迪瑞医疗(300396) - 2025 Q2 - 季度财报

Part I Important Notice, Table of Contents, and Definitions Important Notice The company's Board of Directors, Supervisory Board, and senior management guarantee the truthfulness, accuracy, and completeness of the semi-annual report, with no plans for cash dividends, bonus shares, or capital increase from capital reserves for the half-year period - The company's Board of Directors, Supervisory Board, and senior management guarantee the truthfulness, accuracy, and completeness of the semi-annual report, assuming individual and joint legal responsibility for any false statements, misleading representations, or material omissions[3] - Company负责人 Lang Tao, Chief Accountant Zhang Xingyan, and Head of Accounting Department (Accounting Supervisor) Lian Shuyan declare that the financial report in this semi-annual report is true, accurate, and complete[3] - The company plans not to distribute cash dividends, bonus shares, or convert capital reserves into share capital for the half-year period[4] Table of Contents This section outlines the report's eight main chapters and their starting page numbers, providing investors with an overview of the report's overall structure List of Documents for Reference The company disclosed a list of reference documents, including financial statements signed and sealed by the legal representative, chief accountant, and head of accounting, along with originals of all publicly disclosed company documents and announcements during the reporting period, all available at the company's securities affairs department - Reference documents include financial statements bearing the signatures and seals of Mr. Lang Tao (Legal Representative), Ms. Zhang Xingyan (Chief Accountant), and Ms. Lian Shuyan (Head of Accounting Department)[8] - Reference documents also include the originals and drafts of all company documents publicly disclosed on the website designated by the China Securities Regulatory Commission during the reporting period[9] - The aforementioned reference documents are available at the company's Securities Affairs Department[11] Definitions This section defines common terms used in the report, covering key concepts such as company name, relevant laws and regulations, regulatory bodies, and reporting periods, ensuring clear understanding of the report's content - Dirui Medical, the Company, or this Company refers to Dirui Medical Technology Co., Ltd[12] - The reporting period refers to January 1, 2025, to June 30, 2025[12] - The company's actual controller refers to China Resources Co., Ltd[12] Part II Company Profile and Key Financial Indicators Company Profile Dirui Medical Technology Co., Ltd., stock code 300396, is listed on the Shenzhen Stock Exchange; while contact, disclosure, and registration remained unchanged, the company disclosed changes in business scope on May 20, 2025, and legal representative on August 20, 2025 Basic Company Information | Indicator | Content | | :--- | :--- | | Stock Abbreviation | Dirui Medical | | Stock Code | 300396 | | Stock Exchange | Shenzhen Stock Exchange | | Company's Chinese Name | 迪瑞医疗科技股份有限公司 | | Company's Legal Representative | Lang Tao | - The company disclosed an announcement regarding the industrial and commercial change registration related to the change in business scope on May 20, 2025[19] - The company disclosed an announcement regarding the industrial and commercial change registration related to the change in legal representative on August 20, 2025[19] Key Accounting Data and Financial Indicators The company's 2025 semi-annual operating revenue decreased by 60.07% year-on-year, net profit attributable to shareholders declined by 117.13% to a loss, and basic earnings per share turned negative, while net cash flow from operating activities significantly improved by 97.07%, with total assets and net assets attributable to shareholders both decreasing at period-end Key Accounting Data and Financial Indicators for H1 2025 | Indicator | Current Period (RMB) | Prior Period (RMB) | YoY Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 350,694,494.50 | 878,270,442.69 | -60.07% | | Net Profit Attributable to Shareholders of Listed Company | -28,312,010.46 | 165,242,953.91 | -117.13% | | Net Profit Attributable to Shareholders of Listed Company After Deducting Non-Recurring Gains and Losses | -31,908,614.92 | 162,363,331.56 | -119.65% | | Net Cash Flow from Operating Activities | -8,434,610.80 | -287,719,625.89 | 97.07% | | Basic Earnings Per Share (RMB/share) | -0.1038 | 0.6060 | -117.13% | | Diluted Earnings Per Share (RMB/share) | -0.1038 | 0.6060 | -117.13% | | Weighted Average Return on Net Assets | -1.40% | 7.88% | -9.28% | | Period-End Indicators | Current Period-End (RMB) | Prior Year-End (RMB) | Period-End YoY Change (%) | | Total Assets | 2,961,070,551.54 | 3,107,533,388.27 | -4.71% | | Net Assets Attributable to Shareholders of Listed Company | 1,956,331,633.90 | 2,048,756,770.93 | -4.51% | Differences in Accounting Data Under Domestic and Overseas Accounting Standards The company reported no differences in net profit and net assets between financial reports prepared under international or overseas accounting standards and Chinese accounting standards during the reporting period - The company reported no differences in net profit and net assets between financial reports disclosed under International Accounting Standards and Chinese Accounting Standards during the reporting period[21] - The company reported no differences in net profit and net assets between financial reports disclosed under overseas accounting standards and Chinese Accounting Standards during the reporting period[22] Non-Recurring Gains and Losses Items and Amounts The company's total non-recurring gains and losses for the first half of 2025 amounted to 3.597 million RMB, primarily comprising government grants, non-current asset disposal gains/losses, investment income from entrusted asset management, and fair value changes Non-Recurring Gains and Losses Items and Amounts for H1 2025 | Item | Amount (RMB) | | :--- | :--- | | Gains or losses from disposal of non-current assets (including the write-off portion of asset impairment provisions) | 45,167.71 | | Government grants recognized in current profit or loss (excluding those closely related to the company's normal business operations, compliant with national policies, enjoyed according to fixed standards, and having a continuous impact on the company's profit or loss) | 3,924,261.97 | | Gains or losses from changes in fair value of financial assets and financial liabilities held by non-financial enterprises, and gains or losses from disposal of financial assets and financial liabilities, excluding effective hedge accounting related to the company's normal business operations | 30,660.38 | | Gains or losses from entrusted investments or asset management | 131,347.22 | | Other non-operating income and expenses apart from the above items | 125,576.74 | | Less: Income tax impact | 660,409.56 | | Total | 3,596,604.46 | Part III Management Discussion and Analysis Main Business Activities During the Reporting Period The company primarily engages in R&D, production, marketing, and service of medical testing instruments and reagents, covering seven major series, with the in-vitro diagnostics industry facing both growth opportunities from policy and AI, and short-term pressures from medical insurance cost control and centralized procurement - The company's main business involves the R&D, production, marketing, and service of medical testing instruments and supporting test strips and reagents[31] - The company's products primarily include seven major series: urine analysis, biochemical analysis, chemiluminescence immunoassay, gynecological secretion analysis, blood cell analysis, coagulation analysis, and integrated laboratory solutions[31] - It is projected that by 2030, China's in-vitro diagnostics market size will grow to 288.15 billion RMB, increasing its share in the global market to 33.2%[27] - In 2024, the overall industry scale slowed down due to macroeconomic conditions, medical insurance cost control, and the continuous deepening of centralized procurement[27] Industry Overview and Development Trends The in-vitro diagnostics industry, driven by medical infrastructure, localization policies, and AI, is projected for continuous growth, yet faces short-term pressures from medical insurance cost control and centralized procurement, necessitating cost optimization and international market expansion - The company operates in the broader medical device industry, with its specific segment being in-vitro diagnostics[27] - In recent years, driven by the rapid development of global AI technology, the medical industry has embraced intelligent transformation[27] - It is projected that by 2030, China's in-vitro diagnostics market size will grow to 288.15 billion RMB, increasing its share in the global market to 33.2%[27] New Industry Policies Issued During the Reporting Period During the reporting period, China introduced policies supporting medical device development, including large-scale equipment upgrades, special treasury bonds, and optimized medical service pricing, aiming to promote localization, innovation, and grassroots healthcare, while centralized procurement for IVD reagents drives companies to enhance technology and expand overseas - The National Development and Reform Commission and the Ministry of Finance issued a notice on 'Several Measures to Strengthen Support for Large-Scale Equipment Renewal and Trade-in of Consumer Goods,' increasing support for equipment upgrades and allocating approximately 300 billion RMB in ultra-long-term special treasury bonds[28] - The National Health Commission, National Administration of Traditional Chinese Medicine, and National Disease Control and Prevention Administration jointly formulated the 'Reference Guidelines for Artificial Intelligence Application Scenarios in the Health Industry,' identifying 84 types of application directions covering core areas such as medical service management, grassroots public health services, and the health industry[28] - The General Office of the State Council issued 'Opinions on Comprehensively Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry,' setting long-term goals for 2027 and 2035, and comprehensively promoting innovation and high-quality development in the pharmaceutical and medical device industries through 24 reform measures across five major areas[28] Introduction to the Company's Main Business The company's core business involves the R&D, production, marketing, and service of medical testing instruments and reagents, offering seven major product series for routine physical examinations and auxiliary disease diagnosis, including urine, biochemical, and chemiluminescence immune analysis - The company's main business involves the R&D, production, marketing, and service of medical testing instruments and supporting test strips and reagents[31] - The company's products primarily include seven major series: urine analysis, biochemical analysis, chemiluminescence immunoassay, gynecological secretion analysis, blood cell analysis, coagulation analysis, and integrated laboratory solutions[31] - The company's products are used for routine physical examinations and auxiliary disease diagnosis, providing reference information on physical indicators for disease prevention and treatment through the examination of human body fluids such as urine and blood[31] Business Model The company operates primarily through a distribution model, supplemented by direct sales, focusing on key instrument installations and reagent volume in the domestic market, while pursuing localized production and diversified channels internationally, with procurement emphasizing inventory reduction, standardization, and localization, and production optimized through lean manufacturing - The company operates primarily through a distribution model, supplemented by direct sales[34] - In the domestic market, the company adjusted its channel sales incentive policies and performance appraisal policies for sales personnel and service engineers, clarifying key customers and main product models[34] - The company focused on reducing raw material inventory, standardizing and localizing raw materials, and promoting modular products and outsourcing services[34] - The company completed 'lean manufacturing' management, transforming workshops, optimizing production processes and quality control points, and enhancing the standardization and informatization of production lines[34] Performance Drivers The company's performance is driven by product diversification, market strategy, and empowerment from its actual controller, with continuous high R&D investment fostering product development towards integration, digitalization, and intelligence, while a dual domestic and international market strategy, coupled with its unique position within the China Resources system, provides significant operational and management advantages - The company's product line includes dozens of instrument products such as urine analysis, biochemical, immunoassay, hematology, gynecology, coagulation, and integrated laboratory solutions, along with hundreds of reagent products, capable of meeting the needs of various end customers[35] - The company implements a dual-wheel strategy for domestic and international markets, with a global product distribution system, having exported to over 120 countries and regions internationally[35] - As the sole medical device industry production platform within the China Resources system and a member of its healthcare sector, the company has strengthened its management and business empowerment[35] Industry Analysis The company operates in the in-vitro diagnostics industry, a high-growth segment of the medical device market with accelerating domestic substitution, where its product portfolio covers over 80% of laboratory testing items, supported by 202 authorized invention patents, 414 medical device registration certificates, and 483 CE certifications as of June 2025 - The company operates in the broader medical device industry, with its specific segment being in-vitro diagnostics[36] - The company's current product system can cover over 80% of laboratory testing items[36] - As of June 2025, the company had obtained 202 authorized invention patents; a total of 414 medical device registration certificates, including 62 for diagnostic instruments and 352 for test strips, reagents, and related supporting products; 483 products received CE certification (of which 108 products comply with IVDR regulations), and the company obtained 732 international product registrations[37] Core Competitiveness Analysis The company's core competitiveness stems from its R&D innovation, diversified instrument portfolio, robust quality management, and established overseas presence, driving product industrialization, cost reduction through localization, and international market growth - R&D innovation and technological breakthroughs are the core drivers of the company's development, with over 30 years of independent R&D and technological innovation leading to the development and launch of numerous high-end medical devices[57] - As of June 2025, the company had obtained a total of 202 patents, including 129 invention patents, and 99 software copyrights[59] - The company has successively launched multiple star products across various fields, including high-end urine analysis assembly line products, blood assembly line products, biochemical immunoassay assembly lines, high-speed coagulation products (BCA-4000), and the latest integrated laboratory LA-90[65] - During the reporting period, the company established a Quality Management Center to comprehensively plan and supervise product compliance and quality capability building[67] - The company has had an overseas presence for 25 years, strengthening localized management and product upgrade registrations in recent years, achieving phased results during the reporting period with several high-speed models completing registration in some countries[68] Accelerating R&D Project Industrialization to Enhance Product Market Competitiveness The company's market-oriented R&D, with seven product lines, drives innovation in detection systems, intelligent detection, and diagnosis, launching the industry's first urine stained planar flow imaging automatic urine sediment analyzer FUS-560 and multiple reagent products, while optimizing R&D teams and leveraging AI deep learning for enhanced recognition in urine analysis - The company's R&D continues to be market-oriented, focusing on innovation-driven development, with seven product lines collaborating to continuously explore innovation in detection systems, intelligent detection, and intelligent diagnosis[58] - During the reporting period, the company launched the industry's first urine stained planar flow imaging technology fully automatic urine sediment analyzer FUS-560, achieving high-precision automatic identification and classification of 50 cell types[58] - The company's reagent products, such as adiponectin assay kits and high-sensitivity D-dimer assay kits, obtained certificates, and urine staining solution and analyte washing solution were launched, further complementing and enriching the biochemical, immunoassay, coagulation, and urine menus[58] - In the field of urine analysis, an intelligent recognition system for flow cytometry microscopic images was built based on artificial intelligence + wet chemical staining technology, with deep learning technology as its core[58] Leveraging Diversified Instrument Advantages to Seize Localization Market Opportunities The company leverages its diversified instrument portfolio, including high-end assembly line products and comprehensive reagent coverage for urine, blood, and biochemical analysis, to capitalize on localization opportunities, achieving cost reduction through domestic component sourcing and scaled production, while its global presence in over 120 countries enhances brand influence - Through R&D innovation in recent years, the company has successively launched multiple star products across various fields, including high-end urine analysis assembly line products, blood assembly line products, biochemical immunoassay assembly lines, high-speed coagulation products (BCA-4000), and the latest integrated laboratory LA-90[65] - The company covers most needs in urine analysis, blood cell analysis, and biochemical analysis reagents, with a complete range of test items; immunoassay also meets the detection needs for mainstream diseases[66] - Currently, the company's main products have successively completed registration overseas, with products sold to over 120 countries and regions, establishing a certain brand influence[66] - In response to national centralized procurement and localization policies, instrument products achieve cost reduction and efficiency improvement through localized components and modularization of complete machines and units, while reagents achieve cost reduction through localized raw materials and product scale-up[66] Solidifying Quality Management Foundation and Enhancing Assurance Capabilities During the reporting period, the company established a Quality Management Center to comprehensively plan and supervise product compliance and quality capability building across multiple dimensions, including quality management systems, raw materials, processes, design, and market quality, achieving significant results in meeting customer product quality demands - During the reporting period, the company established a Quality Management Center to comprehensively plan and supervise product compliance and quality capability building[67] - Evaluated by practical indicators such as out-of-box pass rate, failure rate, and return rate, the results are significant, meeting customer demands for product quality[67] Strengthening Overseas Development Foundation for Long-Term Growth With 25 years of overseas presence, the company continues to strengthen localized management and product registration upgrades, achieving phased results during the reporting period with several high-speed models completing registration in countries like Russia and driving international reagent sales growth - The company has had an overseas presence for 25 years, strengthening localized management and product upgrade registrations in recent years[68] - Several high-speed models have completed registration in some countries; for example, in the Russian market, the company's main domestic products such as biochemical CS-2000, urine detection FUS-3000, and blood cell detection BF-7200 series instruments have been certified and are open for business development[68] - International market reagent sales showed year-on-year growth in the first half of the year[68] Main Business Analysis During the reporting period, the company's operating revenue decreased by 60.07% year-on-year, primarily due to domestic market conditions and sales structure adjustments, resulting in a 117.13% decline in net profit attributable to shareholders, turning into a loss, while net cash flow from operating activities significantly improved by 97.07% Year-on-Year Changes in Key Financial Data | Indicator | Current Period (RMB) | Prior Period (RMB) | YoY Change (%) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Operating Revenue | 350,694,494.50 | 878,270,442.69 | -60.07% | Domestic marketing performance was affected by market conditions, and sales structure adjustments led to a short-term decrease in revenue | | Operating Cost | 214,439,455.14 | 499,767,255.82 | -57.09% | Operating revenue decreased, and operating cost decreased accordingly | | Financial Expenses | -23,213,582.06 | -1,382,720.65 | -1,578.83% | Due to increased interest income from maturing large-denomination certificates of deposit and increased exchange gains from RUB and USD | | Income Tax Expense | -2,727,216.18 | 16,589,240.82 | -116.44% | Due to decreased total profit | | R&D Investment | 42,839,638.54 | 69,186,702.15 | -38.08% | Optimized R&D projects, and phased R&D project expenditures decreased | | Net Cash Flow from Operating Activities | -8,434,610.80 | -287,719,625.89 | 97.07% | Sales collections were relatively low in the prior period, but normalized in the current period | Products or Services Accounting for Over 10% of Revenue | Category | Operating Revenue (RMB) | Operating Cost (RMB) | Gross Margin (%) | YoY Change in Operating Revenue (%) | YoY Change in Operating Cost (%) | YoY Change in Gross Margin (%) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | By Product | | | | | | | | Reagents | 200,352,427.18 | 79,086,711.51 | 60.53% | -22.75% | 7.61% | -11.13% | | Instruments | 148,142,423.54 | 133,802,190.26 | 9.68% | -75.97% | -68.46% | -21.52% | | By Region | | | | | | | | Domestic | 124,270,316.29 | 80,212,028.91 | 35.45% | -82.12% | -81.03% | -3.72% | | International | 224,224,534.43 | 132,676,872.86 | 40.83% | 24.02% | 77.21% | -17.76% | Non-Core Business Analysis The company reported no non-core business analysis during the reporting period - The company reported no non-core business analysis during the reporting period[73] Analysis of Assets and Liabilities At the end of the reporting period, the company's total assets and net assets attributable to shareholders both decreased, with increases in construction in progress and right-of-use assets due to project investments and new leasing activities, while long-term borrowings and lease liabilities also increased, and 3.5 million RMB in restricted monetary funds were frozen due to litigation Significant Changes in Asset Composition | Item | Current Period-End (RMB) | Proportion of Total Assets (%) | Prior Year-End (RMB) | Proportion of Total Assets (%) | Change in Proportion (%) | Explanation of Significant Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Monetary Funds | 498,568,460.52 | 16.84% | 586,680,294.87 | 18.88% | -2.04% | | | Construction in Progress | 900,797.35 | 0.03% | 254,293.21 | 0.01% | 0.02% | Due to increased investment in construction projects during the current period | | Right-of-Use Assets | 9,448,354.79 | 0.32% | 6,002,079.18 | 0.19% | 0.13% | Due to the Russian subsidiary's new office and warehouse leasing business during the current period | | Long-Term Borrowings | 363,800,000.00 | 12.29% | 318,213,333.33 | 10.24% | 2.05% | | | Lease Liabilities | 4,096,833.68 | 0.14% | 0.00 | 0.00% | 0.14% | | Period-End Fair Value of Financial Assets Measured at Fair Value | Item | Period-End Amount (RMB) | | :--- | :--- | | Financial Assets Held for Trading | 70,131,347.22 | | Investments in Other Equity Instruments | 117,382,800.00 | | Other Non-Current Financial Assets | 34,628,931.51 | | Subtotal of Financial Assets | 222,143,078.73 | - At period-end, the company had 3.5 million RMB in monetary funds with restricted use due to mortgage, pledge, or freezing, related to litigation[78][79] Significant Changes in Asset Composition At the end of the reporting period, the company's total assets and net assets attributable to shareholders both decreased, with construction in progress increasing due to project investments and right-of-use assets rising from new leasing activities by its Russian subsidiary, while long-term borrowings and lease liabilities also saw an increase in their proportion - Total assets at period-end were 2.961 billion RMB, a 4.71% decrease from the prior year-end[75] - Construction in progress at period-end was 900,797.35 RMB, a 0.02% increase from the prior year-end, primarily due to increased investment in construction projects during the current period[75] - Right-of-use assets at period-end were 9,448,354.79 RMB, a 0.13% increase from the prior year-end, primarily due to the Russian subsidiary's new office and warehouse leasing business during the current period[75] Major Overseas Assets The company reported no major overseas assets during the reporting period - The company reported no major overseas assets during the reporting period[76] Assets and Liabilities Measured at Fair Value At the end of the reporting period, the company's financial assets measured at fair value totaled 222.14 million RMB, primarily comprising financial assets held for trading, investments in other equity instruments, and other non-current financial assets, with a fair value change gain of 131,347.22 RMB for the current period Financial Assets and Liabilities Measured at Fair Value | Item | Beginning Balance (RMB) | Fair Value Change Gain/Loss for Current Period (RMB) | Period-End Balance (RMB) | | :--- | :--- | :--- | :--- | | Financial Assets Held for Trading | 0.00 | 131,347.22 | 70,131,347.22 | | Investments in Other Equity Instruments | 117,382,800.00 | 0.00 | 117,382,800.00 | | Other Non-Current Financial Assets | 126,779,109.59 | 0.00 | 34,628,931.51 | | Subtotal of Financial Assets | 244,161,909.59 | 131,347.22 | 222,143,078.73 | Asset Restrictions as of the End of the Reporting Period As of the end of the reporting period, the company had 3.5 million RMB in monetary funds frozen due to litigation, restricting their use - At period-end, the company had 3.5 million RMB in monetary funds with restricted use due to mortgage, pledge, or freezing[78] Restricted Assets | Item | Period-End Carrying Amount (RMB) | Type of Restriction | Restriction Details | | :--- | :--- | :--- | :--- | | Monetary Funds | 3,500,000.00 | Frozen | Litigation-related | Investment Analysis During the reporting period, the company had no significant equity or non-equity investments, with entrusted wealth management products totaling 70 million RMB outstanding at period-end, all from自有资金, and no derivative investments or entrusted loans Overview of Entrusted Wealth Management During the Reporting Period | Specific Type | Source of Entrusted Wealth Management Funds | Amount of Entrusted Wealth Management (10k RMB) | Outstanding Balance (10k RMB) | | :--- | :--- | :--- | :--- | | Bank Wealth Management Products | Own Funds | 9,000 | 7,000 | | Total | | 9,000 | 7,000 | - The company had no derivative investments during the reporting period[84] - The company had no entrusted loans during the reporting period[85] Overall Situation The company reported no significant equity or non-equity investments during the reporting period - The company had no significant equity or non-equity investments during the reporting period[80] Significant Equity Investments Acquired During the Reporting Period The company reported no significant equity investments during the reporting period - The company had no significant equity investments during the reporting period[80] Significant Non-Equity Investments in Progress During the Reporting Period The company reported no significant non-equity investments during the reporting period - The company had no significant non-equity investments during the reporting period[80] Financial Assets Measured at Fair Value During the reporting period, the company's financial assets measured at fair value totaled 222.14 million RMB at period-end, primarily comprising investments in other equity instruments and financial assets held for trading, funded by own capital, with 90 million RMB purchased and 20 million RMB sold during the period Financial Assets Measured at Fair Value | Asset Category | Initial Investment Cost (RMB) | Fair Value Change Gain/Loss for Current Period (RMB) | Amount Purchased During Reporting Period (RMB) | Amount Sold During Reporting Period (RMB) | Period-End Amount (RMB) | Source of Funds | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Other | 277,510,033.18 | 131,347.22 | 90,000,000.00 | 20,000,000.00 | 222,143,078.73 | Own Funds | Use of Raised Funds The company reported no use of raised funds during the reporting period - The company reported no use of raised funds during the reporting period[82] Entrusted Wealth Management, Derivative Investments, and Entrusted Loans During the reporting period, the company's entrusted wealth management consisted solely of bank wealth management products, with 90 million RMB transacted and 70 million RMB outstanding at period-end, and no derivative investments or entrusted loans Overview of Entrusted Wealth Management During the Reporting Period | Specific Type | Source of Entrusted Wealth Management Funds | Amount of Entrusted Wealth Management (10k RMB) | Outstanding Balance (10k RMB) | | :--- | :--- | :--- | :--- | | Bank Wealth Management Products | Own Funds | 9,000 | 7,000 | | Total | | 9,000 | 7,000 | - The company had no derivative investments during the reporting period[84] - The company had no entrusted loans during the reporting period[85] Significant Asset and Equity Disposals The company did not dispose of any significant assets or equity during the reporting period - The company did not dispose of any significant assets during the reporting period[86] - The company did not dispose of any significant equity during the reporting period[87] Analysis of Major Holding and Associate Companies During the reporting period, major associate company Ningbo Ruiyuan Biotechnology Co., Ltd. achieved 89.05 million RMB in operating revenue and 20.42 million RMB in net profit, with no acquisitions or disposals of subsidiaries by the company Major Associate Company Information | Company Name | Company Type | Main Business | Registered Capital (RMB) | Total Assets (RMB) | Net Assets (RMB) | Operating Revenue (RMB) | Operating Profit (RMB) | Net Profit (RMB) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Ningbo Ruiyuan Biotechnology Co., Ltd. | Associate Company | In-vitro diagnostic reagents | 12,543,491.00 | 448,706,396.52 | 412,516,480.99 | 89,051,399.65 | 22,033,245.03 | 20,415,769.07 | - The company had no acquisitions or disposals of subsidiaries during the reporting period[89] Structured Entities Controlled by the Company The company reported no structured entities under its control during the reporting period - The company reported no structured entities under its control during the reporting period[90] Risks Faced by the Company and Countermeasures The company faces risks from industry regulation, market competition, new product development, distribution models, overseas markets, declining gross margins, exchange rate fluctuations, profit losses, and talent/cash flow, actively responding by monitoring policy, enhancing R&D, optimizing strategies, strengthening risk management, and implementing internal reforms to return to profitability - Industry regulation and policy risks: Medical insurance cost control and centralized procurement bring short-term pressure on profit margins; the company will actively adapt to policies and accelerate the transformation of R&D products[90] - Increased industry market competition risk: Increased investment by domestic and international enterprises leads to severe market price competition; the company will adhere to R&D innovation and closely track industry development trends[91] - Profit loss risk: The company's overall operating performance for mid-2025 resulted in a loss; the company is undergoing reforms, including adjustments to personnel, sales strategies, and incentive measures, aiming to turn losses into profits[95] - Exchange rate fluctuation risk: A portion of revenue is settled in foreign currencies such as USD and RUB, posing exchange rate fluctuation risks; the company will strengthen foreign exchange market research and utilize hedging tools[94] Registration Form for Research, Communication, Interview, and Other Activities During the Reporting Period During the reporting period, the company engaged with institutional, other, and individual investors through online platforms and disclosed two investor relations activity records - On April 1, 2025, and May 27, 2025, the company hosted institutional, other, and individual investors through online communication platforms[96] Formulation and Implementation of Market Value Management System and Valuation Enhancement Plan The company has established a market value management system, formalized by the 'ESG Management System' released on April 19, 2024, which designates the Board of Directors as the ESG management leadership body and authorizes the formation of specialized working groups, including one for market value management, though no specific valuation enhancement plan was disclosed - The company has formulated a market value management system[97] - On April 19, 2024, the company released its 'ESG Management System,' clarifying that the Board of Directors serves as the leading and decision-making body for the company's ESG management[98] - The Board of Directors authorized the General Manager's Office to establish an ESG management working group, under which several specialized working groups, including one for market value management, were set up to establish a comprehensive market value management system[98] Implementation of the "Dual Enhancement of Quality and Returns" Action Plan The company did not disclose an announcement regarding the 'Dual Enhancement of Quality and Returns' action plan - The company did not disclose an announcement regarding the 'Dual Enhancement of Quality and Returns' action plan[99] Part IV Corporate Governance, Environment, and Society Changes in Directors, Supervisors, and Senior Management During the reporting period, the company experienced multiple changes in its Board of Directors, Chairman, General Manager, and Vice General Managers, including the departures of Song Qing, Qin Feng, Wang Xuemin, and Lin Maoliang, and the election of Guo Ting, Lang Tao, Liu Ying, and Li Guang as directors, with Sun Bin appointed as Vice General Manager and Zhang Haitao and Zheng Guoming dismissed from their Vice General Manager roles Changes in Directors, Supervisors, and Senior Management | Name | Position Held | Type | Date | Reason | | :--- | :--- | :--- | :--- | :--- | | Song Qing | Director, Chairman | Departure | August 7, 2025 | Job Transfer | | Wang Xuemin | Director, General Manager | Departure | August 7, 2025 | Job Transfer | | Guo Ting | Director, Chairman | Elected | August 7, 2025 | Job Transfer | | Lang Tao | Director, General Manager | Elected | August 7, 2025 | Job Transfer | | Sun Bin | Vice General Manager | Appointed | August 7, 2025 | Job Transfer | | Zheng Guoming | Vice General Manager | Dismissed | March 27, 2025 | Personal Reasons | Profit Distribution and Capital Reserve Conversion to Share Capital for the Current Reporting Period The company plans not to distribute cash dividends, bonus shares, or convert capital reserves into share capital for the half-year period - The company plans not to distribute cash dividends, bonus shares, or convert capital reserves into share capital for the half-year period[101] Implementation of Equity Incentive Plans, Employee Stock Ownership Plans, or Other Employee Incentive Measures The company reported no equity incentive plans, employee stock ownership plans, or other employee incentive measures and their implementation during the reporting period - The company reported no equity incentive plans, employee stock ownership plans, or other employee incentive measures and their implementation during the reporting period[102] Environmental Information Disclosure The listed company and its major subsidiaries are not included in the list of enterprises required to disclose environmental information by law - The listed company and its major subsidiaries are not included in the list of enterprises required to disclose environmental information by law[103] Social Responsibility The company upholds legal compliance and corporate governance, guided by Party building, continuously invests in R&D for innovation, actively engages in industry collaborations and standard setting, protects intellectual property with 202 patents and 99 software copyrights, prioritizes talent development and employee welfare, promotes green and low-carbon operations, fosters partner collaboration, and strengthens information and safety management - The company strictly adheres to the requirements of laws and regulations such as the 'Company Law of the People's Republic of China,' 'Securities Law of the People's Republic of China,' and 'Guidelines for Corporate Governance of Listed Companies,' standardizing the convening and holding of general meetings of shareholders and treating all investors equally[103] - In the first half of 2025, Dirui Medical's Party General Branch thoroughly studied and implemented the spirit of the 20th National Congress of the Communist Party of China, adhered to Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, and fully implemented the 'Notice of the General Office of the CPC Central Committee on Carrying out In-depth Study and Education on Implementing the Eight-Point Regulations of the Central Committee Across the Party' and the deployment requirements of the provincial and municipal Party committees[104] - The company consistently regards technological innovation as the core driving force for its development, continuously increasing R&D investment, strengthening market orientation, attracting high-end R&D talent, and promoting technological innovation and product upgrades[106] - The company highly values intellectual property protection and management, having formulated specialized work systems such as the 'Intellectual Property Management System,' 'Patent Management Guidelines,' 'Trademark Management Guidelines,' and 'Trade Secret Management Guidelines'[113] - The company highly values talent pipeline construction, continuously improving its human resource management system, and providing solid talent assurance for sustainable business development through multi-level, comprehensive talent cultivation mechanisms[114] - The company thoroughly implements the basic national policy of gender equality, comprehensively safeguarding the legitimate rights and interests of female employees, and establishing systematic protection mechanisms in areas such as career development and welfare benefits[120] - During the reporting period, in active response to national and group 'dual carbon' strategies, the company further strictly controlled energy use, promoted green and low-carbon development in its factory area, and gradually phased out traditional high-energy-consumption lighting fixtures, replacing them with high-efficiency LED energy-saving lamps through an 'intelligent + energy-saving' model[122] - The company consistently places high importance on cybersecurity and privacy protection, having established cybersecurity systems such as the 'Cybersecurity Management Measures' and 'Network Behavior Norms Implementation Rules'[124] Overall Situation The company adheres to legal compliance and corporate governance, guided by Party building, continuously invests in R&D for innovation, actively engages in industry collaborations and standard setting, and highly values intellectual property protection, holding 202 patents and 99 software copyrights - The company strictly adheres to the requirements of laws and regulations such as the 'Company Law of the People's Republic of China,' 'Securities Law of the People's Republic of China,' and 'Guidelines for Corporate Governance of Listed Companies,' standardizing the convening and holding of general meetings of shareholders and treating all investors equally[103] - In the first half of 2025, Dirui Medical's Party General Branch thoroughly studied and implemented the spirit of the 20th National Congress of the Communist Party of China, adhered to Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, and fully implemented the 'Notice of the General Office of the CPC Central Committee on Carrying out In-depth Study and Education on Implementing the Eight-Point Regulations of the Central Committee Across the Party' and the deployment requirements of the provincial and municipal Party committees[104] - The company consistently regards technological innovation as the core driving force for its development, continuously increasing R&D investment, strengthening market orientation, attracting high-end R&D talent, and promoting technological innovation and product upgrades[106] - The company actively promotes industry-academia-research cooperation, focusing on its core business, and achieving complementary advantages and strategic cooperation through technology, talent, and resources across the upstream and downstream of the industrial chain[108] - The company actively participates in industry standard setting, promoting industry standardization and technological progress, and has co-edited national standards such as 'Medical Fully Automatic Sample Processing System'[109] - The company highly values intellectual property protection and management, having formulated specialized work systems such as the 'Intellectual Property Management System,' 'Patent Management Guidelines,' 'Trademark Management Guidelines,' and 'Trade Secret Management Guidelines'[113] Human Resource Management and Employee Benefits The company prioritizes talent pipeline construction and continuously improves its human resource management system, providing robust talent assurance for sustainable business development through multi-level training and diverse career paths, while strictly adhering to labor laws to safeguard employee rights, including those of female employees - The company highly values talent pipeline construction, continuously improving its human resource management system, and providing solid talent assurance for sustainable business development through multi-level, comprehensive talent cultivation mechanisms[114] - Regarding employee rights protection, the company strictly implements labor laws and regulations such as the 'Labor Law' and 'Labor Contract Law,' effectively safeguarding the legitimate rights and interests of laborers; during the reporting period, the employee labor contract signing rate remained at 100%[115] - The company's compensation management adheres to principles of fairness and incentive, implementing dynamic adjustments based on factors such as employee position value, performance, and length of service[116] - The company has established a systematic, multi-level training system; during the reporting period, the company organized a total of 568 training sessions[117] - The company has established a four-dimensional parallel career development pathway (P/M/T/O system) encompassing Professional, Management, Technical, and Operations roles[118] - During the reporting period, the company recruited 139 people, with a localization employment ratio of 66.1%[119] - The company thoroughly implements the basic national policy of gender equality, comprehensively safeguarding the legitimate rights and interests of female employees, and establishing systematic protection mechanisms in areas such as career development and welfare benefits[120] Energy and Resource Management In response to national and group 'dual carbon' strategies, the company actively promotes green and low-carbon development by adopting an 'intelligent + energy-saving' model, replacing high-energy-consumption lighting with efficient LED fixtures, and implementing strict energy efficiency requirements for new equipment to reduce operating costs and carbon emissions - During the reporting period, in active response to national and group 'dual carbon' strategies, the company further strictly controlled energy use and promoted green and low-carbon development in its factory area[122] - By adopting an 'intelligent + energy-saving' model, the company gradually phased out traditional high-energy-consumption lighting fixtures in the factory area, replacing them with high-efficiency LED energy-saving lamps, and deployed sound-controlled and sensor-based lighting modes in different functional areas to achieve refined lighting energy savings[122] - When purchasing new equipment and facilities, strict access mechanisms are established, requiring energy efficiency levels to reach national Class 1 or international advanced standards, thereby systematically improving resource utilization efficiency, reducing both corporate operating costs and carbon emissions[122] Collaborative and Prosperous Development with Partners The company collaborates closely with partners to promote localization of materials, achieving domestic sourcing for 14 types of reagents and 7 types of instrument materials, ensuring green development through regular audits and ROHS certifications, and fostering mutual progress via anti-commercial bribery agreements, sunshine declarations, and regular technical exchange and quality management training sessions - During the reporting period, in the process of promoting the localization of materials, the company collaborated closely with various partners to achieve domestic sourcing for 14 types of reagents and 7 types of instrument materials[123] - Through regular and irregular on-site audits, as well as valid ROHS qualification documents provided by suppliers, the company ensures the implementation of green development and environmental protection requirements[123] - The company signs annual, temporary, and framework contracts with suppliers, which not only include clauses for protecting both parties' rights and interests but also incorporate institutional provisions such as anti-commercial bribery agreements and sunshine declarations[123] Information Security Management The company prioritizes cybersecurity and privacy protection, establishing policies like the 'Cybersecurity Management Measures' and 'Network Behavior Norms Implementation Rules,' conducting multiple employee cybersecurity awareness training sessions, and successfully deploying a new trusted computing hyper-converged server to resolve performance bottlenecks and resource shortages - The company consistently places high importance on cybersecurity and privacy protection, having established cybersecurity systems such as the 'Cybersecurity Management Measures' and 'Network Behavior Norms Implementation Rules'[124] - During the reporting period, the Information Technology Department organized multiple training sessions to enhance all employees' cybersecurity awareness[124] - The trusted computing hyper-converged server has now been accepted and launched, resolving issues such as unstable reagent volume data transmission due to server performance bottlenecks and resource shortages caused by aging hardware in the DMZ zone[124] Safety Management In the first half of 2025, the company fully implemented China Resources' 28 elements to strengthen management, conducted EHS due diligence, reinforced leadership accountability, improved its dual prevention mechanism by identifying and evaluating risk sources, and organized various safety activities and emergency drills to enhance employee safety awareness and response capabilities - In the first half of 2025, the company fully implemented China Resources' 28 elements, continuously solidifying its management foundation and carrying out various tasks according to the 'Six Grasp' management approach (grasping key personnel, timeliness, risk hazards, information confidentiality and security, stakeholders, and details)[125] - EHS due diligence investigations were conducted for leaders at all levels according to China Resources' 28 elements, continuously strengthening their diligent performance of duties in accordance with the 'three management, three musts' and 'dual responsibilities' principles[125] - Concurrently, the dual prevention mechanism system construction was continuously improved, comprehensive risk source identification and evaluation were organized, and key responsible persons led multiple teams to conduct hazard investigations[125] - Additionally, to enhance employee safety awareness and emergency response capabilities, the company organized multiple safety activities and emergency drills[125] Part V Significant Matters Commitments Fulfilled During the Reporting Period and Overdue Unfulfilled Commitments by the Company's Actual Controller, Shareholders, Related Parties, Acquirers, and the Company The company reported no commitments by its actual controller, shareholders, related parties, acquirers, or the company that were fulfilled during the reporting period or overdue and unfulfilled as of the end of the reporting period - The company reported no commitments by its actual controller, shareholders, related parties, acquirers, or the company that were fulfilled during the reporting period or overdue and unfulfilled as of the end of the reporting period[127] Non-Operating Fund Occupation by Controlling Shareholders and Other Related Parties of the Listed Company The company reported no non-operating fund occupation by controlling shareholders or other related parties of the listed company during the reporting period - The company reported no non-operating fund occupation by controlling shareholders or other related parties of the listed company during the reporting period[128] Illegal External Guarantees The company reported no illegal external guarantees during the reporting period - The company reported no illegal external guarantees during the reporting period[129] Appointment and Dismissal of Accounting Firms The company's semi-annual report was not audited - The company's semi-annual report was not audited[130] Explanation by the Board of Directors, Supervisory Board, and Audit Committee on the Accounting Firm's "Non-Standard Audit Report" for the Current Reporting Period The company reported no explanation by the Board of Directors, Supervisory Board, or Audit Committee regarding a 'non-standard audit report' from the accounting firm for the current reporting period - The company reported no explanation by the Board of Directors, Supervisory Board, or Audit Committee regarding a 'non-standard audit report' from the accounting firm for the current reporting period[131] Explanation by the Board of Directors on Matters Related to the Prior Year's "Non-Standard Audit Report" The company reported no explanation by the Board of Directors regarding matters related to the prior year's 'non-standard audit report' - The company reported no explanation by the Board of Directors regarding matters related to the prior year's 'non-standard audit report'[131] Bankruptcy and Reorganization Matters The company reported no bankruptcy and reorganization matters during the reporting period - The company reported no bankruptcy and reorganization matters during the reporting period[131] Litigation Matters During the reporting period, the company had no significant litigation or arbitration matters, with other litigation cases involving 74.79 million RMB, some still pending, and concluded cases being executed as per procedures without significant impact - The company had no significant litigation or arbitration matters during the current reporting period[132] Summary of Other Litigation Matters | Basic Information on Litigation (Arbitration) | Amount Involved (10k RMB) | Whether a Provision for Liabilities is Formed | Litigation (Arbitration) Progress | Litigation (Arbitration) Outcome and Impact | | :--- | :--- | :--- | :--- | :--- | | Summary of other litigation not meeting the disclosure threshold for significant litigation | 7,478.79 | No | Some cases are still pending; concluded cases are executed as per procedures | No significant impact | Penalties and Rectification The company reported no penalties or rectification situations during the reporting period - The company reported no penalties or rectification situations during the reporting period[134] Integrity Status of the Company, its Controlling Shareholder, and Actual Controller The company reported no integrity issues concerning itself, its controlling shareholder, or its actual controller during the reporting period - The company reported no integrity issues concerning itself, its controlling shareholder, or its actual controller during the reporting period[135] Significant Related Party Transactions During the reporting period, the company engaged in daily operating related party transactions, including commodity purchases and sales, labor services, and related leases, totaling 1.24 million RMB against an approved limit of 7 million RMB, with no related party transactions involving asset/equity acquisitions, disposals, joint external investments, or non-operating related party receivables/payables - In 2025, the total approved amount for purchasing goods and services from Huaderun and its related parties was 7 million RMB, with actual transaction amounts totaling 1.2439 million RMB[482] - The company reported no non-operating related party receivables or payables during the reporting period[138] - The company reported no related party transactions involving asset or equity acquisitions or disposals during the reporting period[136] - The company reported no related party transactions involving joint external investments during the reporting period[137] [Related Party Transactions Related to Daily