安旭生物(688075) - 2025 Q2 - 季度财报

Definitions This section provides essential definitions of company, industry, and technical terms to ensure clarity throughout the report Definitions of Common Terms This section defines key company, industry, and technical terms, including IVD, POCT, and various certifications, to facilitate report comprehension - The report defines the company and its main subsidiary names, such as AssureTech Bio, AssureTech Holdings, and Xuke Bio[10] - Core industry terms like In Vitro Diagnostics (IVD) and Point-of-Care Testing (POCT) are thoroughly explained[10] - Multiple international certifications (FDA, CE, TGA) and key technologies (colloidal gold, fluorescence immunoassay, immunochromatography, chemiluminescence immunoassay) are listed and defined[10][11][12] Company Profile and Key Financial Indicators This section provides an overview of the company's fundamental information and presents key accounting data and financial performance indicators Company Basic Information This section outlines the company's registration details, contact information, disclosure channels, and stock profile, confirming its A-share listing on the STAR Market - The company's Chinese name is Hangzhou AssureTech Bio-tech Co., Ltd., abbreviated as AssureTech Bio, with the English name AssureTech(Hangzhou)Co.,Ltd.[14] - The company's legal representative is Ling Shisheng, with its registered and office address at Building 4, No. 1418-50 Moganshan Road, Hangzhou, Zhejiang Province[14] - The company's stock is A-shares, listed on the Shanghai Stock Exchange STAR Market, with stock code 688075[17] Company's Key Accounting Data and Financial Indicators During the reporting period, revenue decreased by 7.42%, and net profit attributable to shareholders fell by 48.57% due to exchange losses and reduced government subsidies, while non-recurring net profit grew by 24.85% and operating cash flow surged by 1420.52% from improved receivables turnover 2025 Semi-Annual Key Accounting Data | Indicator | Current Period (Jan-Jun) (Yuan) | Prior Period (Yuan) | Period-over-Period Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 229,747,240.90 | 248,156,721.31 | -7.42 | | Total Profit | 61,490,861.08 | 123,965,886.15 | -50.40 | | Net Profit Attributable to Shareholders of Listed Company | 59,305,890.78 | 115,319,011.32 | -48.57 | | Net Profit Attributable to Shareholders of Listed Company (Excluding Non-Recurring Items) | 23,586,168.33 | 18,892,096.80 | 24.85 | | Net Cash Flow from Operating Activities | 3,518,551.53 | 231,404.91 | 1,420.52 | | Net Assets Attributable to Shareholders of Listed Company (Period-End) | 5,159,096,687.90 | 5,203,599,188.59 | -0.86 | | Total Assets (Period-End) | 5,786,870,938.25 | 5,769,310,895.27 | 0.30 | 2025 Semi-Annual Key Financial Indicators | Indicator | Current Period (Jan-Jun) (Yuan/share) | Prior Period (Yuan/share) | Period-over-Period Change (%) | | :--- | :--- | :--- | :--- | | Basic Earnings Per Share (Yuan/share) | 0.47 | 0.91 | -48.57 | | Diluted Earnings Per Share (Yuan/share) | 0.47 | 0.91 | -48.57 | | Basic EPS Excluding Non-Recurring Items (Yuan/share) | 0.19 | 0.15 | 26.67 | | Weighted Average Return on Net Assets (%) | 1.13 | 2.23 | -1.10 | | Weighted Average Return on Net Assets Excluding Non-Recurring Items (%) | 0.45 | 0.37 | 0.08 | | R&D Investment as % of Operating Revenue (%) | 20.64 | 20.02 | 0.62 | - The decline in total profit and net profit attributable to parent company shareholders was primarily due to exchange losses from currency fluctuations and reduced government subsidies[20] - Net cash flow from operating activities significantly increased by 1420.52%, mainly due to strengthened accounts receivable turnover during the year[20] Non-Recurring Gains and Losses Items and Amounts This section details the non-recurring gains and losses items and their amounts for the reporting period, totaling 35,719,722.45 Yuan, primarily including fair value changes of financial assets, government grants, and other non-operating income and expenses 2025 Semi-Annual Non-Recurring Gains and Losses Items | Non-Recurring Gains and Losses Items | Amount (Yuan) | | :--- | :--- | | Disposal gains/losses on non-current assets | 131,398.95 | | Government grants recognized in current profit/loss (non-recurring impact) | 4,131,873.20 | | Fair value changes and disposal gains/losses from financial assets and liabilities held by non-financial enterprises | 31,404,761.99 | | Debt restructuring gains/losses | 1,915,250.67 | | Other non-operating income and expenses | 4,670,909.12 | | Less: Income tax impact | 6,866,328.76 | | Minority interest impact (after tax) | -331,857.28 | | Total | 35,719,722.45 | Management Discussion and Analysis This section offers a comprehensive discussion and analysis of the company's operational performance, strategies, and market outlook Description of Company's Industry and Main Business Operations During the Reporting Period The company focuses on R&D, production, and sales of POCT reagents and instruments, with an established product line covering eight major areas, actively expanding into new businesses like home health management, pet health, and medical laboratories, demonstrating strong international competitiveness with over 90% overseas sales, while the global IVD market is expected to grow, and the Chinese market also holds significant potential - The company primarily engages in R&D, production, and sales of POCT reagents and instruments, with products covering eight detection areas: drugs of abuse, infectious diseases, chronic diseases, pregnancy, tumors, myocardial markers, biochemistry, and allergens[25] - During the reporting period, the company's revenue and profit primarily came from POCT rapid diagnostic reagents, with overseas sales accounting for over 90%[25][26] - The global in vitro diagnostics market is projected to grow from $109.2 billion in 2024 to $135.1 billion in 2029, with a CAGR of approximately 4.3%, and POCT accounts for about 22.3% of the market[28] - China's IVD market is estimated at 120 billion Yuan in 2024, with a projected CAGR of 5-8% over the next five years, reaching 165 billion Yuan by 2029[28] - The pet healthcare market is growing rapidly, with the global veterinary in vitro diagnostics market expected to grow from $8.78 billion in 2025 to $17.67 billion in 2030, at a CAGR of 10.5%[30] Discussion and Analysis of Operations In the first half of 2025, the company's operating revenue decreased by 7.42%, and net profit attributable to parent company shareholders fell by 48.57%, but non-recurring net profit grew by 24.85%; the company continues to deepen its presence in the POCT field through technology platform development and product iteration, creating a diversified product matrix, actively exploring new growth points such as smart diagnostics (e.g., chronic disease management App, pet diagnostics) and third-party medical laboratories, while also enhancing operational efficiency through lean management, optimizing its global ecosystem, and strengthening industry-academia-research collaboration to boost core competitiveness 2025 Semi-Annual Key Operating Performance Overview | Indicator | Amount (10,000 Yuan) | Period-over-Period Change (%) | | :--- | :--- | :--- | | Operating Revenue | 22,974.72 | -7.42 | | Net Profit Attributable to Parent Company Owners | 5,930.59 | -48.57 | | Net Profit Attributable to Parent Company Owners (Excluding Non-Recurring Items) | 2,358.62 | 24.85 | | Total Assets (Period-End) | 578,687.09 | 0.30 | | Equity Attributable to Parent Company Owners (Period-End) | 515,909.67 | -0.86 | - The company continues to deeply cultivate the POCT field, possessing eight major technology platforms including biological raw materials, immunochromatography, dry biochemistry, and chemiluminescence, with product lines covering eight detection areas such as drugs of abuse, infectious diseases, and chronic diseases[33] - During the reporting period, the company obtained 30 new authorized patents (6 of which are invention patents), accumulating 335 authorized patents (49 of which are invention patents); it also acquired 133 new international certifications and 15 domestic certifications, totaling 1,728 certifications[34] - The company launched the GluMate-centric chronic disease management App, transitioning from single detection to full-cycle services, and expanded its pet diagnostic product line (serving 12 animal types with over 120 detection items) and third-party medical laboratory business[35][36] - The company enhances operational efficiency through lean management, digital systems, supply chain optimization, and compliance internal controls, while advancing the construction of its headquarters R&D building project[37] - The company accelerates domestic market expansion, obtaining multiple domestic medical device registration certificates, and solidifies its presence in European, American, Oceanian, Asian, and African markets, forming a 'domestic + international' dual-wing development pattern[38] Analysis of Core Competitiveness During the Reporting Period The company's core competitiveness lies in technological innovation, with an integrated industry chain from upstream core biological raw materials to diagnostic reagents and instruments, possessing core biological raw material preparation capabilities, strong R&D and core technological advantages (covering immunochromatography, dry biochemistry, chemiluminescence, and other platforms), a complete product line with efficient iteration capabilities, and stringent quality control and brand advantages, while its core management team drives differentiated competition and technological innovation through a deep understanding of industry technology and precise grasp of market demands - The company's core competitiveness lies in technological innovation, focusing on R&D, production, and sales of POCT reagents and instruments, possessing several major technology platforms including biological raw materials, immunochromatography, and dry biochemistry[40] - Possessing core biological raw material (antigen and antibody) preparation capabilities, the company achieves over 70% self-sufficiency for raw materials required for nearly a hundred reagent products, reducing supply risks and enhancing bargaining power[41][42] - The company boasts strong R&D and core technological advantages, with a multidisciplinary R&D team, pursuing both market-driven and technology-driven strategies, and deploying technology platforms such as immunochromatography, dry biochemistry, chemiluminescence, and precision diagnostics[43] - A POCT reagent product line covering eight major series (infectious diseases, drugs of abuse, chronic diseases, pregnancy, tumors, myocardial markers, biochemistry, and allergens) has been formed, with efficient iteration capabilities[44] - A comprehensive ISO13485 quality management system has been established, adhering to a strategy combining proprietary and ODM brands to enhance brand influence[45] Core Technologies, Their Advancement, and Changes During the Reporting Period The company's core technology platforms include immunochromatography (colloidal gold, fluorescence immunoassay), dry biochemistry, biological raw materials, chemiluminescence, precision diagnostics (molecular diagnostics, mass spectrometry), liquid biochip, microfluidic technologies, and clinical laboratory instrument technology; during the reporting period, the company completed the development of gene recombinant antigens for AIDS and syphilis, and synthetic antigens for new drugs of abuse on its biological raw material platform, and established new R&D technology platforms for recombinant antibodies, bioactive enzymes, and nanomaterials, continuously enhancing technological advancement and industrialization capabilities - The immunochromatography technology platform includes colloidal gold and fluorescence immunochromatography, having developed over 400 colloidal gold products and nearly 80 fluorescence immunoassay products, with sensitivity 5-10 times higher than traditional colloidal gold[49] - The biological raw material technology platform has mastered technologies such as genetic engineering recombinant antigen/antibody, synthetic antigen, and nanosphere preparation, achieving over 70% self-sufficiency for antigen and antibody raw materials required for nearly a hundred reagent products[51] - During the reporting period, the biological raw material platform completed the development of gene recombinant antigens for AIDS and syphilis, and synthetic antigens for new drugs of abuse like PCP and MDMA, establishing new R&D technology platforms for recombinant antibodies, bioactive enzymes, and nanomaterials[51] - The precision diagnostics technology platform focuses on molecular diagnostics and mass spectrometry, combining isothermal amplification and microfluidic technology to achieve sample-in-result-out, and has established mass spectrometry quantitative analysis methods for trace drugs of abuse in hair, wastewater, and saliva[53] - The liquid biochip technology platform, in collaboration with Zhejiang University, has overcome core encoded microsphere technology, completing preliminary prototype designs for autoimmune disease, cytokine, and tumor detection kits, with supporting instruments planned for registration application in 2025[55] R&D Achievements During the Reporting Period During the reporting period, the company obtained 30 new authorized patents (6 of which are invention patents), accumulating 335 authorized patents (49 of which are invention patents); simultaneously, the company actively promoted product registration/filing, acquiring 148 new certifications (133 international, 15 domestic), totaling 1,728 certifications, demonstrating strong R&D innovation and market access capabilities New Intellectual Property During the Reporting Period | Type | New Applications This Period (Units) | New Grants This Period (Units) | Cumulative Applications (Units) | Cumulative Grants (Units) | | :--- | :--- | :--- | :--- | :--- | | Invention Patents | 5 | 6 | 165 | 49 | | Utility Model Patents | 16 | 11 | 140 | 102 | | Design Patents | 28 | 13 | 250 | 184 | | Software Copyrights | 2 | 9 | 52 | 53 | | Other | 0 | 0 | 16 | 11 | | Total | 51 | 39 | 623 | 399 | - During the reporting period, the company obtained 30 new authorized patents, including 6 invention patents; it has accumulated 335 authorized patents, including 49 invention patents[58] - The company acquired 148 new certifications, including 133 international and 15 domestic certifications, totaling 1,728 certifications[59] R&D Investment Table During the reporting period, the company's total R&D investment was 47,409,960.28 Yuan, a year-over-year decrease of 4.56%, but R&D investment as a percentage of operating revenue slightly increased to 20.64%, demonstrating the company's continued emphasis on R&D R&D Investment Status | Indicator | Current Period (Yuan) | Prior Period (Yuan) | Change (%) | | :--- | :--- | :--- | :--- | | Expensed R&D Investment | 47,409,960.28 | 49,673,727.89 | -4.56 | | Total R&D Investment | 47,409,960.28 | 49,673,727.89 | -4.56 | | Total R&D Investment as % of Operating Revenue (%) | 20.64 | 20.02 | 0.62 | R&D Projects Status The company's R&D projects span eight major technology areas, including immunochromatography, dry biochemistry, biological raw materials, chemiluminescence, precision diagnostics, liquid chips, instrument platforms, and microfluidic platforms, with a total estimated investment of 511.44 million Yuan and a current period investment of 47.41 million Yuan; multiple projects have completed product development or are in various R&D stages, aiming to enrich product lines, achieve raw material self-sufficiency, enhance detection efficiency, and expand application areas Main R&D Projects Status | No. | Project Name | Estimated Total Investment (Yuan) | Current Period Investment (Yuan) | Cumulative Investment (Yuan) | Target Objective | Technical Level | Progress or Phased Achievements | Specific Application Prospects | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | 1 | Immunochromatography Platform | 292,998,000.00 | 25,755,135.88 | 315,441,054.24 | Enrich POCT Product Line | Internationally Leading | 16 Projects Completed R&D | Clinical Testing, Food Safety, Forensic Testing | | 2 | Dry Biochemistry Platform | 58,705,000.00 | 6,424,521.72 | 37,091,582.20 | Enrich Chronic Disease Detection Series | Domestically Leading | 20 R&D Projects | Various Medical Institutions, POCT Clinical Testing | | 3 | Biological Raw Material Platform | 33,380,000.00 | 5,462,611.95 | 23,304,417.77 | Achieve Raw Material Self-Sufficiency | Domestically Leading | 9 Projects Completed Development | Diagnostic Reagent Production, R&D | | 4 | Chemiluminescence Platform | 19,890,000.00 | 2,210,835.75 | 9,932,020.65 | Enrich Infectious Disease, Myocardial, Drug of Abuse Detection Series | Domestically Leading | 3 Projects Completed Development | POCT Clinical Testing, Food Safety, Forensic Testing | | 5 | Precision Diagnostics Platform | 39,110,000.00 | 1,884,594.97 | 14,925,676.77 | Detection and Analysis of Target Substances in Samples | Domestically Leading | 9 R&D Projects | POCT Clinical Testing, Food Safety, Forensic Testing | | 6 | Liquid Chip Platform | 28,800,000.00 | 1,564,089.65 | 21,284,093.82 | Tumor Marker Co-detection, Allergen Co-detection | Internationally Advanced | Completed Core Encoded Microsphere Development | Tumor Marker Co-detection, Allergen Co-detection, Cytokines | | 7 | Instrument Platform | 24,673,750.00 | 3,224,570.31 | 25,023,607.02 | Completed Immunochromatography, Miniature Nucleic Acid Analyzer, etc. | Domestically Leading | 1 Project Completed Development | Clinical and POCT-Related Analysis and Automation Systems | | 8 | Microfluidics Platform | 13,880,000.00 | 883,600.05 | 8,252,404.42 | Develop Microfluidic Biochemical, Coagulation Analyzers | Domestically Leading | 5 R&D Projects | Various Medical Institutions, POCT Clinical Testing | | Total | 511,436,750.00 | 47,409,960.28 | 455,254,856.89 | | | | | R&D Personnel Status As of the end of the reporting period, the company's R&D personnel increased to 222 persons, accounting for 30.83% of the total workforce, with total R&D personnel compensation of 19.45 million Yuan and average compensation of 87,600 Yuan; the R&D team is primarily composed of master's and bachelor's degree holders, with an age structure mainly between 30-40 years old, indicating a younger and highly educated profile R&D Personnel Basic Information | Indicator | Current Period | Prior Period | | :--- | :--- | :--- | | Number of Company R&D Personnel (Persons) | 222 | 212 | | R&D Personnel as % of Total Company Personnel (%) | 30.83 | 29.08 | | Total R&D Personnel Compensation (10,000 Yuan) | 1,944.83 | 1,727.73 | | Average R&D Personnel Compensation (10,000 Yuan) | 8.76 | 8.15 | R&D Personnel Educational Background | Educational Background | Number (Persons) | Proportion (%) | | :--- | :--- | :--- | | Doctorate | 4 | 1.80 | | Master's | 78 | 35.14 | | Bachelor's | 121 | 54.50 | | Associate Degree | 17 | 7.66 | | High School and Below | 2 | 0.90 | | Total | 222 | 100.00 | Risk Factors The company faces multiple risks related to core competitiveness (non-patented technology disclosure, loss of key technical personnel), operations (intensified market competition, overseas sales uncertainties, quality control), industry (new EU IVDR regulations, changes in domestic regulatory policies), and the macroeconomic environment (tariff measures); additionally, financial risks include exchange rate fluctuations, accounts receivable bad debts, and gross margin volatility - Core competitiveness risks include the non-patented nature of POCT reagent formulations and preparation technologies, posing disclosure risks, as well as the risk of losing core technical personnel[70] - Operating risks include intensified market competition in the in vitro diagnostics industry, potentially leading to slower growth, decreased market share, and reduced profitability[71] - Overseas sales risks primarily stem from a high proportion of international sales (over 90%), influenced by political, economic, trade, and exchange rate uncertainties, as well as changes in ODM client demand[71] - Industry risks include stricter technical documentation requirements for manufacturers under the new EU IVDR regulations, potentially impacting ODM client sales; changes in domestic in vitro diagnostics industry's strict classification management and production licensing systems may also have adverse effects[73][74][75] - Financial risks include exchange rate fluctuations (overseas sales settled in USD, affecting exchange gains/losses and product price competitiveness), accounts receivable bad debts (period-end accounts receivable of 210 million Yuan), and gross margin fluctuations (intensified market competition, changes in product structure)[77][78][79] Key Operating Performance During the Reporting Period During the reporting period, the company's operating revenue decreased by 7.42%, and net profit attributable to parent company shareholders fell by 48.57%, but non-recurring net profit grew by 24.85%; key financial item changes include operating revenue affected by US tariff increases, financial expenses influenced by exchange rate fluctuations, and a significant increase in net cash flow from operating activities due to enhanced cash collection; regarding assets and liabilities, monetary funds decreased primarily due to increased wealth management, construction in progress saw continuous investment, and other payables significantly increased due to dividend distribution accrual; the company's overseas assets accounted for 26.51% of total assets 2025 Semi-Annual Key Operating Performance Overview | Indicator | Amount (10,000 Yuan) | Period-over-Period Change (%) | | :--- | :--- | :--- | | Operating Revenue | 22,974.72 | -7.42 | | Net Profit Attributable to Parent Company Owners | 5,930.59 | -48.57 | | Net Profit Attributable to Parent Company Owners (Excluding Non-Recurring Items) | 2,358.62 | 24.85 | | Total Assets (Period-End) | 578,687.09 | 0.30 | | Equity Attributable to Parent Company Owners (Period-End) | 515,909.67 | -0.86 | Financial Statement Related Item Fluctuation Analysis | Item | Current Period (Yuan) | Prior Period (Yuan) | Change (%) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Operating Revenue | 229,747,240.90 | 248,156,721.31 | -7.42 | affected by US tariff increases, customers adopting a wait-and-see approach and delaying orders | | Selling Expenses | 27,195,877.65 | 22,695,278.78 | 19.83 | Increased Market Expansion Efforts | | Financial Expenses | 9,857,347.94 | -10,422,562.08 | 194.58 | Exchange Rate Fluctuations | | Net Cash Flow from Operating Activities | 3,518,551.53 | 231,404.91 | 1,420.52 | Increased Cash Collection | | Net Cash Flow from Investing Activities | -243,438,003.08 | 327,348,304.67 | -174.37 | Increased Wealth Management | Asset and Liability Status Changes | Project Name | Current Period-End Amount (Yuan) | Current Period-End Amount as % of Total Assets (%) | Prior Period-End Amount (Yuan) | Prior Period-End Amount as % of Total Assets (%) | Change in Current Period-End Amount vs. Prior Period-End Amount (%) | Explanation | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Monetary Funds | 233,627,337.96 | 4.04 | 467,922,697.94 | 8.11 | -50.07 | mainly due to increased wealth management | | Construction in Progress | 164,392,495.14 | 2.84 | 124,715,040.55 | 2.16 | 31.81 | mainly due to continuous project investment | | Short-term Borrowings | - | - | 280,000.00 | 0.00 | -100.00 | mainly due to loan repayment | | Other Payables | 121,240,267.10 | 2.10 | 13,167,337.50 | 0.23 | 820.77 | mainly due to dividend distribution accrual | - Overseas assets amounted to 1.53 billion Yuan, accounting for 26.51% of total assets[86] Main Holding and Investee Company Analysis (Partial) | Company Name | Company Type | Main Business | Registered Capital (10,000 Yuan) | Total Assets (10,000 Yuan) | Net Assets (10,000 Yuan) | Operating Revenue (10,000 Yuan) | Operating Profit (10,000 Yuan) | Net Profit (10,000 Yuan) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Xuke Bio | Subsidiary | Biological Raw Material R&D and Production | 330 | 11,319.25 | 9,815.45 | 2,324.80 | 1,420.29 | 1,289.19 | | Bojin Medical | Subsidiary | Medical Plastic Parts R&D and Production | 200 | 3,748.79 | 1,938.78 | 1,180.87 | 165.68 | 157.40 | | AssureTech Bio | Subsidiary | POCT Reagent and Instrument Production | 6,000 | 35,245.64 | 16,172.60 | 2,450.71 | -221.12 | -221.12 | | AssureTech (Hong Kong) | Subsidiary | Overseas Sales Platform | 10 USD | 138,666.31 | 20,068.75 | 16,050.19 | 2,384.25 | 2,384.25 | | Xumin Bio | Subsidiary | POCT Reagent and Instrument Production | 10,000 | 89,587.52 | 46,843.37 | 8,133.38 | 1,184.17 | 888.10 | Corporate Governance, Environment, and Society This section details the company's governance structure, profit distribution plans, and employee incentive measures Profit Distribution or Capital Reserve Conversion Plan The company's board of directors resolved that no profit distribution or capital reserve conversion plan will be implemented for the 2025 semi-annual period - The company will not carry out profit distribution or capital reserve conversion for the 2025 semi-annual period[93] Company's Equity Incentive Plan, Employee Stock Ownership Plan, or Other Employee Incentive Measures and Their Impact On April 28, 2025, the company's board of directors and supervisory board approved the cancellation of a portion of restricted shares from the 2024 restricted stock incentive plan, totaling 478,000 shares, due to the non-achievement of vesting conditions for the first vesting period of the initial grant - On April 28, 2025, the company's board of directors resolved to cancel a portion of restricted shares from the 2024 restricted stock incentive plan[94] - The cancellation was due to the non-achievement of vesting conditions for the first vesting period of the initial grant, totaling 478,000 restricted shares[94] Significant Matters This section covers important corporate events, including commitment fulfillment, litigation, and the utilization of raised funds Fulfillment of Commitments The company's controlling shareholders, actual controllers, directors, supervisors, senior management, and other core technical personnel have all strictly fulfilled their various commitments made prior to the initial public offering, including share lock-up and reduction intentions, truthfulness of information disclosure, filling diluted immediate returns, fraudulent issuance repurchase, shareholder information disclosure, binding measures for unfulfilled commitments, avoiding horizontal competition, compensating for unpaid social insurance and housing provident fund losses, and regulating related party transactions; during the reporting period, all commitments were strictly fulfilled on time, with no instances of failure to timely fulfill - Controlling shareholders and shareholders holding 5% or more pledged not to reduce their holdings during the lock-up period, and for 2 years after the lock-up period, the reduction price will not be lower than the offering price[98] - The actual controller and directors, supervisors, and senior management holding shares pledged not to transfer more than 25% of their total shares annually during their tenure, not to transfer shares within six months after resignation, and for 2 years after the lock-up period, the reduction price will not be lower than the offering price[99][100] - Core technical personnel pledged that during their tenure, within 4 years from the expiration of the lock-up period for pre-IPO shares, the number of pre-IPO shares transferred annually will not exceed 25% of their total holdings at the time of listing[100][101] - The company, its controlling shareholders, and actual controller all pledged that there are no fraudulent issuance circumstances, and if such occurs, a share repurchase program will be initiated[105][106] - The controlling shareholders and actual controller issued an irrevocable 'Commitment Letter Regarding Avoiding Horizontal Competition,' pledging not to directly or indirectly engage in activities that constitute horizontal competition with the company[115] - The actual controller pledged to fully compensate the company for any fines or losses incurred due to unpaid employee social insurance and housing provident fund contributions[116][117] - The actual controller pledged to regulate the company's related party transactions, not to illegally or improperly occupy company funds or request the company to provide guarantees, and not to harm the company's interests through non-fair related party transactions[117] Major Litigation and Arbitration Matters The company had no major litigation or arbitration matters during the reporting period - The company had no major litigation or arbitration matters during the reporting period[119] Explanation of Progress in Raised Funds Utilization As of the end of the reporting period, the company's total raised funds amounted to 1.2 billion Yuan, with cumulative funds invested of 578.40 million Yuan, representing an investment progress of 54.78%; some raised investment projects have changed use of funds and been extended, such as the "Marketing and Service Network System Construction Project" where remaining funds were used for permanent working capital replenishment due to market environment changes and the company's own capital investment; additionally, the company has closed some special accounts for raised funds to reduce management costs Overall Use of Raised Funds | Source of Raised Funds | Net Raised Funds (10,000 Yuan) | Total Committed Investment of Raised Funds in Prospectus or Offering Circular (10,000 Yuan) | Cumulative Raised Funds Invested as of Period-End (10,000 Yuan) | Investment Progress as of Period-End (%) | Amount Invested This Year (10,000 Yuan) | Total Raised Funds with Changed Use (10,000 Yuan) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Initial Public Offering (IPO) | 120,029.86 | 105,584.63 | 57,839.61 | 54.78 | 3,641.46 | 23,646.17 | | Total | 120,029.86 | 105,584.63 | 57,839.61 | 54.78 | 3,641.46 | 23,646.17 | - On October 29, 2024, the company reviewed and approved the 'Proposal on Changing the Use of Funds and Extending the Implementation Period for Certain Raised Investment Projects'[124] - The 'Marketing and Service Network System Construction Project' had a low capital investment ratio due to changes in market environment and the company's business development strategy, and the company had already used its own funds for related work; the remaining project funds were used for permanent working capital replenishment[130] - The company has closed some special accounts for raised funds, including those for the 'In Vitro Diagnostic Reagent and POCT Instrument Production Intelligent Transformation Project' and the 'Marketing and Service Network Construction Project,' to reduce management costs[134] Details of Raised Investment Projects (Partial) | Project Name | Planned Total Investment of Raised Funds (10,000 Yuan) | Amount Invested This Year (10,000 Yuan) | Cumulative Raised Funds Invested as of Period-End (10,000 Yuan) | Investment Progress as of Period-End (%) | Period-End Remaining Amount (10,000 Yuan) | Significant Change Occurred | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Annual Production of 300 Million Units of Class II and III Medical Devices, In Vitro Diagnostic Reagents, Instruments, and Supporting Products Project | 25,139.43 | - | 17,178.51 | 68.33 | 7,960.92 | Yes (Completed, Transferred to New Project) | | In Vitro Diagnostic Reagent and POCT Instrument Production Intelligent Transformation Project | 3,996.15 | - | 3,110.36 | 77.83 | 885.79 | Yes (Completed, Used for Permanent Working Capital Replenishment) | | Technology R&D Center Upgrade Project | 8,022.77 | - | 1,237.29 | 15.42 | 6,785.48 | No | | Marketing and Service Network Construction Project | 3,740.24 | - | 89.91 | 2.40 | 3,650.34 | Yes (Completed, Used for Permanent Working Capital Replenishment) | | Replenish Working Capital | 5,000.00 | - | 5,001.20 | 100.02 | - | No | | In Vitro Diagnostic Reagent and Diagnostic Instrument R&D and Production Project (Over-raised) | 50,786.26 | 628.62 | 27,510.00 | 54.17 | - | No | | Technology R&D Headquarters Construction Project (New Raised Investment) | 23,646.17 | 3,012.84 | 3,712.34 | 15.70 | - | No | | Total | 129,230.80 | 3,641.46 | 57,839.61 | | | | Share Changes and Shareholder Information This section outlines changes in share capital, shareholder structure, and information regarding directors, supervisors, and senior management Share Capital Changes During the reporting period, there were no changes in the company's total ordinary share capital or share capital structure - During the reporting period, there were no changes in the company's total ordinary share capital or share capital structure[137] Shareholder Information As of the end of the reporting period, the company had 6,024 ordinary shareholders; among the top ten shareholders, Hangzhou AssureTech Holdings Co., Ltd. and Ling Shisheng held 26.87% and 25.12% of the shares, respectively, serving as the company's controlling shareholder and actual controller; Ling Shisheng and Jiang Xueying are a married couple, together controlling 59.79% of the company's shares Total Ordinary Shareholders as of Period-End | Indicator | Number (Households) | | :--- | :--- | | Total Ordinary Shareholders | 6,024 | | Total Preferred Shareholders with Restored Voting Rights | 0 | | Total Shareholders Holding Special Voting Rights Shares | 0 | Top Ten Shareholders' Shareholding (Partial) | Shareholder Name | Period-End Shareholding (Shares) | Proportion (%) | Shareholder Nature | | :--- | :--- | :--- | :--- | | Hangzhou AssureTech Holdings Co., Ltd. | 34,150,290 | 26.87 | Domestic Non-State-Owned Legal Person | | Ling Shisheng | 31,929,520 | 25.12 | Domestic Natural Person | | Ma Huaxiang | 14,773,360 | 11.62 | Domestic Natural Person | | Lishui Chuangsheng Enterprise Management Partnership (Limited Partnership) | 11,914,000 | 9.37 | Other | | Jiang Xueying | 2,544,830 | 2.00 | Domestic Natural Person | - Ling Shisheng and Jiang Xueying are a married couple; together, through AssureTech Holdings and Lishui Chuangsheng, they control 59.79% of the company's shares, forming control over the company[143] - Shareholder Shao Kui collectively holds 791,857 shares of the company through ordinary securities accounts and margin trading and securities lending accounts[139] Directors, Supervisors, Senior Management, and Core Technical Personnel During the reporting period, there were no changes in the shareholdings of the company's directors, supervisors, senior management, and core technical personnel; on April 28, 2025, the company canceled a portion of restricted shares from the 2024 restricted stock incentive plan, totaling 478,000 shares, due to the non-achievement of vesting conditions for the first vesting period of the initial grant - During the reporting period, no changes in shareholdings of the company's directors, supervisors, senior management, and core technical personnel were disclosed, indicating no changes[144] - On April 28, 2025, the company canceled 478,000 restricted shares from the 2024 restricted stock incentive plan, which were part of the initial grant whose first vesting period conditions were not met[144] Bond-Related Information This section provides details on the company's bond issuances and other debt financing instruments Corporate Bonds (Including Enterprise Bonds) and Non-Financial Enterprise Debt Financing Instruments The company had no corporate bonds (including enterprise bonds) or non-financial enterprise debt financing instruments during the reporting period - The company has no corporate bonds (including enterprise bonds) or non-financial enterprise debt financing instruments[147] Convertible Corporate Bonds The company had no convertible corporate bonds during the reporting period - The company has no convertible corporate bonds[147] Financial Report This section presents the company's comprehensive financial statements, accounting policies, and detailed notes to financial items Financial Statements This section provides the company's 2025 semi-annual consolidated and parent company balance sheets, income statements, cash flow statements, and statements of changes in owners' equity; financial data shows that total assets and net assets remained relatively stable, but net profit declined due to exchange rate fluctuations and reduced government grants; operating cash flow significantly improved, while investing cash flow significantly outflowed due to increased wealth management - The consolidated balance sheet shows period-end total assets of 5.79 billion Yuan and equity attributable to parent company owners of 5.16 billion Yuan[151][152] - The consolidated income statement shows 2025 semi-annual operating revenue of 229.75 million Yuan and net profit attributable to parent company shareholders of 59.31 million Yuan[158][160] - The consolidated cash flow statement shows net cash flow from operating activities of 3.52 million Yuan and net cash flow from investing activities of -243.44 million Yuan[165][167] - The parent company income statement shows 2025 semi-annual operating revenue of 261.95 million Yuan and net profit of 22.55 million Yuan[162][163] Company Basic Information Hangzhou AssureTech Bio-tech Co., Ltd. was restructured and established on August 10, 2019, with a registered capital of 127.08 million Yuan, and its shares were listed on the Shanghai Stock Exchange on November 18, 2021; the company operates in the in vitro diagnostics sector of the pharmaceutical manufacturing industry, with a business scope including medical device manufacturing, wholesale and retail, and biological product technical services; as of June 30, 2025, the company includes 22 full-tier subsidiaries within its consolidated financial statements - The company was restructured and established on August 10, 2019, with a registered capital of 127.08 million Yuan, and its shares were listed on the Shanghai Stock Exchange on November 18, 2021[186] - The company operates in the in vitro diagnostics sector of the pharmaceutical manufacturing industry, with a business scope including medical device manufacturing, wholesale and retail, and biological product technical services[187] - As of June 30, 2025, the Group includes 22 full-tier subsidiaries within its consolidated financial statements[187] Basis of Financial Statement Preparation The company's financial statements are prepared on a going concern basis, adhering to enterprise accounting standards and relevant disclosure regulations of the China Securities Regulatory Commission, using the accrual method and historical cost measurement; management has assessed the company's ability to continue as a going concern for at least the next 12 months - Financial statements are prepared on a going concern basis, adhering to enterprise accounting standards and relevant disclosure regulations of the China Securities Regulatory Commission[188] - Accounting is based on the accrual method, and all items, except financial instruments, are measured at historical cost[188] - Management has assessed the company's ability to continue as a going concern for at least the next 12 months[189] Significant Accounting Policies and Estimates This section details the company's specific accounting policies and estimates for revenue recognition, financial instrument impairment, provisions, long-term asset impairment, and inventory write-downs; the company classifies and measures financial assets based on the business model for managing them and their contractual cash flow characteristics, and explains the recognition, measurement, depreciation, amortization, and impairment provision methods for assets such as inventories, fixed assets, and intangible assets; additionally, it covers important accounting treatment methods for business combinations, cash and cash equivalents, foreign currency transactions, employee compensation, government grants, deferred income tax, and leases - Based on the business model for managing financial assets and their contractual cash flow characteristics, 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[210] - Inventories are valued at actual cost upon acquisition, at weighted average cost upon issuance, and measured at the lower of cost or net realizable value, with provisions for inventory write-downs[221][222] - Fixed assets are depreciated using the straight-line method, with depreciation periods of 20-40 years for buildings and 3-10 years for machinery and equipment[237] - Intangible assets (such as land use rights, software use rights) are amortized using the straight-line method over their estimated useful lives; R&D expenditures are divided into research and development phases, with development phase expenditures recognized as intangible assets when conditions are met[242][243] - Revenue is recognized when the customer obtains control of the related goods; domestic sales are recognized upon customer acceptance, while overseas sales, based on trade terms (FOB, CFR, FCA, EXW), are recognized upon shipment, departure from port, or delivery to carrier and completion of customs procedures[253][254] Taxation The company's main tax types include Value-Added Tax (13%, 6%), Urban Maintenance and Construction Tax (7%, 5%), Property Tax (1.2%, 12%), Education Surcharge (3%), and Local Education Surcharge (2%); the company and some subsidiaries enjoy high-tech enterprise income tax incentives (15%), while other subsidiaries enjoy small and micro-profit enterprise income tax incentives (20%) Main Tax Types and Rates | Tax Type | Tax Basis | Tax Rate | | :--- | :--- | :--- | | Value-Added Tax | Taxable Income | 13%、6% | | Urban Maintenance and Construction Tax | Actual Paid Turnover Tax | 7%、5% | | Property Tax | Original Value of Property or Rental Income | 1.2%、12% | | Education Surcharge | Actual Paid Turnover Tax | 3% | | Local Education Surcharge | Actual Paid Turnover Tax | 2 | Taxable Entities with Different Corporate Income Tax Rates (Partial) | Taxable Entity Name | Corporate Income Tax Rate (%) | | :--- | :--- | | Hangzhou AssureTech Bio-tech Co., Ltd. | 15 | | Hangzhou Xuke Bio-tech Co., Ltd. | 15 | | Hangzhou Bojin Medical Products Co., Ltd. | 20 | | Zhejiang AssureTech Bioengineering Co., Ltd. | 25 | | Hunan Tianzong Yijun Bio-tech Co., Ltd. | 15 | | Wuxi Tianzong Yijun Bio-tech Co., Ltd. | 15 | | Assure Tech Limited | 16.5 | - The company and its subsidiaries Hangzhou Xuke Bio, Hunan Tianzong Yijun, and Wuxi Tianzong Yijun have all passed high-tech enterprise review