赛诺医疗科学技术股份有限公司关于 证券代码：688108 证券简称：赛诺医疗 公告编号：2025-055 证书编号：ELI-00023 产品名称：HT Supreme?药物洗脱支架系统 结构及组成：HT Supreme?药物涂层冠状动脉支架系统是一种药械组合产品，由药物涂层的可扩张钴铬 (CoCr)合金冠状动脉支架和球囊输送系统组成。本支架底部涂覆不可腐蚀的聚合物层，表面涂覆供药物 释放的生物可降解聚合物层。药物释放的生物可降解聚合物层由sirolimus和生物可降解聚合物的混合物 组成。使用快速交换球囊可扩张输送系统来输送支架。产品保存期限为自灭菌之日起18个月。 适用范围：HT SupremeTM 药物涂层冠状动脉支架系统适用于改善因原发冠状动脉病变部位(长度≤40毫 米) 而导致的症状性心脏病病患的冠状动脉管腔直径，其中参考血管直径为2.25毫米至5.00毫米。 二、医疗器械基本情况 公司冠脉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。 重要内容提示： 赛诺医疗科学技术股份有限 ...

Group 1 - Aolide plans to raise no more than 300 million yuan through a simplified procedure for issuing shares to specific targets, with net proceeds allocated to the production base project for OLED display core materials and to supplement working capital [1] - Wanbang's subsidiary has obtained a 10-year exclusive agency for sildenafil oral suspension, which is suitable for patients with swallowing difficulties [2] - Titan Technology and its affiliate plan to jointly invest in increasing capital for its subsidiary, Micro Detection, raising its registered capital from 10 million yuan to 50 million yuan [3] Group 2 - Jindike will not issue new batches of quadrivalent influenza virus split vaccine this year, having produced approximately 1.56 million doses [4] - Aladdin intends to purchase 35% equity of Youke for 61.25 million yuan, funded by its own or raised capital [5] - Gujia Home's application for a private placement of A-shares has been approved by the Shanghai Stock Exchange [7] Group 3 - Honghe Technology's application for a private placement of A-shares has been approved by the China Securities Regulatory Commission [9] - Guangdian Yuntong has won contracts totaling 308 million yuan for the construction of an artificial intelligence application pilot base [10] - Shanghai Mechanical plans to repurchase B-shares worth no more than 278 million yuan [11] Group 4 - Weiling Co. is planning a change of control, with shares representing 7.76% of the total being transferred [14] - Jiugang Hongxing intends to invest 200 million yuan to establish a wholly-owned subsidiary focusing on high-quality special steel materials [16] - Zhongjian Technology has submitted an application for H-share listing [17] Group 5 - Sainuo Medical has received registration approval for its coronary product in Pakistan [18] - Huafeng Aluminum plans to acquire 100% equity of Huafeng Puen for 100 million yuan [20] - Fuda Co. intends to establish a wholly-owned subsidiary with an investment of 30 million yuan [22] Group 6 - Su Yan Jingshen's application for a private placement of shares has been approved by the Shanghai Stock Exchange [24] - Zhongchuang Co. has set the inquiry transfer price at 25.75 yuan per share [25] - Jinpu Garden has had a lawsuit involving 26.557 million yuan accepted by the court [29] Group 7 - ICBC has approved the appointment of Zhao Guid as vice president [30] - Betta Pharmaceuticals has had its drug registration application for ensartinib accepted [32] - Times New Materials plans to invest 6 million euros to establish a wholly-owned subsidiary in Serbia [34] Group 8 - China State Construction has appointed Chen Yong as vice president [36] - Dayang Electric plans to invest 10 million yuan to establish an industrial fund [38] - Advanced Digital has appointed Liu Zhigang as deputy general manager [39] Group 9 - Tianqi Co. plans to transfer 7% equity of Youqi Intelligent for 130 million yuan [40] - Xinguo has submitted an application for H-share issuance and listing [42] - Jinhongshun's shareholder has terminated a share reduction plan [43] Group 10 - Wanrun Co.'s actual controller plans to increase shareholding between 365 million yuan and 730 million yuan [44] - Suzhou High-tech plans to sell 47% equity of its medical device subsidiary for 604 million yuan [45] - Huayou Cobalt's subsidiary has signed a product supply agreement with Yiwei Lithium Energy for approximately 127,800 tons of materials [47] Group 11 - China Communications has won 10 important projects totaling approximately 2.539 billion yuan [49] - Nopushin plans to raise no more than 1.45 billion yuan through a private placement [50] - Yun Aluminum plans to acquire minority stakes in three subsidiaries for a total of 2.267 billion yuan [51] Group 12 - Xiamen Tungsten plans to establish a 500 million yuan merger fund with multiple parties [52] - Aotewei has signed a contract worth approximately 700 million yuan [54] - Hemai Co.'s shareholders plan to reduce their holdings by no more than 3% [56]

HT Supreme™药物洗脱支架系统 证书编号：ELI-00023 证券代码：688108 证券简称：赛诺医疗 公告编号：2025-055 赛诺医疗科学技术股份有限公司关于 公司冠脉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。 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"）于 2023 年 10 月 向巴基斯坦药品监管局（Drug Regulatory Authority of Pakistan，以下简称"DRAP"）递 交了公司 HT Supreme™药物洗脱支架系统的注册申报资料。公司于近日收到通知，递交 的注册申报资料获得 DRAP 的批准。现将相关情况公告如下： 一、注册证内容 三、对公司的影响及风险提示 本次公司产品在巴基斯坦获得注册证，是公司海外业务拓展的重要组成部分，将对 公司产品在海外的销售起到一定的推动和促进作用。上述产品在巴基斯坦上市后，其国 际市场销售可能会受到海外法规政策、市场环境变化、以及汇率波动等不确定因素的影 响，公司尚 ...

HT Supreme™药物涂层冠状动脉支架系统适用于改善因原发冠状动脉病变部位(长度≤40毫米)而导致的 症状性心脏病病患的冠状动脉管腔直径，其中参考血管直径为2.25毫米至5.00毫米。 赛诺医疗(688108.SH)公告，公司于2023年10月向巴基斯坦药品监管局(简称"DRAP")递交了公司HT Supreme™药物洗脱支架系统的注册申报资料。公司于近日收到通知，递交的注册申报资料获得DRAP 的批准。 ...

每经AI快讯，11月26日，赛诺医疗(688108.SH)公告称，公司于2023年10月向巴基斯坦药品监管局递交 了公司HT Supreme™药物洗脱支架系统的注册申报资料，近日收到通知，递交的注册申报资料获得 DRAP的批准。该产品是我国支架厂商自主研发的首个在中国、美国、日本、欧洲同步进行支架上市前 临床研究并在前述国家和地区申请产品注册的心脏支架产品。此次在巴基斯坦获得注册证，是公司海外 业务拓展的重要组成部分，将对公司产品在海外的销售起到一定的推动和促进作用。 ...

赛诺医疗公告，公司于近日收到通知，递交的HT Supreme 药物洗脱支架系统注册申报资料获得巴基斯 坦药品监管局（DRAP）的批准。HT Supreme 药物洗脱支架系统是我国支架厂商自主研发的首个在中 国、美国、日本、欧洲同步进行支架上市前临床研究并在前述国家和地区申请产品注册的心脏支架产 品，于2019年12月获得欧盟CE认证，于2020年12月获得中国国家药监局颁发的《医疗器械注册证》。 ...

Core Viewpoint - The approval of the HT Supreme™ drug-eluting stent system by the Drug Regulatory Authority of Pakistan (DRAP) marks a significant milestone for the company in expanding its overseas business and is expected to boost sales in international markets [1][2] Group 1: Product Registration and Development - The company submitted the registration application for the HT Supreme™ drug-eluting stent system to the Drug Regulatory Authority of Pakistan in October 2023 and has received approval [1] - The HT Supreme™ stent is the first product developed by a Chinese stent manufacturer to conduct pre-market clinical studies simultaneously in China, the United States, Japan, and Europe, receiving CE certification in December 2019 and medical device registration in China in December 2020 [1] - The product has also obtained medical device registrations in multiple countries including Thailand, Uzbekistan, Singapore, Indonesia, Turkey, Taiwan, Malaysia, India, Bangladesh, Hong Kong, South Korea, Egypt, Belarus, Mexico, Kyrgyzstan, Morocco, Peru, Saudi Arabia, Ecuador, Argentina, and Vietnam from 2022 to 2025 [1] Group 2: Impact on Overseas Business - The registration of the product in Pakistan is a crucial part of the company's strategy to expand its overseas business, which is anticipated to enhance the sales of its products in international markets [2]

Core Insights - The endovascular neurointervention for cerebral infarction has experienced explosive growth in China, driven by an aging population and lifestyle changes, leading to a continuous rise in the incidence of cerebral infarction [1][4][12] - The number of endovascular neurointervention procedures is projected to increase significantly, reaching 182,500 in 2024 and 266,600 in 2025 [1][5][4] Industry Definition and Barriers - Cerebral infarction, or acute ischemic stroke (AIS), accounts for approximately 80% of all strokes, primarily affecting individuals aged 45 to 70, with an increasing proportion of younger patients [2][4] - The industry has significant talent and brand barriers, as it requires specialized medical knowledge and substantial funding for product development and market entry [3][4] Current Industry Development - The endovascular neurointervention market has seen a rise from 24,100 procedures in 2017 to 182,500 in 2024, with expectations to reach 266,600 by 2025 [4][5] - The breakdown of procedures in 2024 includes intracranial stent retrieval (84,400 procedures, 46.25%), intracranial thrombectomy (66,500 procedures, 36.44%), and other procedures (31,600 procedures, 17.32%) [5] Industry Chain Structure - The industry chain includes upstream raw materials, production and diagnostic equipment, and professional support services, which influence the overall operation of the midstream device manufacturing and downstream clinical treatment [4][6] Major Companies - Key players in the market include Weikang Medical, Xinyi Medical, and Guichuang Tongqiao, among others, with increasing competition as demand grows [8][9] - Microinvasive Brain Science has established a comprehensive product line for stroke intervention, achieving significant revenue growth from 80 million yuan in 2019 to 402 million yuan in 2024 [9] - Guichuang Tongqiao reported a revenue of 780 million yuan in 2024, a 48.3% increase year-on-year, with a gross profit of 560 million yuan [9][10] Industry Development Trends - The market is expected to grow due to rising economic levels, lifestyle changes, and an aging population, with significant opportunities for domestic device manufacturers [12][13] - The industry is expanding its application range, moving beyond ischemic and hemorrhagic strokes to include complex lesions and combinations with other treatment methods [12][13]

面对复杂的支付难题，黄凯提出了生态共建的解决方案。他强调，单靠企业自身无法突破这一瓶颈，需 要构建包括政府、医保、商保、企业、医院、患者在内的全方位生态系统。 数据资产化：机遇与挑战并存 从数据资产化的实践角度，黄凯分享了赛诺医疗的经验与思考。他透露，公司在支架产品上市后积累了 五六千例上市后临床实验数据，但这些数据的开发利用面临着诸多挑战。 他用创新药的发展历程类比AI医疗，指出重大技术创新都需要经过较长的培育周期，"这一波的结果实 际是2015、2016年甚至更早的资本、商业化的投入，我们最后看到的结果。像AI才刚刚开始，也需要 各个方面的投入。" 本报（chinatimes.net.cn）记者赵文娟 于娜 北京报道 "无论是医保还是药监，期待对于AI包括对于器械企业的创新有更多的包容和支持。"在11月21日举办的 2025华夏大健康产业发展暨康复服务大会上，赛诺医疗董秘黄凯在圆桌对话中发出了这样的呼吁。 本次大会以"智领健康未来"为主题，在《AI医疗的规模化破局：从技术爆发到医疗价值兑现》圆桌环 节，黄凯与迪安诊断、歌锐科技、医脉通等企业代表共同探讨了AI技术在医疗领域面临的商业化挑 战。 作为血管介入 ...

Core Points - The company has received approval from ANVISA for its SC HONKYTONKTM coronary balloon dilation catheter, marking a significant milestone in its overseas business expansion [1][2]. Group 1: Product Registration Details - The SC HONKYTONKTM coronary balloon dilation catheter is designed for the dilation of narrowed segments of coronary arteries and can be used for pre-dilation before PCI stent implantation [2]. - The product has a rapid exchange design and is composed of multiple components, including a tip, balloon protective sheath, and a platinum-iridium alloy radiopaque ring [2]. - The product has previously received various international certifications, including from the National Medical Products Administration of China and the FDA in the United States, among others [2]. Group 2: Impact on the Company - The approval of the product in Brazil is expected to enhance the company's sales in international markets, contributing positively to its overseas business growth [3]. - The company acknowledges that international market sales may be influenced by regulatory policies, market environment changes, and exchange rate fluctuations, which could impact future performance [3].