九强生物(300406) - 2025 Q2 - 季度财报

Section 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, assuming legal responsibility. - The company's Board of Directors, Supervisory Board, and senior management guarantee the truthfulness, accuracy, and completeness of the semi-annual report, with no false statements, misleading representations, or major omissions, and assume individual and joint legal responsibility[4] - Company head Zou Zuojun, chief accountant Liu Wei, and head of accounting department Liu Wei declare that the financial report in this semi-annual report is true, accurate, and complete[4] - Forward-looking statements in this semi-annual report, such as future plans or strategies, do not constitute a substantive commitment by the company to investors, who should maintain sufficient risk awareness regarding them[4] Risk Factors The company faces multiple risks including intensified industry competition, policy changes, new product R&D and registration, and reliance on imported raw materials, addressing these through strategic transformation, R&D investment, policy monitoring, and supply chain optimization. (I) Risk of Intensified Industry Competition The in-vitro diagnostics (IVD) market faces escalating competition, with foreign brands dominating high-end segments and domestic brands accelerating substitution, leading to product homogenization and price competition. - The in-vitro diagnostics market competition is intensifying, evolving from single-product competition to comprehensive strength competition, including product series and solutions[5] - The pathology diagnostics sector shows a competitive landscape where foreign capital dominates the high-end market, coexisting with accelerated substitution by domestic brands, and new technology applications intensify market competition[6] - The company plans to address competition by accelerating strategic transformation, enriching product lines, strengthening sales network construction, enhancing academic marketing, expanding market reach, improving product quality and brand building, and elevating customer service[9] (II) Industry Policy Risk The medical device industry faces strict national regulation, with policies like centralized procurement and DRG/DIP reducing terminal prices and limiting pricing power, accelerating industry consolidation. - Centralized procurement has gradually covered over 120 types of diagnostic reagents across 8 major categories, including chemiluminescence and molecular diagnostics, leading to lower terminal prices[11] - Policies such as "Sunshine Procurement," "Centralized Procurement," "DRG/DIP," and national price linkage mechanisms further compress manufacturers' pricing margins[11] - The company will closely monitor the latest industry policies, promptly formulate countermeasures, flexibly adjust operating strategies, continuously improve its distributor system, and enhance production management levels[11] (III) New Product R&D and Registration Risk The technology-intensive in-vitro diagnostics industry faces long R&D cycles, high conversion risks, and stringent, lengthy product registration processes in both domestic and international markets. - R&D outcomes in the in-vitro diagnostics industry typically take one year or more to transform from laboratory technology to products, posing risks of technical deviation or R&D process setbacks leading to failure[12] - After successful new product R&D, market access requires stages of product standard approval, clinical trials, registration testing, and registration approval, with Chinese approval processes generally taking 1-2 years[13] - The company will increase R&D investment, strengthen communication with end-users, and stabilize and expand its registration team to improve registration efficiency and shorten time-to-market[13] (IV) Risk of Reliance on Imported Upstream Raw Materials China's biochemical raw material preparation technology is nascent, leading to a high reliance on imported core raw materials for in-vitro diagnostic reagents, posing supply chain risks due to global instability. - Domestic enterprises producing core raw materials for in-vitro diagnostic reagents still primarily rely on imports, posing risks of supply shortages or instability[14] - The company's countermeasures include maintaining multiple suppliers for the same raw material and increasing R&D investment to achieve domestic substitution[14] Imported Raw Material Procurement Amount as a Percentage of Total | Year/Period | Percentage | | :---------- | :--- | | 2022 | 16.91% | | 2023 | 17.33% | | 2024 | 14.25% | | H1 2025 | 20.50% | (V) Management Risk from Business Integration and Scale Expansion Expanding through M&A and new business areas increases management complexity, posing challenges for business integration and operational efficiency, which could weaken core competitiveness if not adequately addressed. - The company's M&A and new business expansion demand higher management standards, potentially leading to challenges in business integration and improving overall operational efficiency[16] - The company will continuously conduct operational analysis, promptly optimize its organizational structure and management model, ensuring orderly and efficient operation across all business lines[16] - The company's profit distribution plan, approved by the Board of Directors, is to distribute a cash dividend of RMB 3 (tax inclusive) per 10 shares, with no bonus shares or capital increase from capital reserves[16] Table of Contents This section presents the structured table of contents for the report, including eight main chapters with their starting page numbers and a list of reference documents. - The report's table of contents includes eight main chapters, covering important notices, company profile, management discussion and analysis, corporate governance, significant matters, share changes, bond information, and financial reports[19] - The list of reference documents includes the original semi-annual report signed by the legal representative, financial statements, and original announcements of all publicly disclosed company documents[21][22][23] Definitions This section defines common terms used in the report, including company names, reporting period, stock exchange, industry acronyms like IVD, and certifications such as EU CE and US FDA. - "Strong Biotechnologies" or "the Company" refers to Beijing Strong Biotechnologies, Inc[25] - "Reporting Period" refers to January 1, 2025, to June 30, 2025[25] - "IVD" is an abbreviation for In-Vitro Diagnostics[25] - "CE" is the European Union certification for products, indicating compliance with EU directive safety requirements; "FDA" is the U.S. Food and Drug Administration's evaluation process for product safety and effectiveness for market entry in the United States[25] Section II Company Profile and Key Financial Indicators I. Company Profile This section provides basic information about Beijing Strong Biotechnologies, Inc., including its stock ticker, code, listing exchange, Chinese and English names, and legal representative. Company Basic Information | Indicator | Content | | :--- | :--- | | Stock Abbreviation | Strong Biotechnologies | | Stock Code | 300406 | | Stock Exchange | Shenzhen Stock Exchange | | Company's Chinese Name | 北京九强生物技术股份有限公司 | | Company's Legal Representative | Zou Zuojun | II. Contact Person and Information This section provides contact details for the company's Board Secretary and Securities Affairs Representative, including names, addresses, phone numbers, fax, and email, for investor communication. Contact Person and Information | Position | Board Secretary | Securities Affairs Representative | | :--- | :--- | :--- | | Name | Wang Jianmin | Bao Nan | | Contact Address | 5th Floor, Kuangyi Building, No. 15 Huayuan East Road, Haidian District, Beijing | 5th Floor, Kuangyi Building, No. 15 Huayuan East Road, Haidian District, Beijing | | Phone | 010-82247199 | 010-82247199 | | Email | jiuqiangzhengquan@bsbe.com.cn | jiuqiangzhengquan@bsbe.com.cn | III. Other Information During the reporting period, there were no changes to the company's registered address, office address, website, email, information disclosure and filing locations, or registration status. - The company's registered address, office address, website, and email remained unchanged during the reporting period, as detailed in the 2024 Annual Report[29] - Information disclosure and filing locations remained unchanged during the reporting period, as detailed in the 2024 Annual Report[30] - The company's registration status remained unchanged during the reporting period, as detailed in the 2024 Annual Report[31] IV. Key Accounting Data and Financial Indicators In H1 2025, the company's operating revenue and net profit attributable to shareholders decreased by 18.67% and 30.01% respectively, while net cash flow from operating activities increased by 9.71%. Key Accounting Data and Financial Indicators (Current Reporting Period vs. Same Period Last Year) | Indicator | Current Reporting Period (RMB) | Same Period Last Year (RMB) | Year-on-Year Change | | :--- | :--- | :--- | :--- | | Operating Revenue | 668,335,957.13 | 821,722,324.81 | -18.67% | | Net Profit Attributable to Shareholders of Listed Company | 175,233,795.64 | 250,373,606.97 | -30.01% | | Net Profit Attributable to Shareholders of Listed Company (Excluding Non-Recurring Gains/Losses) | 173,456,836.36 | 248,090,493.65 | -30.08% | | Net Cash Flow from Operating Activities | 244,076,650.72 | 222,466,764.72 | 9.71% | | Basic Earnings Per Share (RMB/share) | 0.30 | 0.43 | -30.23% | | Diluted Earnings Per Share (RMB/share) | 0.30 | 0.43 | -30.23% | | Weighted Average Return on Net Assets | 4.22% | 6.53% | -2.31% | Key Accounting Data and Financial Indicators (End of Current Reporting Period vs. End of Previous Year) | Indicator | End of Current Reporting Period (RMB) | End of Previous Year (RMB) | Change | | :--- | :--- | :--- | :--- | | Total Assets | 5,442,024,152.50 | 5,574,965,162.35 | -2.38% | | Net Assets Attributable to Shareholders of Listed Company | 4,078,022,542.14 | 4,138,374,136.02 | -1.46% | V. Differences in Accounting Data Under Domestic and International Accounting Standards During the reporting period, there were no differences in net profit and net assets between financial reports disclosed under international or overseas accounting standards and Chinese accounting standards. - The company's financial reports for the reporting period show no differences in net profit and net assets when disclosed under international accounting standards versus Chinese accounting standards[33] - The company's financial reports for the reporting period show no differences in net profit and net assets when disclosed under overseas accounting standards versus Chinese accounting standards[34] VI. Non-Recurring Gains and Losses Items and Amounts During the reporting period, the company's total non-recurring gains and losses amounted to RMB 1,776,959.28, primarily from non-current asset disposal, government grants, and other non-operating income/expenses. Non-Recurring Gains and Losses Items and Amounts | Item | Amount (RMB) | | :--- | :--- | | Gains or losses from disposal of non-current assets | -749,603.05 | | Government grants recognized in current profit or loss | 3,286,887.22 | | Other non-operating income and expenses apart from the above | -442,647.85 | | Less: Income tax impact | 314,098.82 | | Impact on minority interests (after tax) | 3,578.22 | | Total | 1,776,959.28 | - The company has no other profit or loss items that meet the definition of non-recurring gains and losses, nor has it classified non-recurring gains and losses as recurring gains and losses[37] Section III Management Discussion and Analysis I. Main Business Activities During the Reporting Period The company primarily engages in in-vitro diagnostics (IVD) products and services across pathology, biochemistry, immunology, molecular, and coagulation, expanding its product lines and market reach through R&D and M&A. (I) Industry Overview The company operates in the in-vitro diagnostics (IVD) industry, a critical segment of pharmaceutical manufacturing, characterized by significant market growth potential in China but facing multiple barriers including technology, talent, and market access. 1. Industry Fundamentals The in-vitro diagnostics (IVD) industry is a key segment of pharmaceutical manufacturing, encompassing various diagnostic categories like pathology, biochemistry, immunology, and molecular diagnostics, with increasing demand in thrombosis and hemostasis. - Sub-segments of in-vitro diagnostic products include pathology diagnostics, biochemical diagnostics, immunological diagnostics, molecular diagnostics, POCT (Point-of-Care Testing), coagulation diagnostics, and hematology[39] - Immunodiagnostics is the fastest-growing segment of China's IVD industry from 2020-2025, with chemiluminescence technology gradually replacing traditional methods[41] - Domestic demand for thrombosis and hemostasis products is continuously increasing, indicating broad future growth potential[41] 2. Market Landscape The global IVD market is dominated by developed economies and international giants, while China is projected to become the largest consumer by 2030, driven by policy and demographic dividends, with centralized procurement accelerating industry consolidation. - The global IVD market size is projected to grow at a compound annual rate exceeding 5% from 2020-2027, with developed economies like North America, Europe, and Japan holding major shares[42][43] - China's IVD market size is expected to grow to RMB 288.15 billion by 2030, increasing its share in the global market to 33.2% and becoming the largest consumer of in-vitro diagnostic products[44] - Centralized procurement has led to reagent price reductions of 50-80%, which, combined with policies like DRG, accelerates industry consolidation, offering rapid development opportunities for leading enterprises with technological barriers, economies of scale, and innovation capabilities[45] 3. Industry Barriers The in-vitro diagnostics industry faces significant barriers including complex technology, scarcity of interdisciplinary talent, high investment in marketing channels, stringent quality control, and strict market entry regulations. - Technical barriers: In-vitro diagnostics is a multidisciplinary field with high technical complexity, requiring continuous R&D investment to maintain competitiveness[46] - Talent barriers: Domestic scarcity of interdisciplinary technical talent makes it difficult for new entrants to quickly build core R&D teams[46] - Marketing channel barriers: Building a professional, extensive marketing network and after-sales service system requires substantial capital investment and time accumulation[47] - Market access barriers: National regulatory authorities implement strict licensing and registration systems for manufacturing and operating enterprises and products, with lengthy approval cycles[47] (II) Main Business Introduction As a leading in-vitro diagnostics enterprise, the company has developed seven major diagnostic systems over 20 years, leveraging R&D and subsidiary expertise to master core technologies and expand product lines. 1. Overview of Main Business With 20 years in in-vitro diagnostics, the company has built seven diverse, high-quality diagnostic systems, including pathology, biochemistry, and coagulation, while its subsidiary Maixin Bio focuses on pathology and AI. - The company, as one of the leading enterprises in China's in-vitro diagnostics industry, has been deeply involved in the field for 20 years, committed to building a diversified, high-quality in-vitro diagnostic testing platform[49] - Currently, it possesses seven major diagnostic systems: pathology diagnostic system, biochemical diagnostic system, coagulation diagnostic system, luminescence diagnostic system, blood typing diagnostic system, POCT diagnostic system, and liquid biopsy system[49] - Wholly-owned subsidiary Maixin Bio focuses on core pathology diagnostic technologies, establishing a four-dimensional integrated approach of "reagent core raw materials + reagent kit development + innovative instruments + diagnostic services," exploring cutting-edge technologies like companion diagnostics and pathology AI[49] 2. Main Business Model The company's business model integrates procurement, production, and marketing, featuring a "production-to-order" approach and a hybrid distribution strategy combining direct sales and dealership networks. 1) Procurement Model The company's procurement model involves four key stages: planning, supplier selection, price negotiation, and quality control, ensuring product quality through departmental collaboration. - Procurement plans are formulated by the Business Department based on inventory, safety stock, delivery times, and prices[51] - Supplier selection is conducted by the R&D Department for availability screening and technical standard output, with the Business Department handling admission[52] - Procurement prices are negotiated and determined by the Business Department with suppliers, generally maintained for at least one year to ensure cost stability[53] - Quality control is performed by the Quality Department, which evaluates and accepts goods based on arrival verification standards to ensure product quality[54] 2) Production Model The company employs a "production-to-order" model, aligning production plans with market demand and inventory to minimize stock accumulation, reduce costs, and optimize resource utilization. - The company implements a production-to-order model, guided by market demand, combining order contracts and historical sales data with current inventory to formulate various levels of production plans[55] - The production process includes formulating weekly plans based on average monthly sales, preparation, sub-packaging, packaging, and warehousing[55] - The on-demand production model avoids inventory backlog and overcapacity, reduces warehousing costs and capital tie-up, and improves resource utilization efficiency[55] 3) Marketing Model The company utilizes a hybrid marketing model, primarily distribution for Strong Biotechnologies and direct sales for Maixin Bio, with strict dealer management to ensure market coverage and product promotion. - The company adopts a "distribution and direct sales combined" marketing model, with Strong Biotechnologies primarily using distribution and Maixin Bio primarily using direct sales[56][59] - The company imposes requirements on dealer qualifications and sales capabilities, implements a unified pricing policy, and offers discounts based on sales performance[60][61][62] - The company provides after-sales service support to dealers, manages accounts receivable, and strictly restricts cross-regional sales by dealers, imposing penalties for violations[63][64] Medical Device Business Disclosure Requirements The company boasts extensive product lines and technology platforms in pathology, biochemistry, coagulation, luminescence, and blood typing diagnostics, with a significant increase in medical device registrations and FDA certifications. - Wholly-owned subsidiary Maixin Bio possesses mature R&D platforms for IHC-related monoclonal antibodies, reagent kit development, and automated instrument development in the field of pathology diagnostics, and is actively developing molecular diagnostics and pathology AI platforms[66] - The company's biochemical testing covers routine indicators and continuously develops new projects; in coagulation, it has developed fully automatic coagulometers and their配套检测项目; in luminescence, it has launched high, medium, and low-speed instruments and expanded its reagent menu; in blood typing, it continuously introduces new products[66] (I) Quantity Statistics At the end of the reporting period, the company saw significant growth in medical device registration certificates, filing certificates, and FDA certifications, with FDA certifications increasing by 180%. Medical Device Certificate Quantity Statistics | Indicator | End of Reporting Period (units) | Same Period Last Year (units) | | :--- | :--- | :--- | | Medical Device Registration Certificates | 395 | 355 | | Medical Device Filing Certificates | 537 | 440 | | CE Certifications | 96 | 96 | | FDA Certifications | 378 | 135 | - At the end of the reporting period, the number of medical device registration certificates increased by 11.27% year-on-year, filing certificates by 21.00%, and FDA certifications by 180.00%[68] (II) Medical Devices Under Registration Application During the Reporting Period During the reporting period, the company had numerous medical devices under registration application, including 53 domestic and 6 CE applications, covering various diagnostic reagents, mostly in technical review or clinical evaluation. - The company has 53 medical device registration certificate/filing certificate applications, primarily for Class II and Class III products, covering various diagnostic reagents such as immunoglobulins, enzymes, mycophenolic acid, gastrin-17, heparin-binding protein, and coagulation factors[69][70][71][72][73][74] - Most registration applications are in the technical review, clinical evaluation, or clinical trial stages, all being first-time registration applications and not classified as innovative medical devices[69][70][71][72][73][74] - The company has 6 CE registration applications, primarily for Class B and Class C products, including D-dimer, sodium, potassium, total bile acid, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol assay kits, all in the technical review stage[75] (III) Newly Registered, Renewed, or Amended Medical Devices During the Reporting Period During the reporting period, the company added, renewed, or amended 195 medical device registrations, including 120 domestic certificates and 75 FDA registrations, primarily for biochemical, immunological, and pathology-related reagents. - During the reporting period, the company newly registered, renewed, or amended 120 medical device registration certificates/filing certificates, covering various diagnostic reagents such as carbon dioxide, β2-microglobulin, cholinesterase, creatine kinase, urea, uric acid, pepsinogen, and cardiac troponin I[76][77][78][79][80][81][82][83][84][85][86][87][88] - Fuzhou Maixin Bio newly registered a large number of Class I Fluorescence In Situ Hybridization (FISH) probe reagents for detecting gene breakage, amplification, or deletion, providing auxiliary diagnostic information for physicians[82][83][84][85][86][87][88] - During the reporting period, the company newly registered 75 FDA products, primarily including Fuzhou Maixin Bio's Mouse Monoclonal Anti-Human and Rabbit Monoclonal Anti-Human antibody reagent series, as well as various Dual Color Break Apart Probes and Dual Color Dual Fusion probes, used for auxiliary information in tumor diagnosis[89][90][91][92][93][94][95][96][97][98][99][100][101][102][103][104][105][106][107][108][109][110][111][112][113][114][115][116][117][118][119][120][121][122][123][124][125][126] II. Analysis of Core Competencies The company's core competencies include continuous R&D, high-quality standards, diversified product lines, strategic partnerships, a robust marketing system, and strong brand building. (I) Continuous Improvement in R&D Capabilities In H1 2025, the company achieved significant R&D milestones, increasing its patent portfolio to 234 with 17 new patents covering calibration models, enzyme mutants, and diagnostic reagents. Patent Certificate Quantity | Indicator | Quantity (units) | | :--- | :--- | | Patent certificates at end of reporting period | 234 | | Patent certificates in same period last year | 217 | - During the reporting period, the company obtained 6 patent authorizations, including a calibration model and method for determining analyte concentration, a 6-phosphoglucose dehydrogenase mutant, a detection reagent and preparation method for novel coronavirus antibodies, and a hematoxylin dye solution suitable for automated immunohistochemistry staining instruments[129] - During the reporting period, the company applied for 11 new patents, including a rivaroxaban content detection kit, a matrix for humanized antibody calibrators, MDC3600/7600 series fully automatic coagulation analyzers, Gi9000 series fully automatic chemiluminescence immunoassay analyzers, and high-pressure immunohistochemistry systems and methods[130] (II) Quality and Brand Advantage The company maintains an international-standard production environment and ISO13485 quality management system, with its reference laboratory achieving CNAS accreditation and global traceability status. - The company has established a quality management system in accordance with ISO13485 and national medical device regulations, undergoing 5 external audits in H1 2025, all with satisfactory results[132] - The company's reference laboratory passed CNAS (ISO17025 and ISO15195) medical reference laboratory accreditation at the end of 2018, with 16 projects currently accredited, and has joined the Joint Committee for Traceability in Laboratory Medicine (JCTLM) as a global traceability service unit[133] - The reference laboratory collaborates extensively with institutions such as the China National Institute of Metrology and the National Center for Clinical Laboratories of the National Health Commission to promote standardization in the IVD industry[134] (III) Product Advantage As a leading biochemical reagent producer, the company leverages seven R&D platforms and M&A to offer a comprehensive product portfolio, including automated chemiluminescence analyzers and advanced pathology solutions. - The company possesses seven biochemical technology R&D platforms, mastering core R&D technologies, and has pioneered the launch of multiple innovative products that fill domestic gaps[135] - The company has officially entered the immunodiagnostics market, successfully launching medium-to-low speed and ultra-high speed fully automatic chemiluminescence analyzers, and continuously enriching its配套试剂, forming synergy with its biochemical and coagulation product lines[135] - Wholly-owned subsidiary Maixin Bio has over 30 years of experience in immunohistochemistry, with product performance reaching or exceeding international leading levels, and is developing molecular and pathology AI, committed to building a "precise, standardized, automated, digital, and intelligent" pathology ecosystem[136] (IV) Deepening Cooperation for Synergistic Effects The company actively collaborates with top-tier distributors like Sinopharm Group to expand sales channels and accelerate performance, achieving mutual benefits in supply chain optimization and brand building. - The company actively engages in close cooperation with first-tier distributors, such as various provincial companies of Sinopharm Group, to rapidly expand sales channels and accelerate company performance growth[137] - The company steadily promotes comprehensive, deep, and lasting cooperation with Sinopharm, from business对接 to operational synergy, fully leveraging both parties' resource advantages to achieve mutual benefit in supply chain optimization and brand co-building[137] (V) Advantage of a Comprehensive Marketing System The company builds a comprehensive marketing system by seizing industry opportunities, expanding globally, and enhancing after-sales service, fostering instrument-reagent synergy and strategic partnerships with industry leaders. - Subsidiary Maixin Bio accelerates the entry of fully automatic immunohistochemistry staining systems into hospitals by expanding its agent channels, driving sales of immunohistochemistry reagents and FISH reagents, achieving synergistic development of instruments and reagents[138] - The company adheres to the "walking with giants" strategy, establishing biochemical strategic partnerships with renowned domestic and international enterprises such as Abbott, Roche, Hitachi, and Mindray, with cooperation with Abbott progressing well and technology transfer revenue continuously growing[139] - In H1 2025, the company actively participated in industry exhibitions in the UAE, visited markets in Turkey and Saudi Arabia, strengthened channel development in South Asia, Southeast Asia, Europe, and South America, and promoted qualification certification for immunohistochemistry reagents and FISH reagents overseas[140] - The company continuously optimizes its after-sales service system, providing comprehensive professional training and technical support from reagent use to instrument maintenance, and plans to introduce AI technology to build an intelligent service ecosystem[141] (VI) Company Brand Building The company strengthens its brand strategy through "Quality Foundation" emphasizing R&D-driven quality across the product lifecycle, and "Cultural Immersion" to instill brand values internally. - The company deepens its brand strategy through "Quality Foundation," practicing the "quality starts with R&D" philosophy, forming a full lifecycle quality closed loop by integrating customer needs, supplier collaboration, technical support, and quality control resources[142] - The company deepens its brand strategy through "Cultural Immersion," adhering to the principle that "a brand should first be established in the minds of internal personnel," building a multi-dimensional brand recognition system to ensure effective penetration of the brand strategy across all organizational levels[143] (VII) Building an Academically-Led Industry-University-Research Cooperation Model The company maintains an academic marketing strategy, participating in national health research projects and successfully completing R&D projects, while fostering collaborative education initiatives. - The company adheres to an academic marketing strategy, utilizing academic conferences, exhibitions, and forums to deepen strategic cooperation with numerous domestic clinical laboratories[144] - In January 2025, the company's project "Establishment of a Clinical Laboratory Reference System for Cardiovascular and Cerebrovascular Diseases and Research on HCY Reference Intervals in the Elderly Population," participated in by the National Health Commission Hospital Management Institute, was successfully approved[144] - In February 2025, the company's project "Establishment and Promotion of a Clinical Testing System for Major Chronic Disease Inflammatory Markers," part of the 2024 National Major Science and Technology Project for Cancer, Cardiovascular, Respiratory, and Metabolic Disease Prevention and Control Research, was successfully approved[144] - In April 2025, the "Development and Industrialization of Fully Automatic Pathology Tissue Staining System" project, submitted by wholly-owned subsidiary Maixin Bio, successfully passed final acceptance[144] - In H1 2025, the company initiated collaborative education projects, with 3 units applying for and completing project approval, involving research on autoimmune liver disease, Brucella infection, and monitoring of thrombotic indicators in colorectal patients[145] (VIII) Awards Received On January 14, 2025, the company received the "First Prize for Military Science and Technology Progress," recognizing its outstanding contributions to technological innovation. - On January 14, 2025, the company was awarded the "First Prize for Military Science and Technology Progress," a high recognition for its outstanding contributions to technological innovation[146] III. Analysis of Main Business The company's core business in biochemical and pathology diagnostics saw H1 2025 operating revenue decrease by 18.67% to RMB 668.34 million, primarily due to centralized procurement and VAT rate changes. - The company's core business is biochemical and pathology diagnostics, gradually expanding into coagulation, luminescence, blood typing, and other fields[147] Operating Revenue and Year-on-Year Change | Indicator | H1 2025 (RMB 10,000) | H1 2024 (RMB 10,000) | Year-on-Year Change | | :--- | :--- | :--- | :--- | | Operating Revenue | 66,833.60 | 82,172.23 | -18.67% | - The decrease in operating revenue is primarily due to the continuous advancement of centralized procurement policies, rapid implementation of DRG, and policies such as mutual recognition of test results; additionally, subsidiary Maixin Bio's VAT rate changed from 3% to 13% starting from 2025[147] - Diagnostic reagent business remains the primary source of operating revenue, accounting for 95.09% of total operating revenue[147] Sales Model Revenue and Gross Margin (H1 2025 vs. H1 2024) | Sales Model | H1 2025 Operating Revenue (RMB 10,000) | H1 2025 Gross Margin | H1 2024 Operating Revenue (RMB 10,000) | H1 2024 Gross Margin | | :--- | :--- | :--- | :--- | :--- | | Direct Sales | 32,873.19 | 90.89% | 35,424.05 | 89.86% | | Distribution | 33,960.41 | 68.65% | 46,748.18 | 67.83% | | Subtotal | 66,833.60 | 79.59% | 82,172.23 | 77.33% | - Distribution model revenue accounted for 50.81% of operating revenue, with sales decreasing by 27.35% year-on-year; direct sales revenue accounted for 49.19%, with sales decreasing by 7.20% year-on-year; the average gross margin increased by 2.26%, mainly due to the increased proportion of subsidiary Maixin Bio's pathology business[148] Procurement Amount (H1 2025 vs. H1 2024) | Item | H1 2025 Procurement Amount (RMB 10,000) | H1 2024 Procurement Amount (RMB 10,000) | Year-on-Year Growth | | :--- | :--- | :--- | :--- | | Raw Materials | 7,599.84 | 8,146.76 | -6.71% | | Agency Reagents | 4,159.97 | 7,547.32 | -44.88% | | Instruments | 1,069.28 | 1,570.18 | -31.90% | | Total | 12,829.10 | 17,264.26 | -25.69% | Major Financial Data Year-on-Year Change | Indicator | Current Reporting Period (RMB) | Same Period Last Year (RMB) | Year-on-Year Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Operating Revenue | 668,335,957.13 | 821,722,324.81 | -18.67% | | | Operating Cost | 136,402,199.32 | 186,299,645.98 | -26.78% | | | Selling Expenses | 148,144,549.11 | 147,674,341.51 | 0.32% | | | Administrative Expenses | 63,385,975.74 | 69,914,142.33 | -9.34% | | | Financial Expenses | 20,002,948.12 | 20,343,818.12 | -1.68% | | | Income Tax Expense | 20,670,296.99 | 50,987,663.65 | -59.46% | Primarily due to decreased profit | | R&D Investment | 84,329,001.80 | 86,944,037.45 | -3.01% | | | Net Cash Flow from Operating Activities | 244,076,650.72 | 222,466,764.72 | 9.71% | | | Net Cash Flow from Investing Activities | -192,930,709.10 | 241,751,436.42 | -179.81% | Primarily due to purchase of large-denomination certificates of deposit in current period | | Net Cash Flow from Financing Activities | -280,795,092.13 | -134,718,051.26 | -108.43% | Primarily due to higher dividend distribution in current period than same period last year | | Net Increase in Cash and Cash Equivalents | -229,722,012.37 | 329,528,728.93 | -169.71% | Primarily due to purchase of large-denomination certificates of deposit and dividend distribution in current period | Product or Service Accounting for Over 10% of Revenue | Product or Service | Operating Revenue (RMB) | Operating Cost (RMB) | Gross Margin | Year-on-Year Change in Operating Revenue | Year-on-Year Change in Operating Cost | Year-on-Year Change in Gross Margin | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | In-vitro Diagnostic Reagents | 635,512,793.08 | 111,606,465.71 | 82.44% | -19.29% | -30.38% | 2.80% | IV. Analysis of Non-Core Business During the reporting period, non-core business activities included negative investment income from equity-accounted long-term equity investments, and non-operating income/expenses from non-recurring items. Non-Core Business Analysis | Item | Amount (RMB) | Percentage of Total Profit | Explanation of Cause | Sustainability | | :--- | :--- | :--- | :--- | :--- | | Investment Income | -742,471.47 | -0.38% | Primarily from long-term equity investment income accounted for using the equity method | Yes | | Non-Operating Income | 209,790.57 | 0.11% | Income from liquidated damages and amounts not required to be paid | No | | Non-Operating Expenses | 652,438.42 | 0.33% | Loss from disposal of non-current assets | No | V. Analysis of Assets and Liabilities At the end of the reporting period, total assets and net assets attributable to shareholders slightly decreased, with cash and cash equivalents reduced by dividends and large-denomination deposits, while certain assets were restricted. Significant Changes in Asset Composition | Item | Amount at End of Current Reporting Period (RMB) | Percentage of Total Assets | Amount at End of Previous Year (RMB) | Percentage of Total Assets | Change in Proportion | Explanation of Significant Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Cash and Cash Equivalents | 878,336,389.47 | 16.14% | 1,042,657,721.31 | 18.70% | -2.56% | Dividends and purchase of large-denomination certificates of deposit, etc. | | Accounts Receivable | 1,054,265,742.56 | 19.37% | 1,077,474,440.62 | 19.33% | 0.04% | | | Inventories | 223,491,471.20 | 4.11% | 220,680,889.10 | 3.96% | 0.15% | | | Total Assets | 5,442,024,152.50 | | 5,574,965,162.35 | | -2.38% | | | Net Assets Attributable to Shareholders of Listed Company | 4,078,022,542.14 | | 4,138,374,136.02 | | -1.46% | | Significant Changes in Liability Composition | Item | Amount at End of Current Reporting Period (RMB) | Percentage of Total Assets | Amount at End of Previous Year (RMB) | Percentage of Total Assets | Change in Proportion | Explanation of Significant Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Short-term Borrowings | 131,798.56 | 0.00% | 105,861.99 | 0.00% | 0.00% | | | Notes Payable | 6,071,759.85 | 0.11% | 1,185,923.33 | 0.02% | 0.09% | | | Employee Benefits Payable | 27,499,598.00 | 0.51% | 64,953,052.45 | 1.16% | -0.65% | | | Taxes Payable | 30,768,275.50 | 0.57% | 45,309,825.56 | 0.81% | -0.24% | | - Fuzhou Maixin Biotechnology Development Co., Ltd. mortgaged its land use rights and construction in progress, valued at RMB 101.09 million, to secure project loans[161] - The company signed a domestic factoring agreement with China Merchants Bank Liaocheng Branch to apply for financing using accounts receivable; as of the end of the reporting period, the related accounts receivable were not derecognized, and "other current liabilities" were recognized[162] VI. Analysis of Investment Status During the reporting period, the company's investment amounted to RMB 236.08 million, a 184.00% increase year-on-year, with no significant equity or non-equity investments, wealth management, or derivatives. Investment Amount During the Reporting Period | Indicator | Amount (RMB) | | :--- | :--- | | Investment amount in current reporting period | 236,083,794.81 | | Investment amount in same period last year | 83,127,236.47 | | Change percentage | 184.00% | - The company had no significant equity investments, non-equity investments, entrusted wealth management, derivative investments, or entrusted loans during the reporting period[164][165][167][168][169][170] Financial Assets Measured at Fair Value | Asset Category | Initial Investment Cost (RMB) | Amount at End of Period (RMB) | Source of Funds | | :--- | :--- | :--- | :--- | | Other | 30,000,000.00 | 30,000,000.00 | Own funds | VII. Significant Asset and Equity Disposals During the reporting period, the company did not undertake any significant asset or equity disposals. - The company did not sell significant assets during the reporting period[171] - The company did not sell significant equity during the reporting period[172] VIII. Analysis of Major Holding and Participating Companies Fuzhou Maixin Biotechnology Development Co., Ltd. is a key wholly-owned subsidiary, generating RMB 380 million in operating revenue and RMB 167 million in net profit from medical reagent and device sales. Major Subsidiary Financial Data | Company Name | Company Type | Main Business | Registered Capital (RMB) | Total Assets (RMB) | Net Assets (RMB) | Operating Revenue (RMB) | Operating Profit (RMB) | Net Profit (RMB) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Fuzhou Maixin Biotechnology Development Co., Ltd. | Subsidiary | Sales of medical reagents and medical devices | 50,000,000.00 | 1,884,014,304.58 | 1,652,415,083.63 | 380,354,381.27 | 194,214,777.58 | 166,597,334.93 | - The company did not acquire or dispose of any subsidiaries during the reporting period[174] IX. Structured Entities Controlled by the Company During the reporting period, the company did not control any structured entities. - The company did not control any structured entities during the reporting period[174] X. Risks Faced by the Company and Countermeasures The company advises investors to thoroughly review the full semi-annual report, paying particular attention to the detailed risk factors outlined in "Section I Important Notice, Table of Contents and Definitions." - The company requests investors to carefully read the full semi-annual report and pay special attention to the risk factors faced by the company, detailed in "Section I Important Notice, Table of Contents and Definitions" of this report[174] XI. Registration Form for Research, Communication, and Interview Activities During the Reporting Period On April 16, 2025, the company held its 2024 annual performance online briefing via the Panorama Network investor relations platform, engaging with various investors on its annual operations. Registration Form for Research, Communication, and Interview Activities During the Reporting Period | Reception Time | Reception Location | Reception Method | Type of Reception Object | Main Content Discussed and Materials Provided | | :--- | :--- | :--- | :--- | :--- | | April 16, 2025 | Company held performance briefing via Panorama Network "Investor Relations Interactive Platform" | Online platform communication | Individuals, institutions, others | Annual operations and other related matters | XII. Formulation and Implementation of Market Value Management System and Valuation Enhancement Plan The company adopted a "Market Value Management System" on March 28, 2025, approved by the Board, to enhance corporate governance, but has not disclosed a valuation enhancement plan. - The company has formulated a market value management system, which was reviewed and approved at the fourteenth meeting of the fifth Board of Directors on March 28, 2025, through the "Proposal on Formulating the Market Value Management System"[177] - The company has not disclosed a valuation enhancement plan[176] XIII. Implementation of the 'Dual Enhancement of Quality and Returns' Action Plan The company has not disclosed an announcement regarding its "Dual Enhancement of Quality and Returns" action plan. - The company has not disclosed an announcement regarding the "Dual Enhancement of Quality and Returns" action plan[178] Section IV Corporate Governance, Environment, and Society I. Changes in Directors, Supervisors, and Senior Management During the reporting period, there were no changes in the company's directors, supervisors, or senior management. - There were no changes in the company's directors, supervisors, and senior management during the reporting period, as detailed in the 2024 Annual Report[180] II. Profit Distribution and Capital Reserve Conversion to Share Capital During the Reporting Period The H1 2025 profit distribution plan proposes a cash dividend of RMB 3.00 (tax inclusive) per 10 shares, totaling RMB 174.83 million, representing 10.34% of distributable profits. H1 2025 Profit Distribution Plan | Indicator | Amount/Quantity | | :--- | :--- | | Number of bonus shares per 10 shares (shares) | 0 | | Dividend per 10 shares (RMB) (tax inclusive) | 3 | | Share capital base for distribution plan (shares) | 582,764,544 | | Cash dividend amount (RMB) (tax inclusive) | 174,829,363.20 | | Total cash dividend (including other forms) as a percentage of total profit distribution | 10.34% | | Distributable profit (RMB) | 1,691,510,224.05 | - The company proposes to distribute a cash dividend of RMB 3.00 (tax inclusive) per 10 shares to all shareholders, based on the total number of shares on the equity registration date when the profit distribution plan is implemented, minus the 3,544,084 shares in the company's repurchased special securities account that do not participate in the distribution[181] - If the company's total share capital changes due to convertible bond conversion or other reasons, the total cash dividend will be adjusted accordingly based on the total share capital on the equity registration date for profit distribution, adhering to the "unchanged distribution ratio" principle[181] III. Implementation of Equity Incentive Plans, Employee Stock Ownership Plans, or Other Employee Incentive Measures In H1 2025, the company approved and completed the repurchase and cancellation of 2,017,966 restricted shares from its fifth equity incentive plan, totaling RMB 18.79 million, due to employee departures and unmet performance targets. - On March 28, 2025, the company's Board of Directors and Supervisory Board reviewed and approved the "Proposal on Repurchasing and Cancelling Part of the Restricted Shares under the Fifth Restricted Stock Incentive Plan"[182] - A total of 2,017,966 restricted shares were repurchased and cancelled due to the departure of incentive recipients and failure to meet company-level performance targets, with a repurchase price of RMB 18,787,263.80[182] - The repurchase and cancellation of these shares were completed on July 22, 2025[182] - The company had no employee stock ownership plans or other employee incentive measures during the reporting period[183] IV. Environmental Information Disclosure The 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[183] V. Social Responsibility The company upholds social responsibility by safeguarding stakeholder interests, ensuring employee welfare, delivering high-quality products, promoting environmental sustainability, and contributing to public health initiatives. - The company effectively safeguards the interests of the company and its small and medium shareholders by improving corporate governance, strictly disclosing information, actively implementing profit distribution policies, and valuing investor relations management[183] - The company strictly adheres to labor laws and regulations, pays five social insurances and one housing fund plus supplementary commercial insurance for employees, and prioritizes talent development, employee safety, labor protection, and physical and mental health[185] - The company adheres to the "quality first" principle, providing high-quality clinical testing items and diversified diagnostic solutions, along with nationwide technical service support[187] - The company advocates for low-carbon and environmentally friendly green office practices, emphasizes environmental protection, actively promotes energy conservation and emission reduction, achieving coordinated and sustainable development with society and nature[188] - The company is a co-developer and producer of the CysC national standard, undertakes national high-tech R&D programs, and co-founded the CSTH Coagulation Cloud Classroom with the Chinese Research Hospital Association's Thrombosis and Hemostasis Professional Committee to promote standardization of coagulation testing in grassroots laboratories[189] Section V Significant Matters I. Commitments Fulfilled and Overdue Unfulfilled by Controlling Shareholder, Shareholders, Related Parties, Acquirers, and the Company During and as of the End of the Reporting Period During the reporting period, there were no fulfilled or overdue unfulfilled commitments by the company's controlling shareholder, shareholders, related parties, acquirers, or the company itself. - During the reporting period, there were no commitments by the company's actual controller, shareholders, related parties, acquirers, or the company itself that were fulfilled or overdue and unfulfilled as of the end of the reporting period[191] II. Non-Operating Fund Occupation by Controlling Shareholder and Other Related Parties During the reporting period, there was no non-operating occupation of listed company funds by the controlling shareholder or other related parties. - During the reporting period, there was no non-operating occupation of listed company funds by the controlling shareholder or other related parties[192] III. Irregular External Guarantees During the reporting period, the company had no irregular external guarantees. - The company had no irregular external guarantees during the reporting period[193] IV. Appointment and Dismissal of Accounting Firms The company's semi-annual financial report was not audited. - The company's semi-annual report was not audited[194] V. Explanations by the Board of Directors, Supervisory Board, and Audit Committee on the Accounting Firm's 'Non-Standard Audit Report' for the Current Period During the reporting period, there were no explanations from the Board, Supervisory Board, or Audit Committee regarding a "non-standard audit report" from the accounting firm. - During the reporting period, there were no explanations from the Board of Directors, Supervisory Board, or Audit Committee regarding the accounting firm's "non-standard audit report" for the current period[195] VI. Explanations by the Board of Directors on the 'Non-Standard Audit Report' for the Previous Year During the reporting period, there were no explanations from the Board of Directors regarding the "non-standard audit report" for the previous year. - During the reporting period, there were no explanations from the Board of Directors regarding the "non-standard audit report" for the previous year[195] VII. Matters Related to Bankruptcy Reorganization During the reporting period, the company had no matters related to bankruptcy reorganization. - The company had no matters related to bankruptcy reorganization during the reporting period[195] VIII. Litigation Matters During the reporting period, the company had no significant litigation, arbitration, or other legal matters. - The company had no significant litigation or arbitration matters during this reporting period[196] - The company had no other litigation matters during the reporting period[196] IX. Penalties and Rectification During the reporting period, the company had no penalties or rectification situations. - The company had no penalties or rectification situations during the reporting period[197] X. Integrity Status of the Company, its Controlling Shareholder, and Actual Controller During the reporting period, there were no integrity issues concerning the company, its controlling shareholder, or actual controller. - During the reporting period, there were no integrity issues concerning the company, its controlling shareholder, or actual controller[198] XI. Significant Related Party Transactions During the reporting period, the company engaged in routine related party transactions with Sinopharm Holdings and its subsidiaries, including procurement, services, and sales, all within approved limits, and financial dealings with Sinopharm Finance Co., Ltd. Related Party Transactions for Purchase and Sale of Goods, Provision and Acceptance of Services | Related Party | Related Transaction Content | Amount in Current Period (RMB) | Approved Transaction Limit (RMB 10,000) | Exceeded Transaction Limit | Amount in Prior Period (RMB) | | :--- | :--- | :--- | :--- | :--- | :--- | | Sinopharm Holdings Co., Ltd. and its subsidiaries | Purchase of goods | 1,074,611.34 | 1,500 | No | 3,098,194.17 | | Sinopharm Holdings Co., Ltd. and its subsidiaries | Acceptance of services | 508,831.13 | 500 | No | 235,783.25 | | Sinopharm Holdings Co., Ltd. and its subsidiaries | Sale of goods | 27,519,061.38 | 9,000 | No | 35,519,065.11 | - The company signed a "Financial Services Agreement" with Sinopharm Group Finance Co., Ltd., where the daily balance of deposits absorbed by Sinopharm Group Finance Co., Ltd. from the company does not exceed RMB 200 million, and a comprehensive credit line of up to RMB 500 million is provided[832] - As of June 30, 2025, the company's deposit balance with Sinopharm Group Finance Co., Ltd. was RMB 11,642.86, and the amount of acceptance bills issued by Sinopharm Group Finance Co., Ltd. in the current reporting period was RMB 11,283,566.68[833][834] - During the reporting period, the company did not engage in related party transactions involving asset or equity acquisition/disposal, joint external investments, or non-operating related party receivables and payables[203][204][205] XII. Significant Contracts and Their Performance During the reporting period, the company had no significant entrustment, contracting, guarantees, or other major contracts, but engaged in various leasing activities for warehouses, offices, and equipment, none of which significantly impacted profit. - The company had no entrustment, contracting, significant guarantees, or other significant contracts during the reporting period[211][212][219][222] - The company leases warehouse space located in Yanqi Economic Development Zone, Huairou District, Beijing, with some lease contracts renewed in December 2023, and rent adjusted upwards by 5% every three years[214][216] - The company leases office space located at No. 108, Yi, Beiyuan Road, Chaoyang District, Beijing, with a new contract signed on April 1, 2024, for a lease term until September 30, 2027, at a rent of RMB 4/square meter[215] - Subsidiary Fuzhou Maixin leases land located in Hengkeng Village, Baizhang Town, Minqing County, Fuzhou City, with a lease term from May 15, 2015, to May 14, 2040[217] - Subsidiary Hunan Jiuqiang leases premises located at No. 229 Guyuan Road, Yuelu District, Changsha City, for a lease period from September 20, 2024, to September 19, 2026[218] - The company had no leasing projects that resulted in profit or loss exceeding 10% of the company's total profit during the reporting period[218] XIII. Explanation of Other Significant Matters During the reporting period, there were no other significant matters requiring explanation by the company. - The company had no other significant matters requiring explanation during the reporting period[223] XIV. Significant Matters of Company Subsidiaries During the reporting period, no significant matters occurred within the company's subsidiaries. - The company had no sig