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赛诺医疗新型血流导向密网支架获批上市 首创颅内自膨药物支架正在注册审批中
Zheng Quan Shi Bao Wang· 2025-05-28 12:58
Core Insights - Sino Medical has received a medical device registration certificate for its blood flow-guided mesh stent, aimed at treating unruptured wide-necked aneurysms in adult patients [1] - The company is also in the process of registering another innovative product, a self-expanding drug-eluting intracranial stent, which is expected to launch soon [1][4] - The introduction of these innovative products marks a significant growth phase for Sino Medical's neuro-interventional business [1][5] Product Details - The blood flow-guided mesh stent, AUCURA, is the first in China that can be delivered through a 0.017'' system and features an anti-thrombotic coating [2] - Clinical data shows a 6-month aneurysm occlusion rate of 89.78% and a 1-year occlusion rate of 96.99%, the best among similar products [3] - The stent has a low 1-year safety composite endpoint of 1.4%, the lowest in its category [3] Market Potential - The number of mesh stent surgeries in China is projected to grow from approximately 4,500 in 2020 to about 110,000 in 2024, with estimates suggesting it may exceed 160,000 by 2025 [3] - The self-expanding drug-eluting intracranial stent is expected to fill a market gap for treating symptomatic intracranial atherosclerotic stenosis [4] - Current average restenosis rates for intracranial stent procedures stand at 14.8%, highlighting the competitive advantage of Sino Medical's products [5]
赛诺医疗(688108) - 赛诺医疗关于子公司血流导向密网支架产品获得国内医疗器械注册证的自愿性披露公告
2025-05-28 11:16
赛诺医疗科学技术股份有限公司 关于子公司血流导向密网支架产品 证券代码:688108 证券简称:赛诺医疗 公告编号:2025-026 适用范围:该产品用于成人患者颈内动脉(岩骨段至末端)与椎动脉未破裂的囊状 或梭状的宽颈(瘤颈宽≥4mm 或瘤体/瘤颈比<2)动脉瘤,且载瘤血管直径≥2.0mm 且 ≤6.0mm。 有效期至:2030 年 5 月 26 日 二、医疗器械基本情况 获得国内医疗器械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: 近日,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")收到国家 药品监督管理局(以下简称"国家药监局")颁发的《中华人民共和国医疗器械注册 证》,现将相关情况公告如下: 一、《医疗器械注册证》内容 注册证编号:国械注准 20253130971 产品名称:血流导向密网支架 结构及组成:该产品由支架、输送导丝和导入鞘管组成,支架压握在输送导丝末端 置入导入鞘管中。支架 ...
赛诺医疗:子公司血流导向密网支架产品获注册证
news flash· 2025-05-28 10:56
Core Viewpoint - Sino Medical announced that its subsidiary, Sino Shenchang Medical Technology Co., Ltd., received the Medical Device Registration Certificate from the National Medical Products Administration of China for a flow-directed mesh stent designed for adult patients with unruptured wide-neck aneurysms in the internal carotid and vertebral arteries [1] Group 1 - The product is the first domestically available flow-directed mesh stent that can be delivered through a 0.017'' system and features an anti-thrombotic coating [1] - This product fills a gap in the company's existing offerings in the neurointerventional hemorrhage field, enhancing the company's product portfolio [1] - The introduction of this stent meets diverse market demands and further enriches the company's product lineup [1]
赛诺医疗董事蔡文彬减持2.00万股,成交均价9.91元
Sou Hu Cai Jing· 2025-05-21 13:00
Core Viewpoint - The news highlights recent stock trading activities by the director of Sino Medical, Cai Wenbin, including a reduction in shareholding and the company's financial performance in the medical device sector [1][2]. Group 1: Stock Trading Activities - On May 20, 2025, Cai Wenbin sold 20,000 shares at an average price of 9.91 yuan, resulting in a transaction amount of 198,200 yuan, leaving him with 136,000 shares [1]. - Cai Wenbin's previous transactions include selling 4,000 shares on May 13, 2025, at 10 yuan, and multiple other trades in early May 2025, indicating a pattern of selling shares in the secondary market [2]. Group 2: Company Overview and Financial Performance - Sino Medical's main business includes the production and operation of Class II and Class III medical devices, along with various technical services and equipment leasing [2]. - As of December 31, 2024, the company's revenue from stents was 261 million yuan, accounting for 56.87% of total revenue, while balloon revenue was 181 million yuan, making up 39.51% [2]. - The total market capitalization of Sino Medical is reported to be 4.11 billion yuan [2].
赛诺医疗: 赛诺医疗科学技术股份有限公司2024年年度股东大会决议公告
Zheng Quan Zhi Xing· 2025-05-19 13:27
Meeting Overview - The shareholders' meeting of Sino Medical Science Technology Co., Ltd. was held on May 19, 2025, at the company's conference room in Beijing [1][2] - A total of 60 ordinary shareholders attended the meeting, holding 102,576,238 voting rights, which represents 24.81% of the company's total voting rights [2] Voting Process - The meeting was chaired by the company's chairman, Mr. Sun Jianhua, and followed the voting procedures as per the Company Law and the company's articles of association [2][7] - The voting method combined on-site and online voting, with legal representatives present to witness the proceedings [2][7] Voting Results - All proposed resolutions were approved with significant majority support, including: - 99.87% of ordinary shareholders voted in favor of the resolutions, with only 0.12% against and 0.004% abstaining [3][5] - Specific resolutions included the remuneration plan for the supervisors and the reappointment of auditors, both of which received over 99% approval [6][7] Legal Compliance - The lawyers present confirmed that the meeting's procedures complied with relevant laws and regulations, ensuring the legitimacy of the attendees and the voting process [7]
赛诺医疗(688108) - 赛诺医疗科学技术股份有限公司2024年年度股东大会决议公告
2025-05-19 12:45
证券代码:688108 证券简称:赛诺医疗 公告编号:2025-025 赛诺医疗科学技术股份有限公司 2024年年度股东大会决议公告 数量的情况: | 1、出席会议的股东和代理人人数 | 60 | | --- | --- | | 普通股股东人数 | 60 | | 2、出席会议的股东所持有的表决权数量 | 102,576,238 | | 普通股股东所持有表决权数量 | 102,576,238 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的比例(%) | 24.8095 | | 普通股股东所持有表决权数量占公司表决权数量的比例(%) | 24.8095 | (四) 表决方式是否符合《公司法》及公司章程的规定,大会主持情况等。 本次股东大会由公司董事会召集,董事长孙箭华先生主持召开。本次股东大会采用现场投 票和网络投票相结合的方式表决。公司聘请了上海市锦天城(北京)律师事务所梁文盛律师、 梁睿律师对本次股东大会进行见证。本次股东大会的召集、召开程序、出席会议人员的资格和 召集人资格、会议的表决程序和表决结果均符合《公司法》及《赛诺医疗科学技术股份有限公 司章程》等的规定。 本公司董事会及全体董事保证公 ...
赛诺医疗(688108) - 上海市锦天城(北京)律师事务所关于赛诺医疗科学技术股份有限公司2024年年度股东大会之法律意见书
2025-05-19 12:45
上海市锦天城(北京)律师事务所 关于赛诺医疗科学技术股份有限公司 2024 年年度股东大会之 法 律 意 见 书 城 律师事 ALLBRIGHT LAW OFFICES 北京市 东城区 东长安街1号 东方广场C1座6层(100738) 6/F,Office Tower C1,Oriental Plaza,No.1 East Chang An Avenue,Beijing 100738,PRC Tel: +86 10 8523 0688 Fax: +86 10 8523 0699 www.allbrightlaw.com 法律意见书 上海市锦天城(北京)律师事务所 关于赛诺医疗科学技术股份有限公司 2024 年年度股东大会之 法律意见书 致:赛诺医疗科学技术股份有限公司 根据《中华人民共和国证券法》(以下简称"《证券法》")、《中华人民 共和国公司法》(以下简称"《公司法》")和中国证券监督管理委员会《上市 公司股东会规则》(以下简称"《股东会规则》")等法律、行政法规、规章和 规范性文件的要求以及《赛诺医疗科学技术股份有限公司章程》(以下简称"《公 司章程》"),上海市锦天城(北京)律师事务所(以下简称"本所 ...
赛诺医疗两款新型支架数据亮丽:颅内支架1年再狭窄率1.87%、密网支架1年闭塞率96.99%
Zheng Quan Shi Bao Wang· 2025-05-19 09:31
Group 1 - The 2025 Oriental Cerebrovascular Disease Conference showcased clinical trial data for the self-expanding intracranial drug-eluting stent by Sino Medical, highlighting its low restenosis rates [2][4] - The 1-year restenosis rate for the Sino Medical stent was reported at only 1.87%, significantly lower than the average restenosis rate of 14.8% for existing intracranial stents [2] - Intracranial artery stenosis is a major cause of stroke in Asian populations, with a high prevalence compared to Western countries, indicating a substantial unmet medical need [2] Group 2 - The new coated flow-diverting stent demonstrated a 1-year aneurysm occlusion rate of 96.99%, the highest among similar products [3] - The stent achieved a 6-month occlusion rate of 89.78%, outperforming competitors that require a full year to reach similar results [3] - The safety composite endpoint for the new stent was reported at 1.4%, the lowest among comparable products, indicating a significant advancement in safety [3] Group 3 - The aging population is driving a rapid increase in the demand for cardiovascular disease treatments, with domestic innovations in neurointerventional devices opening new avenues for safety and efficacy [4] - Sino Medical's intracranial self-expanding drug-eluting stent system has received approval from the National Medical Products Administration and is undergoing registration in Europe and domestically [4] - The new coated flow-diverting stent is also in the registration approval process, reflecting ongoing advancements in the field [4]
赛诺医疗“低级”差错考验公司内控有效性?量增价减盈利不佳 遭多位高管集中减持
Xin Lang Zheng Quan· 2025-05-16 09:34
Core Viewpoint - The article discusses the increasing number of accounting errors among listed companies, with over 40 companies correcting such errors in 2025, highlighting the potential risks and implications for investors [1] Group 1: Accounting Errors and Company Responses - Accounting errors are defined as unintentional omissions or misstatements in financial reports, contrasting with accounting fraud, which is intentional [1] - Companies like Sainuo Medical have recently disclosed accounting errors, including a miscalculation of equity stakes leading to significant adjustments in financial statements [2][3] - Sainuo Medical's adjustments included a reduction in investment income by 9.59 million yuan and a decrease in net profit attributable to shareholders by 4.17 million yuan, among other corrections [3][4] Group 2: Financial Performance and Market Dynamics - Sainuo Medical's revenue has shown volatility, with a drop from 300 million yuan in 2020 to below 200 million yuan in 2021 and 2022, followed by a rebound in 2023 and continued growth in 2024 [9][11] - The company's main products, coronary stents and balloons, accounted for 56.97% and 39.58% of total revenue, respectively, indicating a reliance on these core products [9] - The impact of centralized procurement policies on Sainuo Medical's sales has been significant, with a notable decline in market share during the first round of procurement [11] Group 3: Management and Governance Issues - The company has faced scrutiny regarding its internal controls and the effectiveness of its financial oversight, particularly in light of repeated accounting errors [6][7] - Sainuo Medical's management has been criticized for inconsistent judgments regarding accounting errors, raising questions about the company's financial practices [6][7] - Recent insider selling by multiple executives, including core technical personnel, has raised concerns about management confidence in the company's future performance [16]
5月9日晚间重要公告一览
Xi Niu Cai Jing· 2025-05-09 10:22
Group 1 - Yitong Century won a bid for a communication engineering construction service project from China Mobile, with a total bid amount of 228 million yuan (including tax) [1] - Zhiyuan New Energy plans to repurchase shares worth between 33 million and 66 million yuan, with a maximum repurchase price of 22.00 yuan per share [1] - GAC Group reported April automobile sales of 116,400 units, a year-on-year decrease of 12.66% [2] - JAC Motors reported April automobile sales of 30,764 units, a year-on-year decrease of 3.55% [3] Group 2 - Fosun Pharma's subsidiary received FDA approval for a clinical trial of a live biotherapeutic product aimed at treating androgenetic alopecia [4] - Liangxin Co. obtained multiple patent certificates, including 2 invention patents and 32 utility model patents [5] - Sainuo Medical's two products received medical device registration certificates in Mexico and Ecuador [5] - Huayu Pharmaceutical's two products received marketing approvals in France and Spain [6] Group 3 - Shengnong Development reported April sales revenue of 1.533 billion yuan, a year-on-year increase of 0.68% [6] - Hasi Lian's potassium chloride and sodium chloride injection passed the consistency evaluation [7] - Shapuaisi received approval for a supplemental application for levofloxacin eye drops [9] - Tianyu Biological reported April sales revenue of 59.32 million yuan from pig sales [10] Group 4 - *ST Weihai was pre-awarded a project worth 108 million yuan [12] - Luoniushan reported April sales revenue of 125 million yuan from pig sales, a year-on-year increase of 12.72% [13] - Minhe Co. reported April sales revenue of 68.30 million yuan from chick sales, a year-on-year increase of 0.51% [14] Group 5 - Double Ring Technology's application for a specific stock issuance was approved by the Shenzhen Stock Exchange [15] - Hualu Hengsheng plans to repurchase shares worth between 200 million and 300 million yuan [16] - Baolong Technology plans to repurchase shares worth between 100 million and 200 million yuan [17] Group 6 - Huasheng Technology's subsidiary plans to sell shares of a company for 200 million yuan [24] - *ST Gengxing's controlling shareholder plans to increase holdings worth between 30 million and 60 million yuan [25] - Ruihuatai's shareholder plans to reduce holdings by up to 1% of the company's shares [26] Group 7 - Foton Motor reported April commercial vehicle sales of 54,816 units, a year-on-year increase of 21.63% [20] - China Merchants Bank plans to invest 15 billion yuan to establish a financial asset investment company [22] - Jinchengxin plans to invest approximately 231 million USD in the Alacran copper-gold-silver mine project [23] Group 8 - Zhongji United's controlling shareholder plans to reduce holdings by up to 2% of the company's shares [30] - Ningbo Huaxiang signed a strategic cooperation agreement to strengthen collaboration in various areas [31] - SMIC reported a net profit of 1.356 billion yuan for Q1 2025, a year-on-year increase of 166.5% [32] Group 9 - FAW Fuwi received a project notification to develop seat products for a luxury brand, with a total sales amount expected to be 1.39 billion yuan [33] - Huakang Clean won a bid for a purification project worth 64.425 million yuan [34] - Lihua Co. reported April sales revenue of 1.125 billion yuan from chicken sales [35]