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].

Group 1 - Shengxin Lithium Energy signed a framework agreement with Huayou Cobalt for the procurement of 221,400 tons of lithium salt products over five years [1] - Wehua New Materials' subsidiary plans to acquire 70% of He Yutai for 154 million yuan [1] - Xiamen Tungsten plans to invest 600 million yuan to establish a wholly-owned subsidiary for a project with an annual production capacity of 50,000 tons of high-performance battery materials [1][2] Group 2 - *ST Songfa's subsidiary signed a shipbuilding contract worth approximately 200-300 million USD for two VLCCs [3] - Hailianxun's stock will resume trading on November 19 after the end of the acquisition request period [5] - Yunnan Energy Investment obtained the development rights for a 25,000 kW wind power project [7] Group 3 - China Resources Double Crane's subsidiary received a drug registration certificate for Oxcarbazepine tablets [8] - Jincheng Pharmaceutical's subsidiary received a CEP certificate for glutathione raw materials [9] - Jinkong Electric plans to transfer 51% of Tongying Thermal Power to an affiliate for 266 million yuan [9] Group 4 - Clean Technology's subsidiary won a bid for a waste incineration power generation project in Thailand with a total investment of up to 4.27 million USD [12] - Tonglian Precision's shareholders set the transfer price for shares at 43.67 yuan each [13] - Hu Nong Commercial Bank's executives collectively purchased 259,100 shares of the company [13] Group 5 - Huatai Medical's subsidiary obtained a medical device registration certificate for polyethylene embolization microspheres [13] - Fosun Pharma's subsidiary's drug registration application was accepted by the National Medical Products Administration [13] - Xianhui Technology signed contracts worth 796 million yuan with multiple subsidiaries of CATL [15] Group 6 - Ningbo Fangzheng signed a strategic cooperation agreement with Huaxiang Qiyuan for the development of various robotic technologies [15] - Ruida Futures' vice president resigned for personal reasons [16] - Samsung Medical is expected to win contracts worth approximately 125 million yuan from the State Grid [17] Group 7 - Tianjin Pharmaceutical's injectable methylprednisolone sodium succinate received registration from Panama's Ministry of Health [19] - Yaxing Anchor Chain plans to invest up to 300 million yuan in a project for deep-sea floating equipment [20] - Zejing Pharmaceutical's clinical trial for ZG006 was approved by the National Medical Products Administration [21] Group 8 - Weiye Co., Ltd. won a bid for a project worth approximately 2.086 billion yuan [23] - Ruimao Tong plans to sell 8.5794 million repurchased shares [25] - Guangge Technology's shareholders plan to reduce their holdings by up to 3.99% [26] Group 9 - Hongsheng Development signed a debt restructuring contract for a total of 2 billion yuan [27][28] - Yatai Co., Ltd. plans to reduce its holdings by up to 1% [30] - Dexin Technology's shareholder plans to reduce its holdings by up to 1% [31] Group 10 - Yaji International's shareholder plans to reduce its holdings by up to 1% [33] - Shenzhen New Star's subsidiary received approval for trial production of a boron trifluoride project [35] - Shengyi Electronics plans to raise up to 2.6 billion yuan through a private placement [36]

Core Viewpoint - The company announced the approval of its SC HONKYTONK coronary balloon dilation catheter by Brazil's National Health Surveillance Agency (ANVISA) after submitting the registration application in November 2024 [1] Group 1 - The SC HONKYTONK catheter is designed for balloon catheter dilation of narrowed segments of coronary arteries or bypass grafts to improve myocardial perfusion [1]

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]