证券代码：688108 证券简称：赛诺医疗 公告编号：2025-054 赛诺医疗科学技术股份有限公司关于公司 冠脉球囊产品在海外获得注册证的自愿性披露公告 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。 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 2024 年 11 月向 巴西国家卫生监督局（ANVISA）递交了公司 SC HONKYTONK TM 冠脉球囊扩张导管的注册申报资 料。公司于近日收到 ANVISA 的通知，公司 SC HONKYTONK TM 冠脉球囊扩张导管的注册申报资料 获得 ANVISA 的批准。现将相关情况公告如下： 一、注册证内容 证书编号：80047300917 产品名称：SC HONKYTONK TM 冠脉球囊扩张导管 结构及组成：冠脉球囊扩张导管为快速交换型（Rx 型）球囊扩张导管。主要由 TIP 头、 球囊保护鞘、球囊、球囊内管、球囊外管、金属导管组成，球囊内有铂铱合金显影环。产品经 环氧乙烷灭菌，一次性使用，货架有效期 3 年。 适用范围：该产品适用于对冠状动脉的狭窄 ...

Core Viewpoint - The company, Sino Medical (688108.SH), has successfully received approval from Brazil's National Health Surveillance Agency (ANVISA) for its SC HONKYTONK TM coronary balloon dilation catheter, which is designed to improve myocardial perfusion by dilating narrowed segments of coronary arteries or bypass grafts [1] Group 1 - The company submitted the registration application for the SC HONKYTONK TM coronary balloon dilation catheter to ANVISA in November 2024 [1] - The approval from ANVISA indicates a significant milestone for the company in expanding its product offerings in the Brazilian market [1] - The SC HONKYTONK TM product is specifically aimed at treating coronary artery stenosis, which is a critical area in cardiovascular health [1]

Core Viewpoint - Sino Medical (688108.SH) has received approval from Brazil's National Health Surveillance Agency (ANVISA) for its SC HONKYTONKTM coronary balloon dilation catheter, which is designed to improve myocardial perfusion by dilating narrowed segments of coronary arteries or bypass grafts [1]. Group 1 - The company submitted the registration application for the SC HONKYTONKTM product to ANVISA in November 2024 [1]. - The approval from ANVISA indicates a significant milestone for the company's expansion into international markets [1]. - The SC HONKYTONKTM product is specifically intended for use in coronary artery interventions [1].

Core Viewpoint - Sino Medical (688108) has successfully received approval from Brazil's National Health Surveillance Agency (ANVISA) for its SC HONKYTONK™ coronary balloon dilation catheter registration application submitted in November 2024 [1] Group 1 - The company submitted the registration application for the SC HONKYTONK™ coronary balloon dilation catheter to ANVISA on November 18, 2024 [1] - The approval from ANVISA was recently communicated to the company, indicating a positive regulatory outcome for the product [1]

Core Viewpoint - The company has received approval from Brazil's National Health Surveillance Agency (ANVISA) for its SC HONKYTONKTM coronary balloon dilation catheter registration application submitted in November 2024 [1] Group 1 - The company submitted the registration application for the SC HONKYTONKTM coronary balloon dilation catheter to ANVISA in November 2024 [1] - The approval from ANVISA indicates a significant milestone for the company's product in the Brazilian market [1]

Core Viewpoint - Sino Medical (688108) experienced a slight decline in stock price, closing at 19.49 yuan, down 1.27% from the previous week [1] Company Performance - The highest intraday price for Sino Medical during the week was 20.06 yuan on November 10, while the lowest was 19.16 yuan on November 13 [1] - The current total market capitalization of Sino Medical is 8.109 billion yuan, ranking 48th out of 126 in the medical device sector and 2308th out of 5165 in the overall A-share market [1] Upcoming Events - Sino Medical will hold a Q3 2025 earnings presentation on November 17, 2025, from 14:00 to 15:00 via the Shanghai Stock Exchange Roadshow Center [1] - The presentation will cover the company's Q3 2025 operational results and financial status, with participation from key executives including Chairman Sun Jianhua and independent directors [1] - Investors can submit questions in advance from November 10 to 14, and the meeting content will be available for viewing afterward [1]

Core Viewpoint - Sino Medical has shown significant stock performance with a year-to-date increase of 102.66%, despite recent fluctuations in the stock price [1][2] Group 1: Stock Performance - As of November 14, Sino Medical's stock price reached 19.78 CNY per share, with a market capitalization of 8.229 billion CNY [1] - The stock experienced a net inflow of 8.0564 million CNY from major funds, with large orders accounting for 20.37% of total buy orders [1] - The stock has seen a decline of 29.83% over the past 20 days and 34.93% over the past 60 days [1] Group 2: Financial Performance - For the period from January to September 2025, Sino Medical reported a revenue of 364 million CNY, reflecting a year-on-year growth of 14.24% [2] - The net profit attributable to the parent company was 21.118 million CNY, marking a substantial increase of 293.46% year-on-year [2] - The company has distributed a total of 41 million CNY in dividends since its A-share listing, with no dividends paid in the last three years [2] Group 3: Company Overview - Sino Medical, established on September 21, 2007, specializes in the research, production, and sales of high-end interventional medical devices [1] - The company's product line includes key areas such as cardiovascular, cerebrovascular, and structural heart disease interventions, with stents contributing 59.76% and balloons 32.68% to its revenue [1][2] - As of September 30, the number of shareholders increased to 29,400, with an average of 14,170 circulating shares per shareholder [2]

Core Viewpoint - The company has introduced a new innovative medical device, the mesh stent, which is expected to begin market sales in the second half of 2025, with positive initial sales performance reported [1] Group 1: Product Launch and Market Expectations - The mesh stent received its registration certificate this year, indicating it is a newly developed product by the company [1] - The company anticipates that 2026 will be a market education and introduction period, with low sales expected during this time [1] - Investors are encouraged to expect a significant increase in sales starting in 2027 [1]

Group 1 - The coronary business shows steady growth with continuous improvement in profitability [1] - The neurointerventional business demonstrates resilience, with significant new products entering the harvest phase [1] - The internationalization strategy is accelerating, leading to key breakthroughs in overseas markets [1]

Market Overview - The medical device sector experienced a slight decline of 0.13% on November 11, with Danaher Biomedical leading the drop [1] - The Shanghai Composite Index closed at 4002.76, down 0.39%, while the Shenzhen Component Index closed at 13289.0, down 1.03% [1] Top Performers - Anxu Bio (688075) saw a closing price of 42.54, with an increase of 4.39% and a trading volume of 23,700 [1] - Nanwei Medical (688029) closed at 86.17, up 3.89% with a trading volume of 31,700 [1] - Yirui Technology (688301) closed at 109.90, increasing by 2.65% with a trading volume of 22,000 [1] Underperformers - Danaher Biomedical (920009) closed at 77.69, down 4.91% with a trading volume of 16,300 [2] - Ruimait (301367) closed at 86.41, down 4.32% with a trading volume of 18,600 [2] - Tianchen Medical (688013) closed at 52.68, down 3.59% with a trading volume of 26,900 [2] Capital Flow - The medical device sector saw a net outflow of 642 million yuan from institutional investors, while retail investors contributed a net inflow of 463 million yuan [2][3] - The top net inflows from retail investors were observed in Nanwei Medical (688029) with 46.22 million yuan, and Tianchen Medical (688013) with 24.78 million yuan [3]