三鑫医疗(300453) - 2025 Q2 - 季度财报

Important Notes, Table of Contents, and Definitions This section provides essential preliminary information, a structured overview of the report's content, and clear definitions of key terms to ensure comprehensive understanding Important Notes The Board of Directors, Supervisory Board, and senior management guarantee the truthfulness, accuracy, and completeness of the semi-annual report, with the company's head, chief accountant, and accounting department head affirming the financial report's accuracy; forward-looking statements do not constitute substantial commitments, and a semi-annual profit distribution plan of RMB 1 (tax inclusive) per 10 shares is proposed - The company's Board of Directors, Supervisory Board, and senior management guarantee the truthfulness, accuracy, and completeness of the semi-annual report, free from false records, misleading statements, or major omissions[4] - Company head Peng Yixing, chief accountant Liu Ming, and head of accounting department Shu Nanmei declare that the financial report in this semi-annual report is true, accurate, and complete[4] 2025 Semi-Annual Profit Distribution Plan | Indicator | Content | | :--- | :--- | | Distribution Basis | 522,237,525 shares | | Dividend per 10 shares | 1 RMB (tax inclusive) | | Bonus Shares | 0 shares (tax inclusive) | | Capital Reserve to Share Capital | No conversion | Table of Contents The report's clear table of contents lists eight main chapters covering important notes, company profile, management discussion and analysis, corporate governance, significant matters, share changes, bond information, and financial reports, along with a list of reference documents - The report comprises eight main chapters, clearly structured for easy reference[7] - Reference documents include signed and sealed financial statements and original drafts of publicly disclosed documents, available at the company's Securities Investment Department[9][10][11] Definitions This section defines common terms used in the report, including company names, subsidiaries, regulatory bodies, reporting period, and various medical device-related professional terms, ensuring accurate understanding of the report's content - Clearly defines entity names such as "Sansin Medical," "Company," and "This Company"[13] - Provides detailed explanations of various medical technology terms including blood purification (HD, HF, HDF, HP, PE, PD), PTA, and CRRT[13][14] - Clarifies medical device classifications (Class I, II, III) and quality management and market access standards such as ISO 13485, ISO 9001, CE(MDR), and FDA 510(k)[14][15] Company Profile and Key Financial Indicators This section provides an overview of the company's fundamental information and presents its key accounting data and financial performance metrics Company Profile Jiangxi Sansin Medical Technology Co., Ltd. (stock code: 300453) is listed on the Shenzhen Stock Exchange, with Peng Yixing as its legal representative, and its contact information, registration changes, and information disclosure locations remained unchanged during the reporting period Company Basic Information | Indicator | Content | | :--- | :--- | | Stock Abbreviation | Sansin Medical | | Stock Code | 300453 | | Listing Exchange | Shenzhen Stock Exchange | | Chinese Name | 江西三鑫医疗科技股份有限公司 | | Legal Representative | Peng Yixing | - The company's contact information, registration changes, and information disclosure locations remained unchanged during the reporting period, as detailed in the 2024 annual report[19][20][21] Key Accounting Data and Financial Indicators During the reporting period, the company's operating revenue increased by 10.83% to RMB 761 million, net profit attributable to shareholders rose by 8.35% to RMB 115 million, and net cash flow from operating activities significantly grew by 38.94%, with total assets and net assets attributable to shareholders also showing slight increases Key Accounting Data and Financial Indicators (2025 Semi-Annual vs. Prior Year Period) | Indicator | Current Reporting Period (RMB) | Prior Year Period (RMB) | YoY Change | | :--- | :--- | :--- | :--- | | Operating Revenue | 760,807,967.78 | 686,452,593.92 | 10.83% | | Net Profit Attributable to Shareholders of Listed Company | 115,118,078.10 | 106,247,789.77 | 8.35% | | Net Profit Attributable to Shareholders of Listed Company After Deducting Non-Recurring Gains and Losses | 103,229,980.04 | 94,483,488.59 | 9.26% | | Net Cash Flow from Operating Activities | 189,193,541.41 | 136,165,789.55 | 38.94% | | Basic Earnings Per Share (RMB/share) | 0.2207 | 0.2045 | 7.92% | | Diluted Earnings Per Share (RMB/share) | 0.2204 | 0.2045 | 7.78% | | Weighted Average Return on Net Assets | 8.35% | 8.53% | -0.18% | Key Balance Sheet Indicators (End of Current Reporting Period vs. End of Prior Year) | Indicator | End of Current Reporting Period (RMB) | End of Prior Year (RMB) | Change | | :--- | :--- | :--- | :--- | | Total Assets | 2,245,710,557.75 | 2,222,709,961.44 | 1.03% | | Net Assets Attributable to Shareholders of Listed Company | 1,346,375,965.44 | 1,324,065,860.86 | 1.68% | Non-Recurring Gains and Losses and Amounts During the reporting period, the company's total non-recurring gains and losses amounted to RMB 11.8881 million, primarily from government grants, fair value changes in financial assets, and entrusted investment income Non-Recurring Gains and Losses Items and Amounts | Item | Amount (RMB) | | :--- | :--- | | Gains and Losses from Disposal of Non-Current Assets | -248,634.69 | | Government Grants Included in Current Profit and Loss | 9,050,069.98 | | Gains and Losses from Changes in Fair Value of Financial Assets and Financial Liabilities Held by Non-Financial Enterprises, and from Disposal of Financial Assets and Financial Liabilities, Excluding Effective Hedging Activities Related to the Company's Normal Business Operations | 3,205,585.59 | | Gains and Losses from Entrusted Investment or Asset Management | 2,193,129.98 | | Other Non-Operating Income and Expenses Apart from the Above Items | 103,607.00 | | Less: Income Tax Impact | 2,098,314.22 | | Minority Interest Impact (After Tax) | 317,345.58 | | Total | 11,888,098.06 | Management Discussion and Analysis This section provides a comprehensive analysis of the company's operations, financial performance, and future outlook, covering business activities, industry position, core competencies, and risk management Company's Main Business Activities During the Reporting Period The company primarily operates in medical devices, covering blood purification, drug delivery devices, and cardiothoracic surgery, with blood purification as its core business, accounting for over 80% of revenue, boasting a full industry chain and technological leadership, and actively expanding overseas markets, adding 3 new medical device registration certificates during the period - The company's main business is medical devices, a knowledge-intensive and capital-intensive industry involving polymer materials, medicine, and bioengineering, subject to strict national regulation[30] - Operating revenue from blood purification products accounts for over 80% of the company's total revenue, making it the core business[45] - The company holds 105 medical device registration certificates, with approximately 75% being Class III medical device registration certificates[47] - The company's products have obtained CE (MDD) and CE (MDR) certifications, received US FDA 510(k) market clearance and WHO-PQ pre-qualification, and successfully completed product registrations in countries such as Indonesia, Peru, and Mexico[47] Industry Overview The global medical device market continues to grow, projected to exceed USD 1 trillion by 2033, with consumables outpacing equipment; China's market, though slowing, remains the second largest, impacted by centralized procurement, but policy support for internationalization, innovation, and equipment upgrades presents new opportunities Global Medical Device Market Size and Forecast | Year | Market Size (billion USD) | CAGR (2020-2024) | Forecast (2030) | Forecast (2033) | | :--- | :--- | :--- | :--- | :--- | | 2024 | 6,230 | 8.1% | 8,697 | 10,424 | China Medical Device Market Size and Forecast | Year | Market Size (billion RMB) | CAGR (2020-2024) | YoY Growth (2024) | Forecast (2030) | Forecast (2035) | | :--- | :--- | :--- | :--- | :--- | :--- | | 2024 | 941.7 | 6.6% | -2.23% | 1,326.0 | 1,813.4 | - North America and Europe contribute over 70% of the global medical device market share, with demand primarily driven by technological innovation and product upgrades[33][34] - In 2024, China's total medical device import and export volume reached USD 84.55 billion, a 1.89% year-on-year increase, with exports growing by 7.3%, indicating steady progress in the internationalization of medical device enterprises[37] - The National Healthcare Security Administration continues to promote normalized and institutionalized centralized procurement, with the company's main products winning bids, further expanding its market share[38][39] - The state has introduced multiple policies to encourage the development of innovative medical devices, focusing on key new productive forces such as medical robots, high-end medical imaging equipment, and AI medical devices[40][41] - The state is promoting large-scale equipment renewal and trade-ins for consumer goods, requiring medical equipment investment to grow by over 25% by 2027 compared to 2023, creating development opportunities for domestic high-end and innovative medical equipment[42][43] Company's Industry Position The company is a global medical device R&D, manufacturing, sales, and service provider, particularly leading in blood purification as one of the first domestic enterprises with a full product chain for hemodialysis equipment and consumables, achieving 10.83% revenue growth and 67.30% overseas business growth during the reporting period, with breakthroughs in dialysis membrane localization and innovative product development - The company is a global medical device R&D, manufacturing, sales, and service provider, with existing products covering three major areas: blood purification, drug delivery devices, and cardiothoracic surgery[45] - The company is one of the first key enterprises in the industry to achieve a full product chain for hemodialysis equipment and consumables through independent R&D and establish multiple manufacturing bases nationwide[45] 2025 H1 Operating Performance | Indicator | Amount (million RMB) | YoY Growth | | :--- | :--- | :--- | | Operating Revenue | 76,080.80 | 10.83% | | Overseas Business Revenue | 18,700.17 | 67.30% | - In recent two years, the company has successively obtained the "first certificates" for domestic brands such as dialysis indwelling needles and "wet membrane" dialyzers, breaking the monopoly of imported brands in similar products[45] - The company is collaborating with upstream and downstream partners in the industry chain to overcome the localization technology for medical polysulfone, a key raw material for dialysis membranes, and has independently mastered a series of critical technologies such as dry-jet wet spinning and precise pore size control for hollow fiber hemodialysis membranes[46] Company's Main Business The company's main business encompasses blood purification, drug delivery devices, and cardiothoracic surgery products, with expansion into diabetes treatment, early/mid-stage kidney disease intervention, and vascular intervention, holding 105 medical device registration certificates (75% Class III) and actively pursuing overseas market certifications, adding three new certificates during the reporting period - The company's core business has strategically transformed from traditional infusion and injection to blood purification, and is expanding into vascular intervention and diabetes-related fields[47] New Medical Device Registration Certificates During the Reporting Period | No. | Product Name | Registration Class | Scope of Application | Product Features | | :--- | :--- | :--- | :--- | :--- | | 1 | Hemodialysis Concentrate | Class III | Used for hemodialysis in patients with acute and chronic renal failure | This hemodialysis concentrate is sugar-containing, meeting the personalized needs of hemodialysis patients and improving their dialysis efficacy and quality of life | | 2 | Pre-filled Catheter Flush Syringe | Class III | Suitable for sealing and flushing the distal end of catheter lines during intervals between different drug treatments | A single-use sterile product, featuring a needle-free, pre-filled, and anti-reflux design, enhancing safety and convenience for medical staff while reducing infection risk for patients | | 3 | Mobile Water Purification System for Hemodialysis | Class II | For medical departments to prepare water for hemodialysis, powder concentrate preparation, dialysate preparation, and dialyzer reprocessing | The mobile water purification system for hemodialysis is flexible and portable, breaking the limitations of traditional fixed dialysis scenarios, enhancing the flexibility and accessibility of dialysis treatment, and promoting the implementation of hierarchical diagnosis and treatment | Blood Purification Products Blood purification is the company's core business, covering various treatment modalities; the global and Chinese End-Stage Renal Disease (ESRD) patient population is growing, driven by diabetic nephropathy, fueling steady demand for hemodialysis, with national policies promoting market penetration and domestic substitution, and the company has established a full hemodialysis product chain with innovative product first certificates - Hemodialysis is currently the most widely used blood purification treatment method, suitable for most acute and chronic renal failure patients[49] Global ESRD Patient Population and Forecast | Year | Patient Population (ten thousand cases) | CAGR | | :--- | :--- | :--- | | 2019 | 913.32 | 5.09% (2019-2023) | | 2023 | 1,113.86 | | | 2027 (Forecast) | 1,328.6 | 4.51% (2023-2027) | China ESRD Patient Population and Forecast | Year | Patient Population (ten thousand cases) | CAGR | | :--- | :--- | :--- | | 2019 | 302.53 | 8.07% (2019-2023) | | 2023 | 412.59 | | | 2027 (Forecast) | 527.13 | 6.32% (2023-2027) | - In 2024, diabetic nephropathy patients accounted for 29.5% of new hemodialysis patients in China, ranking first[57] - The National Health Commission requires all counties with a permanent population exceeding 100,000 to provide hemodialysis services, accelerating the penetration of the hemodialysis market into lower-tier regions[64] - China's total hemodialysis medical device market size is steadily growing, projected to reach RMB 51.515 billion by 2030[70] - During the reporting period, the company's sales volume of hemodialysis equipment increased by 84% year-on-year[77] Drug Delivery Devices Business Drug delivery devices, as essential clinical consumables, have a vast market but face intense competition; increasing demand for safety, convenience, and precision drives industry transformation towards high-end products, where the company holds influence, participates in standard setting, and continuously introduces innovative products like pre-filled catheter flush syringes and needle-free injectors - Drug delivery devices are widely used in clinical medical fields such as surgery, anesthesia, and nursing, serving as essential clinical and nursing consumables with rigid demand and a sufficiently large market capacity[82] - Clinical demands for drug delivery devices in terms of safety, convenience, and precision are increasing, prompting enterprises to strengthen independent innovation and gradually transition towards high-end drug delivery device products[82][83] - The company participated in the formulation or revision of multiple national/industry standards for drug delivery device products, including "GB 8368-2018 Single-Use Infusion Sets, Gravity Feed Type"[84] - During the reporting period, the company obtained a new product registration certificate for pre-filled catheter flush syringes, further extending its drug delivery device product line[85] - The company launched a medical needle-free injector, addressing the pain points of long-term, multiple insulin injections for diabetic patients, enabling needle-free, comfortable, and efficient insulin delivery[85] Cardiothoracic Surgery Business In 2023, China's cardiac and major vascular surgery volume significantly increased, with extracorporeal circulation procedures growing by 23.76%; subsidiary Ningbo Filar is an industry leader in cardiac surgery extracorporeal circulation consumables, covering over 400 top-tier hospitals nationwide, holding leading market shares in products like arterial microembolism filters, and actively participating in industry standard setting 2023 China Cardiac Surgery and Extracorporeal Circulation Data | Indicator | 2023 Annual | YoY Growth (vs 2022) | | :--- | :--- | :--- | | Number of Hospitals Performing Surgery | 771 hospitals | | | Total Surgery Volume | 341,800 cases | 29.8% | | Extracorporeal Circulation Surgery Volume | 197,900 cases | 23.76% | | Extracorporeal Circulation Consumables Market Size | Approximately 0.25 billion RMB | | - Subsidiary Ningbo Filar primarily engages in the R&D, production, and sales of cardiac surgery extracorporeal circulation consumables, with products covering over 400 top-tier hospitals nationwide that perform cardiac surgery with extracorporeal circulation[93] - Ningbo Filar's arterial microembolism filter products hold over 50% of the domestic market share, while other products like disposable cardiopulmonary bypass tubing packs account for over 30% of the domestic market, establishing its leading position in the cardiac surgery extracorporeal circulation consumables sector[94] - Ningbo Filar, as a member of the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment, has led and participated in the formulation/revision of 7 industry standards[94] Diabetes Treatment Devices, Early and Mid-Stage Kidney Disease Intervention and Treatment Devices, Vascular Intervention Devices The company is committed to comprehensive kidney disease treatment, expanding into diabetes treatment, early/mid-stage kidney disease intervention, and vascular intervention devices; China's large diabetic population drives demand for needle-free insulin injectors, while subsidiary Jiangxi Shengdankang offers colon dialysis for early kidney disease, and the vascular intervention business focuses on dialysis fistula protection, with PTA high-pressure balloon catheters selected for centralized procurement - Building on its deep expertise in end-stage renal disease treatment devices, the company is further extending into the entire kidney disease treatment process, gradually achieving an integrated strategic layout covering "primary kidney disease (diabetes) - early and mid-stage kidney disease - end-stage renal disease"[98] - In 2024, the total number of adult diabetic patients (20-79 years old) in China was approximately 148 million, projected to reach 168 million by 2050, creating immense demand for blood glucose management[99] - The company has developed and launched a medical needle-free injector to address the pain points of diabetic patients using metal needle injection devices, such as needle breakage, puncture infections, and local skin changes[100] - Subsidiary Jiangxi Shengdankang is dedicated to providing early chronic kidney disease management solutions, having obtained registration certificates for disposable sterile rectal catheters and colonic hydrotherapy machines, which, when used together, can achieve high colon cleansing and delay the progression of chronic kidney disease[102][103] - China's peripheral vascular intervention device market is in its early stages of development, with the peripheral arterial interventional stent and balloon market projected to grow to RMB 6.8 billion by 2030, indicating vast potential for domestic substitution[105][106] - The company has obtained multiple registration certificates for products such as PTA high-pressure balloon dilatation catheters, vascular sheath sets, and disposable balloon inflation devices, with PTA high-pressure balloon dilatation catheters selected for inter-provincial alliance centralized procurement projects for peripheral vascular interventional access[109] Key Operating Models The company employs an IPD R&D model driven by clinical needs, combining independent and collaborative research; procurement is production-driven, mixing centralized and decentralized approaches; production is sales-driven batch manufacturing; and sales primarily rely on distribution channels, supplemented by direct sales to foster innovation and meet specific clinical demands - R&D Model: Adopts Integrated Product Development (IPD), guided by clinical needs, combining independent R&D with external collaborative R&D[114] - Procurement Model: Production-driven procurement, combining centralized procurement of raw and auxiliary materials with scattered procurement of low-value consumables[115] - Production Model: Implements a sales-driven, batch production approach, with production plans formulated based on sales forecasts and customer demand[116] - Sales Model: Adopts a combined distribution and direct sales model, primarily distribution-based with direct sales as a supplement, to rapidly expand business and promote product R&D innovation[117][118][119] Key Performance Drivers The company's performance is driven by favorable national policies supporting medical device innovation and globalization, the vast growth potential of domestic and international hemodialysis industries due to increasing patient numbers and market penetration, and strong technological innovation capabilities, including continuous R&D investment, product matrix expansion, and new registrations - Industry policies remain favorable, with the state continuously introducing multiple policies to encourage the development and innovation of the medical device industry, and supporting medical device enterprises in expanding into international markets[120] - The domestic and international hemodialysis industry has significant growth potential, with a continuous increase in ESRD patients in China, accelerated penetration of hemodialysis into county-level markets, improved dialysis treatment rates, and broad prospects for domestic hemodialysis equipment and consumables in overseas markets[121] - The company is deeply implementing an innovation-driven development strategy, focusing on its main business, aiming to improve its product portfolio for various blood purification treatment modalities, promoting iterative upgrades of hemodialysis products, and strategically expanding into diabetes, early and mid-stage kidney disease, and vascular intervention fields from a full kidney disease management perspective[122][123] Overview of Company's Operating Results During the reporting period, the company's operating revenue reached RMB 761 million, a 10.83% increase, with net profit attributable to shareholders at RMB 115 million, up 8.35%; blood purification products generated RMB 626 million, growing 19.73% and accounting for 82.23% of total revenue, driven by significant overseas business growth, while drug delivery devices revenue decreased by 15.06% and cardiothoracic surgery revenue slightly increased by 0.74%; the company enhanced competitiveness through multi-country market access, optimized R&D and production layouts, intelligent operations, and a shared technology ecosystem, holding 105 medical device registration certificates with 3 new additions 2025 Semi-Annual Operating Performance | Indicator | Amount (million RMB) | YoY Growth | | :--- | :--- | :--- | | Operating Revenue | 76,080.80 | 10.83% | | Net Profit Attributable to Shareholders of Listed Company | 11,511.81 | 8.35% | | Net Profit Attributable to Shareholders of Listed Company After Deducting Non-Recurring Gains and Losses | 10,323.00 | 9.26% | Revenue Contribution by Business Segment | Business Segment | Operating Revenue (million RMB) | YoY Growth | Proportion of Total Revenue | | :--- | :--- | :--- | :--- | | Blood Purification | 62,559.16 | 19.73% | 82.23% | | Drug Delivery Devices | 8,240.98 | -15.06% | 10.83% | | Cardiothoracic Surgery | 3,498.03 | 0.74% | 4.60% | | Other | 1,782.63 | | 2.34% | - Overseas business achieved operating revenue of RMB 187.0017 million, a year-on-year increase of 67.30%, becoming a significant driver of the company's performance growth[126] - The company optimized its national R&D and production base layout, with both the Sichuan production base and Jiangxi R&D and production base successfully passing acceptance and obtaining production licenses, further expanding the production capacity for hemodialysis series products[127][128] - The company is building an intelligent operating system, deepening the application of 5G technology, creating digital application scenarios across the R&D, production, management, and distribution value chain, and launching an AI empowerment project[129] - The company, as the lead unit, established the Jiangxi Provincial High-Performance Medical Device Industry Science and Technology Innovation Consortium, promoting collaborative innovation among government, industry, academia, research, and medicine[130] Changes in Medical Device Registration Certificate Numbers During the Reporting Period | Certificate Holder | Number of Medical Device Registration Certificates at End of Current Reporting Period | Number of New Medical Device Registration Certificates During the Reporting Period | | :--- | :--- | :--- | | Sansin Medical | 70 | 2 | | Chengdu Weilison | 4 | 1 | | Total | 105 | 3 | Analysis of Core Competencies The company's core competencies include providing comprehensive blood purification solutions, leading R&D and engineering capabilities, advanced manufacturing and strict quality systems, a robust market sales network, and strong brand advantages, having achieved large-scale production of domestic hemodialysis equipment with several technologies reaching international advanced levels, while continuously strengthening competitive advantages through digital transformation and global expansion - The company is a leading enterprise in China that first completed the full product chain layout for hemodialysis equipment and consumables, capable of providing one-stop services from equipment to consumables, and was the first to achieve large-scale production of hemodialyzers and hollow fiber hemodialysis membranes using domestic equipment[138] - The company possesses R&D platforms such as the Jiangxi Provincial Blood Purification Equipment Engineering Research Center and a provincial academician workstation, participates in the formulation of multiple national and industry standards, and has been recognized as a "National Intellectual Property Advantage Enterprise"[139] - The company independently masters precise pore size control technology for hollow fiber hemodialysis membranes, demonstrating excellent performance in partial molecule clearance rate and low porogen residue, recognized by experts as reaching international advanced levels[141] - Through a lean management system and deep application of automation and digitalization, the company possesses the ability to quickly replicate existing production models and efficiently expand capacity, with its dialyzer assembly line recognized as an "Excellent Smart Manufacturing Scenario" by the Ministry of Industry and Information Technology[143] - The company's products and services are exported to over 110 countries and regions, deepening its global business layout through initiatives such as establishing a Hong Kong subsidiary, forming a worldwide marketing and service network[145] - The brand influence of the company's trademarks such as "Sansin" and "Yixin" is growing, with multiple products selected as "Jiangxi Fine Products" and listed on the "2025 China Brand Value Evaluation Information"榜单[147] Main Business Analysis During the reporting period, the company's operating revenue increased by 10.83%, with operating costs up 11.04%; sales expenses decreased by 13.89%, management expenses rose by 24.70%, and financial expenses significantly increased by 140.69% due to reduced interest income; net cash flow from operating activities grew by 38.94%; blood purification business revenue increased by 19.73% with a 0.41% rise in gross margin, while drug delivery devices revenue decreased by 15.06% with a 5.11% drop in gross margin; overseas business revenue surged by 67.30% with a 4.31% increase in gross margin Year-on-Year Changes in Key Financial Data | Item | Current Reporting Period (RMB) | Prior Year Period (RMB) | YoY Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Operating Revenue | 760,807,967.78 | 686,452,593.92 | 10.83% | | | Operating Cost | 494,731,989.90 | 445,557,916.04 | 11.04% | | | Selling Expenses | 37,032,161.29 | 43,005,654.40 | -13.89% | | | Administrative Expenses | 57,583,518.20 | 46,176,422.84 | 24.70% | | | Financial Expenses | 188,826.65 | -464,007.15 | 140.69% | Primarily due to decreased interest income during the reporting period | | Net Cash Flow from Operating Activities | 189,193,541.41 | 136,165,789.55 | 38.94% | Primarily due to increased sales revenue and higher sales collections compared to the prior year period | | Investment Income (Losses indicated by "-") | 670,776.86 | -159,917.33 | 519.45% | Primarily due to increased wealth management income during the reporting period | | Gains from Changes in Fair Value (Losses indicated by "-") | 3,205,585.59 | 5,277,284.63 | -39.26% | Primarily due to decreased fair value changes in financial assets held for trading during the reporting period | Products or Services Accounting for Over 10% | By Product or Service | Operating Revenue (RMB) | Operating Cost (RMB) | Gross Margin | YoY Change in Operating Revenue | YoY Change in Operating Cost | YoY Change in Gross Margin | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Medical Device Industry | 759,129,622.81 | 494,431,791.82 | 34.87% | 10.91% | 11.17% | -0.15% | | Blood Purification | 625,591,593.52 | 411,007,718.32 | 34.30% | 19.73% | 18.98% | 0.41% | | Drug Delivery Devices | 82,409,828.82 | 60,036,461.59 | 27.15% | -15.06% | -8.66% | -5.11% | | Domestic | 573,806,283.53 | 374,767,206.04 | 34.69% | -0.15% | 1.55% | -1.09% | | International | 187,001,684.25 | 119,964,783.86 | 35.85% | 67.30% | 56.78% | 4.31% | Analysis of Assets and Liabilities At the end of the reporting period, the company's total assets were RMB 2.246 billion, a 1.03% increase from the prior year-end; financial assets held for trading significantly grew by 3.89% due to increased wealth management product purchases; construction in progress increased by 1.67%, and right-of-use assets by 0.18% due to increased property leases; development expenditures decreased by 0.29% as new products obtained certificates and were transferred to intangible assets; long-term borrowings and notes payable both increased Significant Changes in Asset Composition | Item | Proportion of Total Assets at End of Current Reporting Period | Change in Proportion | Explanation of Significant Change | | :--- | :--- | :--- | :--- | | Monetary Capital | 9.60% | -3.44% | | | Accounts Receivable | 3.70% | -0.05% | | | Inventories | 8.75% | -0.05% | | | Long-Term Equity Investments | 0.89% | -0.08% | | | Fixed Assets | 43.74% | 0.66% | | | Construction in Progress | 7.48% | 1.67% | | | Right-of-Use Assets | 0.25% | 0.18% | Primarily due to increased property leases during the reporting period | | Short-Term Borrowings | 2.23% | 0.43% | | | Contract Liabilities | 2.04% | -0.33% | | | Long-Term Borrowings | 8.29% | 1.24% | | | Lease Liabilities | 0.22% | 0.16% | | | Development Expenditures | 0.18% | -0.29% | Primarily due to new products obtaining certificates and being transferred to intangible assets during the reporting period | | Financial Assets Held for Trading | 11.92% | 3.89% | Primarily due to increased purchases of wealth management products during the reporting period | | Deferred Income | 3.55% | 0.27% | | | Non-Current Assets Due Within One Year | 0.00% | -2.39% | Primarily due to redemption of debt investments due within one year during the reporting period | | Taxes Payable | 0.74% | -0.25% | | Financial Assets Measured at Fair Value | Item | Beginning Balance (RMB) | Fair Value Change Gains/Losses for Current Period (RMB) | Amount Purchased in Current Period (RMB) | Amount Sold in Current Period (RMB) | Ending Balance (RMB) | | :--- | :--- | :--- | :--- | :--- | :--- | | Financial Assets Held for Trading (Excluding Derivative Financial Assets) | 178,481,242.87 | 3,200,442.32 | 409,000,000.00 | 323,007,000.00 | 267,674,685.19 | | Other Non-Current Financial Assets | 9,827,569.45 | -57,133.27 | | | 9,770,436.18 | | Subtotal of Financial Assets | 188,308,812.32 | 3,143,309.05 | 409,000,000.00 | 323,007,000.00 | 277,445,121.37 | Asset Restriction Status (End of Period) | Item | Book Balance (RMB) | Book Value (RMB) | Restriction Status | | :--- | :--- | :--- | :--- | | Monetary Capital | 6,127,538.76 | 6,127,538.76 | Deposit | | Intangible Assets | 16,174,341.19 | 15,550,919.11 | Land Use Right Mortgage Loan | | Total | 22,301,879.95 | 21,678,457.87 | | Analysis of Investment Status During the reporting period, the company's investment amounted to RMB 5.8 million, a 25.16% year-on-year decrease; total entrusted wealth management transactions were RMB 361 million, with an outstanding balance of RMB 264 million at period-end, primarily bank and brokerage wealth management products, with no overdue unrecovered amounts; the company had no significant equity investments, non-equity investments, derivative investments, or entrusted loans during the reporting period Investment Amount During the Reporting Period | Indicator | Amount (RMB) | YoY Change | | :--- | :--- | :--- | | Investment Amount During the Reporting Period | 5,800,000.00 | -25.16% | Overview of Entrusted Wealth Management | Specific Type | Entrusted Wealth Management Transaction Amount (million RMB) | Outstanding Balance (million RMB) | | :--- | :--- | :--- | | Bank Wealth Management Products | 7,100 | 1,300 | | Brokerage Wealth Management Products | 29,000 | 25,099.3 | | Total | 36,100 | 26,399.3 | - The company had no significant equity investments, non-equity investments, derivative investments, or entrusted loans during the reporting period[157][159][162][163] Analysis of Major Holding and Associate Companies The company's main holding subsidiaries include Yunnan Sansin Medical Technology, Ningbo Filar Medical Products, Chengdu Weilison Biotechnology, and Sichuan Weilison Medical Technology; among these, Chengdu Weilison and Ningbo Filar significantly impacted the company's net profit, achieving RMB 13.8604 million and RMB 11.6070 million in net profit, respectively; there were no acquisitions or disposals of subsidiaries during the reporting period Operating Performance of Major Subsidiaries | Company Name | Net Assets (RMB) | Operating Revenue (RMB) | Net Profit (RMB) | | :--- | :--- | :--- | :--- | | Yunnan Sansin Medical Technology Co., Ltd. | 185,958,263.90 | 50,325,547.18 | 1,759,137.09 | | Ningbo Filar Medical Products Co., Ltd. | 77,809,633.15 | 35,041,848.03 | 11,606,985.86 | | Chengdu Weilison Biotechnology Co., Ltd. | 96,967,309.67 | 80,553,157.92 | 13,860,350.50 | | Sichuan Weilison Medical Technology Co., Ltd. | 243,116,380.05 | 76,503,319.73 | 5,020,730.30 | - There were no acquisitions or disposals of subsidiaries during the reporting period[166] Risks Faced by the Company and Countermeasures The company faces risks from regulatory policy changes, quality control, market competition, product R&D, and overseas sales; to mitigate these, it will closely monitor policy shifts, strengthen quality management, use precise pricing and diversified product portfolios to navigate centralized procurement, increase R&D investment to maintain technological leadership, and reduce overseas sales risks through assessments and insurance - Regulatory Policy Change Risk: The medical device industry is highly regulated by the state, and policy changes may affect the competitive landscape. Countermeasures include strict adherence to regulations, close monitoring of policy changes, flexible adjustment of operating strategies, and increased R&D investment[167] - Quality Control Risk: The company's main products are Class III medical devices, whose safety and effectiveness are critical to human health and life. Countermeasures include continuously and effectively implementing quality management control systems and measures, strengthening daily quality management, and providing safe, effective, and quality-controlled products to the market[167][168] - Market Competition Risk: The domestic blood purification market is highly competitive, with pressure from centralized procurement price reductions. Countermeasures include expanding market share through precise pricing strategies, building a complete end-stage renal disease blood purification product system, and further focusing on the entire kidney disease treatment process[168][169] - Product R&D Risk: The company's main business products undergo rapid iterative innovation, posing a risk of misjudging technological directions. Countermeasures include prioritizing R&D system construction, strengthening forward-looking strategic planning, increasing investment in new product R&D aligned with market demand, and accelerating technological upgrades and optimization of existing products[169] - Overseas Market Sales Risk: Overseas markets may experience changes in exchange rate policies, economic policies, trade policies, or even government stability in export countries, leading to potential sales risks. Countermeasures include formulating risk assessment strategies for overseas customers, adopting more secure sales models such as payment in advance and letters of credit, and implementing multiple measures, including purchasing China Export & Credit Insurance, to reduce overseas market sales collection (settlement) risks[170] Record of Investor Relations Activities During the Reporting Period During the reporting period, the company engaged with numerous institutional and online investors, including Huachuang Securities, Southwest Securities, Guojin Securities, and China Asset Management, through conference calls, on-site visits, and online inquiries, discussing its main business, product planning, financial status, capacity expansion, internationalization plans, centralized procurement impact, raw material R&D, diabetes business, vascular intervention products, and future outlook - The company communicates with investors through various methods, including conference calls, on-site investigations, and online inquiries[172][173] - The research content covers the company's main business, future plans for wet membrane dialyzer products, reasons for the year-on-year increase in gross margin and decrease in net profit margin in 2024, the company's capacity expansion plans, internationalization plans, competitive landscape of hemodialyzer and hemodialysis equipment products, R&D progress of polysulfone (PES) raw materials, and the company's future development outlook[172][173] - Guests included institutional investors such as Huachuang Securities, Southwest Securities, Cinda Securities, Soochow Securities, Huian Securities, Guosheng Securities, CITIC Asset Management, Jinhong Fund, Orient Securities, Fangwu Fund, GF Fund, Yingke Consulting, Zhongtian Guofu, AVIC Trust, Huian Fund, Harvest Fund, Guoxin Securities, Southern Asset Management, Red Chip Investment, Huajin Securities, Xiangju Capital, Kaisi Fund, Zhicheng Haiwei, E Fund Global, Hengbang Zhaofeng, Zundao Asset, BOC International, China Life, Yuelan Private Equity, China Post Securities, Guorong Proprietary, Qingli Investment, Xihong Private Equity, Willing Capital Management, Haitong Securities, Hehe Qingchuan, Dacheng Fund, China Asset Management, China Asset Management Jiuying, Tianhong Asset Management, Huashang Fund, Yinhua Fund, and online inquiring investors[172][173] Implementation of Market Value Management System and Valuation Enhancement Plan The company has established a "Market Value Management System," revised and approved by the Board of Directors on August 7, 2025, which outlines market value management organizations, responsibilities, methods, and content, but no valuation enhancement plan has been disclosed - The company has formulated the "Market Value Management System," which was revised and approved at the 21st meeting of the Fifth Board of Directors on August 7, 2025[174] - The market value management system primarily includes the market value management organization and responsibilities, as well as the methods and content of market value management[174] - The company has not disclosed a valuation enhancement plan[175] Corporate Governance, Environment, and Society This section details the company's commitment to robust corporate governance, environmental stewardship, and social responsibility initiatives, including profit distribution, employee incentives, and community engagement Profit Distribution and Capital Reserve Conversion to Share Capital During the Reporting Period The company's proposed 2025 semi-annual profit distribution plan is to distribute a cash dividend of RMB 1 (tax inclusive) per 10 shares to all shareholders, based on 522,237,525 shares, with no bonus shares or capital reserve conversion to share capital, totaling RMB 52,223,752.50 in cash dividends, representing 100% of distributable profits, pending shareholder approval 2025 Semi-Annual Profit Distribution Plan | Indicator | Content | | :--- | :--- | | Bonus Shares per 10 shares | 0 shares | | Dividend per 10 shares (tax inclusive) | 1 RMB | | Share Capital Base for Distribution Plan | 522,237,525 shares | | Cash Dividend Amount (tax inclusive) | 52,223,752.50 RMB | | Proportion of Total Cash Dividend (including other methods) to Total Profit Distribution | 100.00% | | Distributable Profit | 572,151,795.37 RMB | - This profit distribution plan needs to be submitted to the company's first extraordinary general meeting of shareholders in 2025 for review and approval[179] Implementation of Equity Incentive Plans, Employee Stock Ownership Plans, or Other Employee Incentive Measures On August 30, 2024, the company completed the registration of the first tranche of restricted shares under its 2024 Restricted Stock Incentive Plan, granting 8.13565 million shares to 116 incentive recipients at an exercise price of RMB 3.50 per share, with no employee stock ownership plans or other employee incentive measures during the reporting period - The company completed the grant registration of the first tranche of restricted shares under its 2024 Restricted Stock Incentive Plan on August 30, 2024[181] Equity Incentive Grant Status | Indicator | Content | | :--- | :--- | | Grant Date | August 30, 2024 | | Grant Price | 3.50 RMB/share | | Number of Incentive Recipients | 116 persons | | Number of Shares Granted | 8.13565 million shares | - There were no employee stock ownership plans or other employee incentive measures in the company during the reporting period[182] Social Responsibility Upholding its mission "to contribute to the advancement of health," the company actively fulfills social responsibilities through standardized governance, investor relations, product services, customer management, employee development, and social welfare, establishing a sound corporate governance structure, enhancing product quality through innovation, prioritizing customer satisfaction, fostering employee growth, and engaging in public welfare initiatives to support rural revitalization - The company has established a corporate governance structure comprising the General Meeting of Shareholders, Board of Directors, Supervisory Board, and management, strictly adhering to laws and regulations, with no major litigation cases involving corruption or unfair competition[183] - The company actively and proactively engages in communication and exchange through various channels, including online performance briefings, investor hotlines, email, investor relations interactive platforms, and on-site investor visits, ensuring shareholders' rights to information and participation[184] - The company accelerates the cultivation and development of new productive forces and enhances industrial core competitiveness through Integrated Product Development (IPD) model, Product Lifecycle Management (PLM) tools, etc., and its independently developed disposable hemodialyzer (wet membrane, high-flux/low-flux series) products have obtained medical device registration certificates, making it the first domestic brand to hold such a certificate for this product[185] - The company has established a strict quality management system, passing ISO9001, ISO 13485, and EN ISO 13485 quality management system certifications; some products have successively obtained CE (MDD) and CE (MDR) certifications, and received US FDA 510(k) market clearance and World Health Organization (WHO) procurement qualifications[185] - The company adheres to a "people-oriented" talent development philosophy, implementing a compensation incentive mechanism combining performance appraisal and equity incentives, organizing various employee activities, and establishing an enterprise care fund to enhance employee sense of belonging and cohesion[187] - The company actively supported the successful hosting of the "2025 Nanchang Xianghu Half Marathon" as a "Strategic Event Partner" and contributed to social welfare and rural revitalization through various dimensions, including public education, care for kidney disease patients, assistance for vulnerable social groups, and rural donations[188][189] Significant Matters This section outlines important events and contractual obligations that significantly impact the company's operations and financial standing Litigation Matters During the reporting period, the company had no significant litigation or arbitration matters; two other pending litigation cases include a subsidiary's equipment procurement contract dispute, which has entered the enforcement stage with partial payments received, and another contract dispute awaiting trial; four concluded cases had no significant impact - The company had no significant litigation or arbitration matters during the current reporting period[196] Other Litigation Matters (Pending Cases) | Case Type | Amount Involved (million RMB) | Progress | Outcome and Impact | | :--- | :--- | :--- | :--- | | Subsidiary Yunnan Sansin Equipment Procurement Contract Dispute | 1.2868 | The court ruled that the other party should refund the paid goods, overdue delivery penalties, and case acceptance fees of 0.3009 million RMB, and it is currently in the enforcement stage | Subsidiary Yunnan Sansin's equipment procurement contract dispute case has received partial payments | | Contract Dispute Case | (Undisclosed) | The company has submitted litigation materials and pre-litigation preservation, awaiting trial | The contract dispute case is awaiting trial | - A total of 4 concluded cases were summarized, involving an amount of RMB 0.202 million, all of which have been closed with no significant impact[196] Significant Contracts and Their Performance During the reporting period, the company had no significant entrustment, contracting, leasing, major guarantees, or other significant contracts, and daily operating significant contracts were not subject to disclosure requirements - The company had no entrustment situations during the reporting period[205] - The company had no contracting situations during the reporting period[206] - The company had no leasing situations during the reporting period[207] - The company had no significant guarantee situations during the reporting period[208] - The company had no other significant contracts during the reporting period[211] Share Changes and Shareholder Information This section details any changes in the company's share capital and provides an overview of its shareholder structure and major shareholdings Share Fluctuation During the reporting period, the company's total share capital remained unchanged at 522,397,525 shares, with the proportion of restricted and unrestricted shares also constant; restricted shares primarily consist of those held by directors, supervisors, senior management, and their associates, as well as equity incentive restricted shares Share Fluctuation | Share Class | Number Before Change (shares) | Proportion Before Change | Increase/Decrease in Current Change (shares) | Number After Change (shares) | Proportion After Change | | :--- | :--- | :--- | :--- | :--- | :--- | | Restricted Shares | 165,183,790.00 | 31.62% | 0.00 | 165,183,790.00 | 31.62% | | Unrestricted Shares | 357,213,735.00 | 68.38% | 0.00 | 357,213,735.00 | 68.38% | | Total Shares | 522,397,525.00 | 100.00% | 0.00 | 522,397,525.00 | 100.00% | - The company's total share capital remained unchanged during the reporting period[215] - Restricted shares primarily consist of those locked by directors, supervisors, and senior management and their associates, as well as equity incentive restricted shares, with 75% locked annually during their tenure[217] Number of Shareholders and Shareholding Structure At the end of the reporting period, the total number of common shareholders was 18,251; among the top ten shareholders, Peng Yixing held 24.68% as the largest shareholder, forming a concerted action group with his wife Lei Fenglian, Peng Haibo, and Peng Jiulian; Foresea Life Insurance Co., Ltd. - Dividend Insurance Product Huatai Portfolio was the fifth largest shareholder Total Number of Common Shareholders at End of Reporting Period | Indicator | Number | | :--- | :--- | | Total Number of Common Shareholders at End of Reporting Period | 18,251 | Shareholding of Shareholders Holding 5% or More or Top 10 Shareholders | Shareholder Name | Shareholder Nature | Shareholding Proportion | Number of Shares Held at End of Reporting Period (shares) | Number of Restricted Shares Held (shares) | Number of Unrestricted Shares Held (shares) | | :--- | :--- | :--- | :--- | :--- | :--- | | Peng Yixing | Domestic Natural Person | 24.68% | 128,926,044 | 96,694,533 | 32,231,511 | | Lei Fenglian | Domestic Natural Person | 5.19% | 27,120,496 | 20,340,372 | 6,780,124 | | Peng Haibo | Domestic Natural Person | 4.75% | 24,828,700 | 18,621,525 | 6,207,175 | | Wan Xiaoping | Domestic Natural Person | 3.20% | 16,709,766 | 150,000 | 16,559,766 | | Foresea Life Insurance Co., Ltd. - Dividend Insurance Product Huatai Portfolio | Other | 2.05% | 10,694,660 | 0 | 10,694,660 | - Peng Yixing and Lei Fenglian, as the controlling shareholders and actual controllers of the company, along with Peng Haibo (son of Peng Yixing and Lei Fenglian) and Peng Jiulian (sister of Peng Yixing), constitute a concerted action group[220] Bond-Related Information The company had no bond-related information during the reporting period - The company had no bond-related information during the reporting period[226] Financial Report This section presents the company's comprehensive financial statements, including balance sheets, income statements, cash flow statements, and statements of changes in owners' equity, along with detailed notes on accounting policies and specific financial items Audit Report The company's semi-annual financial report was unaudited - The company's semi-annual financial report was unaudited[228] Financial Statements This section presents the company's 2025 semi-annual consolidated and parent company balance sheets, income statements, and cash flow statements, along with consolidated and parent company statements of changes in owners' equity, comprehensively reflecting the company's financial position, operating results, and cash flows at the end of the reporting period - Includes consolidated balance sheet, parent company balance sheet, consolidated income statement, parent company income statement, consolidated cash flow statement, and parent company cash flow statement[229][233][235][237][239][241] - Includes consolidated statement of changes in owners' equity and parent company statement of changes in owners' equity[244][253] Company Basic Information Jiangxi Sansin Medical Technology Co., Ltd., established on March 7, 1997, converted to a joint-stock company in 2010, and listed on the Shenzhen Stock Exchange ChiNext in May 2015, had a registered capital of RMB 522,397,525.00 as of June 30, 2025, with its registered office and headquarters in Nanchang County, Jiangxi Province, primarily engaged in medical device manufacturing, offering blood purification, drug delivery devices, and cardiothoracic surgery products, with financial statements approved by the Board of Directors on August 7, 2025 - Jiangxi Sansin Medical Technology Co., Ltd., formerly Jiangxi Sansin Medical Device Group Co., Ltd., was established on March 7, 1997[262] - The company was listed on the ChiNext board of the Shenzhen Stock Exchange on May 15, 2015[262] Company Registration Information | Indicator | Content | | :--- | :--- | | Registered Capital (as of June 30, 2025) | 522,397,525.00 RMB | | Unified Social Credit Code | 91360100613026983X | | Legal Representative | Peng Yixing | - The company's registered office and headquarters address: No. 999 Fushan Avenue, Xiaolan Economic Development Zone, Nanchang County, Jiangxi Province[263] - The company operates in the medical device manufacturing industry; its main products include blood purification, drug delivery devices, cardiothoracic surgery, and other medical consumables series products[264] - These financial statements were approved for issuance by the 21st meeting of the Fifth Board of Directors on August 7, 2025[265] Basis of Financial Statement Preparation The company's financial statements are prepared on a going concern basis, in accordance with the "Accounting Standards for Business Enterprises" issued by the Ministry of Finance and significant accounting policies and estimates, affirming the company's ability to continue operations for at least 12 months without major issues affecting its going concern status - The company's financial statements are prepared on a going concern basis, according to actual transactions and events, and based on the "Accounting Standards for Business Enterprises - Basic Standards" and specific accounting standards issued by the Ministry of Finance, as well as significant accounting policies and estimates[266] - The company has the ability to continue as a going concern for at least 12 months from the end of the reporting period, with no significant matters affecting its going concern ability[267] Significant Accounting Policies and Estimates This section details the company's significant accounting policies and estimates for financial statement preparation, including compliance with accounting standards, accounting period, operating cycle, functional currency, materiality criteria, business combinations, consolidated financial statements, joint arrangements, cash and cash equivalents, foreign currency translation, financial instrument classification and measurement, expected credit losses, contract assets, inventories, long-term equity investments, fixed assets, construction in progress, borrowing costs, intangible assets, long-term deferred expenses, contract liabilities, employee compensation, share-based payments, revenue recognition, contract costs, government grants, deferred income tax assets/liabilities, and leases, with no changes in significant accounting policies or estimates during the reporting period - The financial statements prepared by the company comply with the requirements of the "Accounting Standards for Business Enterprises," truly and completely reflecting the company's financial position as of June 30, 2025, operating results for January-June 2025, and related cash flow information[269] - The company's accounting year is the calendar year, from January 1 to December 31 annually; a 12-month period is considered the normal operating cycle; and the functional currency is RMB[270][271][272] Materiality Criteria Determination Methods and Selection Basis (Partial) | Item | Materiality Standard | | :--- | :--- | | Significant Accounts Receivable for Which Individual Impairment Provisions are Made | Over 1% of the corresponding accounts receivable amount, and exceeding RMB 2 million | | Significant Financial Assets Held for Trading | Over 10% of financial assets held for trading, and exceeding RMB 10 million | | Significant Construction in Progress Projects | Investment budget amount exceeding 10% of existing fixed asset scale, and period-end balance exceeding 10% | - The company classifies financial assets into three categories: measured at amortized cost, measured at fair value with changes recognized in other comprehensive income, and measured at fair value with changes recognized in current profit or loss[289][290] - The company adopts a simplified approach for accounts receivable and lease receivables, consistently measuring loss provisions based on expected credit losses over their entire lifetime[300] - Capitalization point for R&D expenditures: For R&D projects requiring clinical trials, the capitalization point is when the hospital ethics committee approves and the ethics approval document is obtained; for R&D projects not requiring clinical trials, the capitalization point is when the third-party testing agency certifies compliance and the "Testing Report" is obtained[331] - The company had no changes in significant accounting policies or estimates during the current reporting period[366] Taxation The