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迈克生物(300463.SZ):新产品取得产品注册证书
Ge Long Hui A P P· 2025-10-21 14:38
Core Viewpoint - The company, Maike Bio (300463.SZ), has received a medical device registration certificate from the Sichuan Provincial Drug Administration for its new product, the Glial Fibrillary Acidic Protein Assay Kit, which is intended for auxiliary diagnosis of central nervous system diseases [1] Group 1: Product Registration and Purpose - The Glial Fibrillary Acidic Protein Assay Kit is a new reagent product under the company's direct chemiluminescence platform, used in conjunction with the company's fully automated chemiluminescence immunoassay analyzers (i6000, i3000, i1000, and i800 series) [1] - The company has obtained a total of 138 product registration certificates for reagent products under the direct chemiluminescence platform, covering various disease detections including thyroid function, infectious diseases, myocardial, tumor markers, anemia, inflammation, autoimmune diseases, reproductive hormones, and bone metabolism [1] - The blood cell analyzer quality control products and calibration products are newly added to the company's blood cell platform, ensuring the accuracy of clinical blood cell analysis results [1] Group 2: Registration Details - The blood cell analyzer quality control product has a registration number of 20252400168, valid from September 24, 2025, to September 23, 2030, and is used for quality control of blood cell analysis projects [2] - The Glial Fibrillary Acidic Protein Assay Kit has a registration number of 20252400179, valid from October 17, 2025, to October 16, 2030, for the quantitative measurement of glial fibrillary acidic protein concentration in human serum or plasma [2] - The blood cell analyzer calibration product has a registration number of 20252400180, valid from October 17, 2025, to October 16, 2030, for calibrating parameters such as WBC, RBC, HGB, HCT, and PLT in blood cell analysis [2]
迈克生物:新产品取得产品注册证书
Ge Long Hui· 2025-10-21 14:31
Core Viewpoint - The company, Maike Bio (300463.SZ), has received a medical device registration certificate from the Sichuan Provincial Drug Administration for its new product, the Glial Fibrillary Acidic Protein Assay Kit, which is intended for auxiliary diagnosis of central nervous system diseases [1] Group 1: Product Registration and Purpose - The Glial Fibrillary Acidic Protein Assay Kit is a new reagent product under the company's direct chemiluminescence platform, primarily used for the auxiliary diagnosis of central nervous system diseases [1] - The company has obtained a total of 138 registration certificates for reagent products under the direct chemiluminescence platform, covering various disease detections including thyroid function, infectious diseases, cardiac markers, tumor markers, anemia, inflammation, autoimmune diseases, reproductive hormones, and bone metabolism [1] - The blood cell analyzer quality control product is a new quality control product for the blood cell platform, used to monitor the operational status of blood cell analyzers to ensure the accuracy of clinical blood cell analysis results [1] Group 2: Calibration Products - The blood cell analyzer calibration product is also a new addition to the blood cell platform, used for calibrating parameters such as WBC, RBC, HGB, HCT, and PLT in blood cell analyzers, establishing metrological traceability for measurement results [1] - The registration certificates for the blood cell analyzer quality control product and calibration product are valid until September 24, 2030, and October 16, 2030, respectively [2]
迈克生物:公司新产品取得产品注册证书
Xin Lang Cai Jing· 2025-10-21 11:00
Core Viewpoint - The company has received medical device registration certificates for new products, which will enhance its product portfolio and market competitiveness, positively impacting future operations, although actual sales depend on market promotion effectiveness [1] Product Registration - The company has obtained registration for quality control products for blood cell analyzers, a reagent kit for measuring glial fibrillary acidic protein (using direct chemiluminescence), and calibration products for blood cell analyzers [1] Market Impact - The introduction of these new products is expected to enrich the company's offerings and improve its overall market competitiveness [1] - The actual impact on future revenue remains uncertain and is contingent upon the effectiveness of market promotion strategies [1]
迈克生物(300463) - 关于公司新产品取得产品注册证书的公告
2025-10-21 10:54
第 1 页 共 2 页 迈克生物股份有限公司 关于公司新产品取得产品注册证书的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假记载、误导性 陈述或者重大遗漏。 迈克生物股份有限公司(以下简称"公司")于近日收到四川省药品监督管理局颁发的《医 疗器械注册证》(体外诊断试剂),具体情况如下: 一、产品注册证具体情况 | 产品名称 | 注册证书 | 注册 | | 注册证有效期 | | | | 预期用途 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 编号 | 类别 | | | | | | | | 血细胞分析仪用质 | 川械注准 | Ⅱ | 2025 年 | 9 | 月 24 | | 日至 | 本品用于全自动血细胞分析仪 | | 控品 | 20252400168 | | 年 2030 | 9 | 月 23 | 日 | | 血细胞分析项目的质量控制。 | | 胶质纤维酸性蛋白 | 川械注准 | | 年 2025 | 10 | 月 | 17 | 日 | 本品用于体外定量测定人血清 | | 测定试剂盒(直接化 | 2025240 ...
迈克生物(300463) - 关于担保进展的公告
2025-10-20 08:20
证券代码:300463 证券简称:迈克生物 公告编号:2025-095 迈克生物股份有限公司 近日,公司与兴业银行股份有限公司成都分行(以下简称"兴业成都分行")签订《最高 额保证合同》,为公司的优质经销商向兴业成都分行申请授信提供担保,具体情况见下表: | | 债权人 | | 保证人 | | 债务人 | | | 本次实际担 | | | | 签署日期 | | 审议的担保额 | | 截至本次担保 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | | | 保金额 | | | | | | 度 | | 前的担保余额 | | | 兴 | 业 | 银 | 迈 克 | 生 | 成都 | 惠泽 | 生物 | 3,000 | 万元 | 2025 | 年 | 10 | 月 17 | 5,000 | 万元 | | 0 | | 行 | 股 | 份 | | | 科技有限公司 | | | | | 日 | | | | | | | | | ...
迈克生物(300463) - 2025年第三次临时股东大会决议公告
2025-10-15 10:50
证券代码:300463 证券简称:迈克生物 公告编号:2025-093 迈克生物股份有限公司 2025 年第三次临时股东大会决议公告 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假记载、误导性 陈述或者重大遗漏。 特别提示: 一、会议的召开和出席情况 迈克生物股份有限公司(以下简称:"公司")2025 年第三次临时股东大会于 2025 年 10 月 15 日(星期三)在公司会议室以现场投票和网络投票相结合的方式召开。会议通知于 2025 年 9 月 30 日以公告形式发出。通过深圳证券交易所系统进行网络投票的具体时间为:2025 年 10 月 15 日上午 9:15-9:25,9:30-11:30,下午 13:00-15:00;通过深圳证券交易所互联网投票系 统投票的具体时间为:2025 年 10 月 15 日 9:15-15:00 期间的任意时间。 表决结果:同意 247,035,847 股,占出席会议股东所持有效表决股份总数的 98.6451%;反 对 3,148,208 股,占出席会议股东所持有效表决股份总数的 1.2571%;弃权 245,000 股,占出席 会议股东所持有效表决股份总 ...
迈克生物(300463) - 上海市锦天城律师事务所关于迈克生物股份有限公司2025年第三次临时股东大会的法律意见书
2025-10-15 10:50
上海市锦天城律师事务所 关于迈克生物股份有限公司 2025 年第三次临时股东大会的 法律意见书 地址:上海市浦东新区银城中路 501 号上海中心大厦 9/11/12 层 电话:021-20511000 传真:021-20511999 邮编:200120 上海市锦天城律师事务所 法律意见书 上海市锦天城律师事务所 关于迈克生物股份有限公司 2025 年第三次临时股东大会的 法律意见书 致:迈克生物股份有限公司 上海市锦天城律师事务所(以下简称"本所")接受迈克生物股份有限公司 (以下简称"公司")委托,就公司召开 2025 年第三次临时股东大会(以下简 称"本次股东大会")的有关事宜,根据《中华人民共和国公司法》(以下简称 《公司法》)、《上市公司股东会规则》等法律、法规、规章和其他规范性文件 以及《迈克生物股份有限公司章程》(以下简称《公司章程》)的有关规定,出 具本法律意见书。 为出具本法律意见书,本所及本所律师依据《律师事务所从事证券法律业务 管理办法》和《律师事务所证券法律业务执业规则(试行)》等规定,严格履行 了法定职责,遵循了勤勉尽责和诚实信用原则,对本次股东大会所涉及的相关事 项进行了必要的核查和 ...
迈克生物(300463) - 关于非独立董事辞职暨选举职工代表董事的公告
2025-10-15 10:50
证券代码:300463 证券简称:迈克生物 公告编号:2025-094 迈克生物股份有限公司 关于非独立董事辞职暨选举职工代表董事的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假记载、误导性 陈述或者重大遗漏。 一、关于非独立董事辞职的情况 迈克生物股份有限公司(以下简称"公司"或"迈克生物")董事会于近日收到公司非独 立董事尹珊女士的书面辞职报告。因公司组织架构调整原因,尹珊女士提请辞去公司第六届董 事会非独立董事职务,辞去董事职务后,尹珊女士将继续担任公司财务负责人职务。 根据《中华人民共和国公司法》及《公司章程》等有关规定,尹珊女士的辞职不会导致公 司董事会人数低于法定最低人数,不会影响公司董事会的正常运行,亦不会对公司的日常经营 管理及未来发展产生不利影响,尹珊女士的辞职报告自送达董事会之日起生效。尹珊女士担任 公司董事的原定任期为2025年1月13日至第六届董事会任期届满之日,即2025年1月13日至2028 年1月12日止。 截至本公告披露之日,尹珊女士直接持有公司股份38,930股。经核查,尹珊女士不存在应 当履行而未履行的承诺事项,其辞职后将继续严格执行任职期间作出的各项 ...
迈克生物:关于转让控股子公司全部股份进展暨完成工商变更登记的公告
Zheng Quan Ri Bao· 2025-10-13 13:37
Core Points - The company announced the transfer of 51% equity of its subsidiary Shandong Mike Biological Technology Co., Ltd. to Han Siguang for a transaction price of RMB 17,412,879.00 [2] - The transfer has been completed with the necessary changes registered with the market supervision administration, and a new business license has been issued [2] Summary by Category Company Actions - The company held its sixth board meeting and sixth supervisory board meeting on June 11, 2025, where the proposal for the equity transfer was approved [2] - The equity transfer process has been finalized, including the completion of the business registration changes [2] Financial Details - The transaction price for the 51% equity transfer is set at RMB 17,412,879.00 [2]
迈克生物:高管史炜已减持0.02%
Ge Long Hui· 2025-10-13 13:25
格隆汇10月13日|迈克生物公告,公司高级管理人员史炜已于2025年9月25日至10月13日通过集中竞价 累计减持15万股,减持均价11.57元/股,占公司总股本0.02%,减持计划实施完成,持股降至116.81万 股,占0.19%。 ...