Sinocare(300298)

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三诺生物:CGM通过FDA受理,出海战略持续推进
GOLDEN SUN SECURITIES· 2024-12-19 03:17
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].
三诺生物:关于持续葡萄糖监测系统获得美国FDA注册受理的公告
2024-12-18 11:11
| 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 ...
三诺生物:关于会计政策变更的公告
2024-12-18 11:11
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》 ( ...
三诺生物(300298) - 2024年12月17日投资者关系活动记录表
2024-12-17 11:35
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 ...
三诺生物:第二代CGM国内获批,产品迭代升级持续增强用户粘性
GOLDEN SUN SECURITIES· 2024-12-17 06:23
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]
三诺生物:新一代产品获批,产品竞争力不断提升
Soochow Securities· 2024-12-17 05:28
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]
三诺生物:新一代CGM国内获批,产品升级迭代加速
SINOLINK SECURITIES· 2024-12-17 03:08
Investment Rating - Maintains a "Buy" rating [1] Core Views - The company's new generation Continuous Glucose Monitoring (CGM) system has been approved domestically, marking a significant upgrade in its product line [2] - The new CGM products, including models H6/h6 and i6/i6s/i6Pro, offer extended usage periods of up to 8 days and 15 days respectively, catering to both medical institutions and home environments [2] - The company's proprietary third-generation direct electron transfer technology enhances the CGM system's performance, offering low potential, oxygen independence, reduced interference, and high stability and accuracy [2] - The company has signed a distribution agreement with A MENARINI DIAGNOSTICS S r l for the European market, which is expected to drive sales growth in overseas markets [2] Financial Projections - The company's net profit attributable to the parent company is projected to be RMB 368 million, RMB 507 million, and RMB 637 million for 2024, 2025, and 2026 respectively, representing year-on-year growth rates of 30%, 38%, and 26% [2] - The current price corresponds to a PE ratio of 41x, 30x, and 24x for 2024, 2025, and 2026 respectively [2] Product Development - The new CGM products feature improved design and manufacturing processes, including a one-piece implantation design that simplifies user experience and optimized product dimensions for better wearability [2] - The company's CGM product line expansion is expected to meet diversified market demands and establish a closed-loop system of "perception + evaluation + intervention" [2] Market Expansion - The company's partnership with A MENARINI DIAGNOSTICS S r l covers over 20 European countries and regions, with the potential for rapid sales growth following the overseas launch of the second-generation CGM products [2] Financial Performance - The company's revenue is expected to grow from RMB 4,059 million in 2023 to RMB 5,914 million in 2026, with a compound annual growth rate (CAGR) of 16.25% [5] - The company's net profit margin is projected to increase from 7.0% in 2023 to 10.8% in 2026, reflecting improved profitability [5]
三诺生物:关于三诺转债2024年付息的公告
2024-12-16 10:35
| 证券代码:300298 | 证券简称:三诺生物 | 公告编号:2024-087 | | --- | --- | --- | | 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 关于三诺转债2024年付息的公告 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、"三诺转债"(债券代码:123090)将于2024年12月23日按面值支付第 四年利息,每10张"三诺转债"(面值1,000元)利息为15.00元(含税)。 2、债权登记日:2024年12月20日(星期五) 3、付息日:2024年12月23日(星期一) 4、除息日:2024年12月23日(星期一) 5、本次付息期间及票面利率:计息期间为2023年12月21日至2024年12月20 日,票面利率为1.50%。 6、"三诺转债"本次付息的债权登记日为2024年12月20日,截至2024年12 月20日下午深圳证券交易所收市后,在中国证券登记结算有限责任公司深圳分 公司(以下简称"中国结算深圳分公司")登记在册的"三诺转债"持有人享有 本次派发的利息,在202 ...
三诺生物:关于持续葡萄糖监测系统取得医疗器械注册证的公告
2024-12-16 10:26
| 证券代码:300298 | 证券简称:三诺生物 | 公告编号:2024-086 | | --- | --- | --- | | 债券代码:123090 | 债券简称:三诺转债 | | | 序 | 产品名称 | 注册证编号 | 注册证 | 注册 | 型号、规格 | 适用范围 | | --- | --- | --- | --- | --- | --- | --- | | 号 | | | 有效期 | 分类 | | | | 1 | 监测系统 | 20243072505 | 2024.12.13 | | | 该产品配合持续葡萄糖监测系统应用程 序(型号规格:iCGM-APP Pro、iCGM 系统管理软件(发布版本:01)使用,可 葡萄糖水平的连续或定期监测。该产品 | | | | | | | | APP;发布版本:02)、持续葡萄糖监测 | | | 持续葡萄糖 | 国械注准 | | | | 用于糖尿病成年患者(≥18岁)的组织液 | | | | | 至 | III类 | H6/h6 | | | | | | 2029.12.12 | | | 仅供单个用户在医疗机构使用,不需要 | | | | | | | | 用户校 ...
三诺生物:欧洲经销商协议落地,CGM出海兑现加速
Huafu Securities· 2024-12-09 02:59
Investment Rating - The report maintains a "Buy" rating for the company, reflecting confidence in its growth prospects and market position [3][5] Core Views - The company has signed a 7-year exclusive distribution agreement with A Menarini Diagnostics S r l to distribute its first and second-generation CGM products in over 20 European countries and regions under a co-branding arrangement [1] - The European CGM market is the second largest globally, with a projected CAGR of 20 6% from 2020 to 2030, reaching USD 7 8 billion by 2030 [2] - The company is making progress in product improvements and FDA registration for the US market, which could further enhance its market share [2] Financial Projections - Revenue is expected to grow from CNY 4 32 billion in 2024 to CNY 5 93 billion in 2026, with year-over-year growth rates of 6%, 15%, and 19% respectively [3] - Net profit attributable to the parent company is projected to increase from CNY 330 million in 2024 to CNY 635 million in 2026, with growth rates of 16%, 55%, and 24% respectively [3] - EPS is forecasted to rise from CNY 0 59 in 2024 to CNY 1 13 in 2026 [3] Market and Industry Analysis - The European CGM market is expected to grow significantly, providing a substantial opportunity for the company to expand its presence through the new distribution agreement [2] - The company's CGM products are well-positioned to benefit from the growing demand in Europe, leveraging the strong distribution network of A Menarini Diagnostics [1][2] Product Development and Market Expansion - The company is continuously improving its product offerings, with next-generation products under review for enhanced user experience [2] - Efforts to enter the US market are ongoing, with FDA registration progressing, which could open up additional growth opportunities [2]