三诺生物传感股份有限公司（以下简称"公司"或"三诺生物"）于近日收 到湖南省药品监督管理局颁发的一项《中华人民共和国医疗器械注册证》，现将 具体情况公告如下： | 证券代码：300298 | 证券简称：三诺生物 | 公告编号：2024-090 | | --- | --- | --- | | 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 关于取得医疗器械注册证的公告 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。 二〇二四年十二月二十六日 | 序 | 产品名称 | 注册证编号 | 注册证 | 注册 | 适用范围 | | --- | --- | --- | --- | --- | --- | | 号 | | | 有效期 | 分类 | | | 1 | 血糖尿酸血脂仪 | 湘械注准 20242221261 | 2024.12.09 | | 本产品与配套试条配合使用，用于定量检测 | | | | | | | 新鲜毛细血管全血、静脉全血和动脉全血中 | | | | | | | 的葡萄糖浓度，新鲜毛细血管全血、静脉全 | | | | | ...

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Insights - The company has achieved significant milestones in its overseas market expansion, particularly with its Continuous Glucose Monitoring (CGM) system, which has received FDA acceptance and NMPA approval for various models [1][2] - The CGM product line is expected to see substantial sales growth, with projected revenues of 300 to 500 million yuan in 2024, following an estimated 80 million yuan in sales for 2023 [2] - The company has signed a distribution agreement with A.MENARINI DIAGNOSTICS S.r.l. for exclusive distribution in over 20 European countries, indicating strong international market penetration [1][3] Summary by Sections Product Development and Approval - The company’s CGM products have received necessary approvals, including FDA 510(k) acceptance and NMPA approval, with five models categorized for home and medical use [1] - The new generation of CGM products reflects the company's commitment to innovation and expanding its diabetes monitoring product line [2] Sales and Revenue Projections - The company anticipates a sales target of 300 to 500 million yuan for its CGM products in 2024, with profitability expected by 2025 [2] - The CGM industry is projected to experience accelerated growth, benefiting from the company's long-term investment in sensor technology since 2008 [2] International Expansion - The company has received CE certification for its CGM products and is poised for significant market penetration in Europe, with clinical trials in the U.S. progressing well [3] - The operational performance of overseas subsidiaries is improving, with expectations of profitability in the near term [3]

Investment Rating - The report maintains a "Buy" rating for the company, with a positive outlook on its future performance [5] Core Views - The company's Continuous Glucose Monitoring (CGM) products are expected to drive significant growth, with sales projected to reach 300-500 million yuan in 2024 and profitability anticipated by 2025 [2] - The company has achieved a milestone with its CGM products receiving FDA 510(k) acceptance and NMPA approval, further enhancing its product portfolio [1] - The company's international expansion is progressing well, with a distribution agreement signed for over 20 European countries and regions, and potential FDA approval in the US by 2025 [3] Financial Performance - Revenue is forecasted to grow from 2,814 million yuan in 2022 to 5,353 million yuan in 2026, with a CAGR of 19.15% to 10.77% [7] - Net profit is expected to increase from 431 million yuan in 2022 to 550 million yuan in 2026, with a CAGR of 300.56% to 27.70% [7] - ROE is projected to rise from 13.80% in 2022 to 13.89% in 2026, indicating improving profitability [7] Product Development - The company has launched new CGM models, including i6, i6s, i6Pro for home use (up to 15 days) and H6, h6 for medical institutions (up to 8 days) [1] - The company has been developing CGM products since 2008, with the latest generation approved in 2023, showcasing strong R&D capabilities [2] Market Expansion - The company has established a global sales network and brand resources, with significant potential for international market penetration, particularly in Europe and the US [3] - The company's overseas subsidiaries are expected to achieve profitability, marking a turning point in their operations [3] Valuation Metrics - The company's P/E ratio is expected to decrease from 36 in 2022 to 28 in 2026, indicating improving valuation attractiveness [7] - The P/B ratio is projected to decline from 5.0 in 2022 to 3.9 in 2026, reflecting potential undervaluation [7] Industry Outlook - The CGM industry is expected to experience accelerated growth, driven by the company's innovative products and expanding market presence [2] - The company's focus on diabetes monitoring and its diversified product line position it well to capitalize on market opportunities [2]

证券研究报告·公司点评报告·医疗器械 三诺生物（300298） FDA 审批受理， 强力催化落地，CGM 出海 杨帆起航 2024 年 12 月 19 日 买入（维持） | --- | --- | --- | --- | --- | --- | |------------------------------|--------|---------|--------|--------|--------| | 盈利预测与估值 [Table_EPS] | 2022A | 2023A | 2024E | 2025E | 2026E | | 营业总收入（百万元） | 3952 | 4059 | 4630 | 5288 | 6093 | | 同比（ % ） | 67.38 | 2.69 | 14.06 | 14.22 | 15.23 | | 归母净利润（百万元） | 446.51 | 284.40 | 412.26 | 523.78 | 621.61 | | 同比（ % ） | 315.09 | (36.31) | 44.96 | 27.05 | 18.68 | | EPS- 最新摊薄（元 / 股） | 0.79 | 0. ...

Investment Rating - The report maintains a "Buy" rating for the company [4][7]. Core Views - The company has successfully passed the FDA 510(k) acceptance review for its Continuous Glucose Monitoring (CGM) system, entering the substantive review phase, which is expected to enhance its profitability in the U.S. market [2]. - The U.S. CGM market is substantial, with a 2020 market size of $2.7 billion and a CAGR of 26.7% from 2015 to 2020, indicating significant growth potential for the company's products [2]. - The company has established strong marketing networks through its U.S. subsidiaries, Trividia and PTS, which are expected to facilitate rapid market penetration for its CGM products in the U.S. [3]. - Recent agreements and product registrations, including a seven-year distribution agreement in Europe and the registration of a second-generation CGM product, demonstrate the company's strong execution capabilities and commitment to expanding its market presence [4]. Financial Summary - Revenue projections for 2024, 2025, and 2026 are estimated at 42.54 billion, 47.96 billion, and 54.92 billion CNY, respectively, with year-over-year growth rates of 4.8%, 12.7%, and 14.5% [4]. - The company's net profit attributable to shareholders is forecasted to be 3.33 billion, 4.02 billion, and 4.95 billion CNY for the same years, reflecting growth rates of 17.1%, 20.6%, and 23.3% [4]. - The report provides a P/E ratio forecast of 47X, 39X, and 32X for the years 2024, 2025, and 2026, respectively [4].

| 证券代码：300298 | 证券简称：三诺生物 | 公告编号：2024-088 | | --- | --- | --- | | 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 关于持续葡萄糖监测系统获得美国FDA注册受理的公告 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。 三诺生物传感股份有限公司（以下简称"公司"或"三诺生物"）于近日收 到 U.S. Food & Drug Administration（美国食品药品监督管理局，以下简称"FDA") 的正式通知，公司自主研发的"持续葡萄糖监测系统"产品已通过FDA510(k)的 受理审核（Acceptance Review），正式进入510(k) 实质性审查阶段（Substantive Review）。现将相关情况公告如下： 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 注册分类：510(k) 预期用途：TRUE VIE持续血糖监测系统是一种持续血 ...

关于会计政策变更的公告 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。 特别提示： 1、三诺生物传感股份有限公司（以下简称"公司"）根据中华人民共和国财 政部（以下简称"财政部"）发布的《关于印发<企业会计准则解释第 17 号>的通 知》（财会〔2023〕21 号）、财政部会计司编写发行的《企业会计准则应用指南汇 编 2024》要求变更会计政策。本次会计政策变更是公司根据法律、行政法规和国 家统一的会计制度要求执行的变更，根据《深圳证券交易所上市公司自律监管指 引第 2 号——创业板上市公司规范运作》的有关规定，无需提交公司董事会和股 东大会审议批准。 证券代码：300298 证券简称：三诺生物 公告编号：2024-089 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 2、本次会计政策变更不会对公司财务状况、经营成果和现金流量产生重大 影响，也不存在损害公司及股东利益的情形。现将具体情况公告如下： 一、本次会计政策变更情况概述 1、会计政策变更原因 2023 年 10 月，财政部发布《关于印发<企业会计准则解释第 17 号>的通知》 （ ...

编号：2024-12-01 证券代码：300298 证券简称：三诺生物 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投资者关系活动记录表 | --- | --- | --- | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | 投资者关系活动 \n类别 | 特定对象调研 \n□ 媒体采访 \n□ 新闻发布会 \n□ 现场参 ...

Investment Rating - The report maintains a "Buy" rating for Sanofi Biologicals [4] Core Views - The second-generation Continuous Glucose Monitoring (CGM) product has been approved in China, enhancing user engagement and product competitiveness [2] - The company has made significant strides in international markets, including a distribution agreement in Europe and successful clinical trials in the United States [2] - Revenue forecasts for 2024-2026 are projected to grow, with net profit also expected to increase significantly during the same period [2][3] Financial Summary - Revenue for 2024 is estimated at 42.54 billion, with a year-on-year growth of 4.8% [3] - Net profit for 2024 is projected to be 3.33 billion, reflecting a year-on-year increase of 17.1% [3] - The company’s P/E ratios for 2024, 2025, and 2026 are expected to be 46X, 38X, and 31X respectively [2][3] Product Development - The second-generation CGM products feature improved design and user experience, with longer usage times and no need for user calibration [2] - The company continues to focus on enhancing monitoring accuracy, reducing production costs, and improving user experience [2] Market Expansion - Sanofi Biologicals has established a presence in over 135 countries and regions, with product registrations completed in 85 countries [2] - The company is actively developing e-commerce channels and has set up local warehouses in 17 countries to facilitate logistics [2]

Investment Rating - The report maintains a "Buy" rating for Sinocare (300298) [1] Core Views - Sinocare's new Continuous Glucose Monitoring (CGM) system has obtained medical device registration, enhancing product competitiveness [2] - The CGM system features third-generation direct electron transfer technology, offering high accuracy and stability, catering to both home and clinical settings [3] - The company has established a partnership with A Menarini Diagnostics S r l, a leading European diagnostics company, which is expected to boost Sinocare's market presence in Europe [4] - Sinocare's CGM product, "Sinocare AiKan," has been approved in multiple regions including China, Indonesia, and the EU, with potential FDA approval expected by Q3 2025 [4] - The company is projected to achieve significant revenue and net profit growth from 2024 to 2026, with revenue expected to reach 4 63 billion, 5 29 billion, and 6 09 billion yuan respectively, and net profit projected at 412 million, 524 million, and 622 million yuan [5] Financial Projections - Revenue for 2024, 2025, and 2026 is forecasted at 4 63 billion, 5 29 billion, and 6 09 billion yuan, with year-over-year growth rates of 14 06%, 14 22%, and 15 23% respectively [1] - Net profit attributable to the parent company is expected to be 412 million, 524 million, and 622 million yuan for 2024, 2025, and 2026, with growth rates of 44 96%, 27 05%, and 18 68% respectively [1] - EPS for 2024, 2025, and 2026 is projected at 0 73, 0 93, and 1 10 yuan per share, with corresponding P/E ratios of 36 97, 29 10, and 24 52 [1] Market and Product Development - Sinocare's CGM system is designed for both home and clinical use, with usage durations of up to 15 days and 8 days respectively [2] - The company's CGM product has been approved in multiple regions, including China, Indonesia, and the EU, and is expected to achieve FDA approval by Q3 2025 [4] - The partnership with A Menarini Diagnostics S r l is anticipated to enhance Sinocare's strategic positioning in the European market [4] Financial Metrics - The company's gross margin is expected to improve from 54 06% in 2023 to 56 89% in 2026 [12] - ROE is projected to increase from 9 24% in 2023 to 13 56% in 2026 [12] - The company's P/B ratio is forecasted to decrease from 5 16 in 2023 to 3 42 in 2026 [12] Valuation - The current P/E ratio is 53 59, with projected P/E ratios of 36 97, 29 10, and 24 52 for 2024, 2025, and 2026 respectively [1] - The company's market capitalization is 15 24 billion yuan, with a circulating A-share market value of 12 30 billion yuan [8]