Policy Developments - Shanghai is advancing the standardization research of medical accompaniment services, with a project led by East China Hospital identified as a key research topic for 2024, focusing on service institutions, personnel requirements, service processes, and quality evaluation [2] Drug and Device Approvals - Maike Bio has received a medical device registration certificate for its coagulation factor activity measurement kits, valid from July 8, 2025, to July 7, 2030, aimed at monitoring treatments for coagulation factor deficiencies [3] - Kewang Pharmaceutical's vitamin K1 drops have received a registration acceptance notice from the National Medical Products Administration, intended to prevent vitamin K deficiency bleeding in infants [4] - CanSino has been approved for clinical trials of its trivalent poliovirus vaccine, which is being developed using protein structure design and VLP assembly technology, currently undergoing I/II phase trials in Indonesia [5] Financial Reports - Johnson & Johnson reported Q2 revenue of $23.74 billion, a 5.8% increase year-over-year, exceeding market expectations, with projected annual sales between $93.2 billion and $93.6 billion [6] Capital Markets - Tuoxin Pharmaceutical plans to invest 10 million yuan in Jiangsu Jinsan Biotechnology Co., acquiring a 1.75% stake, with Jinsan successfully producing high-purity ergothioneine for various products [7] - Tsinghua Unigroup's stock auction resulted in the sale of 58.607 million shares, potentially leading to a change in control of the company, with the shares sold at an average price significantly above the latest closing price [8] Industry Events - China National Pharmaceutical Group responded to rumors regarding the "return" of a licensing agreement with Merck for a PD-1/VEGF bispecific antibody, stating that the collaboration is progressing normally and a milestone payment of $300 million is expected upon completion of technology transfer by 2025 [9] Public Sentiment Alerts - A senior executive of Astellas Pharma in China was sentenced to three and a half years in prison for espionage, highlighting potential risks in the pharmaceutical industry [10] Stock Market Alerts - ST Weiming's stock has been placed under risk warning due to a significant price drop and expected losses of 55 million to 85 million yuan for the first half of 2025, leading to a change in its trading name and restrictions on price fluctuations [11]

迈克生物股份有限公司 证券代码:300463 证券简称:迈克生物 公告编号:2025-061 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： 二、对公司的影响 凝血因子Ⅱ、V、Ⅶ、Ⅹ活性测定试剂盒（凝固法）均系公司凝血平台新试剂产品，主要 用于凝血因子Ⅱ、V、Ⅶ、Ⅹ缺乏或活性减低治疗监测，配套公司全自动凝血分析系统H 2600、 H 3800系列、H 5000系列。新产品取得注册证进一步丰富了公司产品项目菜单，有助于提升公 司市场综合竞争力，对市场的拓展以及公司未来的经营将产生积极影响。 三、风险提示 上述注册证书涉及的产品实际销售情况取决于未来市场推广效果，目前尚无法预测该产品 对公司未来营业收入的影响，敬请广大投资者注意投资风险。 第 1 页 共 2 页 证券代码:300463 证券简称:迈克生物 公告编号:2025-061 特此公告。 迈克生物股份有限公司 董事会 二〇二五年七月十六日 第 2 ...

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 | | | | | | | | 肺炎衣原体 IgM 抗 | | | | | | | | 本产品用于体外定性检测人血 | | | 国械注准 | | 2025 | 年 | 7 月 | 4 | 日至 | | | 体检测试剂盒（直接 | 20253401303 | Ⅲ | 2030 | 年 7 | 月 | 3 | 日 | 清或血浆样本中的肺炎衣原体 | | 化学发光法） | | | | | | | | IgM 抗体。 | | 脂蛋白(a)测定试剂 盒（胶乳免疫比浊 | 川械注准 | Ⅱ | 2025 | 年 | 7 月 | 8 | 日至 | 本产品用于体外定量测定人血 | | | 20252400112 | | 2030 | 年 7 | 月 | 7 | 日 | 清或血浆中脂蛋白(a)的含量。 | | 法） | | | | | | | | | | 胰岛素样生长因子 | 川械 ...

Company Overview - The main business of the company is the research, production, sales, and related services of in vitro diagnostic products, including a wide range of test reagents for liver function, kidney function, glucose metabolism, lipid metabolism, infectious diseases, and more [2]. Financial Performance - In the first quarter of 2025, the company reported revenue of 510 million yuan, a year-on-year decrease of 17.22%, and a net profit of 23.98 million yuan, down 80.09% year-on-year, with a gross profit margin of 56.76% [2]. Market Position - As of July 9, the company's stock closed at 12.24 yuan, up 1.92%, with a rolling price-to-earnings (PE) ratio of 247.07, marking a new low in 65 days. The total market capitalization is 7.497 billion yuan [1]. - The average PE ratio in the medical device industry is 51.36, with a median of 37.22, placing the company at the 119th position in the industry ranking [1][3]. Shareholder Information - As of March 31, 2025, the number of shareholders is 35,022, a decrease of 1,242 from the previous count, with an average holding value of 352,800 yuan and an average holding of 27,600 shares per shareholder [1].

证券代码：300463 证券简称：迈克生物 公告编号：2025-059 迈克生物股份有限公司 关于使用部分闲置募集资金进行现金管理的进展公告 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第六届董事会第二次会议、第六届监事会第二次会议审议通过了 《关于继续使用部分闲置募集资金进行现金管理的议案》，为提高暂时闲置募集资金的使用效 率，增加资金收益，在保证募集资金投资项目建设和募集资金正常使用的情况下，同意使用不 超过人民币6,000万元的暂时闲置募集资金进行现金管理，用于购买安全性高、流动性好、满足 保本要求的理财产品，自公司第六届董事会第二次会议审议通过之日起十二个月内有效，在上 述使用期限及额度内，资金可以循环滚动使用。闲置募集资金现金管理到期后将及时归还至募 集资金专户，同时授权公司董事长行使相关投资决策权，财务负责人办理具体相关事宜。公司 已于2025年3月7日在巨潮资讯网刊登了《关于继续使用部分闲置募集资金进行现金管理的公告》 （公告编号：2025-012）。 近日，公司使用部分闲置募集资金购买的理财产品已到期赎回，并继续使用人民币 ...

Core Viewpoint - The in vitro diagnostics sector experienced a slight increase of 0.24% on July 4, with a net outflow of funds amounting to 42.33 million [1] Group 1: Market Performance - A total of 18 stocks in the sector saw gains, while 49 stocks declined [1] - The top decliners included Dongfang Ocean (-6.51%), Xilong Scientific (-3.81%), and Nearshore Protein (-2.54%) [1][1] Group 2: Stock Performance - Notable gainers included: - Hotgen Biotech with a price of 194.81 and an increase of 20.08%, attracting a net fund inflow of 2.125 million [1] - Saily Medical at 21.08, up 10.02%, with a net inflow of 1.758 million [1] - Zhongyuan Union at 25.87, rising 9.99%, with a net inflow of 1.38 billion [1] - Decliners included: - Botao Biotech at 37.34, down 3.38%, with a net outflow of 1.087 million [1] - Maike Biotech at 7.99, down 2.44%, with a net inflow of 176.92 thousand [1]

Group 1 - The core viewpoint of the news highlights that Maike Biological's stock price closed at 12.03 yuan, with a PE ratio of 242.83, marking a new low in 19 days, and a total market capitalization of 7.368 billion yuan [1] - The average PE ratio for the medical device industry is 51.48, with a median of 36.88, positioning Maike Biological at the 118th rank within the industry [1] - As of March 31, 2025, the number of shareholders for Maike Biological is 35,022, a decrease of 1,242 from the previous count, with an average holding value of 352,800 yuan and an average shareholding of 27,600 shares per shareholder [1] Group 2 - Maike Biological specializes in the research, production, sales, and related services of in vitro diagnostic products, with a wide range of testing reagents for various health conditions [2] - The latest quarterly report for Q1 2025 shows that the company achieved a revenue of 510 million yuan, a year-on-year decrease of 17.22%, and a net profit of 23.98 million yuan, down 80.09% year-on-year, with a gross profit margin of 56.76% [2] - The PE ratio (TTM) for Maike Biological is 242.83, while the industry average is 51.48, indicating a significant disparity in valuation [3]

证券代码:300463 证券简称:迈克生物 公告编号:2025-058 迈克生物股份有限公司 截至本公告披露日，公司已按要求将上述税款及滞纳金缴纳完毕，主管税务部门未对该事 项给予处罚。 三、相关情况说明及对公司的影响 1、根据《企业会计准则第28号——会计政策、会计估计变更和差错更正》，上述补缴税 款及滞纳金事项不属于前期会计差错，不涉及前期财务数据追溯调整。公司补缴上述税款及滞 纳金将计入2025年当期损益，预计将影响公司2025年度归属于上市公司股东的净利润2,128.15 万元，最终以2025年度经审计的财务报表为准。 2、公司管理层将持续加强公司税务管理工作，同时组织相关部门及人员认真学习有关法 律法规及财务、税务知识，加深对政策的理解和应用。 关于补缴相关款项的公告 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"）于近日收到税务部门的《税务处理决定书》 （成税三稽处[2025]110号）（以下简称"《决定书》"），并就《决定书》相关内容进行了自 查以及税款补缴，现将有关情况公告如下： 一、基本情况 根据税务部门 ...

证券代码:300463 证券简称:迈克生物 公告编号:2025-056 迈克生物股份有限公司 2025 年第二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 年第二次临时股东大会于 2025 年 6 月 27 日（星期五）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 6 月 12 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 6 月 27 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 6 月 27 日 9:15-15:00 期间的任意时间。 本次股东大会由公司董事会召集，董事长唐勇先生主持本次会议。公司全部董事、监事出 席了本次会议；公司全部高级管理人员列席了本次会议。上海市锦天城律师事务所委派张灵芝、 毛卫律师见证了本次会议并出具法律意见书。本次会议的召集、召开与表决程序符合法律、行 政 ...

证券代码：300463 证券简称：迈克生物 公告编号：2025-057 迈克生物股份有限公司 关于注销部分股份减少注册资本暨通知债权人的公告 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、公司注销部分股份减少注册资本的基本情况 迈克生物股份有限公司（以下简称"公司"）于 2025 年 6月 11 日召开第六届董事会第四次会 议、第六届监事会第四次会议，并于 2025 年 6 月 27 日召开 2025 年第二次临时股东大会，会议 均审议通过了《关于终止实施 2024 年限制性股票激励计划暨回购注销第一类限制性股票及作废 第二类限制性股票的议案》《关于调整公司回购专用证券账户持有股份用途并注销的议案》 《关于减少注册资本并修改<公司章程>的议案》，同意注销部分公司股票减少注册资本，详见 2025 年 6 月 12日公司在巨潮资讯网上披露的公告。 鉴于公司已终止实施 2024 年限制性股票激励计划并回购注销已授予尚未解锁的第一类限 制性股票，即回购注销已授予尚未解锁的全部第一类限制性股票 3,844,966 股，约占目前公司 股本总额 612,469,590 ...