关于变更医疗器械生产许可证的公告 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。 证券代码：300396 证券简称：迪瑞医疗 公告编号：2025-040 迪瑞医疗科技股份有限公司 特此公告。 迪瑞医疗科技股份有限公司董事会 2025 年 09 月 11 日 迪瑞医疗科技股份有限公司（以下简称"公司"）于近日取得了吉林省药品 监督管理局批准变更的《医疗器械生产许可证》（许可证编号：吉药监械生产许 20170005 号），本次主要涉及法定代表人、企业负责人的变更，公司医疗器械生 产许可证法定代表人和企业负责人变更为郎涛。 除上述变更外，公司医疗器械生产许可证记载的其他内容未发生变化。医疗 器械生产许可证记载的其他内容可详见公司于 2025 年 2 月 5 日披露于巨潮资讯 网（www.cninfo.com.cn）上的相关公告。 ...

Group 1 - The core point of the announcement is that Guangdong Hengjian International Investment Co., Ltd., a shareholder holding more than 5% of the shares, has completed its share reduction plan without executing any sales during the designated period [1] - As of the announcement date, Hengjian International holds 33,123,600 shares of Dirui Medical Technology Co., Ltd., representing 12.15% of the company's total share capital [1] - The share reduction plan complies with various relevant laws and regulations, including the Company Law of the People's Republic of China and the Securities Law of the People's Republic of China [1]

证券代码：300396 证券简称：迪瑞医疗 公告编号：2025-039 迪瑞医疗科技股份有限公司 关于持股 5%以上股东减持股份计划实施期限届满的公告 持股 5%以上的股东广东恒健国际投资有限公司保证向本公司提供的信 息内容真实、准确、完整，没有虚假记载、误导性陈述或重大遗漏。 截至本公告披露日，恒健国际本次减持计划实施期限已届满，本次减持计划 期间内未减持其持有的公司股份。恒健国际持有公司股份数量为 33,123,600 股， 占公司目前总股本比例为 12.15%。 二、其他相关说明 1、恒健国际本次减持计划符合《中华人民共和国公司法》《中华人民共和国 证券法》《上市公司收购管理办法》《深圳证券交易所创业板股票上市规则》《上 市公司股东减持股份管理暂行办法》《深圳证券交易所上市公司自律监管指引第 18 号——股东及董事、高级管理人员减持股份》等法律、法规及规范性文件的 规定。 2、上述股东本次减持公司股份事项已按照相关规定进行了预披露，本次减 持符合已披露的减持计划，本次减持计划期间未减持公司股份，不存在违规情形。 截至目前，本次减持计划实施期限已届满。 三、备查文件 恒健国际出具的《关于减持迪瑞医疗股份计 ...

Group 1: Financial Performance - The company experienced a loss in the first half of 2025 due to multiple factors including macroeconomic slowdown, ongoing procurement policies, and intensified industry competition [2] - Total expenses for sales, management, and R&D decreased by 16% year-on-year, enhancing operational efficiency [5] - Cash flow increased by 97.07% year-on-year, indicating improved financial health [6] Group 2: International Market Strategy - The international business grew by 24% year-on-year, with significant growth in key markets such as India, Asia-Pacific, and Turkey [3] - The company has over 20 years of experience in overseas operations, focusing on local management to enhance brand value [3] Group 3: Strategic Adjustments - A new management team with industry backgrounds is conducting a strategic review to enhance the company's operational effectiveness [4] - The company aims to focus on three core areas in the second half of 2025: expanding international markets, accelerating domestic equipment installation, and optimizing the supply chain [2] Group 4: R&D and Technological Advancements - The company launched a fully automated urine analyzer, achieving high precision in identifying 50 types of cells [6] - Progress in AI integration within medical technology is being pursued, with advancements in intelligent recognition systems for medical imaging [7] Group 5: Cost Management - Financial expenses saw a significant reduction due to improved fund management and currency risk control, with interest income increasing by approximately 1.391 million [6] - The company implemented precise resource allocation in marketing, leading to enhanced cost efficiency [5]

据证券之星公开数据整理，近期迪瑞医疗（300396）发布2025年中报。截至本报告期末，公司营业总收 入3.51亿元，同比下降60.07%，归母净利润-2831.2万元，同比下降117.13%。按单季度数据看，第二季 度营业总收入1.68亿元，同比下降22.0%，第二季度归母净利润-4399.07万元，同比下降201.26%。本报 告期迪瑞医疗三费占比上升明显，财务费用、销售费用和管理费用总和占总营收同比增幅达83.13%。 本次财报公布的各项数据指标表现不尽如人意。其中，毛利率38.85%，同比减9.85%，净利率-8.07%， 同比减142.92%，销售费用、管理费用、财务费用总计1.07亿元，三费占营收比30.61%，同比增 83.13%，每股净资产7.17元，同比减4.81%，每股经营性现金流-0.03元，同比增97.05%，每股收益-0.1 元，同比减117.13% | 项目 | 2024年中报 | 2025年中报 | 同比增幅 | | --- | --- | --- | --- | | 营业总收入(元) | 8.78亿 | 3.51亿 | -60.07% | | 归母净利润(元) | 1.65亿 ...

证券代码：300396 证券简称：迪瑞医疗 公告编号：2025-036 一、重要提示 登录新浪财经APP 搜索【信披】查看更多考评等级 本半年度报告摘要来自半年度报告全文，为全面了解本公司的经营成果、财务状况及未来发展规划，投 资者应当到证监会指定媒体仔细阅读半年度报告全文。 所有董事均已出席了审议本报告的董事会会议。 非标准审计意见提示 □适用 √不适用 董事会审议的报告期利润分配预案或公积金转增股本预案 □适用 √不适用 公司计划不派发现金红利，不送红股，不以公积金转增股本。 董事会决议通过的本报告期优先股利润分配预案 □适用 √不适用 公司是否需追溯调整或重述以前年度会计数据 □是 √否 ■ 3、公司股东数量及持股情况 单位：股 ■ □适用 √不适用 公司是否具有表决权差异安排 □是 √否 二、公司基本情况 1、公司简介 ■ 2、主要会计数据和财务指标 4、控股股东或实际控制人变更情况 控股股东报告期内变更 □适用 √不适用 公司报告期控股股东未发生变更。 持股5%以上股东、前10名股东及前10名无限售流通股股东参与转融通业务出借股份情况 □适用 √不适用 前10名股东及前10名无限售流通股股东因转融通 ...

Core Viewpoint - DIRUI Medical Technology Co., Ltd. reported a significant decline in revenue and net profit for the first half of 2025, indicating challenges in the medical device industry, particularly in the in vitro diagnostics (IVD) sector, amidst increasing competition and regulatory pressures [4][6]. Company Overview and Financial Indicators - The company’s stock code is 300396, and it is listed on the Shenzhen Stock Exchange [4]. - For the reporting period, the company generated revenue of approximately ¥350.69 million, a decrease of 60.07% compared to the same period in 2024 [4]. - The net profit attributable to shareholders was a loss of approximately ¥28.31 million, a decline of 117.13% year-on-year [4]. - The company plans not to distribute cash dividends or issue bonus shares [4]. Industry Analysis - The medical device industry, particularly the IVD sector, is experiencing a transformation driven by AI technology and increasing domestic demand [6]. - The IVD market in China is projected to grow to ¥288.15 billion by 2030, capturing 33.2% of the global market share [6]. - The industry is facing challenges due to macroeconomic conditions, healthcare cost control, and intensified centralized procurement, which may slow overall growth in 2024 [6]. Business Operations - The company focuses on the research, production, marketing, and service of medical testing instruments and related reagents, covering a wide range of diagnostic applications [6][10]. - DIRUI Medical employs a sales model that emphasizes distribution partnerships while also engaging in direct sales [10]. - The company has made significant investments in R&D, aiming to enhance product quality and expand its market presence both domestically and internationally [10]. Regulatory Environment - Recent government policies aim to support the medical device sector through measures such as large-scale equipment updates and the establishment of a unified national market for medical devices [5]. - The company has obtained numerous medical device registrations and certifications, including 414 medical device registration certificates and 483 CE certifications [12]. Market Trends - The IVD sector is expected to benefit from policies promoting domestic production and innovation, which may help local companies gain market share against international competitors [6]. - The trend towards centralized procurement and cost control in hospitals is pushing companies to optimize their cost structures and improve product differentiation [6]. Product Portfolio - DIRUI Medical's product lines include urine analysis, biochemical analysis, immunoassay, and coagulation analysis, among others, covering over 80% of testing items in clinical laboratories [10]. - The company’s products are designed to provide critical diagnostic information for disease prevention and treatment [10].

Core Viewpoint - The report indicates a significant decline in the company's financial performance for the first half of 2025, with a notable drop in revenue and net profit compared to the same period last year [2][3]. Financial Performance - The company's operating revenue for the reporting period was approximately ¥350.69 million, representing a decrease of 60.07% compared to ¥878.27 million in the same period last year [2]. - The net profit attributable to shareholders was a loss of approximately ¥28.31 million, a decline of 117.13% from a profit of ¥165.24 million in the previous year [2]. - The net profit after deducting non-recurring gains and losses was approximately -¥31.91 million, down 119.65% from ¥162.36 million in the previous year [2]. - The net cash flow from operating activities was approximately -¥8.43 million, showing an improvement of 97.07% compared to -¥287.72 million in the previous year [2]. - Basic and diluted earnings per share were both -¥0.1038, a decrease of 117.13% from ¥0.6060 in the previous year [2]. - The weighted average return on net assets was -9.28%, down from 7.88% in the previous year [2]. Asset and Equity Position - Total assets at the end of the reporting period were approximately ¥2.96 billion, a decrease of 4.71% from ¥3.11 billion at the end of the previous year [2]. - The net assets attributable to shareholders were approximately ¥1.96 billion, down 4.51% from ¥2.05 billion at the end of the previous year [3]. Shareholder Information - The largest shareholder, Shenzhen Huadexin Run Equity Investment Co., Ltd., holds 28.34% of the shares, with a total of 77,288,400 shares [3]. - Other significant shareholders include Guangdong Hengjian International Investment Co., Ltd. with 12.15% and individual shareholders such as Song Jie and Yi Xiangping with 5.40% and 3.21% respectively [3][4]. - The report notes that there have been no changes in the controlling shareholder or actual controller during the reporting period [4]. Important Events - Several directors, including Song Qing, Qin Feng, Wang Xueming, and Lin Maoliang, have resigned from their positions, and new non-independent directors have been elected [4]. - Sun Bin has been appointed as the vice general manager of the company [4].

据了解，迪瑞医疗国际市场经过二十余年的积累，已成功实现从早期的"多点布局"到如今的"精耕细 作"战略升级。公司基于全球医疗器械行业发展趋势及区域市场需求特点，动态调整国际市场策略，以 十二个重点国家市场为核心，集中优势资源打造核心市场竞争力。在人才队伍建设方面，销售团队在继 续落实本地化的基础上，成立多部门组成的项目组推动仪器、试剂本地化许可生产业务，加强国际公共 关系管理，利用仪器和试剂多元化优势，提高重点国际市场基础医疗领域的市场占有率。 公开资料显示，迪瑞医疗的七大系列产品远销120多个国家和地区，主推的尿分、生化、血球等仪器和 试剂产品已拥有稳定的销售渠道和品牌影响力。(燕云) 8月25日晚间，迪瑞医疗（300396）发布2025年半年度报告，报告显示，上半年公司营业收入3.51亿 元，较上年同比下降60.07%，归属于上市公司股东的净利润亏2831万元，较上年同比下降117.13%。其 中，国际市场保持相对平稳，国际市场营业收入比上年同期增两成。 迪瑞医疗表示，公司持续推动国内、国际双轮驱动战略。近年持续强化本地化管理，产品升级迭代注 册。报告期内，取得了阶段性成果，多款高速机型完成部分国家的注册， ...

Group 1 - The core viewpoint of the article is that Diri Medical (300396.SZ) reported a significant decline in revenue and net profit for the first half of 2025, indicating financial challenges [1] Group 2 - The company achieved operating revenue of 351 million yuan in the first half of 2025, representing a year-on-year decrease of 60.07% [1] - The net profit attributable to shareholders of the listed company was -28.31 million yuan, marking a shift from profit to loss compared to the previous year [1] - The net profit attributable to shareholders after deducting non-recurring gains and losses was -31.91 million yuan [1] - The basic earnings per share were -0.1038 yuan [1]