新产业(300832) - 2025 Q2 - 季度财报

Part I Important Notice, Table of Contents, and Definitions Important Notice The company's board, supervisory board, and senior management guarantee the report's integrity, with financial reports declared accurate, and no cash dividends or bonus shares planned - The company's board of directors, supervisory board, and senior management guarantee the truthfulness, accuracy, and completeness of the report content and assume legal responsibility[3] - Company head Rao Wei, chief accountant Ding Chenliu, and head of accounting department Ding Chenliu declare the financial report is true, accurate, and complete[3] - The company plans not to distribute cash dividends, bonus shares, or convert capital reserves into share capital[5] Table of Contents This section lists the report's complete directory structure, covering eight main chapters from important notices to financial reports, providing quick navigation for investors - The report contains eight main chapters, covering company profile, financial indicators, management discussion and analysis, corporate governance, significant matters, share changes, bond information, and financial reports[7] Reference Documents This section lists all reference documents publicly disclosed by the company during the reporting period, ensuring information disclosure completeness and traceability - Reference documents include the original semi-annual report signed by the legal representative and stamped with the company seal, signed and stamped financial statements, original drafts of all company documents and announcements disclosed on designated websites, and other relevant materials[9] Definitions This section defines common terms and abbreviations used in the report, including company names, subsidiaries, industry terms, and various certifications, to help readers accurately understand the content - The report defines the names of the company and its main subsidiaries, such as Shenzhen New Industries Biomedical Engineering Co., Ltd., Tibet Snibe, and Hong Kong Snibe[11] - Core industry terms such as In Vitro Diagnostics (IVD), IVD reagents, Chemiluminescence Immunoassay (CLIA), and Point-of-Care Testing (POCT) are explained[11][12] - The meanings of various domestic and international certifications are clarified, including CE certification, NMPA (National Medical Products Administration), FDA (U.S. Food and Drug Administration), ISO13485 certification, and MDSAP certification[11][12] Part II Company Profile and Key Financial Indicators I. Company Profile This section introduces the company's basic information, including stock abbreviation, code, listing exchange, full Chinese and English names and abbreviations, and legal representative, providing an overview for investors Company Basic Information | Indicator | Content | | :--- | :--- | | Stock Abbreviation | Snibe | | Stock Code | 300832 | | Listed Stock Exchange | Shenzhen Stock Exchange | | Chinese Name | 深圳市新产业生物医学工程股份有限公司 | | Foreign Name Abbreviation | Snibe | | Legal Representative | Rao Wei | II. Contact Person and Contact Information This section provides detailed contact information for the company's board secretary and securities affairs representative, including name, address, phone, fax, and email, facilitating investor communication and inquiries Contact Information | Position | Name | Contact Address | Phone | Fax | Email | | :--- | :--- | :--- | :--- | :--- | :--- | | Board Secretary | Zhang Lei | 21st Floor, Snibe Bio-Building, No. 23 Jinxiu East Road, Jinsha Community, Kengzi Street, Pingshan District, Shenzhen | 0755-86540062 | 0755-26654800 | snibeinfo@snibe.cn | | Securities Affairs Representative | Li Yujie | 21st Floor, Snibe Bio-Building, No. 23 Jinxiu East Road, Jinsha Community, Kengzi Street, Pingshan District, Shenzhen | 0755-86540062 | 0755-26654800 | snibeinfo@snibe.cn | III. Other Information This section states that the company's contact information, information disclosure, and registration changes remained unchanged during the reporting period, with details available in the 2024 annual report - The company's registered address, office address, website, and email remained unchanged during the reporting period[16] - Information disclosure and storage locations remained unchanged during the reporting period[17] - The company's registration status remained unchanged during the reporting period[18][19] IV. Key Accounting Data and Financial Indicators The company's key financial indicators for this reporting period show a slight year-on-year decrease in operating revenue, double-digit declines in net profit attributable to shareholders and non-recurring net profit, a significant reduction in net cash flow from operating activities, and a decrease in total assets and net assets Key Accounting Data and Financial Indicators (Current Reporting Period vs. Prior Year Period) | Indicator | Current Reporting Period (yuan) | Prior Year Period (yuan) | Year-on-year change | | :--- | :--- | :--- | :--- | | Operating Revenue | 2,184,828,547.37 | 2,210,936,110.91 | -1.18% | | Net Profit Attributable to Shareholders of Listed Company | 771,072,535.19 | 903,149,037.81 | -14.62% | | Net Profit Attributable to Shareholders of Listed Company Excluding Non-recurring Gains and Losses | 725,809,595.81 | 867,514,728.03 | -16.33% | | Net Cash Flow from Operating Activities | 461,456,489.11 | 618,461,493.76 | -25.39% | | Basic Earnings Per Share (yuan/share) | 0.9814 | 1.1495 | -14.62% | | Diluted Earnings Per Share (yuan/share) | 0.9814 | 1.1495 | -14.62% | | Weighted Average Return on Net Assets | 8.77% | 11.29% | Decrease of 2.52 percentage points | Key Accounting Data and Financial Indicators (End of Current Reporting Period vs. End of Prior Year) | Indicator | End of Current Reporting Period (yuan) | End of Prior Year (yuan) | Change | | :--- | :--- | :--- | :--- | | Total Assets | 8,983,627,781.48 | 9,619,453,527.11 | -6.61% | | Net Assets Attributable to Shareholders of Listed Company | 8,311,000,071.18 | 8,576,607,474.91 | -3.10% | V. Differences in Accounting Data Under Domestic and Foreign Accounting Standards During the reporting period, the company had no differences in net profit and net assets between financial reports disclosed under international or foreign accounting standards and those under Chinese accounting standards - The company had 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 had no differences in net profit and net assets between financial reports disclosed under foreign accounting standards and Chinese accounting standards during the reporting period[22] VI. Non-recurring Gains and Losses and Amounts The company's total non-recurring gains and losses for this reporting period amounted to 45,262,939.38 yuan, primarily from government subsidies, gains and losses from entrusted investments or asset management, and fair value changes, after deducting income tax effects Non-recurring Gains and Losses and Amounts | Item | Amount (yuan) | | :--- | :--- | | Gains and losses from disposal of non-current assets | -1,078,746.76 | | Government subsidies recognized in current profit or loss | 24,120,461.00 | | Gains and losses from changes in fair value of financial assets and liabilities held by non-financial enterprises, and disposal gains and losses | 6,807,795.88 | | Gains and losses from entrusted investments or asset management | 24,219,349.54 | | Other non-operating income and expenses apart from the above | -818,714.64 | | Less: Income tax impact | 7,987,205.64 | | Total | 45,262,939.38 | - The company has no other profit or loss items that meet the definition of non-recurring gains and losses, nor does it classify non-recurring gains and losses as recurring gains and losses[25] Part III Management Discussion and Analysis I. Main Business Activities of the Company During the Reporting Period The company primarily engages in the R&D, production, sales, and service of in vitro diagnostic products, covering chemiluminescence immunoassay, biochemical diagnosis, coagulation diagnosis, and molecular diagnosis, continuously launching new instruments and reagents, and building a comprehensive technical platform and sales service system, with no significant changes in its main business during the reporting period - The company primarily engages in the R&D, production, sales, and customer service of in vitro diagnostic products, used for disease prevention, diagnosis, treatment monitoring, and other purposes[27] - The company has established four major technology platforms: magnetic bead R&D, key reagent raw material R&D, fully automatic diagnostic instrument R&D, and diagnostic reagent R&D[27] - As of the end of the reporting period, the company sells 239 chemiluminescence immunoassay reagents globally, with 196 registered domestically; 72 biochemical diagnostic reagents; 7 coagulation diagnostic reagents; and some molecular diagnostic reagents have obtained CE access and domestic registration certificates[28] - The company's X-series flagship model, MAGLUMI X10 fully automatic chemiluminescence immunoassay analyzer, obtained domestic product registration, with a detection speed of up to 1,000 tests/hour. The high-end flagship fully automatic biochemical analyzer Biossays C10 obtained domestic product registration in July 2025, with a biochemical module detection speed of 2,000 tests/hour[29] - The company's SATLARS T8 fully automatic sample processing system was officially launched in June 2024, integrating five major professional fields, supporting modular design and intelligent scheduling. The iXLAB smart laboratory platform completed the local deployment of the DeepSeek-R1 model[30] - As of the end of the reporting period, the company has provided services to 1,835 tertiary hospitals domestically, with a tertiary hospital coverage rate of 47.60%, including a 63.51% coverage rate for domestic Grade A tertiary hospitals; in overseas markets, the company has provided services to medical terminals in 161 countries and regions[31] (I) Main Business, Products, and Their Uses The company specializes in in vitro diagnostics, offering magnetic beads, reagent raw materials, fully automatic instruments, and diagnostic reagents across chemiluminescence, biochemical, coagulation, and molecular diagnostics, continuously launching high-performance new products like MAGLUMI X10 and Biossays C10, serving domestic and international medical terminals - The company primarily engages in the R&D, production, sales, and customer service of in vitro diagnostic products, used for disease prevention, diagnosis, treatment monitoring, prognosis observation, health status evaluation, and genetic disease prediction[27] - The company has established four major technology platforms: magnetic bead R&D, key reagent raw material R&D, fully automatic diagnostic instrument R&D, and diagnostic reagent R&D[27] - As of the end of the reporting period, the company sells 239 chemiluminescence immunoassay reagents globally, with 196 registered domestically; 72 biochemical diagnostic reagents; 7 coagulation diagnostic reagents; and some molecular diagnostic reagents have obtained CE access and domestic registration certificates[28] - The company's X-series flagship model, MAGLUMI X10 fully automatic chemiluminescence immunoassay analyzer, obtained domestic product registration, with a detection speed of up to 1,000 tests/hour. The high-end flagship fully automatic biochemical analyzer Biossays C10 obtained domestic product registration in July 2025, with a biochemical module detection speed of 2,000 tests/hour[29] - The company developed the open fully automatic sample processing system SATLARS T8, officially launched in June 2024, comprehensively integrating five major professional fields, supporting modular design and intelligent scheduling. The iXLAB smart laboratory platform completed the local deployment of the DeepSeek-R1 model[30] - As of the end of the reporting period, the company has provided services to 1,835 tertiary hospitals domestically, with a tertiary hospital coverage rate of 47.60%, including a 63.51% coverage rate for domestic Grade A tertiary hospitals; in overseas markets, the company has provided services to medical terminals in 161 countries and regions[31] (II) Company's Production and Operation Model The company's production and operation model strictly adheres to medical device production and operation license scope, establishing a comprehensive quality management system and obtaining international certifications such as ISO 9001, ISO 13485, and MDSAP. The procurement model implements supplier access approval and hierarchical management, while the production model adopts a "production based on sales, appropriate inventory" principle, with strict product quality control - The company strictly produces within the scope licensed by the National Medical Products Administration, possesses a comprehensive quality management system, and has obtained EU ISO 9001, ISO 13485, and MDSAP system certifications[33] - The company is the first domestic manufacturer to obtain EU IVDR CE certification for chemiluminescence products and the first domestic manufacturer to obtain US FDA access for chemiluminescence products[33] - The procurement model implements a supplier access approval system, involving document review, sample verification, and price evaluation, along with hierarchical management and regular monitoring of suppliers[34] - The production model adopts a "production based on sales, appropriate inventory" principle, with production plans strictly formulated according to sales plans and safety stock standards, and a rigorous quality management system established[35] (III) Company's Business Model The company employs a "combination of distribution and direct sales, with distribution as the primary" sales model, having established a marketing network covering the entire country and key overseas markets. The profitability model centers on "instrument sales driving reagent sales, and reagent sales promoting instrument sales," achieving continuous growth through closed-system products and quality services - The company adopts a "combination of distribution and direct sales, with distribution as the primary" sales model, having established a marketing network covering the entire country and key overseas markets[36] - The domestic distribution model involves the company's marketing team promoting products and providing after-sales service, assisting distributors in market development. The overseas distribution model involves selecting distributors for secondary marketing and supply[36] - The direct sales model involves the company directly signing sales contracts with end-users, handling shipments, and collecting payments[36] - The company's main revenue source, chemiluminescence immunoassay products, operates as a closed system, with a profitability model of "instrument sales driving reagent sales, and reagent sales promoting instrument sales"[37] (IV) Industry Overview, Development Stage, and Cyclical Characteristics The global in vitro diagnostics market is projected to reach $109.2 billion, with rapid growth in emerging markets. The Chinese market is approximately 99.813 billion yuan, with immunodiagnostics having the largest share. Industry trends indicate a two-tiered technological development, with domestic brands accelerating import substitution, especially in chemiluminescence immunoassay - The global in vitro diagnostics market is projected to reach $109.2 billion in 2024, with North America and Western Europe as major markets, and emerging markets (such as China, India) experiencing rapid growth[39] - The global in vitro diagnostics market is expected to grow at a compound annual growth rate of 4.3% from 2024 to 2029[39] - In 2024, the global immunodiagnostics and biochemical diagnostics market sizes reached $27.729 billion and $10.534 billion, respectively, accounting for 25.5% and 9.6% of the global in vitro diagnostics market[40] - In 2023, the Chinese in vitro diagnostics market size was approximately 99.813 billion yuan, with the immunodiagnostics market reaching 37.521 billion yuan, accounting for 37.59%, where multinational corporations still dominate (71.2%)[41][42] - Trends in China's in vitro diagnostics industry include a two-tiered technological development (high-throughput assembly lines and POCT), narrowing technological gaps between domestic and international players, and gradual substitution of imported brands by domestic brands[44][45][46] 1、Global In Vitro Diagnostics Market Size and Development Stage The global in vitro diagnostics market is projected to reach $109.2 billion in 2024, with North America and Western Europe as primary markets, while emerging markets are growing rapidly, expecting a 4.3% CAGR over the next five years. Immunodiagnostics and biochemical diagnostics are the largest sub-sectors, with chemiluminescence immunoassay being the mainstream technology - The global in vitro diagnostics market size is projected to reach $109.2 billion in 2024[39] - North America and Western Europe are the main markets for in vitro diagnostics, with emerging markets (China, India, Turkey, Russia, Brazil) experiencing rapid growth[39] - The global in vitro diagnostics market is expected to grow at a compound annual growth rate of 4.3% from 2024 to 2029[39] - In 2024, the global immunodiagnostics and biochemical diagnostics market sizes reached $27.729 billion and $10.534 billion, respectively, accounting for 25.5% and 9.6% of the global in vitro diagnostics market[40] - Chemiluminescence immunoassay has become the mainstream diagnostic technology in the immunoassay field due to its good specificity, high sensitivity, and precise quantification advantages[40] 2、China In Vitro Diagnostics Market Size and Development Stage In 2023, China's in vitro diagnostics market was approximately 99.813 billion yuan, with immunodiagnostics accounting for 37.59%, still dominated by multinational corporations. Influenced by policies, the domestic market faces short-term adjustments, but domestic substitution is accelerating, and market penetration is evident - In 2023, the Chinese in vitro diagnostics market size was approximately 99.813 billion yuan[41] - In 2023, the domestic immunodiagnostics market reached 37.521 billion yuan, accounting for 37.59% of the domestic in vitro diagnostics market, with multinational corporations and domestic manufacturers accounting for 71.2% and 28.8%, respectively[42] - In 2023, the domestic biochemical diagnostics market was 11.149 billion yuan, a year-on-year increase of 5%, with domestic manufacturers' market share expected to further increase, and multinational corporations and domestic manufacturers accounting for 53.2% and 46.8%, respectively[42] - The domestic immunodiagnostics market faces short-term adjustments due to medical industry rectification, centralized procurement price reductions, and DRG/DIP policies, but domestic substitution and market penetration will accelerate[42][43] 3、Analysis of China's In Vitro Diagnostics Industry Development Trends China's in vitro diagnostics industry shows a two-tiered technological development trend, with high-end hospitals demanding high-throughput, high-efficiency products, and grassroots hospitals requiring moderate, stable products. The technological gap between domestic and international players is narrowing, with domestic brands approaching international levels in biochemical diagnostics and gradually achieving import substitution in chemiluminescence immunoassay - In vitro diagnostic technology shows a two-tiered development: integrated immunoassay and biochemical assembly lines meet the needs of high-end hospitals, while Point-of-Care Testing (POCT) meets the needs of grassroots hospitals[44] - The technological gap between domestic and international players in China's in vitro diagnostics industry is narrowing, with domestic enterprises in biochemical diagnostic reagents approaching international levels and gradually achieving import substitution[45][46] - The chemiluminescence immunoassay market is still primarily dominated by imported brands, but domestic brands will gradually replace imported brands in the future[46] (V) Company's Industry Position and Competitive Advantages As a leader in China's in vitro diagnostics sector, the company has broken the monopoly of overseas giants in the chemiluminescence immunoassay market through 30 years of dedication and technological innovation. It possesses four major technology platforms, has launched multiple leading instruments (such as MAGLUMI X10) and a comprehensive reagent menu, and is actively expanding into chronic disease management. The company's product quality has received numerous international certifications, demonstrating significant market position and competitiveness - In 2010, the company successfully developed and launched the first domestic fully automatic chemiluminescence immunoassay analyzer, breaking the monopoly of overseas giants[47] - As of the end of the reporting period, the company's products have been sold to 161 countries and regions overseas, and it has established 14 overseas branches to implement regional management and localized operations[47] - The company possesses four major technology platforms: magnetic bead R&D, key reagent raw material R&D, fully automatic diagnostic instrument R&D, and diagnostic reagent R&D, continuously optimizing product R&D processes[48] - The MAGLUMI X10 fully automatic chemiluminescence immunoassay analyzer obtained domestic product registration, with a detection speed of up to 1,000 tests/hour. The company offers 239 chemiluminescence immunoassay reagents, of which 200 have obtained EU access[48] - The company is actively developing product pipelines in chronic disease areas such as cardiovascular diseases, oncology, endocrine metabolism, and respiratory system diseases, launching innovative products like small molecule double antibody sandwich reagents, overcoming the limitations of traditional detection methods[49][50] - The company is the first Chinese chemiluminescence manufacturer to obtain US FDA market access, the first to receive an IVDR CE certificate in China's chemiluminescence field, and the first domestic chemiluminescence manufacturer to obtain CE List A certification for infectious disease projects HBV, HCV, and HIV[51] (VI) Significant Impact of Newly Promulgated Laws, Regulations, and Industry Policies on the Company's Industry The National Healthcare Security Administration continues to advance centralized procurement reforms, leading to price reductions for in vitro diagnostic reagents, which the company actively addresses and has successfully bid on. Immediate settlement reforms for medical insurance funds have eased financial pressure on medical institutions. DRG/DIP payment reforms promote refined operations in medical institutions, and hierarchical diagnosis and treatment create development opportunities for regional testing centers, collectively driving the industry towards orderly growth - The National Healthcare Security Administration continues to advance centralized volume-based procurement reforms for drugs and high-value medical consumables, establishing a normalized mechanism that has led to price reductions for in vitro diagnostic reagents. The company successfully bid on all participating chemiluminescence testing centralized procurement projects, entering Group A[53][54] - The National Healthcare Security Administration proposed centralized procurement principles of "stabilizing clinical practice, ensuring quality, preventing bid rigging, and countering internal competition," optimizing the "anchor point" for price difference calculation[54] - The national medical insurance fund immediate settlement reform aims to achieve basic immediate settlement in about 80% of all coordinated regions by 2025, and as of July 2025, it has covered 91% of coordinated regions, easing financial pressure on medical institutions[55][56] - DRG/DIP payment method reforms have covered all coordinated regions nationwide, prompting medical institutions to optimize diagnostic and treatment processes and driving the in vitro diagnostics industry back to orderly growth[57] - The implementation of hierarchical diagnosis and treatment creates development opportunities for regional testing centers, which become important support for hierarchical diagnosis and treatment through centralized testing, standardized management, and information sharing[58] (VII) Explanation of Performance Drivers and Significant Business Changes During the Reporting Period During the reporting period, the company adhered to independent innovation, launching high-end instruments like MAGLUMI X10 and Biossays C10, and deepening industry-academia-research cooperation. The domestic market saw a 12.81% decline in main business revenue due to centralized procurement and DRG/DIP policies, though instrument revenue grew. The overseas market achieved both quantity and quality growth through a "regional operation + localized deep cultivation" strategy, with main business revenue and reagent business revenue significantly increasing. High-end products like MAGLUMI X8 and SATLARS T8 continued to see increased installations. The company's comprehensive gross margin decreased, and net profit declined year-on-year - The company continued technological innovation, with high-end flagship fully automatic chemiluminescence immunoassay analyzer MAGLUMI X10 and fully automatic biochemical analyzer Biossays C10 obtaining domestic product registration certificates[59] - The domestic market's main business revenue decreased by 12.81% year-on-year due to price reductions from inter-provincial alliance procurement of in vitro diagnostic reagents and DRG/DIP policies, with reagent business revenue decreasing by 18.96% and instrument revenue increasing by 18.18% year-on-year[60] - The overseas market achieved 952.3575 million yuan in main business revenue, a year-on-year increase of 19.57%, with reagent business growing by 36.86%, through a "regional operation + localized deep cultivation" strategy[61][62] Main Business Revenue (First Half of 2025) | Region | Revenue (yuan) | Year-on-year change | | :--- | :--- | :--- | | Domestic | 1,228,948,000.00 | -12.81% | | Overseas | 952,357,500.00 | 19.57% | - The flagship model MAGLUMI X8 has accumulated 4,300 installations. The SATLARS T8 total laboratory automation assembly line has accumulated 179 global installations/sales, with 92 achieved during the reporting period[64] - During the reporting period, the company's comprehensive gross margin was 68.64%, with instrument product gross margin at 26.16% (a year-on-year decrease of 3.66 percentage points). Operating revenue was 2,184.8285 million yuan (a year-on-year decrease of 1.18%), and net profit attributable to shareholders of the listed company was 771.0725 million yuan (a year-on-year decrease of 14.62%)[65] (VIII) Progress of Domestic Medical Device Product Registration As of the end of the reporting period, the company's medical device registration certificates reached 432, with 24 new additions this period and no expired certificates, demonstrating continuous progress in product compliance and market access Medical Device Registration Certificate Quantity | Indicator | Quantity | | :--- | :--- | | Number of medical device registration certificates at the end of the reporting period | 432 | | Number of medical device registration certificates at the end of the previous year | 408 | | Number of new medical device registration certificates during the reporting period | 24 | | Number of expired medical device registration certificates during the reporting period | 0 | (IX) R&D Progress of New Reagent Projects The company's reagent R&D team adheres to market orientation, with 13 reagent projects having obtained registration inspection reports and entered the NMPA review stage by the end of the reporting period, and another 44 new products having obtained registration inspection reports and entered or completed clinical evaluation. The company has obtained 281 chemiluminescence immunoassay reagent registration certificates and successfully established an anti-companion antibody R&D platform and a single B-cell preparation technology platform, achieving self-production of key magnetic bead component iron powder, significantly accelerating small molecule immunoassay project development and improving reagent performance - As of the end of the reporting period, the company has 13 reagent projects that have obtained registration inspection reports and entered the NMPA review stage, covering categories such as infectious diseases, gonadal hormones, tumor markers, cardiovascular, liver function, immune, hypertension, and thyroid[68] - As of the end of the reporting period, the company has 44 new reagent products that have obtained registration inspection reports and entered or completed clinical evaluation, covering EB virus, infectious diseases, eugenics, kidney function, glucose metabolism, gonadal hormones, liver function, anemia, hypertension, cardiovascular and myocardial markers, pancreatic, colloidal gold/chromatography, reproductive tract infection/nucleic acid reagents, infectious disease/nucleic acid reagents, and respiratory tract infection/nucleic acid reagents[69] - As of now, the company has obtained 281 domestic chemiluminescence immunoassay reagent registration certificates (covering 196 reagent projects), 106 biochemical diagnostic reagent registration certificates (covering 72 reagent projects), 7 coagulation diagnostic reagent registration certificates, 1 molecular diagnostic reagent registration certificate, and 1 colloidal gold detection reagent registration certificate[70] - The company has completed the establishment of an anti-companion antibody R&D platform, accelerating small molecule immunoassay project development, and has completed product registration for 14 small molecule double antibody sandwich reagents. Simultaneously, it has established a single B-cell preparation technology platform and achieved self-production of key magnetic bead component iron powder[71] (X) Instrument R&D Progress The company's instrument R&D platform utilizes a full lifecycle R&D management platform, dedicated to technological innovation and product line strategic planning. As of the end of the reporting period, the Molecision R8 fully automatic nucleic acid detection and analysis system is undergoing domestic registration, while the mid-to-high throughput fully automatic biochemical analyzer Biossays C6 and the fully automatic methylation nucleic acid extraction and purification instrument Molecision MP16M are in the prototype stage, continuously enhancing the company's competitiveness in the in vitro diagnostics field - The company's instrument R&D platform uses a full lifecycle R&D management platform to enhance project management capabilities and ensure robust instrument product development[72] - The Molecision R8 fully automatic nucleic acid detection and analysis system is undergoing domestic registration, featuring innovations such as modularity, multiple detection modules, automatic cap opening/closing, and global anti-contamination[72] - The Biossays C6 fully automatic biochemical analyzer is in the prototype stage, supporting electrolyte and total glycated hemoglobin detection, can be connected to chemiluminescence immunoassay analyzers, and integrated into a total laboratory automation system[72] - The Molecision MP16M fully automatic methylation nucleic acid extraction and purification instrument is in the prototype stage, supporting methylation tumor early screening extraction and conversion experiments for various sample types, using pre-packaged reagent strips to achieve full-process automation[72] II. Core Competitiveness Analysis The company's core competitiveness lies in its complete industrial chain R&D system, serialized product portfolio, high-quality product manufacturing, global marketing network, professional and timely after-sales service, and strong technical talent reserves. These advantages collectively support the company's leading position and sustainable development in the in vitro diagnostics field - The company possesses four major technology platforms: magnetic bead, key reagent raw material, fully automatic diagnostic instrument, and diagnostic reagent, achieving revolutionary technological breakthroughs in the small molecule field[73] - It offers 12 models of fully automatic chemiluminescence immunoassay analyzers, covering low, medium, and high-speed models to meet diverse customer needs, with the MAGLUMI X10 achieving a detection speed of up to 1,000 tests/hour[74][75] - The company maintains strict product quality, evidenced by ISO13485, FDA 510(K), IVDR CE, and MDSAP certifications, with infectious disease projects HBV, HCV, HIV obtaining CE List A certification, and the Human Immunodeficiency Virus Antigen and Antibody Detection Kit receiving IVDR CE highest risk level Class D certification[76][77] - It has established a marketing network covering 28 domestic offices and 161 countries and regions overseas, with localized marketing and service teams in 14 key countries[79] - A nationwide after-sales service network ensures 48-hour response time, with 170 service points, offering ISO 15189 full-process support, and earning the "2024 China Medical Equipment National Brand Gold Award" and "Product Line First Place"[81][82] - The company boasts a multidisciplinary, multi-level talent team covering R&D, technical production, product promotion, and after-sales service, holding 415 patents (179 invention patents) and 58 computer software copyrights[83] (I) Advantages of a Complete Industrial Chain R&D System The company has focused on in vitro diagnostics R&D for 30 years, establishing four major technology platforms: magnetic beads, key reagent raw materials, fully automatic diagnostic instruments, and diagnostic reagents, effectively improving new product R&D efficiency and existing product upgrades, particularly achieving technological breakthroughs in small molecules, overcoming the limitations of traditional detection methods - The company has focused on in vitro diagnostics product R&D for 30 years, establishing four major technology platforms: magnetic bead R&D, key reagent raw material R&D, fully automatic diagnostic instrument R&D, and diagnostic reagent R&D[73] - Through continuous technological innovation and product development, it has achieved revolutionary technological breakthroughs in the small molecule field, solving problems such as low sensitivity and poor accuracy of competitive assays for small molecules, and improving specificity, sensitivity, precision, and linearity[73] (II) Competitive Advantages of Serialized Products The company offers 12 models of fully automatic chemiluminescence immunoassay analyzers, covering low, medium, and high-speed models to meet diverse customer needs. The flagship MAGLUMI X10 achieves a detection speed of up to 1,000 tests/hour. The company sells 239 chemiluminescence immunoassay reagents globally, providing one of the most comprehensive reagent menus in the industry, which, combined with its closed-system features, effectively enhances product competitiveness - The company offers 12 models of fully automatic chemiluminescence immunoassay analyzers, covering low, medium, and high-speed models to meet the needs of different types of customers[74] - MAGLUMI X8 was the first chemiluminescence immunoassay instrument globally to break the 600 tests/hour single-machine speed. The MAGLUMI X10 fully automatic chemiluminescence immunoassay analyzer has obtained domestic product registration, with a detection speed of up to 1,000 tests/hour[74][75] - The company sells 239配套 chemiluminescence immunoassay reagents globally, of which 200 have obtained EU access, making it one of the manufacturers offering the most comprehensive chemiluminescence immunoassay reagent menus in the industry[75] (III) Advantages of High-Quality Product Manufacturing The company strictly adheres to product quality standards, optimizes R&D and production quality control processes, and customizes automated production lines. It is the first domestic chemiluminescence enterprise to obtain FDA 510(K) access, received the first IVDR CE certificate in China's chemiluminescence field, and obtained MDSAP quality management system certification. Infectious disease projects HBV, HCV, HIV all passed CE List A certification, and the Human Immunodeficiency Virus Antigen and Antibody Detection Kit received IVDR CE highest risk level Class D certification, fully demonstrating the company's excellent product quality and reliable performance - The company first passed the German TÜV SÜD ISO13485 medical device quality management system certification in 2007[76] - In 2017, it entered the US market as the first domestic enterprise to obtain FDA 510(K) product access for chemiluminescence immunoassay reagents[76] - In December 2020, the company obtained the first IVDR CE certificate in China's chemiluminescence field. In February 2024, it obtained MDSAP quality management system certification[76] - The company's infectious disease projects for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV) detection products all passed CE List A certification, making it the first domestic chemiluminescence manufacturer to obtain all such certifications[77] - In September 2024, the company's Human Immunodeficiency Virus Antigen and Antibody Detection Kit obtained the IVDR CE highest risk level Class D certification certificate[77] - The company's reference testing laboratory obtained CNAS accreditation and became a JCTLM stakeholder member, establishing over 20 reference measurement procedures, of which 11 are CNAS accredited[78] (IV) Advantages of a Global Marketing Network The company has established a marketing network covering the entire country and key overseas markets, with 28 domestic offices, and further enhanced its layout through fundraising projects. Its products are sold in 161 countries and regions overseas, with localized marketing and service teams established in 14 key countries and regions, significantly boosting its global marketing capabilities and brand influence - The company has established a marketing network covering the entire country and key overseas markets, with 28 offices in the domestic market[79] - The implementation of the fundraising project "Snibe Marketing Network Upgrade Project" further improved the domestic market network layout, enhancing customer service levels and brand influence[79] - The company's products have been sold to 161 countries and regions overseas, and it has established localized marketing and service teams in key overseas countries and regions, having completed the establishment of 14 overseas branches[79] (V) Advantages of Professional and Timely After-Sales Service The company has established a nationwide professional after-sales service network, ensuring a 48-hour response time to customer service requests, with 170 after-sales service points. Through a professional training system and technical level management, service quality is ensured. The company practices the "Service+" philosophy, providing ISO 15189 full-process support, and has been awarded the "2024 China Medical Equipment National Brand Gold Award" and "Product Line First Place," demonstrating high customer satisfaction - The company has established a nationwide after-sales service network in China, ensuring a 48-hour response time to customer service requests[81] - As of the end of the reporting period, the company has accumulated 170 after-sales service points in China[81] - The company relies on its R&D platform to establish a professional training system, providing systematic technical training for after-sales service engineers and implementing technical level management[81] - The company practices the "Service+" philosophy, providing ISO 15189 full-process support to help hospital laboratories establish standardized quality management systems[81] - The company was awarded the "2024 China Medical Equipment National Brand Gold Award" and "Product Line First Place," ranking first in comprehensive satisfaction, repurchase intention, Net Promoter Score, and training system satisfaction among tertiary hospitals[82] (VI) Advantages of Technical Talent Reserve Adhering to its core values of "taking on heavy responsibilities, enjoying challenges, and pursuing excellence," the company has cultivated a multidisciplinary, multi-level, and well-structured talent team through 30 years of independent R&D. Through a technical level assessment system, it has established a professional talent pipeline supporting its sustainable development. As of the end of the reporting period, the company holds 415 patents and 58 computer software copyrights, demonstrating strong technological innovation capabilities - Through 30 years of independent R&D, the company has cultivated a multidisciplinary, multi-level, and well-structured talent team covering R&D, technical production, product promotion, and after-sales service[83] - The company has established and reserved a professional talent pipeline supporting its sustainable development through a technical level assessment system across multiple centers[83] - As of the end of the reporting period, the company holds 415 patents, including 179 invention patents, 158 utility model patents, and 78 design patents; it also holds 58 computer software copyrights[83] III. Main Business Analysis During the reporting period, the company's main business revenue slightly decreased year-on-year, while operating costs, selling expenses, and R&D investment all increased. Financial expenses significantly increased due to fluctuations in exchange gains and losses. The gross margin for in vitro diagnostics business was 68.64%, with reagent gross margin at 87.08% and instrument gross margin at 26.16%. Domestic market revenue decreased, and gross margin declined; overseas market revenue increased, and gross margin improved Major Financial Data Year-on-Year Changes | Indicator | Current Reporting Period (yuan) | Prior Year Period (yuan) | Year-on-year change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Operating Revenue | 2,184,828,547.37 | 2,210,936,110.91 | -1.18% | No significant change | | Operating Cost | 689,592,962.17 | 605,533,588.41 | 13.88% | No significant change | | Selling Expenses | 369,976,929.62 | 334,010,160.37 | 10.77% | No significant change | | Administrative Expenses | 59,249,087.81 | 57,554,228.20 | 2.94% | No significant change | | Financial Expenses | -28,997,689.28 | -12,592,152.00 | 130.28% | Primarily due to fluctuations in exchange gains and losses during the reporting period | | Income Tax Expense | 104,139,303.15 | 137,151,431.20 | -24.07% | No significant change | | R&D Investment | 237,188,096.62 | 204,352,338.65 | 16.07% | No significant change | | Net Cash Flow from Operating Activities | 461,456,489.11 | 618,461,493.76 | -25.39% | No significant change | | Net Cash Flow from Investing Activities | 665,836,921.33 | -112,786,969.38 | -690.35% | Primarily due to different maturities of wealth management products purchased, leading to significant differences in net cash flow from investing activities at the balance sheet date | | Net Cash Flow from Financing Activities | -1,023,930,835.48 | -788,582,370.07 | 29.84% | No significant change | | Net Increase in Cash and Cash Equivalents | 115,876,140.95 | -282,038,008.08 | -141.09% | Primarily due to changes in wealth management products, cash dividend payments, and exchange rate fluctuations during the reporting period | Products or Services Accounting for Over 10% of Revenue | Category | Operating Revenue (yuan) | Operating Cost (yuan) | Gross Margin | Year-on-year change in Operating Revenue | Year-on-year change in Operating Cost | Year-on-year change in Gross Margin | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | By Industry | | | | | | | | In Vitro Diagnostics | 2,181,305,516.49 | 684,001,357.65 | 68.64% | -1.12% | 13.92% | -4.14% | | By Product or Service | | | | | | | | Reagents | 1,521,159,649.64 | 196,560,320.66 | 87.08% | -4.40% | 7.39% | -1.42% | | Instruments | 660,145,866.85 | 487,441,036.99 | 26.16% | 7.37% | 16.78% | -5.95% | | By Region | | | | | | | | Domestic | 1,228,948,004.18 | 371,551,406.19 | 69.77% | -12.81% | 17.45% | -7.79% | | Overseas | 952,357,512.31 | 312,449,951.46 | 67.19% | 19.57% | 9.99% | 2.86% | IV. Non-Main Business Analysis The company's non-main business income primarily stems from investment income, fair value change gains and losses, and government subsidies, but these items are not sustainable. Simultaneously, asset impairment and non-operating expenses also impact total profit Non-Main Business Gains and Losses | Item | Amount (yuan) | Proportion of Total Profit | Explanation of Formation | Sustainability | | :--- | :--- | :--- | :--- | :--- | | Investment Income | 24,219,349.54 | 2.77% | Income from wealth management products | No | | Gains and Losses from Changes in Fair Value | 6,807,795.88 | 0.78% | Fair value changes of investment targets | No | | Asset Impairment | -14,293,195.53 | -1.63% | Provision for bad debts | No | | Non-operating Income | 74,420.62 | 0.01% | Liquidated damages | No | | Non-operating Expenses | 1,972,082.02 | 0.23% | External donations and disposal of fixed assets | No | | Other Income | 24,120,461.00 | 2.76% | Government subsidies | No | V. Analysis of Assets and Liabilities At the end of the reporting period, the company's total assets and net assets attributable to shareholders of the listed company both decreased. Trading financial assets significantly reduced due to the redemption of wealth management products, and accounts payable and employee compensation also decreased significantly. Concurrently, notes receivable, prepayments, and non-current assets due within one year increased Significant Changes in Asset Composition (End of Current Reporting Period vs. End of Prior Year) | Item | Amount at End of Current Reporting Period (yuan) | Proportion of Total Assets | Amount at End of Prior Year (yuan) | Proportion of Total Assets | Change in Proportion | Explanation of Significant Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Cash and Bank Balances | 1,035,407,816.79 | 11.53% | 919,531,675.84 | 9.56% | 1.97% | No significant change | | Accounts Receivable | 1,014,746,427.59 | 11.30% | 950,133,510.82 | 9.88% | 1.42% | No significant change | | Inventories | 1,066,810,665.69 | 11.88% | 1,197,993,634.12 | 12.45% | -0.57% | No significant change | | Trading Financial Assets | 596,226,774.64 | 6.64% | 1,723,492,391.65 | 17.92% | -11.28% | Primarily due to redemption of wealth management products during the reporting period | | Notes Receivable | 11,262,608.15 | 0.13% | 7,354,821.21 | 0.08% | 0.05% | Primarily due to new commercial acceptance bills during the reporting period | | Prepayments | 16,317,457.57 | 0.18% | 10,750,051.32 | 0.11% | 0.07% | Primarily due to increased prepayments for materials | | Non-current Assets Due Within One Year | 361,014,570.44 | 4.02% | 216,043,775.88 | 2.25% | 1.77% | Primarily due to increased debt investments and long-term receivables due within one year | | Accounts Payable | 177,009,600.39 | 1.97% | 456,617,121.10 | 4.75% | -2.78% | Primarily due to decreased payables for materials | | Employee Compensation Payable | 116,543,428.15 | 1.30% | 154,108,123.12 | 1.60% | -0.30% | Primarily due to payment of accrued 2024 compensation during the reporting period | - The company had no major overseas assets during the reporting period[94] - The company's main asset measurement attributes did not undergo significant changes during the reporting period, and there were no asset rights restrictions at the end of the reporting period[97] VI. Investment Analysis During the reporting period, the company had no significant equity investments but continued non-equity investments, primarily for the Snibe Bio-Operations Building project. The company engaged in entrusted wealth management and derivative investments using its own funds, with a large amount in entrusted wealth management and derivative investments mainly for hedging foreign exchange swap transactions to mitigate exchange rate fluctuation risks - The company had no significant equity investments during the reporting period[99] Significant Non-Equity Investments in Progress During the Reporting Period | Project Name | Investment Method | Is it a Fixed Asset Investment | Industry Involved in Investment Project | Amount Invested in Current Reporting Period (yuan) | Cumulative Actual Investment Amount as of End of Reporting Period (yuan) | Source of Funds | Project Progress | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Snibe Bio-Operations Building | Self-built | Yes | In Vitro Diagnostics | 93,446,488.31 | 459,875,744.29 | Own Funds | 77.12% | Financial Assets Measured at Fair Value | Asset Category | Initial Investment Cost (yuan) | Fair Value Change Gains and Losses in Current Period (yuan) | Amount Purchased in Reporting Period (yuan) | Amount Sold in Reporting Period (yuan) | Amount at Period End (yuan) | | :--- | :--- | :--- | :--- | :--- | :--- | | Others (Wealth Management Products) | 1,705,990,400.00 | 6,795,795.88 | 833,379,000.00 | 1,951,951,600.00 | 596,214,774.64 | | Financial Derivatives | 0.00 | 12,000.00 | 432,833,029.00 | 216,662,552.00 | 12,000.00 | | Stocks | 71,738,487.99 | 0.00 | 0.00 | 0.00 | 38,639,242.08 | | Trust Products | 75,000,000.00 | 0.00 | 0.00 | 0.00 | 75,000,000.00 | | Total | 1,915,632,087.99 | 6,807,795.88 | 1,266,212,029.00 | 2,168,614,152.00 | 851,881,411.88 | Overview of Entrusted Wealth Management | Specific Type | Source of Entrusted Wealth Management Funds | Amount of Entrusted Wealth Management (10,000 yuan) | Unmatured Balance (10,000 yuan) | | :--- | :--- | :--- | :--- | | Bank Wealth Management Products | Own Funds | 373,381.16 | 263,692.92 | | Trust Wealth Management Products | Own Funds | 7,500.00 | 7,500.00 | | Total | | 380,881.16 | 271,192.92 | - The company conducts forward foreign exchange settlement and foreign exchange swap transactions for hedging purposes, generating a cumulative investment loss of -3,485,118.84 yuan during the reporting period, aiming to mitigate the impact of exchange rate fluctuations on operating performance[109] VII. Significant Asset and Equity Sales During the reporting period, the company did not engage in any significant asset sales or significant equity sales - The company did not sell significant assets during the reporting period[112] - The company did not sell significant equity during the reporting period[113] VIII. Analysis of Major Holding and Participating Companies During the reporting period, the company had no important holding or participating company information that should be disclosed - The company had no important holding or participating company information that should be disclosed during the reporting period[113] IX. Information on Structured Entities Controlled by the Company During the reporting period, the company had no structured entities under its control - The company had no structured entities under its control during the reporting period[114] X. Risks Faced by the Company and Countermeasures The company faces multiple risks including policy changes, new product R&D and registration, distributor sales models, market competition, and technological substitution. The company actively responds by closely monitoring policies, increasing R&D investment, strictly managing distributors, enhancing product competitiveness, and increasing new product R&D investment - The company faces policy change risks, such as medical insurance centralized procurement leading to pressure on reagent prices and gross margins. The company is actively increasing market share to offset the impact and closely monitoring industry regulatory policies for adjustments[114] - New product R&D and registration risks are high, with long R&D cycles and potential for R&D failure or delayed registration. The company has strengthened early technical feasibility studies and market research, and established a Quality Assurance Department, Domestic Registration Department, and Overseas Registration Department to ensure timely product registration[115][116] - The distributor sales model carries risks such as management disarray and illegal activities. The company will continue to strengthen distributor management through strict access and elimination mechanisms for supervision[117] - Market competition is fierce, with international giants dominating the high-end market and domestic competition intensifying. The company promotes high-speed chemiluminescence immunoassay instruments and assembly line products to increase coverage in medium and large medical terminals and boost reagent consumption[118] - Overseas markets face uncertainties in import and export policies, trade barriers, and exchange rate fluctuations. The company closely monitors these and prepares risk countermeasures in advance[119] - Technological substitution risks may lead to a decline in the company's product competitiveness. The company's R&D and marketing departments will strengthen communication, increase investment in new product R&D, and aim to have one generation of products for sale, one for R&D, and one for reserve[120] XI. Registration Form for Research, Communication, Interview, and Other Activities During the Reporting Period During the reporting period, the company actively engaged in investor relations activities, hosting over 170 events including phone calls, on-site visits, and strategy conferences, with numerous institutional and individual investors such as Huatai-PineBridge Fund, China Asset Management, Ping An Securities, and Invesco Great Wall Fund, strengthening interaction and communication with investors - The company conducted over 170 investor relations activities in the first half of 2025, including phone calls, on-site visits, and strategy conferences[121][122][123] - The main recipients were institutional investors, such as Huatai-PineBridge Fund, Tianhong Asset Management, China Asset Management, Ping An Securities, Galaxy Securities, Invesco Great Wall Fund, Noah Fund, SWANSTONE Fund, Harvest Fund, China Life Asset Management, CCB Pension, Zhongheng Securities, Pioneer Futures, CMB Wealth Management, E Fund, etc[121][122][123] - The company disclosed investor relations activity record forms through Juchao Information Network, ensuring information transparency[121][122][123] XII. Formulation and Implementation of Market Value Management System and Valuation Enhancement Plan The company has formulated and the board of directors approved the "Market Value Management System" to enhance investment value and investor returns. This system defines the purpose, principles, departments, methods, prohibited behaviors, and early warning mechanisms for market value management. The board aims for a long-term goal of achieving a price-to-earnings ratio higher than the average for the in vitro diagnostics industry to stabilize the company's market capitalization - The company has formulated the "Market Value Management System," which was reviewed and approved by the third meeting of the fifth board of directors on April 25, 2025[124] - The "Market Value Management System" clarifies the purpose and basic principles of market value management, departments and personnel, main methods and daily market value management approaches, prohibited behaviors, and monitoring and early warning mechanisms and countermeasures[124] - The company's board of directors intends to set the long-term goal for market value management as: actively carrying out market value management work, stabilizing investors' confidence in the company's long-term development, and striving for the company's price-to-earnings ratio to be higher than the average price-to-earnings ratio of the in vitro diagnostics industry to stabilize the company's market capitalization[124] XIII. Implementation of "Quality and Return Dual Improvement" Action Plan The company actively implements the "Quality and Return Dual Improvement" action plan, focusing on its main business, expanding into large domestic medical terminals with high-speed chemiluminescence immunoassay analyzers and assembly line products, and enhancing brand influence in overseas markets through academic promotion and localized operations. The company continuously innovates products, adding multiple reagent registration ce