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美康生物(300439) - 关于公司及控股子公司取得医疗器械注册证的公告
2025-08-28 12:34
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,美康生物科技股份有限公司(以下简称"美康生物"或"公司")及控 股子公司江西美康盛德生物科技有限公司(以下简称"江西美康")分别取得了由 浙江省药品监督管理局和江西省药品监督管理局颁发的《中华人民共和国医疗器 械注册证(体外诊断试剂)》(以下简称"《注册证》"),具体情况如下: | 序号 | 注册人名称 | 产品名称 | 注册证编号 | | 注册证有效期间 预期用途 | | --- | --- | --- | --- | --- | --- | | 1 | 美康生物 | 茶碱检测试剂盒 | 浙 械 注 准 | 年 2025 | 月 日至 用于体外定量检测人血清或血 8 21 | | | | (质谱法) | 20252401615 | 2030 年 | 8 月 20 日 浆中茶碱的浓度。 | | | | 甲氨蝶呤检测试剂盒(液 | 赣 械 注 准 | 2025 年 | 8 月 18 日至 (MTX)浓度的体外定量检测。 | | 2 | 江西美康 | | | | | | | | 相色谱-串联质谱法) | 202 ...
美康生物(300439) - 2025年半年度募集资金存放与使用情况的专项报告
2025-08-28 12:34
美康生物科技股份有限公司 的专项报告 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。 根据中国证券监督管理委员会《上市公司募集资金监管规则(2025年)》《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》以及 《深圳证券交易所创业板上市公司自律监管指南第2号——公告格式》的相关规 定,公司董事会将2025年半年度募集资金存放与使用情况作如下专项报告: 一、募集资金基本情况 (一)实际募集资金金额、资金到位情况 证券代码:300439 证券简称:美康生物 公告编号:2025-050 美康生物科技股份有限公司 2025 年半年度募集资金存放与使用情况 经中国证券监督管理委员会证监许可[2021]310号文"关于同意美康生物科技 股份有限公司向特定对象发行股票注册的批复"核准,同意公司向特定对象发行 39,999,995股人民币普通股(A股),每股发行价为人民币15.00元,共募集资金 人民币599,999,925.00元。截至2021年3月17日止,公司实际已发行人民币普通股 (A股)39,999,995股,募集资金总额为人民币599,999 ...
美康生物(300439) - 关于使用闲置自有资金进行委托理财的公告
2025-08-28 12:34
一、本次使用闲置自有资金进行委托理财概述 美康生物科技股份有限公司 证券代码:300439 证券简称:美康生物 公告编号:2025-052 美康生物科技股份有限公司 关于使用闲置自有资金进行委托理财的公告 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。 美康生物科技股份有限公司(以下简称"公司")于 2025 年 8 月 28 日召开 公司第五届董事会第十五次会议、第五届监事会第十四次会议,分别审议通过了 《关于使用闲置自有资金进行委托理财的议案》。为进一步提高公司自有资金使 用效率,在保证日常经营资金需求和资金安全的前提下,董事会同意公司(含子 公司)使用额度不超过人民币 60,000 万元暂时闲置的自有资金进行委托理财, 用于购买安全性高、流动性好、风险可控的现金管理类产品或理财产品,上述额 度自公司董事会审议通过之日起 12 个月内可循环滚动使用。如单笔交易的存续 期超过了授权期限,则授权期限自动顺延至单笔交易终止时止。同意授权公司法 定代表人或指定的授权代理人在规定额度范围内行使相关投资决策权并签署相 关文件,公司财务部负责组织实施。具体情况如下: 1 ...
美康生物(300439) - 关于增加2025年度日常关联交易预计的公告
2025-08-28 12:34
美康生物科技股份有限公司 2、本次预计新增关联交易情况 基于2025年度的实际经营情况与业务发展需要,公司预计新增与关联方鄞州 中医院、浙江盈实私募基金管理合伙企业(有限合伙)(以下简称"浙江盈实基 金")发生日常关联交易事项,新增关联交易的预计金额不超过人民币220万元。 公司于2025年8月28日召开第五届董事会第十五次会议、第五届监事会第十四次 会议,审议通过《关于增加2025年度日常关联交易预计的议案》,邹炳德先生、 邹继华先生两名关联董事已回避表决。本事项已经公司第五届董事会独立董事第 四次专门会议审议通过。 1 / 6 证券代码:300439 证券简称:美康生物 公告编号:2025-051 美康生物科技股份有限公司 关于增加 2025 年度日常关联交易预计的公告 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。 一、日常关联交易基本情况 1、公司已预计的2025年日常关联交易的情况 2025年3月14日,美康生物科技股份有限公司(以下简称"公司")召开第 五届董事会第十一次会议、第五届监事会第十次会议,分别审议通过了《关于公 司2025年日常关联交易 ...
美康生物(300439) - 监事会决议公告
2025-08-28 12:30
美康生物科技股份有限公司 证券代码:300439 证券简称:美康生物 公告编号:2025-047 美康生物科技股份有限公司 第五届监事会第十四次会议决议公告 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。 美康生物科技股份有限公司(以下简称"公司")第五届监事会第十四次会 议于 2025 年 8 月 28 日在公司会议室以现场结合通讯方式召开,会议通知已于 2025 年 8 月 18 日以电话、邮件等方式送达全体监事。会议应出席监事 3 人,实 际出席监事 3 人,会议由监事会主席田晓燕女士召集并主持。本次会议的召集、 召开符合《中华人民共和国公司法》《美康生物科技股份有限公司章程》(以下 简称"《公司章程》")等有关规定,合法有效。 经与会监事审议与表决,通过了如下议案: 一、审议并一致通过《关于公司<2025 年半年度报告>及其摘要的议案》 公司编制了《2025 年半年度报告全文》及《2025 年半年度报告摘要》。经 审议,监事会认为:公司上述报告的编制和审核程序符合法律、行政法规和《公 司章程》的规定,其内容与格式符合中国证券监督管理委员会和深圳证券交易 ...
美康生物(300439) - 董事会决议公告
2025-08-28 12:29
美康生物科技股份有限公司 证券代码:300439 证券简称:美康生物 公告编号:2025-046 美康生物科技股份有限公司 第五届董事会第十五次会议决议公告 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。 美康生物科技股份有限公司(以下简称"公司")第五届董事会第十五次会 议于 2025 年 8 月 28 日在公司会议室以现场结合通讯方式召开,会议通知已于 2025 年 8 月 18 日以电话、邮件等方式送达全体董事。会议应出席董事 5 人,实 际出席董事 5 人,会议由董事长邹炳德先生召集并主持。本次会议的召集、召开 符合《中华人民共和国公司法》《美康生物科技股份有限公司章程》(以下简称 "《公司章程》")等有关规定,合法有效。 经与会董事审议与表决,通过了如下议案: 一、审议并一致通过《关于公司<2025 年半年度报告>及其摘要的议案》 公司编制了《2025 年半年度报告全文》及《2025 年半年度报告摘要》。公 司 2025 年半年度报告及摘要的内容真实、准确、完整地反映了公司 2025 年半年 度经营的实际情况,不存在任何虚假记载、误导性陈述或者重大遗 ...
美康生物:2025年上半年净利润5683.37万元,同比下降68.15%
Xin Lang Cai Jing· 2025-08-28 12:15
美康生物公告,2025年上半年营业收入7.36亿元,同比下降22.43%。净利润5683.37万元,同比下降 68.15%。 ...
美康生物(300439) - 2025 Q2 - 季度财报
2025-08-28 12:10
Financial Performance - The company reported a significant increase in revenue, achieving a total of 500 million RMB for the first half of 2025, representing a 20% year-over-year growth[1]. - The company's revenue for the reporting period was RMB 736,221,523.12, a decrease of 22.43% compared to RMB 949,125,024.71 in the same period last year[19]. - The net profit attributable to shareholders was RMB 56,833,722.63, down 68.15% from RMB 178,463,238.99 in the previous year[19]. - The net profit after deducting non-recurring gains and losses was RMB 30,024,575.42, reflecting an 80.03% decline from RMB 150,328,234.93 year-on-year[19]. - The basic earnings per share decreased to RMB 0.1480, a drop of 68.16% compared to RMB 0.4648 in the same period last year[19]. - The total operating revenue for the first half of 2025 was ¥736.22 million, a decrease of 22.4% compared to ¥949.13 million in the first half of 2024[183]. - Net profit for the first half of 2025 was ¥55.61 million, down 68.9% from ¥178.33 million in the same period of 2024[184]. - The company reported a significant reduction in income tax expenses, down 91.85% to ¥1,335,896.63, due to a decrease in pre-tax profit[68]. Market Outlook and Growth Strategy - The company has provided a positive outlook for the second half of 2025, projecting a revenue growth of 25%[1]. - New product launches are expected to contribute an additional 100 million RMB in revenue by the end of 2025[1]. - The company is expanding its market presence, targeting an increase in market share by 10% in the next fiscal year[1]. - International business revenue reached 17.14 million yuan, representing a significant growth of 142.27% compared to the previous year, driven by expansion in Southeast Asia and the Middle East[35]. - The company aims to enhance its competitive position in the IVD industry by optimizing product structure and expanding the industrial chain[49]. Research and Development - Research and development investments have increased by 30%, focusing on innovative technologies in the biotechnology sector[1]. - The company invested CNY 71.45 million in R&D, accounting for 9.71% of its revenue during the reporting period[50]. - As of the end of the reporting period, the company has applied for 474 patents in China, including 247 invention patents, and has obtained 307 valid authorized patents[51]. - The company continues to focus on technology innovation and R&D in areas such as chemiluminescence, mass spectrometry, and molecular diagnostics[50]. - The company has established multiple R&D centers in locations including Ningbo, Changchun, Shenzhen, Hangzhou, and the United States[50]. Product Development and Innovation - The company has obtained 497 product registration certificates for in vitro diagnostic reagents and 50 for in vitro diagnostic instruments as of the end of the reporting period[27]. - The company launched two new biochemical products, including D-dimer and lipoprotein(a) testing kits, enhancing its biochemical product line[35]. - The company is developing a new software for HPV nucleic acid typing analysis, which compares melt curve characteristics with known genotypes[56]. - The company is focused on expanding its product line with innovative diagnostic solutions in the field of clinical testing[55]. - The company has registered multiple diagnostic kits, including the Interleukin testing kits, which are classified as Class II medical devices[57]. Operational Efficiency - The company aims to enhance operational efficiency, targeting a 15% reduction in operational costs by the end of 2025[1]. - The company has implemented a "sales-driven production" model to optimize inventory control and production efficiency[30]. - The company has established a comprehensive marketing network covering major cities and provinces in China, enhancing brand influence and customer service capabilities[59]. - The company emphasizes continuous improvement in quality management through the implementation of international standards such as ISO9001:2015 and ISO13485:2016[32]. Financial Management and Investments - The total investment during the reporting period was ¥209,554,542.00, a slight increase of 0.73% compared to ¥208,044,150.29 in the previous year[76]. - The company has committed RMB 17 million for in vitro diagnostic product R&D, with RMB 477.77 thousand invested in the reporting period, achieving 63.48% of the investment progress[83]. - The company has invested RMB 54 million in entrusted financial management, with RMB 19.5 million remaining unexpired[88]. - The company has not experienced any significant changes in project feasibility[84]. Risk Management - The management has identified potential risks, including regulatory changes and market competition, and is developing strategies to mitigate these risks[1]. - The company is closely monitoring industry regulations and policies to adapt to changes, particularly in centralized procurement, which has become a normalized practice since 2018[95]. - The company anticipates potential declines in gross margin due to centralized procurement policies, which could negatively impact profitability[99]. Corporate Governance and Compliance - The company is committed to compliance and governance, ensuring the protection of shareholder rights and efficient operation of its board and committees[110]. - The company has established a dedicated team to manage investor relations, ensuring effective communication and transparency with investors through various platforms[113]. - The company has implemented an international quality management system based on ISO9001:2015 and ISO13485:2016, achieving a 99.2% pass rate in inter-laboratory quality evaluation activities[63]. Legal Matters - The company is involved in a significant lawsuit regarding a shareholder dispute, with a claim amounting to RMB 53.63 million[124]. - The company has initiated bankruptcy proceedings against its subsidiary, Meikang Baosheng, due to unpaid debts totaling RMB 2.51 million[124]. - The company has received a final judgment in a lawsuit against a shareholder, which has been appealed[124]. Shareholder Information - The total number of common shareholders at the end of the reporting period is 25,679[166]. - The largest shareholder, Zou Bingde, holds 28.34% of shares, totaling 108,897,635 shares[166]. - The company’s total share capital increased due to the completion of the vesting registration and business change procedures for the second category of restricted stock[160].
美康生物:2025年公司在深圳市宝安区新设深圳美康盛德生物科技有限公司
Zheng Quan Ri Bao Wang· 2025-08-21 12:44
证券日报网讯美康生物(300439)8月21日在互动平台回答投资者提问时表示,2025年公司在深圳市宝 安区新设深圳美康盛德生物科技有限公司,主要从事体外诊断产品研发及国际贸易业务。 ...
百济神州:上半年净利润4.5亿元 同比扭亏为盈丨公告精选
Group 1: Company Performance - BeiGene reported a net profit of 450 million yuan for the first half of 2025, marking a turnaround from losses in the previous year, with product revenue increasing by 45.8% to 17.36 billion yuan and total revenue rising by 46.0% to 17.52 billion yuan [1] - CITIC Securities announced that Huaxia Fund achieved an operating income of 4.258 billion yuan and a net profit of 1.123 billion yuan in the first half of 2025, with total comprehensive income of 1.106 billion yuan [3] - Shanghai Pudong Development Bank's net profit for the first half of 2025 was 29.737 billion yuan, reflecting a year-on-year growth of 10.19%, with total operating income of 90.559 billion yuan, up 2.62% [6] - Xianhe Co. plans to invest approximately 11 billion yuan in a new integrated high-performance paper-based material project, with an expected annual output value of about 5.15 billion yuan from the first phase [7] - Shengmei Shanghai reported a net profit of 696 million yuan for the first half of 2025, representing a year-on-year increase of 56.99% [14] Group 2: Regulatory and Corporate Actions - Sino Medical's subsidiary received breakthrough medical device designation from the FDA for its intracranial atherosclerosis treatment product, marking it as the first of its kind globally [2] - *ST Dongtong's actual controller and chairman is under investigation by the China Securities Regulatory Commission for suspected violations of information disclosure laws [8] - Tianyang Technology is planning to purchase equity in Tonglian Financial Services, with key transaction details still under negotiation [10] - Dongfang Guoxin's major shareholder reduced their stake by 2.68 million shares, decreasing their total shareholding from 27.06% to 26.82% [5] - Filinger's president reduced his holdings by 8,600 shares during a period of stock price volatility, while other executives did not sell shares [4]