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康泰医学:关于公司医疗器械产品获得美国FDA批准函的公告
2024-05-06 10:21
证券代码:300869 证券简称:康泰医学 公告编号:2024-029 债券代码:123151 债券简称:康医转债 特此公告。 康泰医学系统(秦皇岛)股份有限公司董事会 2024 年 5 月 6 日 康泰医学系统(秦皇岛)股份有限公司 关于公司医疗器械产品获得美国 FDA 批准函的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 近日,康泰医学系统(秦皇岛)股份有限公司(以下简称"公司")收到美 国食品药品监督管理局 U.S. Food and Drug Administration(以下简称"FDA") 签发的实质等同批准函(substantial equivalence letter)。公司产品 Color Doppler Ultrasound Diagnostic System 彩 色 多 普 勒 超 声 诊 断 系 统 (CMS1700B,CMS1700C)和 B-Ultrasound Diagnostic System B 型超声诊断设备 (CMS600P2PLUS)已通过 FDA 的 510(K)实质等同批准。510(K)号码分别为 K2329 ...
康泰医学:第四届监事会第六次会议决议公告
2024-04-28 07:47
证券代码:300869 证券简称:康泰医学 公告编号:2024-027 债券代码:123151 债券简称:康医转债 本公司及监事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 一、监事会会议召开情况 康泰医学系统(秦皇岛)股份有限公司(以下简称"公司")第四届监事会 第六次会议于 2024 年 4 月 26 日以现场方式在公司会议室召开,公司于 2024 年 4 月 16 日通过邮件的方式通知了全体监事。会议应出席监事 3 人,实际出席监 事 3 人。本次会议由监事会主席高瑞斌女士召集主持。本次会议的召集、召开及 表决程序符合《公司法》等法律、法规、部门规章、规范性文件和《公司章程》 的有关规定。 二、监事会会议审议情况 康泰医学系统(秦皇岛)股份有限公司 第四届监事会第六次会议决议公告 经监事会审议和表决,形成决议如下: 审议通过《关于公司 2024 年第一季度报告的议案》 经审议,监事会认为:董事会编制和审核公司 2024 年第一季度报告的程序 符合法律、行政法规和中国证监会的规定,报告内容真实、准确、完整地反映了 公司 2024 年第一季度经营的实际情况,不存在任何 ...
康泰医学:第四届董事会第九次会议决议公告
2024-04-28 07:47
证券代码:300869 证券简称:康泰医学 公告编号:2024-026 债券代码:123151 债券简称:康医转债 表决结果:同意 5 票;反对 0 票;弃权 0 票。本议案表决获得通过。 康泰医学系统(秦皇岛)股份有限公司(以下简称"公司")第四届董事会 第九次会议通知于 2024 年 4 月 16 日以邮件方式向各位董事发出,会议于 2024 年 4 月 26 日以现场会议方式在公司会议室召开。会议由胡坤先生召集并主持, 应出席会议的董事 5 人,实际出席会议的董事 5 人,公司监事及高级管理人员列 席了会议。本次会议的召集、召开及表决,符合《中华人民共和国公司法》和《康 泰医学系统(秦皇岛)股份有限公司章程》(以下简称"《公司章程》")的规 定,会议合法有效。 二、董事会会议审议情况 审议通过《关于公司 2024 年第一季度报告的议案》 董事会认为:公司编制和审核的《2024 年第一季度报告》程序符合法律、 行政法规和中国证监会的规定。董事会保证公司 2024 年第一季度报告内容真实、 准确、完整,不存在任何虚假记载、误导性陈述或者重大遗漏,一致同意公司《2024 年第一季度报告》。 具体内容详见公司同 ...
康泰医学(300869) - 2024 Q1 - 季度财报
2024-04-28 07:44
Financial Performance - The company's revenue for Q1 2024 was ¥99,175,164.46, a decrease of 73.10% compared to ¥368,699,882.77 in the same period last year[5] - Net profit attributable to shareholders was ¥4,351,935.11, down 97.44% from ¥170,052,052.02 year-on-year[5] - Basic earnings per share decreased to ¥0.0108, down 97.45% from ¥0.4232 in the same period last year[5] - Total operating revenue for Q1 2024 was ¥99,175,164.46, a decrease of 73.1% compared to ¥368,699,882.77 in the same period last year[20] - Net profit for Q1 2024 was ¥4,351,935.11, a significant decline from ¥170,052,052.02 in Q1 2023[21] - Earnings per share for Q1 2024 was ¥0.0108, compared to ¥0.4232 in the previous year[21] - The company reported a total comprehensive income of ¥4,216,671.58 for Q1 2024, down from ¥169,492,486.63 in Q1 2023[21] Cash Flow - The net cash flow from operating activities was -¥546,439.44, a decline of 100.54% compared to ¥101,516,355.63 in the previous year[5] - The net cash flow from operating activities for Q1 2024 was -546,439.44, compared to 101,516,355.63 in Q1 2023, indicating a significant decline[24] - Total cash inflow from investment activities was 1,254,098,774.06, while cash outflow was 973,982,712.86, resulting in a net cash flow of 280,116,061.20, compared to -159,393,812.47 in the previous year[25] - Cash inflow from financing activities totaled 143,160,301.37, while cash outflow was 142,278,214.92, leading to a net cash flow of 882,086.45, contrasting with -210,776,064.17 in Q1 2023[25] - The total cash and cash equivalents at the end of Q1 2024 amounted to 749,573,920.22, up from 467,223,246.73 at the beginning of the quarter[25] Assets and Liabilities - Total assets at the end of Q1 2024 were ¥3,098,264,542.21, a decrease of 3.54% from ¥3,211,946,652.17 at the end of the previous year[5] - Total current assets decreased from CNY 2,482,164,235.52 to CNY 2,150,686,350.48, a reduction of approximately 13.36%[17] - Total assets decreased from CNY 3,211,946,652.17 to CNY 3,098,264,542.21, a decrease of approximately 3.52%[18] - Total liabilities decreased to ¥1,049,248,899.15 from ¥1,167,149,962.89 year-over-year, reflecting a reduction of 10.1%[20] - Total equity increased slightly to ¥2,049,015,643.06 from ¥2,044,796,689.28, showing a growth of 0.2%[20] Shareholder Information - Total number of common shareholders at the end of the reporting period is 37,793[12] - The largest shareholder, Hu Kun, holds 46.84% of shares, totaling 188,189,252 shares[12] Operating Costs and Expenses - The company experienced a 62.06% reduction in operating costs, which amounted to ¥50,192,307.62 compared to ¥132,298,048.27 in the previous year[9] - Total operating costs for Q1 2024 were ¥102,176,199.13, down 48.2% from ¥197,193,260.98 year-over-year[20] - Research and development expenses for Q1 2024 were ¥27,140,047.87, up 8.6% from ¥25,005,015.83 in the previous year[20] - The company paid 42,581,872.43 in employee compensation, a decrease from 59,520,945.56 in the same quarter last year[24] Investment Income - The company reported a significant decrease in investment income, which fell by 71.86% to ¥7,695,776.25 from ¥27,350,274.44 year-on-year[9] - Cash received from investment income was 63,948,774.06, an increase from 26,683,525.05 in Q1 2023[24] Other Financial Metrics - The weighted average return on equity was 0.21%, down 8.24% from 8.45% in the same period last year[5] - The financial expenses for Q1 2024 showed a significant improvement, with a net income of -¥4,926,415.19 compared to -¥15,783,191.97 in the same period last year[20] - The company maintained a stable capital reserve of ¥345,145,796.40, reflecting consistent financial management[20] - The impact of exchange rate changes on cash and cash equivalents was 1,898,965.28, compared to 8,989,326.22 in Q1 2023[25] Miscellaneous - The company has not reported any changes in the number of preferred shareholders or any significant events during the reporting period[15] - The company has not indicated any new product developments or market expansion strategies in the current report[16] - Other receivables increased from CNY 7,093,404.07 to CNY 19,590,340.71, an increase of approximately 176.66%[17] - Short-term borrowings decreased from CNY 347,000,000.00 to CNY 237,000,000.00, a reduction of approximately 31.83%[18] - Accounts payable decreased from CNY 17,787,231.43 to CNY 13,996,438.68, a decrease of approximately 21.00%[18]
康泰医学:《对外担保管理办法》
2024-04-24 08:57
康泰医学系统(秦皇岛)股份有限公司 对外担保管理办法 第一章 总则 第一条 为规范康泰医学系统(秦皇岛)股份有限公司(以下简称"公司") 对外担保行为,有效控制担保风险,保证公司资产安全,根据《中华人民共和国 公司法》和《康泰医学系统(秦皇岛)股份有限公司章程》(以下简称"《公司 章程》")的有关规定,结合公司实际情况,制定本办法。 第二条 本办法所称对外担保是指公司为他人提供的担保,包括公司对控股 子公司的担保。 第三条 未经公司董事会或股东大会批准,不得对外提供担保。 第四条 本办法适用于公司、全资及控股子公司。 公司控股子公司为公司合并报表范围内的法人或其他组织提供担保的,公司 应当在控股子公司履行审议程序后及时披露。 公司控股子公司为前款规定主体以外的其他主体提供担保的,视同公司提供 担保,应比照本办法规定执行;公司控股子公司的对外担保事项在按照权限由公 司董事会或股东大会审议通过后,再由子公司董事会(或执行董事)、股东会(或 股东)审议。公司控股子公司应在其董事会(或执行董事)或股东会(或股东) 做出决议后,及时通知公司按规定履行信息披露义务。 第二章 对外担保的审批权限 第五条 公司下列对外担保行 ...
康泰医学:2023年度财务决算报告
2024-04-24 08:54
康泰医学系统(秦皇岛)股份有限公司 2023 年度财务决算报告 康泰医学系统(秦皇岛)股份有限公司 2023 年度财务决算报告 一、2023 年度财务报表的审计情况 公司 2023 年财务报表经德勤华永会计师事务所(特殊普通合伙)审计,出具了 标准无保留意见审计报告。会计师的意见是:康泰医学的财务报表在所有重大方面 按照企业会计准则的规定编制,公允反映了康泰医学 2023 年 12 月 31 日的合并及母 公司财务状况以及 2023 年度的合并及母公司经营成果和现金流量。 二、主要财务数据和财务指标 | | 2023 年 | 2022 年 | | 本年比上年增减 | | --- | --- | --- | --- | --- | | 营业收入(万元) | 74,690.21 | 71,211.45 | | 4.89% | | 归属于上市公司股东的净利润(万元) | 16,576.60 | 19,620.26 | | -15.51% | | 归属于上市公司股东的扣除非经常性损益的净利润(万元) | 14,974.70 | 14,468.86 | | 3.50% | | 经营活动产生的现金流量净额(万元) | 1 ...
康泰医学(300869) - 2023 Q4 - 年度财报
2024-04-24 08:54
Financial Performance - The company's operating revenue for 2023 was ¥746,902,140.39, representing a 4.89% increase compared to ¥712,114,538.93 in 2022[18]. - The net profit attributable to shareholders for 2023 was ¥165,765,985.80, a decrease of 15.51% from ¥196,202,558.53 in the previous year[18]. - The net profit after deducting non-recurring gains and losses was ¥149,747,034.60, which is a 3.50% increase from ¥144,688,613.92 in 2022[18]. - The net cash flow from operating activities increased by 74.63% to ¥181,014,720.43, up from ¥103,656,852.33 in 2022[18]. - The total assets at the end of 2023 were ¥3,211,946,652.17, a decrease of 13.95% from ¥3,732,805,832.45 at the end of 2022[18]. - The net assets attributable to shareholders increased by 6.04% to ¥2,044,796,689.28, compared to ¥1,928,333,829.26 at the end of 2022[18]. - The basic earnings per share for 2023 were ¥0.41, down 16.33% from ¥0.49 in 2022[18]. - The diluted earnings per share were ¥0.40, a decrease of 16.67% from ¥0.48 in the previous year[18]. - The weighted average return on net assets was 8.36%, down from 10.54% in 2022, reflecting a decline of 2.18%[18]. Market Overview - The medical device industry in China is projected to grow at a compound annual growth rate (CAGR) of 10.54% over the past five years, making it the second-largest market globally[31]. - In 2023, the market size of China's medical device industry reached approximately 1.25 trillion, representing a year-on-year growth of 16%[32]. - The circulation market size in China reached approximately 1.45 trillion in 2023, with a year-on-year growth of 13%[32]. - The global medical device market is expected to grow from approximately 600 billion in 2023 to 700 billion by 2025, indicating a robust growth trajectory[30]. Product Development and Innovation - The company has established a comprehensive product system, including hospital, home, and other categories, covering various medical devices such as blood oxygen monitors, ECG machines, and ultrasound equipment[36]. - The company is committed to high-level R&D investment, focusing on new technology and product development to enhance its market competitiveness[36]. - The company has developed a complete industrial chain from mold injection to product assembly, which enhances its rapid response to orders and large-scale production capabilities[35]. - The company aims to improve its smart manufacturing level and continue to expand its market depth and breadth through a long-term capacity enhancement plan[36]. - The company has developed a digital EEG topography instrument that detects multi-channel EEG signals and can continuously record for over 24 hours, providing clear analysis software for user convenience[49]. - The company has made significant advancements in new product development, particularly in monitoring equipment, IVD, and medical endoscopes, with several new products launched during the reporting period[87]. Regulatory Compliance and Challenges - The new EU MDR and IVDR regulations will impose stricter requirements on medical devices entering the European market, potentially increasing compliance costs and extending certification timelines for the company[34]. - The introduction of the UKCA mark as a new certification standard post-Brexit will require the company to adapt to changing regulatory landscapes in the UK market[34]. - The company is committed to complying with EU regulations and has implemented a compliance management strategy to ensure its products meet market requirements[116]. Sales and Distribution - The company has expanded its global market presence, selling products to over 140 countries and regions, enhancing its brand recognition internationally[35]. - The company achieved a 145.32% increase in sales for its fetal heart monitor product on the Tmall platform compared to 2022, ranking among the top in the industry during major sales events[110]. - The company has established five overseas warehouses in the US, Spain, France, Germany, and Russia to enhance logistics efficiency and user experience[108]. - The company is actively expanding its international market presence, particularly in countries along the "Belt and Road" initiative, achieving significant sales growth in Indonesia, UAE, and Algeria[106]. Research and Development - The company has a strong focus on R&D, with 657 R&D personnel accounting for 37.09% of total employees, and holds 353 domestic patents and 96 foreign patents[73]. - R&D expenses for the period were 110.60 million yuan, representing an 18.60% increase, significantly higher than the revenue growth rate[83]. - The company is focusing on new product development, with significant breakthroughs in several technologies, including zirconia blocks for all-ceramic dentures and diagnostic test kits[86]. - The company has received multiple awards for its products, including the 2023 IF Design Award and the 2023 Guangzhou Design Innovation Award, highlighting its commitment to innovation[75]. Financial Management - The company has invested a total of 434.39 million CNY in fundraising projects, with 169.30 million CNY invested in the current year and a remaining balance of 683.04 million CNY[100]. - The company has temporarily invested up to 650 million CNY of idle raised funds in cash management products to improve fund utilization efficiency[105]. - The company has established a stable long-term cooperation with hundreds of qualified suppliers, ensuring material procurement is not restricted by resources or other factors[64]. - The company has improved its governance structure, enhancing decision-making capabilities and operational efficiency, which supports its steady growth[117]. Future Outlook - The company anticipates a positive outlook for the upcoming fiscal year, with projected revenue growth driven by new product launches and market demand[137]. - The company has set a future outlook with a revenue target of 1.8 billion RMB for 2024, indicating a projected growth rate of 20%[141]. - The company plans to enhance its distribution network, aiming for a 30% increase in sales channels by the end of 2024[141]. - The company is committed to research and development, investing in innovative technologies to improve patient care and monitoring solutions[137].
康泰医学:《董事会薪酬与考核委员会工作细则》
2024-04-24 08:54
康泰医学系统(秦皇岛)股份有限公司 董事会薪酬与考核委员会工作细则 第一章 总则 第一条 为进一步建立健全康泰医学系统(秦皇岛)股份有限公司(以下简 称"公司")董事(包括非独立董事)及高级管理人员的考核和薪酬管理制度, 完善公司治理结构,根据《中华人民共和国公司法》、《公司章程》等规定,公 司特设立董事会薪酬与考核委员会,并制定本工作细则。 第二条 薪酬与考核委员会是董事会按照股东大会决议设立的专门工作机构, 主要负责制定、审查公司董事、高级管理人员的薪酬政策与方案,负责制定公司 董事及高级管理人员的考核标准并进行考核,对董事会负责。 第二章 人员组成 第三条 薪酬与考核委员会由三名董事组成,其中独立董事两名。 第四条 薪酬与考核委员会委员由董事长、二分之一以上独立董事或者全体 董事的三分之一提名,并由董事会选举产生。 第五条 薪酬与考核委员会设主任委员(召集人)一名,由独立董事担任, 负责主持委员会的工作。主任委员由董事会在委员中任命。 第六条 薪酬与考核委员会委员任期与董事任期一致,委员任期届满,连选 可以连任。期间如有委员不再担任公司董事职务,自动失去委员资格。董事会应 根据《公司章程》及本制度增补新 ...
康泰医学:独立董事述职报告(李华)
2024-04-24 08:54
各位董事、各位股东: 本人作为康泰医学系统(秦皇岛)股份有限公司(以下简称"康泰医学"或 "公司")的独立董事,严格按照《中华人民共和国公司法》《上市公司治理准则》 和《上市公司独立董事管理办法》等法律法规以及《康泰医学系统(秦皇岛)股 份有限公司公司章程》(以下简称"《公司章程》")的规定,认真履行独立董事职 责,认真、勤勉地行使公司所赋予独立董事的权利,充分发挥独立董事作用,切 实维护了公司整体利益及全体股东尤其是中小股东合法权益。现将本人 2023 年 度履职情况总结如下: 康泰医学系统(秦皇岛)股份有限公司 独立董事 2023 年度述职报告 一、独立董事的基本情况 报告期内,本人任职符合《上市公司独立董事管理办法》第六条规定的独立 性要求,不存在影响独立性的情况。本人履历如下: 李华,独立董事,女,中国国籍,无境外永久居留权,1971 年 11 月出生, 汉族,本科学历,中国注册会计师、中国注册税务师、造价工程师、高级会计师。 历任秦皇岛市财政局人事教育科科员、秦皇岛会计师事务所注册会计师、秦皇岛 嘉华会计师事务所所长助理;2001 年 12 月至 2010 年 11 月在秦皇岛正源会计师 事务所任部 ...
康泰医学:《股东大会议事规则》
2024-04-24 08:54
康泰医学系统(秦皇岛)股份有限公司 股东大会议事规则 第一章 总则 第一条 为维护康泰医学系统(秦皇岛)股份有限公司(以下简称"公司") 股东合法权益,明确股东大会的职责权限,保证股东大会依法行使职权,根据《中 华人民共和国公司法》(以下简称"《公司法》")和《康泰医学系统(秦皇岛) 股份有限公司章程》(以下简称"公司章程")以及国家的相关法律、法规及规 范性文件的规定,制定本规则。 第二条 公司应当严格按照法律、法规、公司章程及本规则的相关规定召开 股东大会,保证股东能够依法行使权利。公司董事会应当切实履行职责,认真、 按时组织股东大会。公司全体董事应当勤勉尽责,确保股东大会正常召开和依法 行使职权。 第三条 股东大会是公司的权力机构,应当在《公司法》等相关法律、法规 和规范性文件以及公司章程规定的范围内依法行使职权,依法行使下列职权: (一)决定公司的经营方针和投资计划; (二)选举和更换非由职工代表担任的董事、监事,决定有关董事、监事的 报酬事项; (六)审议批准公司的利润分配方案和弥补亏损方案; (七)对公司增加或者减少注册资本作出决议; (八)对发行公司债券作出决议; 1 (九)对公司合并、分立、解 ...