根据分析结果，三诺生物首代CGM产品iCani3已满足FDA iCGM所要求性能标准，但其已完成的临床数 据在统计效能上仍不足以证明其与FDA最近批准的iCGM产品具备实质等同性。 "鉴于可能需要额外开展临床研究，公司决定将资源聚焦于下一代产品的推进。"三诺生物方面进一步表 示。 此前，三诺生物已经完成了第二代CGM产品的研发并实现国内上市，第二代CGM产品是首代产品的升 级款，用户使用的便捷性、佩戴的舒适性有所提升。记者留意到，本月三诺生物第二代CGM产品已经 在欧洲市场取得捷报——获得欧盟CE-MDR认证。三诺生物表示，这一认证结果表明该产品可在认可欧 盟MDR资质的国家进行销售，将对海外市场拓展起到积极促进作用。 日前，三诺生物（300298）宣布撤回首代CGM产品在美国FDA注册申请。就此，三诺生物今日(7月30 日)回应称，本次注册申请撤回是公司主动安排，旨在加快下一代解决方案进入美国市场的进程。 三诺生物在近日收到FDA(即美国食品药品监督管理局)的注册申请撤回确认函，同意公司撤回自主研发 的持续葡萄糖监测系统(即公司首代CGM产品)的注册申请。回溯公告，三诺生物在去年12月宣布持续葡 萄糖监测系 ...

7月30日，三诺生物今日收盘21.22元，下跌1.03%，滚动市盈率PE（当前股价与前四季度每股收益总和 的比值）达到37.45倍，总市值118.89亿元。 从行业市盈率排名来看，公司所处的医疗器械行业市盈率平均55.15倍，行业中值37.48倍，三诺生物排 名第75位。 最新一期业绩显示，2025年一季报，公司实现营业收入10.42亿元，同比2.76%；净利润7211.51万元， 同比-10.90%，销售毛利率48.69%。 序号股票简称PE(TTM)PE(静)市净率总市值(元)13三诺生物37.4536.443.60118.89亿行业平均 55.1550.114.80115.74亿行业中值37.4836.822.6955.61亿1九安医疗11.0711.200.87186.87亿2英科医疗 14.0715.171.25222.33亿3新华医疗15.9114.751.30101.98亿4振德医疗16.1515.221.0358.62亿5山东药玻 16.2116.261.86153.29亿6奥美医疗16.3215.991.6858.96亿7康德莱17.1917.201.4237.04亿8九强生物 17.501 ...

Core Viewpoint - Sanofi Biologics has voluntarily withdrawn its 510(K) application for the first-generation continuous glucose monitoring system iCan i3 to expedite the entry of the next-generation solution into the U.S. market [1] Group 1: Product Development - The first-generation continuous glucose monitoring system iCan i3 has met the performance standards required by the FDA for iCGM, but the clinical data completed is statistically insufficient to demonstrate substantial equivalence to recently approved iCGM products [1] - The company has decided to focus resources on advancing the next-generation product due to the potential need for additional clinical research [1] Group 2: Regulatory Achievements - The latest generation continuous glucose monitoring system iCan i6 has obtained CE-MDR certification in the European Union [1] - The company aims to combine the high accuracy and reliability of the i3 system with greater usability and affordability to continue supporting global continuous glucose monitoring system users [1]

Group 1 - The medical device industry experienced a decline of 0.17% on July 29, with a net outflow of 351 million yuan in main funds, where 55 stocks rose and 43 fell [1] - The companies with the highest net outflow of main funds included Yirui Technology (14.03 million yuan), Meihao Medical (13.99 million yuan), Aohua Endoscopy (13.90 million yuan), Kangzhong Medical (13.42 million yuan), and Microelectrophysiology (12.50 million yuan) [1] Group 2 - Notable stock performance included BGI Genomics with a price of 53.69 and a rise of 3.17%, attracting a net inflow of 745.64 million yuan, representing 10.25% of the main fund [2] - Other companies with significant movements included Nanwei Medical, which fell by 1.27% to 84.08, with a net inflow of 535.99 million yuan (11.35%); Sanofi Biological, which dropped by 6.62% to 21.44, with a net inflow of 507.66 million yuan (6.33%); and Haooubo, which rose by 2.86% to 124.82, with a net inflow of 426.62 million yuan (18.96%) [2]

中新网长沙7月28日电 (刘曼)高频事项办理效率再压缩20%以上的"新区速度"，与"科创贷""天天麓演"等 构建的金融服务体系相互赋能；20余所高校孕育的创业种子获亿元级金融活水"浇灌"，共育产业森林； 500余家侨资企业"扎根"，万余名海归人才聚力创新……作为中部地区首个国家级新区及湖南省创新程 度最高、经济活力最强的区域之一，湖南湘江新区正以营商环境之"优"、双创生态之"热"、引智发展 之"活"，谱写高质量发展新篇章。 "梧桐叶茂凤来栖" 营商环境是企业赖以生存和发展的土壤，也是地区经济发展的"晴雨表"。湖南湘江新区始终将优化营商 环境作为推动高质量发展的"先手棋"和"关键招"。 "项目刚落地，服务就上门。"近日，湖南揽月机电科技有限公司负责人将一面印有"审批高效办实事， 服务贴心优环境"字样的锦旗，送到湖南湘江新区行政审批服务局工作人员手中。 上述公司投资3亿元的揽月空间技术研发生产基地项目于2023年9月落地湘江新区，在审批过程中，湘江 新区行政审批服务局提供"提前指导、窗口陪同、协调跟进"全流程服务，该项目人防许可、施工许可等 多项审批业务平均办理时限压缩近40%。目前，项目一期工程部分厂房已建成并 ...

7月28日，三诺生物今日收盘22.96元，下跌2.13%，滚动市盈率PE（当前股价与前四季度每股收益总和 的比值）达到40.52倍，总市值128.64亿元。 从行业市盈率排名来看，公司所处的医疗器械行业市盈率平均55.28倍，行业中值38.06倍，三诺生物排 名第80位。 最新一期业绩显示，2025年一季报，公司实现营业收入10.42亿元，同比2.76%；净利润7211.51万元， 同比-10.90%，销售毛利率48.69%。 序号股票简称PE(TTM)PE(静)市净率总市值(元)13三诺生物40.5239.423.89128.64亿行业平均 55.2850.194.76115.43亿行业中值38.0638.632.7156.35亿1九安医疗11.0111.130.87185.78亿2英科医疗 13.3414.381.19210.81亿3新华医疗15.4114.281.2698.77亿4振德医疗16.1715.241.0358.70亿5奥美医疗 16.2315.911.6758.64亿6山东药玻16.2516.301.87153.69亿7康德莱16.9917.001.4136.60亿8九强生物 17.5016 ...

Core Viewpoint - Sanofi Biologics has received confirmation from the U.S. Food and Drug Administration (FDA) regarding the withdrawal of its registration application for the first-generation Continuous Glucose Monitoring (CGM) product, TRUE VIE Continuous Glucose Monitoring System, which was intended for diabetes management [1] Group 1 - The product aimed to replace fingerstick blood glucose testing for diabetes treatment decisions [1] - The decision to withdraw the registration application was influenced by FDA's supplementary requirements and market changes [1] - The withdrawal of the registration application is a carefully considered decision by the company and will not have a significant impact on its current operations [1]

| 证券代码：300298 | 证券简称：三诺生物 | 公告编号：2025-066 | | --- | --- | --- | | 债券代码：123090 | 债券简称：三诺转债 | | 三诺生物传感股份有限公司 关于撤回持续葡萄糖监测系统美国FDA注册申请的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 近日，三诺生物传感股份有限公司（以下简称"公司"或"三诺生物"）收 到U.S. Food & Drug Administration（美国食品药品监督管理局，以下简称"FDA"） 的注册申请撤回确认函，同意公司撤回自主研发的持续葡萄糖监测系统（即公司 第一代CGM产品）的注册申请。现将具体情况公告如下： 一、产品基本信息 申请人：三诺生物传感股份有限公司 产品名称：TRUE VIE Continuous Glucose Monitoring System (I3) 受理号：K243695 二、终止的原因及对公司的影响 CGM（Continuous Glucose Monitoring System），即持续葡萄糖监测系统， 是指通过葡萄糖感应器监测皮下 ...

Core Insights - The construction of the Sanofi Global R&D Center in Changsha High-tech Zone has reached the final stages, with completion expected by the end of the year, marking the full establishment of the Sanofi Biotech Park [1] - The total investment for the third phase of the project is approximately 500 million yuan, focusing on the biosensor industry chain and aiming for a production value of 3 billion yuan annually upon completion [1][2] - Sanofi has established itself as a leader in the blood glucose monitoring system industry in China, holding over 50% market share domestically and exporting products to 187 countries [2] Investment and Economic Impact - The new R&D center will contribute over 200 million yuan in tax revenue and create nearly 2,000 new jobs [1] - The center will integrate software and hardware product development, talent training, testing, and result transformation, enhancing the company's capabilities in diabetes management [2] Company Background - Founded in 2002, Sanofi has become a high-tech enterprise specializing in the research and application of biosensor technology, successfully listed on the Shenzhen Stock Exchange in 2012 [2] - The company has established several national-level R&D platforms, including the National Enterprise Technology Center and the National Engineering Laboratory for Medical Big Data Application Technology [2]

Core Insights - The article highlights the rapid growth and strategic importance of the nano-metal materials industry in China, driven by technological advancements and increasing market demand [1][14]. Industry Overview - Nano-metal materials, characterized by grain sizes between 1-100 nanometers, exhibit superior properties such as ultra-high strength, excellent thermal stability, and unique electromagnetic characteristics [1][14]. - The market size for nano-metal materials in China is projected to grow from 28.98 billion yuan in 2018 to 74.451 billion yuan in 2024, with a compound annual growth rate (CAGR) of 17.03% [1][14]. - Key applications of nano-metal materials include electronics, new energy development, biomedicine, and aerospace [1][14]. Production Methods - The production methods for nano-metal materials are categorized into physical and chemical methods, including evaporation-condensation, high-energy ball milling, and chemical reduction [5]. Policy Support - The Chinese government has identified nano-materials as a key area for development, with various policies aimed at promoting innovation and industrial upgrades [7]. Industry Chain - The upstream of the nano-metal materials industry includes raw material supply and manufacturing equipment, while the downstream encompasses applications in biomedical, aerospace, construction, automotive, and electronics sectors [9]. Key Companies - Notable companies in the nano-metal materials sector include Jiangsu Boqian New Materials Co., Ltd., Jiangxi Baohong Nano Technology Co., Ltd., and Shandong Changxin Nano Technology Co., Ltd., which are involved in the R&D and production of high-performance nano-metal materials [17][19][21]. Development Trends - The industry is moving towards high-performance and multifunctional materials, with innovations in atomic-level structure design and surface modification technologies [25]. - There is a shift towards green and low-carbon production methods, emphasizing sustainable practices in the manufacturing of nano-metal materials [26][27]. - Cross-disciplinary integration is expanding the application boundaries of nano-metal materials, particularly in biomedicine and information technology [28].