming Medical** - Four TAVI products have been approved and marketed in over **ten countries**. New TAVI products are under development, with expectations for a tricuspid valve replacement product to be approved in Europe by **2027** [1][9] Market Trends and Future Outlook - The medical device sector is expected to see a **catalyst for growth** in the second half of the year due to potential equipment upgrades, particularly in **3.0T MRI and 64-slice CT** products [2][17] - Companies like **Huitai Medical** are projected to have strong performance due to new product launches and market expansion [11][23] Competitive Strategies - Domestic medical device companies are enhancing their international competitiveness through: - **Patent breakthroughs** and early clinical trials [4] - Focusing on less crowded market segments for differentiation [4] - Collaborations with international firms to leverage global networks for faster commercialization [5] Financial Performance Expectations - Companies such as **Huitai Medical** and **Mingrui Medical** are expected to show strong growth in the second half of the year, despite some companies facing short-term pressures due to high bases from previous years [10][11][15] - The **IVD sector** is experiencing pressure from policy changes, but improvements are anticipated in the latter half of the year as companies adjust pricing strategies [28] Regulatory and Policy Impact - The medical industry is facing challenges from **DRG cost control policies** and increased compliance requirements, impacting overall performance and cash flow [33] Conclusion - The domestic medical device industry is poised for growth with innovative products and strategic collaborations, despite facing regulatory challenges and market competition. Companies are actively seeking to enhance their international presence and capitalize on emerging market opportunities.

Core Viewpoint - The neurointervention industry has undergone significant changes since the introduction of centralized procurement in 2021, leading to drastic price reductions and a shift in market dynamics, with a notable increase in the market share of domestic products and a concentration of market share among leading companies [1][2]. Group 1: Price Changes and Market Dynamics - The average price of spring coils dropped from 12,000 yuan to around 6,400 yuan, a decrease of 46.82%, with the highest drop reaching 66% [1]. - The minimum winning price for spring coils is now approximately 3,244 yuan, while the average price for intracranial thrombectomy stents has fallen from 26,900 yuan to below 4,000 yuan [1]. - The market share of domestic neurointervention products surged from less than 10% to 26% by 2024, indicating a significant shift in the competitive landscape [1]. Group 2: Financial Performance of Leading Companies - Despite gaining market share, leading companies in the neurointervention sector have faced continuous losses, with notable losses reported by companies such as MicroPort Brain Science and Guichuang Tongqiao [2]. - By 2024, these companies have turned profitable, with MicroPort Brain Science achieving a net profit of 249 million yuan, marking a significant turnaround from previous losses [2]. Group 3: Revenue Growth Factors - Revenue growth for leading companies has been substantial, with Guichuang Tongqiao's neurointervention business experiencing revenue growth rates of 463%, 108%, 64%, and 38.4% from 2021 to 2024 [3][4]. - The number of approved and commercialized products has increased significantly, with MicroPort Brain Science expanding from 8 to 25 products from 2021 to 2024 [5]. Group 4: Sales and Market Expansion Strategies - Centralized procurement has accelerated the commercialization of neurointervention products, leading to increased sales volumes despite lower prices [7][9]. - Companies like MicroPort Brain Science have expanded their product reach to approximately 520 hospitals, significantly increasing their market presence [8]. Group 5: Cost Management and Efficiency - Leading companies have focused on improving operational efficiency to reduce costs, with Guichuang Tongqiao reducing its sales and distribution expenses from 31% to 22.3% of total revenue [14]. - Companies have also optimized their supply chains and production processes, with MicroPort Brain Science achieving a 90% localization rate for raw materials by the end of 2023 [15][16]. Group 6: International Market Expansion - In response to domestic market pressures, leading companies are increasingly targeting international markets, with MicroPort Brain Science conducting over 50 overseas training and academic exchange events in 2024 [10][11]. - Guichuang Tongqiao reported international business revenue of 22.6 million yuan in 2024, a 58.2% increase, indicating successful market penetration in Europe and Asia [11].

Company Overview - Sino Medical's closing price on July 2 was 11.08 yuan, down 1.34%, with a rolling PE ratio of 750.79 times and a total market value of 4.61 billion yuan [1] - The company specializes in the research, production, and sales of high-end interventional medical devices, including biodegradable drug-coated coronary stent systems and various types of balloon dilatation catheters [1] Financial Performance - In the first quarter of 2025, the company achieved operating revenue of 101 million yuan, a year-on-year increase of 10.75%, and a net profit of 2.97 million yuan, a year-on-year increase of 277.50% [2] - The sales gross margin for the same period was 59.66% [2] Shareholder Information - As of March 31, 2025, the number of shareholders for Sino Medical was 11,044, an increase of 381 from the previous count, with an average holding value of 352,800 yuan and an average holding quantity of 27,600 shares [1] Industry Comparison - The average PE ratio for the medical device industry is 51.29 times, with a median of 37.02 times, placing Sino Medical at the 121st position in the industry ranking [1] - The company's static PE ratio is 3077.74 times, and its price-to-book ratio is 5.30 [2]