证券代码:300463 证券简称:迈克生物 公告编号:2023-063 迈克生物股份有限公司 关于持股 5%以上股东部分股份质押、解除质押的公告 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"）于近日收到持股 5%以上股东郭雷先生的通知，获悉 郭雷先生将其持有的部分公司股份办理了质押及解除质押手续，现将具体情况公告如下： 一、股东股份质押、解除质押的基本情况 （一）股东股份质押的基本情况 2023 年 9 月 26 日，公司持股 5%以上股东郭雷先生将其持有的部分公司股份 6,200,000 股办理了 质押式回购交易手续，情况如下： | 股东 | 是否为第 | 本次质 | 占其所 | 占公 | 是否 | 是否为 | | | 质押到期 | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 一大股东 | 押股数 | 持股份 | 司总 | 为限 | 补充质 | 质押起始 | | | | 质权人 | 用 ...

证券代码:300463 证券简称:迈克生物 公告编号:2023-062 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》，具体情况如下： 一、产品注册证具体情况 | 血清淀粉样蛋白 A | | | 2023 | 年 | 9 月 | 7 至 | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 测定试剂盒（免疫 | 川械注准 20232400275 | II | | | | | 定人全血样本中血清 | | | | 产品名称 散射比浊法） | 注册证书编号 | 注册类别 | 2028 | 年 | 注册证有效期 9 月 | 6 日 | 预期用途 本品用于体外定量测 淀粉样蛋白 | A | 的含量。 | 二、对公司的影响 血清淀粉样蛋白A测定试剂盒（免疫散射比浊法）主要用于感染性疾病的辅助诊断，系公 司生化平台新产品。新产品取得 ...

证券代码:300463 证券简称:迈克生物 公告编号:2023-061 | 产品名称 | 注册证书编号 | 注册类别 | | | 注册证有效期 | | | 预期用途 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 肝素质控品 | 川械注准 | II | 2023 | 年 8 | 月 | 17 | 至 | 本品用于肝素项目分 | | | 20232400266 | | 2028 | 年 8 | 月 | 16 | 日 | 析工作的质量控制。 | | 胰淀粉酶测定试 剂盒（免疫抑制 | 川械注准 20232400267 | II | 2023 | 年 8 | 月 | 17 | 至 | 本品用于体外定量测 定人血清、血浆或尿液 | | | | | 2028 | 年 8 | 月 | 16 | 日 | | | EPS 底物法） | | | | | | | | 中胰淀粉酶的活力。 | 二、对公司的影响 肝素质控品主要用于抗Xa测定试剂盒（发色底物法）产品的质量控制，系公司临床检测凝 血平台新产品；胰淀粉酶测定试剂盒（免疫抑制-EPS底物法）主要用于胰腺 ...

证券代码:300463 证券简称:迈克生物 公告编号:2023-060 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五届董事会第七次会议、第五届监事会第七次会议审议通过了 《关于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60,000万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，自公司第五届董事会第七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2023年3月11日在巨潮资讯网刊登了《关于使用部分闲置募集资金进行现金管理 的公告》（公告编号：2023-014）。 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 2 ...

Financial Performance - In the first half of 2023, the company reported revenue of 1.38 billion CNY, a year-on-year decline of 22.5% [3] - The net profit attributable to the parent company was 175 million CNY, down 56.9% year-on-year [3] - The sales revenue from self-developed regular products was 810 million CNY, while COVID-19 related products contributed approximately 5 million CNY [3] Product Sales Breakdown - The revenue from self-developed products in immunology, clinical testing, and other areas grew by 16%, 3%, and 39% respectively [3] - The overall growth rate for regular business was 13% year-on-year [3] - The company’s reagent sales structure showed a significant contribution from self-developed products, with a total of 810 million CNY from regular products and 496 million CNY from agency products [3] Instrument and Production Line Promotion - In the first half of 2023, nearly 600 immunology instruments were shipped, including 244 units of model i3000, 211 units of i1000, and 140 units of i800 [4] - The company aims to maintain a target of installing no less than 200 production lines this year, with a focus on secondary and tertiary hospitals [4] Market and Pricing Strategy - The company is actively participating in collective procurement projects, with 18 projects in Anhui province, which may impact pricing and market share [5] - The collective procurement for liver function tests in Jiangxi province involves 23 projects, expected to affect approximately 30% of the company’s biochemical sales volume [6] Inventory and Impairment - The company recognized an impairment provision of over 40 million CNY for COVID-19 related inventory due to the unsustainable nature of the pandemic [6] - In 2022, the sales revenue from COVID-19 related products was approximately 600 million CNY, with a significant contribution in the first half of the year [6] Agency Business Performance - The agency business generated 490 million CNY in revenue in the first half of 2023, a decrease of 21% year-on-year [7] - The expected decline in agency product sales is projected to be between 20% and 30% for the full year [7] Overseas Market Expansion - The company anticipates a nearly 200% growth in overseas sales, focusing on immunology and hematology products [9] - The gross margin for overseas reagents is around 60%, while instrument sales contribute to a lower margin of about 10% [9] - By 2025, the overseas market is expected to account for 10-20% of the company's total revenue [10]

Financial Performance - The company's operating revenue for the first half of 2023 was ¥1,380,723,264.24, a decrease of 22.51% compared to ¥1,781,810,340.82 in the same period last year[25]. - The net profit attributable to shareholders for the first half of 2023 was ¥174,836,659.46, down 56.91% from ¥405,770,027.70 in the previous year[25]. - The net profit after deducting non-recurring gains and losses was ¥178,097,020.12, a decrease of 55.41% compared to ¥399,415,092.66 in the same period last year[25]. - The basic earnings per share for the first half of 2023 was ¥0.2855, down 57.57% from ¥0.6728 in the same period last year[25]. - The total assets at the end of the reporting period were ¥8,235,194,791.43, an increase of 0.90% from ¥8,161,865,314.41 at the end of the previous year[25]. - The net assets attributable to shareholders at the end of the reporting period were ¥6,247,695,812.30, a decrease of 0.72% from ¥6,293,274,947.87 at the end of the previous year[25]. - The net cash flow from operating activities for the first half of 2023 was ¥409,725,254.95, a slight decrease of 2.92% compared to ¥422,069,913.69 in the same period last year[25]. - The weighted average return on equity for the first half of 2023 was 2.76%, down 6.25% from 9.01% in the same period last year[25]. - The company reported a significant reduction in financial expenses by 49.21% to ¥8,148,119.25, mainly due to decreased loan interest and increased exchange gains[89]. - The total investment during the reporting period was ¥346,474,228.17, a decrease of 28.17% compared to the same period last year[99]. Research and Development - The total R&D investment for the company reached 163.7 million CNY in the first half of 2023, representing a year-on-year increase of 32.76%[60]. - The company has a total of 1,080 R&D personnel, accounting for 33.74% of the total workforce, with 421 being mid-to-senior level researchers[60]. - The company has initiated 41 new R&D projects in the first half of 2023 across various diagnostic fields, including 12 in raw materials and 10 in rapid testing[60]. - The company has completed 30 development projects during the reporting period, with a total of 83 ongoing projects[61]. - The company has established R&D centers for reagents and instruments, focusing on biochemistry, immunology, clinical testing, molecular diagnostics, and pathology[36]. - The company has a strong focus on technological innovation, with ongoing projects aimed at enhancing product quality and performance[39]. - The company has completed the registration for hepatitis A and E virus diagnostic products, which will aid in marketing and bidding efforts[61]. - The company is developing a digital PCR product for quantifying hepatitis B and C virus DNA, with plans for registration and market introduction[61]. Product Development and Market Expansion - The company launched 38 new products during the reporting period, bringing the total number of product registrations to 495[43]. - The company aims to enhance its self-developed product sales ratio and market share by adjusting its business structure and focusing on product innovation[43]. - The company has established partnerships with multiple overseas distributors, covering 118 countries and regions, and has received positive feedback for its new i800 fully automated chemiluminescence immunoassay analyzer[47]. - The company is actively managing costs through raw material procurement and production optimization to improve product efficiency and reduce production costs[46]. - The company is focusing on expanding its product menu in liver and kidney disease diagnostics, with several products in various stages of development and registration[63]. - The company is committed to continuous innovation, as evidenced by the ongoing development of multiple new products across various medical device categories[65]. - The company is focusing on expanding its market presence through new product registrations and technological advancements in automated testing solutions[64]. - The company is developing a fully automated biochemical analyzer, which is expected to strengthen its product line and support domestic substitution of imported products[63]. Market Trends and Competitive Landscape - The global in vitro diagnostics market is expected to reach 140 billion USD by 2027, growing at a compound annual growth rate of 1.6%[52]. - The global IVD market is dominated by the top 20 companies, which account for 80% of the market share, with Abbott, Roche, Danaher, Siemens, and Thermo Fisher Scientific leading the industry[54]. - China's IVD market has grown from 45 billion CNY in 2016 to 124.3 billion CNY in 2021, maintaining a compound annual growth rate (CAGR) of 22.5%[55]. - The domestic immunodiagnostics market is projected to grow at a CAGR of 15% to 20% in the coming years, while the molecular diagnostics sector has seen a CAGR of approximately 29% over the past six years[56]. - The competition in the in vitro diagnostic industry has intensified, shifting from product competition to comprehensive solution offerings, necessitating continuous improvement in product quality and service capabilities[122]. Corporate Governance and Compliance - The board of directors has confirmed the accuracy and completeness of the financial report for the first half of 2023[3]. - All directors attended the board meeting to review the half-year report[4]. - The company has maintained a strong pipeline of innovative products, with all registered products classified under various categories, ensuring compliance with international standards[67]. - The company has established a comprehensive quality management system, achieving certifications such as TUV ISO9001 and ISO13485, ensuring international advanced quality management standards[82]. - The company has not engaged in any derivative investments or entrusted loans during the reporting period, indicating a conservative financial strategy[116][117]. Environmental and Social Responsibility - The company has implemented advanced pollution control technologies, ensuring compliance with local emission standards for air pollutants[141]. - The company has established emergency response plans for environmental incidents, valid until 2025[144]. - The company donated medical diagnostic equipment worth CNY 2.3228 million to medical institutions through charitable organizations during the reporting period[154]. - The company organized a plant science activity themed "Planting Green" to promote ecological awareness among employees[154]. - The company has engaged in community service activities, including a "Clean Mountain Action" to promote environmental protection and awareness[154]. Shareholder Information - The company plans not to distribute cash dividends, issue bonus shares, or increase share capital from reserves[5]. - The company had a shareholder participation rate of 43.09% in the 2022 annual general meeting held on May 15, 2023[131]. - Major shareholders include Tang Yong with 11.11% (68,062,301 shares) and Wang Dengming with 7.43% (45,534,495 shares)[184]. - The company has a total of 41,697 common stock shareholders at the end of the reporting period[184]. - The report indicates that there are no changes in the number of shares held by state-owned entities[180].

Financial Performance - The company's revenue for Q1 2023 was ¥676,400,369.15, a decrease of 26.85% compared to ¥924,725,004.03 in the same period last year[6] - Net profit attributable to shareholders was ¥116,873,753.42, down 42.10% from ¥201,843,094.15 year-on-year[6] - The company's basic earnings per share decreased by 43.87% to ¥0.1908 from ¥0.3399 in the same period last year[6] - The net profit for the current period is CNY 117,826,419.32, a decrease of 44.4% compared to CNY 212,187,393.54 in the previous period[34] - The total profit for the current period is CNY 135,041,876.58, down from CNY 248,718,876.40, representing a decline of 45.3%[34] - The operating profit for the current period is CNY 140,309,024.10, compared to CNY 250,526,631.03 in the previous period, reflecting a decrease of 44%[34] - The total comprehensive income for the current period is CNY 109,493,201.32, down from CNY 212,187,393.54 in the previous period, a decline of 48.3%[34] Cash Flow - The net cash flow from operating activities increased by 39.08% to ¥167,046,659.56, compared to ¥120,108,068.54 in the previous year[12] - The cash flow from operating activities for the current period is CNY 167,046,659.56, an increase of 39.1% from CNY 120,108,068.54 in the previous period[39] - The company’s investment activities generated a net cash flow of ¥31,799,722.54, a 102.97% increase compared to a net outflow of ¥1,070,469,152.48 in the previous year[12] - The cash inflow from investment activities is CNY 706,876,521.14, while cash outflow is CNY 675,076,798.60, resulting in a net cash flow of CNY 31,799,722.54[41] Assets and Liabilities - The total assets at the end of Q1 2023 were ¥8,270,656,198.29, reflecting a 1.33% increase from ¥8,161,865,314.41 at the end of the previous year[6] - Total assets as of March 31, 2023, amounted to CNY 8,270,656,198.29, up from CNY 8,168,239,295.99, indicating a growth of approximately 1.25%[30] - Total liabilities decreased slightly to CNY 1,631,911,191.11 from CNY 1,638,987,490.13, a reduction of about 0.4%[27] - The company's equity attributable to shareholders increased to CNY 6,401,572,687.34 from CNY 6,293,032,151.92, reflecting a growth of approximately 1.7%[30] Research and Development - Research and development expenses rose by 25.80% to ¥58,345,527.09, up from ¥46,379,511.10 in the same period last year[12] - Research and development expenses for Q1 2023 were CNY 58,345,527.09, up from CNY 46,379,511.10, indicating an increase of approximately 25.8%[31] Shareholder Information - The total number of common shareholders at the end of the reporting period is 42,002, with the largest shareholder, Tang Yong, holding 11.11% of shares, amounting to 68,062,301 shares[16] - The largest shareholder, Wang Dengming, holds 7.43% of shares, amounting to 45,534,495 shares[16] - The total number of restricted shares at the beginning of the period was 117,119,807, with no shares released or added during the period, maintaining the same total[19] - The company reported a total of 51,046,726 restricted shares held by Tang Yong, which remain locked due to executive restrictions[19] - The company has a total of 117,119,807 restricted shares, all of which are subject to lock-up agreements[19] - The company has no new shares added to the restricted category during the reporting period[19] Project Updates - The company has extended the completion date for the "Mike Bio Tianfu International Bio City IVD Industrial Park Project" to the end of December 2024, based on prudent principles and actual project progress[20] - The company’s independent directors agreed that the project extension aligns with the company's operational needs and long-term development plans[20] Other Financial Metrics - The weighted average return on equity decreased to 1.84%, down from 4.59% in the same period last year[6] - The company experienced a 54.40% decrease in notes receivable, which fell to ¥17,937,900.02 from ¥39,335,042.95[12] - Deferred tax assets increased from 154,968,997.84 RMB to 161,342,979.42 RMB, reflecting an adjustment of 6,373,981.58 RMB due to the implementation of new accounting standards[20] - The total assets increased from 8,161,865,314.41 RMB to 8,168,239,295.99 RMB, with an adjustment of 6,373,981.58 RMB[20] - Inventory levels increased to CNY 1,125,736,819.18 from CNY 1,039,480,640.38, marking an increase of about 8.3%[24] - The company reported a decrease in short-term borrowings to CNY 233,822,506.34 from CNY 248,075,777.91, a reduction of about 5.7%[27] - The company reported a decrease in other comprehensive income after tax of CNY -8,333,218.00 for the current period[34] - The company has not undergone an audit for the first quarter report[43]

Research and Development - The company has increased its investment in the research and development of biochemical raw materials, aiming to reduce reliance on imports and improve the self-sufficiency rate of key raw materials[13]. - The company plans to enhance its research and development efforts to meet customer demands for cost reduction, efficiency improvement, and precise testing[46]. - The company has a strong focus on building a robust research and development system to support its positioning as a full-line supplier in the in vitro diagnostic sector[29]. - The company aims to accelerate the realization of its product development goals, focusing on systematization, serialization, automation, and independence across its product lines[46]. - The company recognizes the risk of technological innovation failure and is committed to enhancing its core technology protection mechanisms[22]. Market Position and Strategy - The company plans to enhance its competitive position by improving product quality, variety structure, research and development capabilities, and sales and service aspects[26]. - The company aims to transition from merely selling products to providing comprehensive solutions to customers, reflecting a shift in industry competition dynamics[26]. - The company is closely monitoring industry regulatory policies and is prepared to adjust its operational strategies accordingly to adapt to changes in the healthcare system[19]. - The company has reported that the domestic in vitro diagnostic industry is experiencing accelerated integration due to new procurement policies and market regulations[18]. Environmental Responsibility - During the reporting period, the company invested a total of 5.0682 million yuan in environmental governance and protection, primarily for daily maintenance and upgrades of wastewater and air pollution control facilities[56]. - The company is committed to reducing its carbon footprint as part of its sustainability initiatives, as detailed in its 2022 sustainability report[58]. - The company has implemented a comprehensive monitoring system for wastewater and air emissions, adhering to national environmental standards[52]. - The company has not faced any administrative penalties related to environmental issues during the reporting period[83]. - The company has established temporary storage areas for hazardous waste, medical waste, and general solid waste, all compliant with environmental regulations[149]. Financial Performance and Shareholder Information - The basic earnings per share for the reporting period was RMB 1.7308, compared to RMB 1.4331 in the previous period[114]. - The net asset value per share increased from RMB 6.8150 to RMB 7.7247[114]. - The company reported a total distributable profit of RMB 707,952,208.97 for the year[183]. - The company distributed a cash dividend of RMB 3.47 per 10 shares, totaling RMB 212,526,947.73, which represents 30.02% of the distributable profit[183]. - The total share capital increased from 556,469,590 shares to 612,469,590 shares following the issuance[110]. Corporate Governance - The company has established an independent financial department with a complete financial accounting system, ensuring compliance with tax obligations and independent financial decision-making[50]. - The company has not engaged in any related party transactions during the reporting period, reflecting a focus on transparency and governance[69]. - The company’s board and supervisory board have completed their term and held elections for the new board members[105]. - The internal control system is complete, reasonable, and effective as of December 31, 2022, ensuring compliance with laws and regulations[156]. - The internal control audit report received a standard unqualified opinion, indicating no significant defects in non-financial reporting[166]. Shareholder Actions and Changes - The company’s major shareholders have pledged 80% of their shares, indicating significant leverage on their holdings[180]. - The actual controller of the company changed on March 28, 2022, with the new controllers being Tang Yong, Wang Dengming, and Liu Qilin[179]. - The company’s major shareholder Guo Lei pledged 6,200,000 shares in a repurchase transaction on October 28, 2022[173]. - The company’s major shareholder Guo Lei also released 4,020,000 shares from a previous pledge on December 12, 2022[176]. - The company has established a consistent action relationship among shareholders Tang Yong, Wang Dengming, and Liu Qilin[194].

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:2023-020 第 1 页 共 2 页 证券代码:300463 证券简称:迈克生物 公告编号:2023-020 关于举办 2022 年度业绩说明会并征集相关问题的公告 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"迈克生物"或"公司"）《2022年年度报告》及其摘要将 于2023年4月25日在巨潮资讯网（http://www.cninfo.com.cn）披露。 为了让广大投资者进一步了解公司2022年年度经营业绩情况，公司拟定于2023年4月28日 （星期五）15:00-17:00在价值在线举办2022年度业绩说明会，本次年度业绩说明会将采用网络 远程的方式举行，投资者可登陆价值在线（https://eseb.cn/13YENl1raVO）参与本次年度业绩说 明会。 出席本次说明会的人员有：公司总经理吴明建、市场运营总监胥胜国、财务总监尹珊、董 事会秘书史炜、独立董事傅代国、保荐代表人鄢坚。 为充分尊重投资者、提升交流的针对性，现就公司2022年度业绩 ...