艾德生物(300685) - 2025 Q2 - 季度财报

Part I Important Notice, Table of Contents, and Definitions This section provides essential preliminary information, including important notices, the report's structure, and definitions of key terms Important Notice The company's board, supervisors, and senior management guarantee the semi-annual report's accuracy, highlighting forward-looking plans and industry risks - Company's board, supervisors, and senior management guarantee the truthfulness, accuracy, and completeness of the semi-annual report[3] - In-vitro diagnostics industry faces risks of rapid technological updates, long R&D cycles, high investment, and strict regulation[3] - Company plans no cash dividends, bonus shares, or capital reserve conversions for this half-year[4] Table of Contents This section outlines the report's eight main chapters, covering company profile, management analysis, governance, significant events, and financial reports - The report is divided into eight main chapters with a clear structure[6] List of Reference Documents This section lists the company's reference documents for the reporting period, available at the securities affairs department - Reference documents include signed and sealed financial statements and original publicly disclosed company documents[8][9] - Reference documents are available at the company's securities affairs department[10] Definitions This section defines key terms used in the report, clarifying company references and time concepts - "Company," "the Company," and "AmoyDx" all refer to Amoy Diagnostics Co., Ltd[11] - The reporting period is from January 1, 2025, to June 30, 2025[11] Part II Company Profile and Key Financial Indicators This section provides the company's basic information and a summary of its key financial performance for the reporting period 1. Company Profile This section introduces the company's basic listing information and legal representative Company Basic Information | Indicator | Content | | :--- | :--- | | Stock Abbreviation | AmoyDx | | Stock Code | 300685 | | Listing Exchange | Shenzhen Stock Exchange | | Legal Representative | LI-MOU ZHENG | 2. Contact Persons and Information This section provides contact details for the company's Board Secretary and Securities Affairs Representative Company Contact Information | Position | Name | Phone | Email | | :--- | :--- | :--- | :--- | | Board Secretary | Chen Ying | 0592-6806830 | sid@amoydx.com | | Securities Affairs Representative | Yang Shouqian | 0592-6806830 | sid@amoydx.com | 3. Other Information This section confirms that the company's key administrative and disclosure details remained unchanged during the reporting period - Company contact information, information disclosure and reference locations, and registration status remained unchanged during the reporting period[16][17][18] 4. Key Accounting Data and Financial Indicators This section presents the company's key financial performance for the first half of 2025, showing growth in revenue and net profit Key Accounting Data and Financial Indicators for H1 2025 | Indicator | Current Period (RMB) | Prior Year Period (RMB) | YoY Change | | :--- | :--- | :--- | :--- | | Operating Revenue | 579,344,557.65 | 543,017,402.22 | 6.69% | | Net Profit Attributable to Shareholders of Listed Company | 189,037,382.96 | 143,856,566.01 | 31.41% | | Net Profit Attributable to Shareholders of Listed Company (Excluding Non-Recurring Items) | 184,796,186.31 | 132,020,965.71 | 39.97% | | Net Cash Flow from Operating Activities | 170,583,283.15 | 139,148,728.65 | 22.59% | | Basic Earnings Per Share (RMB/share) | 0.48 | 0.36 | 33.33% | | Diluted Earnings Per Share (RMB/share) | 0.48 | 0.36 | 33.33% | | Weighted Average Return on Net Assets | 9.92% | 8.14% | 1.78% | | Indicator | End of Current Period (RMB) | End of Prior Year (RMB) | Change from End of Prior Year | | :--- | :--- | :--- | :--- | | Total Assets | 2,193,822,756.62 | 2,064,801,711.06 | 6.25% | | Net Assets Attributable to Shareholders of Listed Company | 1,885,663,181.93 | 1,843,264,757.86 | 2.30% | - Value-added tax rate for diagnostic reagents adjusted to 13% starting January 1, 2025[19] 5. Differences in Accounting Data Under Domestic and International Accounting Standards This section confirms no discrepancies in net profit and net assets between domestic and international accounting standards for the reporting period - No differences in accounting data under domestic and international accounting standards during the reporting period[20][21] 6. Non-Recurring Gains and Losses and Their Amounts This section details the company's non-recurring gains and losses for the first half of 2025, totaling RMB 4,241,196.65 Non-Recurring Gains and Losses for H1 2025 | Item | Amount (RMB) | | :--- | :--- | | Gains/Losses from Disposal of Non-Current Assets | -44,133.07 | | Government Subsidies Included in Current Profit/Loss | 4,405,158.18 | | Gains/Losses from Fair Value Changes and Disposal of Financial Assets and Liabilities | 3,856,948.27 | | Other Non-Operating Income and Expenses Apart from the Above | -3,228,330.26 | | Less: Income Tax Impact | 748,446.47 | | Total | 4,241,196.65 | - No other profit/loss items meet the definition of non-recurring gains/losses, nor have non-recurring items been reclassified as recurring[24] Part III Management Discussion and Analysis This section provides an in-depth analysis of the company's operations, core competencies, financial performance, and risk management strategies 1. Principal Business Activities During the Reporting Period The company's core business remains focused on tumor gene detection and companion diagnostics, offering comprehensive solutions and services - Company's principal business remained unchanged, focusing on tumor gene detection and companion diagnostics[26] - Company provides detection reagents, software, supporting instruments, professional testing services, and drug clinical research services[26] (I) Principal Business The company offers a comprehensive tumor precision detection solution, leveraging multiple technology platforms and a wide range of approved products and services - Company provides comprehensive tumor precision detection solutions, focusing on companion diagnostics for various cancers like lung and colorectal cancer[26] - Company's technology platforms include mainstream methodologies such as PCR, NGS, IHC, and FISH[26] - Company independently developed and obtained approval for 32 tumor gene detection products (Class III medical devices) in China, making it a leading enterprise with the most comprehensive product range in the industry[27] 1. Detection Reagents, Software, and Supporting Instruments The company maintains a robust product line with numerous domestic approvals, international certifications, and market access - Company holds 32 Class III medical device registration certificates in China, with HER-2 antibody reagent and estrogen receptor antibody reagent as newly approved products[27][31] - Companion diagnostic products ROS1, PCR11 gene, FGFR2 approved and covered by local medical insurance in countries like Japan[27][36] - Over 20 products obtained EU CE certification, and over 20 products secured market access in Southeast Asia, the Middle East, and Latin America[36][37] 2. Testing Services The company operates three independent, internationally accredited third-party medical testing institutions, offering diverse pathology clinical testing services - Company operates three independent third-party medical testing institutions: Xiamen AmoyDx, Shanghai Xiamenwei, and AmoyDx (North America) Laboratories[38] - AmoyDx (North America) Laboratory is certified by US CLIA and New York State Department of Health; domestic laboratories are CAP accredited and ISO15189 recognized[38][39] - Laboratories are qualified and capable of providing cytopathology, histopathology, and molecular pathology clinical testing services[39] 3. Drug Clinical Research Services The company partners with leading pharmaceutical companies to provide comprehensive central laboratory testing and companion diagnostic registration services for drug clinical research - Company collaborates with AstraZeneca, LOXO ONCOLOGY, Johnson & Johnson, Pfizer, and other renowned pharmaceutical companies on companion diagnostics[40] - Company provides professional central laboratory testing and companion diagnostic registration services to support drug clinical research at various stages[40] (II) Business Model The company employs a centralized procurement, molecular diagnostic production, and a hybrid domestic/international sales model - Procurement model is centralized, focusing on key raw material supplier management, with no single import supplier risk[41] - Production model primarily molecular diagnostic reagents, with some automated processes and strict production control[41][42] - Domestic sales adopt a "direct and distribution sales combined, direct sales primary" model, with a sales team of nearly 400 people[42] - International market operations cover over 60 countries and regions, through distributors, end-customers, and multinational pharmaceutical collaborations[42] (III) Industry Development The oncology treatment sector is rapidly advancing into the "precision medicine" era, driving significant growth in the tumor gene detection market - Oncology treatment is fully entering the "precision medicine" era, with a booming tumor gene detection market[43] - Detection demand expanded to full life-cycle management of cancer patients, covering early screening, auxiliary diagnosis, companion diagnostics, efficacy monitoring, and recurrence prediction[43] 2. Analysis of Core Competencies The company's core strengths lie in its independent innovation, extensive sales channels, and strong brand image, ensuring its leading market position - Company's core competencies are in independent innovation, sales channels, and brand image[44] (I) Independent Innovation Advantage The company maintains a strong innovation edge through continuous R&D investment, multi-technology platforms, and extensive intellectual property, earning national recognition - Company possesses a precision oncology product system covering PCR, NGS, IHC, and FISH platforms, with proprietary technologies like ADx-ARMS® and Super-ARMS®[45] - R&D investment during the reporting period was RMB 90.5262 million, accounting for 15.63% of operating revenue[47] - Company holds 32 Class III medical device registration certificates, 69 authorized patents (including 63 invention patents), and 26 software copyrights[47] - Company received numerous national and industry honors, including "National Enterprise Technology Center" and "Manufacturing Single Champion Enterprise"[48] (II) Sales Channel Advantage The company boasts a robust sales network, integrating R&D and sales, with extensive domestic hospital coverage and a global presence through international distributors and subsidiaries - Domestic market has a direct sales network covering over 500 leading hospitals and a sales team of nearly 400 people[51] - International business team of over 70 people works with over 100 international distributors, covering over 60 countries and regions globally[51] - Company has wholly-owned subsidiaries in Singapore, Hong Kong, Canada, and a European logistics center in the Netherlands to support global sales[51] (III) Brand Image Advantage The company has cultivated a strong brand image in precision oncology through innovation, quality, and strategic collaborations, achieving market leadership and international recognition - Company has over a decade of experience in precision oncology, with industry-leading product quality and technology[52] - Deep companion diagnostic collaborations with multiple global leading oncology pharmaceutical companies enhance brand influence[52] - Products participate in multiple international multi-center clinical trials as companion diagnostics, successfully entering developed markets like Japan and being included in local medical insurance[52] 3. Analysis of Principal Business This section analyzes the company's principal business, highlighting key financial data changes and revenue sources, with detection reagents as the primary driver - Company's profit composition or sources of profit did not undergo significant changes during the reporting period[55] Year-on-Year Changes in Key Financial Data Operating revenue increased by 6.69%, net profit by 31.41%, while financial expenses significantly decreased due to exchange gains Year-on-Year Changes in Key Financial Data | Indicator | Current Period (RMB) | Prior Year Period (RMB) | YoY Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Operating Revenue | 579,344,557.65 | 543,017,402.22 | 6.69% | | | Operating Cost | 92,683,800.76 | 80,621,369.42 | 14.96% | | | Sales Expenses | 149,133,204.14 | 160,378,604.52 | -7.01% | | | Administrative Expenses | 43,671,009.11 | 44,033,803.71 | -0.82% | | | Financial Expenses | -24,207,166.65 | -10,261,583.63 | -135.90% | Primarily due to increased exchange gains | | Income Tax Expense | 30,472,468.46 | 14,567,526.82 | 109.18% | Primarily due to increased profit | | R&D Investment | 90,526,230.52 | 106,212,012.43 | -14.77% | | | Net Cash Flow from Operating Activities | 170,583,283.15 | 139,148,728.65 | 22.59% | | | Net Cash Flow from Investing Activities | -31,235,310.25 | 108,191,267.75 | -128.87% | Primarily due to reduced redemption of wealth management products | | Net Cash Flow from Financing Activities | -107,598,107.53 | -92,209,716.20 | -16.69% | | | Net Increase in Cash and Cash Equivalents | 41,095,790.72 | 154,071,808.02 | -73.33% | Primarily due to reduced redemption of wealth management products | Products or Services Accounting for Over 10% of Revenue | 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 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Detection Reagents | 483,334,684.62 | 44,845,878.80 | 90.72% | 7.93% | 9.94% | -0.17% | | Testing Services | 32,504,937.59 | 16,688,132.64 | 48.66% | 0.92% | 6.75% | -2.80% | | Drug Clinical Research Services | 56,988,281.06 | 26,707,033.52 | 53.14% | -5.00% | 20.18% | -9.81% | By Business Management Category | Category | Current Period Operating Revenue (RMB 10,000) | Prior Year Period Operating Revenue (RMB 10,000) | YoY Change | | :--- | :--- | :--- | :--- | | Domestic Sales | 44,194.14 | 41,260.50 | 7.11% | | International Sales & Pharma Business | 13,740.31 | 13,041.24 | 5.36% | 4. Analysis of Non-Principal Business This section analyzes the non-principal business items, noting their positive and negative impacts on total profit and their non-sustainable nature Non-Principal Business Gains and Losses and Their Impact | Item | Amount (RMB) | Percentage of Total Profit | Sustainability | | :--- | :--- | :--- | :--- | | Investment Income | 249,174.30 | 0.11% | No | | Gains/Losses from Fair Value Changes | 3,241,563.21 | 1.48% | No | | Asset Impairment | 55,922.24 | 0.03% | No | | Non-Operating Income | 203,350.51 | 0.09% | No | | Non-Operating Expenses | 3,431,680.77 | 1.56% | No | | Other Income | 4,405,158.18 | 2.01% | No | | Credit Impairment Losses | -5,726,317.57 | -2.61% | No | 5. Analysis of Assets and Liabilities This section analyzes the company's asset and liability composition and changes, highlighting shifts in monetary funds and financial assets, and restricted assets 1. Significant Changes in Asset Composition Monetary funds and accounts receivable increased their proportion of total assets, while financial assets held for trading decreased, mainly due to wealth management product redemptions Significant Changes in Asset Composition | Item | Amount at Period-End (RMB) | % of Total Assets | Amount at Prior Year-End (RMB) | % of Total Assets | % Change in Proportion | Explanation of Significant Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Monetary Funds | 984,160,214.99 | 44.86% | 828,873,935.82 | 40.14% | 4.72% | Primarily due to increased redemption of wealth management products and operating cash inflows | | Accounts Receivable | 596,645,448.48 | 27.20% | 526,249,288.21 | 25.49% | 1.71% | | | Financial Assets Held for Trading | 242,347,632.37 | 11.05% | 351,885,744.55 | 17.04% | -5.99% | Primarily due to increased redemption of wealth management products | 2. Major Overseas Assets The company had no major overseas assets requiring disclosure during the reporting period - No major overseas assets during the reporting period[63] 3. Assets and Liabilities Measured at Fair Value The company's financial assets measured at fair value primarily consist of wealth management products, with a period-end balance of RMB 242 million Financial Assets Measured at Fair Value | Item | Beginning Balance (RMB) | Fair Value Change Gain/Loss for Current Period (RMB) | Amount Purchased During Current Period (RMB) | Amount Sold During Current Period (RMB) | Ending Balance (RMB) | | :--- | :--- | :--- | :--- | :--- | :--- | | Financial Assets Held for Trading | 351,885,744.55 | 3,241,563.21 | 90,000,000.00 | 202,779,675.39 | 242,347,632.37 | 4. Asset Restrictions as of the End of the Reporting Period As of the reporting period end, RMB 627 million in monetary funds were restricted due to fixed deposits held to maturity Asset Restrictions | Item | Carrying Amount at Period-End (RMB) | Reason for Restriction | | :--- | :--- | :--- | | Monetary Funds | 626,833,800.00 | Fixed deposits planned to be held to maturity | 6. Analysis of Investment Status This section analyzes the company's investment activities, noting no significant equity or non-equity investments, and details its entrusted wealth management activities 4. Financial Assets Measured at Fair Value The company's financial derivatives had a period-end balance of RMB 242 million, with a fair value change gain of RMB 3.2416 million for the current period Financial Assets Measured at Fair Value | Asset Category | Initial Investment Cost (RMB) | Fair Value Change Gain/Loss for Current Period (RMB) | Amount Purchased During Current Period (RMB) | Amount Sold During Current Period (RMB) | Ending Balance (RMB) | Source of Funds | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Financial Derivatives | 351,885,744.55 | 3,241,563.21 | 90,000,000.00 | 202,779,675.39 | 242,347,632.37 | Own Funds | 6. Entrusted Wealth Management, Derivative Investments, and Entrusted Loans The company engaged in entrusted wealth management totaling RMB 386.108 million, with an outstanding balance of RMB 247.108 million at period-end, and no derivative investments or entrusted loans Overview of Entrusted Wealth Management During the Reporting Period | Specific Type | Source of Entrusted Wealth Management Funds | Amount of Entrusted Wealth Management (RMB 10,000) | Outstanding Balance (RMB 10,000) | Overdue Unrecovered Amount (RMB 10,000) | | :--- | :--- | :--- | :--- | :--- | | Bank Wealth Management Products | Own Funds | 36,610.8 | 22,710.8 | 0 | | Brokerage Wealth Management Products | Own Funds | 2,000 | 2,000 | 0 | | Total | | 38,610.8 | 24,710.8 | 0 | - No derivative investments or entrusted loans during the reporting period[70][71] 7. Disposal of Major Assets and Equity The company did not dispose of any major assets or equity during the reporting period - Company did not dispose of any major assets or equity during the reporting period[72][73] 8. Analysis of Major Holding and Participating Companies The company had no major holding or participating company information requiring disclosure during the reporting period - No major holding or participating company information requiring disclosure during the reporting period[73] 9. Structured Entities Controlled by the Company The company had no structured entities under its control during the reporting period - No structured entities controlled by the company during the reporting period[74] 10. Risks Faced by the Company and Countermeasures The company addresses industry policy, R&D, gross margin, and competition risks through strategic initiatives and internal controls - Company faces risks from changes in industry policies; countermeasures include establishing policy monitoring and early warning mechanisms, increasing R&D investment, optimizing internal management, and expanding international markets[75] - Countermeasures for new product R&D and registration risks include establishing market-demand-oriented R&D mechanisms, improving R&D management systems, strengthening communication with regulatory authorities, and implementing innovative talent incentive programs[76] - Countermeasures for declining gross margin risks include strictly implementing "cost control, quality assurance, and efficiency improvement" principles, strengthening budget management, and optimizing product structure[77] - Countermeasures for intensified industry competition risks include continuously increasing R&D investment, strengthening intellectual property protection, optimizing marketing network layout, and improving talent incentive mechanisms[79] 11. Registration Form for Investor Relations Activities During the Reporting Period During the reporting period, the company engaged in two investor activities, discussing operating performance for 2024 and Q1 2025 Registration Form for Investor Relations Activities During the Reporting Period | Reception Date | Reception Method | Type of Reception Object | Main Content Discussed | | :--- | :--- | :--- | :--- | | April 22, 2025 | Phone Communication | Institutional Investors | Operating performance for 2024 and Q1 2025 | | May 15, 2025 | Online Platform Exchange | Public Investors | Operating performance for 2024 and Q1 2025 | 12. Formulation and Implementation of Market Value Management System and Valuation Enhancement Plan The company has established a market value management system to ensure compliance and protect investor interests, but has not disclosed a valuation enhancement plan - Company has formulated a "Market Value Management System" to ensure legal, compliant, scientific, and effective market value management[81] - Company has not disclosed a valuation enhancement plan[81] 13. Implementation of "Dual Improvement in Quality and Returns" Action Plan The company has disclosed its "Dual Improvement in Quality and Returns" action plan, focusing on market expansion, innovation, governance, and stable dividends to enhance value - Company has disclosed its "Dual Improvement in Quality and Returns" action plan to enhance listed company quality and investment value[82][83] - Key initiatives include focusing on core business to expand markets, fostering new quality productive forces through innovation, strengthening standardized operations and information disclosure, and implementing a stable dividend policy[83] Part IV Corporate Governance, Environment, and Society This section covers changes in the company's governance structure, profit distribution, employee incentives, environmental disclosures, and social responsibility initiatives 1. Changes in Directors, Supervisors, and Senior Management During the reporting period, several changes occurred in the company's leadership, including resignations, appointments, and elections Changes in Directors, Supervisors, and Senior Management | Name | Position | Type | Date | Reason | | :--- | :--- | :--- | :--- | :--- | | Wang Hongyu | Chairman of Supervisory Board, Employee Representative Supervisor | Resignation | January 07, 2025 | Job transfer | | Wang Hongyu | Deputy General Manager | Appointment | January 08, 2025 | Job transfer | | Tu Dongming | Chairman of Supervisory Board, Employee Representative Supervisor | Election | January 07, 2025 | Job transfer | | Yang Shuang | Deputy General Manager | Appointment | January 08, 2025 | Job transfer | | Dong Zhengwei | Deputy General Manager | Appointment | January 08, 2025 | Job transfer | 2. Profit Distribution and Capital Reserve Conversion to Share Capital for the Current Reporting Period The company plans no cash dividends, bonus shares, or capital reserve conversions for this half-year - Company plans no cash dividends, bonus shares, or capital reserve conversions for the half-year[86] 3. Implementation of Equity Incentive Plans, Employee Stock Ownership Plans, or Other Employee Incentive Measures The company's 2023 Restricted Stock Incentive Plan saw initial grants and subsequent repurchases, with no other employee incentive measures in place - Company's 2023 Restricted Stock Incentive Plan completed initial grant registration, and 1,525,825 restricted shares were repurchased and cancelled on May 22, 2025[87] - No employee stock ownership plans or other employee incentive measures during the reporting period[88] 4. Environmental Information Disclosure The company and its major subsidiaries are not designated as enterprises required to disclose environmental information by law - Company and its major subsidiaries are not included in the list of enterprises required to disclose environmental information by law[89] 5. Social Responsibility The company actively fulfills its social responsibilities by prioritizing patient care, strengthening governance, promoting sustainability, engaging in public welfare, and fostering employee development - Company deeply implements Party building requirements, integrating Party building with corporate culture construction[89] - Company strictly adheres to laws and regulations, continuously improves governance structure, strengthens internal control, and highly values investor rights protection[90] - Company actively responds to "carbon peak and carbon neutrality" strategies, integrating environmental protection into the entire project lifecycle to promote green and low-carbon development[90] - Company actively participates in cancer prevention and treatment public welfare, conducting popular science education and disease screening activities[90] - Company is committed to building a comprehensive employee development system, including talent cultivation, incentives, and cultural construction, and safeguarding employees' rights to participate in corporate governance[91] Part V Significant Events This section details important events, including commitments, related party transactions, litigation, and other material matters affecting the company 1. Commitments Fulfilled During the Reporting Period and Overdue Unfulfilled Commitments by Controlling Shareholder, Shareholders, Related Parties, Acquirers, and the Company During the reporting period, all relevant parties fulfilled their commitments, with no overdue unfulfilled commitments - No overdue unfulfilled commitments by relevant parties during the reporting period[93] 2. Non-Operating Funds Occupied by Controlling Shareholder and Other Related Parties from the Listed Company During the reporting period, there were no instances of non-operating funds being occupied by the controlling shareholder or other related parties from the listed company - No non-operating funds occupied by controlling shareholder or other related parties during the reporting period[94] 3. Irregular External Guarantees The company had no irregular external guarantees during the reporting period - No irregular external guarantees during the reporting period[95] 4. Appointment and Dismissal of Accounting Firms The company's semi-annual financial report was not audited - Company's semi-annual financial report was not audited[96] 5. Explanation by the Board of Directors, Supervisory Board, and Audit Committee on the "Non-Standard Audit Report" for the Current Reporting Period This section is not applicable as the company's semi-annual report was not audited, thus there is no non-standard audit report - This section is not applicable as the company's semi-annual report was not audited[97] 6. Explanation by the Board of Directors on the "Non-Standard Audit Report" for the Prior Year This section is not applicable as the company had no non-standard audit report for the prior year - This section is not applicable as the company had no non-standard audit report for the prior year[97] 7. Bankruptcy and Reorganization Matters The company had no bankruptcy and reorganization matters during the reporting period - No bankruptcy and reorganization matters during the reporting period[97] 8. Litigation Matters The company is involved in significant arbitration for RMB 13.955 million due to outstanding technology transfer fees, and other minor lawsuits Significant Litigation and Arbitration Matters | Basic Information of Litigation (Arbitration) | Amount Involved (RMB 10,000) | Provision for Estimated Liabilities | Litigation (Arbitration) Progress | Disclosure Date | | :--- | :--- | :--- | :--- | :--- | | Company initiated arbitration against Hangzhou Aiveke Biotechnology Co., Ltd. due to outstanding technology transfer fees | 1,395.5 | No | Under review | May 16, 2025 | Other Litigation Matters | Basic Information of Litigation (Arbitration) | Amount Involved (RMB 10,000) | Provision for Estimated Liabilities | Litigation (Arbitration) Progress | | :--- | :--- | :--- | :--- | | Summary of other lawsuits not meeting the disclosure threshold for significant litigation (company and subsidiaries as plaintiffs) | 549.6 | No | Under review | 9. Penalties and Rectification The company had no penalties or rectification situations during the reporting period - No penalties or rectification situations during the reporting period[100] 10. Integrity Status of the Company, its Controlling Shareholder, and Actual Controller During the reporting period, the company, its controlling shareholder, and actual controller maintained good integrity - Company, its controlling shareholder, and actual controller maintained good integrity[101] 11. Significant Related Party Transactions During the reporting period, the company had no significant related party transactions or financial business with related financial companies - No significant related party transactions related to daily operations during the reporting period[102] - No related party transactions involving acquisition or disposal of assets or equity during the reporting period[103] - No related party creditor-debtor relationships during the reporting period[105] - No deposits, loans, credit lines, or other financial business between the company and related financial companies[107] 12. Significant Contracts and Their Performance The company had no significant entrustment, contracting, leasing projects exceeding 10% of total profit, guarantees, or other major contracts during the reporting period - No entrustment or contracting situations during the reporting period[110][111] - No leasing projects generated profit exceeding 10% of total profit during the reporting period[112] - No significant guarantees during the reporting period[113] - No major contracts for daily operations or other significant contracts during the reporting period[116] 13. Explanation of Other Significant Matters The company had no other significant matters requiring explanation during the reporting period - No other significant matters requiring explanation during the reporting period[117] 14. Significant Matters of Company Subsidiaries The company had no significant matters concerning its subsidiaries during the reporting period - No significant matters concerning company subsidiaries during the reporting period[118] Part VI Share Changes and Shareholder Information This section details changes in the company's share capital, securities issuance, shareholder structure, and director/supervisor/senior management shareholdings 1. Share Changes The company's total shares decreased by 6,900,665 shares due to executive lock-up expirations, new appointments, and share repurchases/cancellations, with minimal impact on EPS Share Changes | Category | Quantity Before Change (shares) | Increase/Decrease in This Change (shares) | Quantity After Change (shares) | | :--- | :--- | :--- | :--- | | I. Restricted Shares | 3,527,230 | -1,588,449 | 1,938,781 | | II. Unrestricted Shares | 394,909,579 | -5,312,216 | 389,597,363 | | III. Total Shares | 398,436,809 | -6,900,665 | 391,536,144 | - Share changes primarily due to expiration of lock-up periods for former senior executives, appointment of new senior executives, cancellation of 5,374,840 repurchased shares, and repurchase and cancellation of 1,525,825 restricted shares[121][122] - Total share capital reduction had minimal impact on earnings per share and diluted earnings per share[124] 2. Securities Issuance and Listing The company had no securities issuance or listing during the reporting period - No securities issuance or listing during the reporting period[128] 3. Shareholder Numbers and Shareholding At period-end, the company had 25,310 common shareholders, with Forward-looking Investment (Hong Kong) Co., Ltd. as the largest shareholder, holding 22.40% - Total number of common shareholders at period-end was 25,310[128] Shareholding of Shareholders Holding 5% or More or Top 10 Shareholders | Shareholder Name | Shareholder Nature | Shareholding Percentage | Number of Shares Held at Period-End (shares) | Number of Unrestricted Shares Held (shares) | | :--- | :--- | :--- | :--- | :--- | | Forward-looking Investment (Hong Kong) Co., Ltd. | Overseas Legal Person | 22.40% | 87,701,616 | 87,701,616 | | Hong Kong Securities Clearing Company Limited | Overseas Legal Person | 8.09% | 31,670,556 | 31,670,556 | | Xiamen Yixiang Investment Partnership (Limited Partnership) | Domestic Non-State Legal Person | 5.11% | 20,026,900 | 20,026,900 | | Xiamen Keying Investment Partnership (Limited Partnership) | Domestic Non-State Legal Person | 4.07% | 15,940,946 | 15,940,946 | | Bank of China Co., Ltd. - Huabao CSI Medical ETF | Other | 2.31% | 9,036,600 | 9,036,600 | | National Social Security Fund 413 Portfolio | Other | 1.31% | 5,121,500 | 5,121,500 | | Xiamen Haicang District Rundingsheng Investment Partnership (General Partnership) | Domestic Non-State Legal Person | 1.05% | 4,098,726 | 4,098,726 | | Lin Zuohua | Domestic Natural Person | 0.77% | 3,006,263 | 3,006,263 | | Song Ning | Domestic Natural Person | 0.76% | 2,970,000 | 2,970,000 | | Huang Mei | Domestic Natural Person | 0.67% | 2,606,221 | 2,606,221 | - No associated relationship or concerted action relationship found among the above shareholders[129] 4. Changes in Shareholdings of Directors, Supervisors, and Senior Management The total shareholdings of directors, supervisors, and senior management decreased, primarily due to the repurchase and cancellation of restricted shares for certain individuals Changes in Shareholdings of Directors, Supervisors, and Senior Management | Name | Position | Shares Held at Beginning of Period (shares) | Shares Reduced During Current Period (shares) | Shares Held at End of Period (shares) | Restricted Shares Granted at End of Period (shares) | | :--- | :--- | :--- | :--- | :--- | :--- | | Luo Jiemin | Director, General Manager | 151,875 | 0 | 151,875 | 0 | | Ruan Li | Director, Senior Deputy General Manager | 153,075 | 0 | 153,075 | 0 | | Zheng Huibin | Deputy General Manager | 151,875 | 0 | 151,875 | 0 | | Chen Ying | CFO, Board Secretary | 151,875 | 0 | 151,875 | 0 | | Yang Shuang | Deputy General Manager | 62,150 | 17,500 | 44,650 | 17,500 | | Dong Zhengwei | Deputy General Manager | 24,500 | 12,250 | 12,250 | 12,250 | | Tu Dongming | Supervisor | 85,560 | 24,500 | 61,060 | 0 | | Total | | 780,910 | 54,250 | 726,660 | 29,750 | - Yang Shuang and Dong Zhengwei had some restricted shares repurchased and cancelled due to the company's performance assessment not being met[131][132] - Tu Dongming's restricted shares were repurchased and cancelled as he no longer met incentive eligibility after being elected supervisor[132] 5. Changes in Controlling Shareholder or Actual Controller The company's controlling shareholder or actual controller did not change during the reporting period - No changes in controlling shareholder or actual controller during the reporting period[133] 6. Preferred Share Information The company had no preferred shares during the reporting period - No preferred shares during the reporting period[134] Part VII Bond-Related Matters This section confirms that the company had no bond-related matters during the reporting period Bond-Related Matters The company had no bond-related matters during the reporting period - No bond-related matters during the reporting period[136] Part VIII Financial Report This section presents the company's unaudited semi-annual financial statements, including balance sheets, income statements, cash flow statements, and detailed notes 1. Audit Report The company's semi-annual financial report was not audited - Company's semi-annual financial report was not audited[138] 2. Financial Statements This section provides the company's comprehensive financial statements for the first half of 2025, detailing its financial position, operating results, and cash flows - This section includes consolidated and parent company balance sheets, income statements, cash flow statements, and statements of changes in owners' equity[139][143][147][151][155][159][163][167] 3. Company Basic Information The company, established in 2008 and listed in 2017, operates in pharmaceutical manufacturing, with its main business activities including technical services, medical device production and sales, testing services, and import/export of goods - Company established on February 14, 2008, listed on Shenzhen Stock Exchange in August 2017, belongs to pharmaceutical manufacturing industry[172] - As of June 30, 2025, total issued share capital was 391,536,144 shares[173] - Main business activities include technical services, medical device production and sales, testing services, and import/export of goods[173] - Controlling shareholder is Forward-looking Investment (Hong Kong) Co., Ltd., actual controller is LI-MOU ZHENG[173] 4. Basis of Financial Statement Preparation These financial statements are prepared in accordance with Chinese accounting standards and CSRC regulations, on a going concern basis - Financial statements prepared in accordance with Accounting Standards for Business Enterprises and CSRC regulations[174] - Financial statements prepared on a going concern basis[175] 5. Significant Accounting Policies and Accounting Estimates This section details the company's adherence to accounting standards, key accounting policies, and estimates for financial reporting accuracy - Financial statements comply with Accounting Standards for Business Enterprises, truly and completely reflecting the company's financial position, operating results, and cash flows[178] - Company's operating cycle is 12 months, using RMB as the functional currency[180][181] - Company classifies financial assets into those measured at amortized cost, at fair value through other comprehensive income, and at fair value through profit or loss[195][197] - Company recognizes revenue when the customer obtains control of the related goods or services, using different recognition methods based on the nature of performance obligations[253][258] 6. Taxation This section outlines the company's main tax categories, rates, and various tax incentives, including high-tech enterprise status and R&D expense super deductions Main Tax Categories and Rates | Tax Category | Tax Rate | | :--- | :--- | | Value-Added Tax | 3%, 6%, 13% | | Urban Maintenance and Construction Tax | 7%, 5% | | Corporate Income Tax | 15%, 16.5%, 17%, 20%, 21%, 25%, 27% | | Education Surcharge | 3% | | Local Education Surcharge | 2%, 1% | - Company and its subsidiary Xiamen AmoyDx Biotechnology Research Center Co., Ltd. enjoy a 15% corporate income tax rate as high-tech enterprises[275] - Subsidiary Xiamen AmoyDx Biotechnology Research Center Co., Ltd. enjoys VAT exemption for medical service projects provided[276] - Company and some subsidiaries enjoy R&D expense super deduction policy: R&D expenses not forming intangible assets are 100% super deducted, while those forming intangible assets are amortized at 200%[278][279] 7. Notes to Consolidated Financial Statement Items This section provides detailed explanations for all major items in the consolidated financial statements, including balances, changes, and accounting policies - Monetary funds ending balance is RMB 984 million, of which RMB 627 million are fixed deposits planned to be held to maturity[282] - Financial assets held for trading ending balance is RMB 242 million, a decrease from RMB 352 million at the beginning of the period[284] - Accounts receivable ending balance is RMB 597 million, an increase from RMB 526 million at the beginning of the period, with a bad debt provision rate of 4.92%[297] - Long-term equity investments ending carrying amount is RMB 10.9502 million, a decrease from RMB 11.9518 million at the beginning of the period, mainly due to investment gains/losses accounted for under the equity method[391] - Share capital ending balance is RMB 392 million, a decrease from RMB 398 million at the beginning of the period, mainly due to repurchase and cancellation of shares[467][468] - Operating revenue for the current period is RMB 579 million, operating cost is RMB 93 million, with a high gross margin for principal business[483] 8. Research and Development Expenses This section details the company's R&D expenditure for the reporting period, totaling RMB 90.5262 million, with all expenses recognized in current profit or loss R&D Expense Composition | Item | Amount for Current Period (RMB) | Amount for Prior Period (RMB) | | :--- | :--- | :--- | | Personnel Expenses | 52,607,388.63 | 47,739,502.46 | | Direct Inputs | 18,168,699.96 | 27,287,965.41 | | Depreciation and Amortization of Long-Term Expenses | 12,149,036.67 | 12,689,031.86 | | Travel Expenses | 2,369,405.23 | 2,754,397.26 | | Technical Service Fees | 2,311,232.73 | 7,813,317.32 | | Share-Based Payment Expenses | 940,219.45 | 6,246,803.58 | | Other | 1,980,247.85 | 1,680,994.54 | | Total | 90,526,230.52 | 106,212,012.43 | - Company expenses all costs incurred during R&D, clinical trials, and registration to current profit or loss[238] - No R&D projects met capitalization criteria during the reporting period[130][535] 9. Changes in Consolidation Scope During the reporting period, the company experienced no changes in its consolidation scope due to business combinations, reverse acquisitions, or disposals of subsidiaries - No business combinations under non-common control during the reporting period[130][537] - No business combinations under common control during the reporting period[132][542] - No reverse acquisitions or disposals of subsidiaries leading to loss of control during the reporting period[133][541][546] 10. Interests in Other Entities This section discloses the company's interests in its 9 wholly-owned subsidiaries and associates, detailing their business nature and financial performance - Company owns 9 wholly-owned subsidiaries, all with 100% shareholding[173][547][548] - Subsidiaries' main business nature includes biotechnology R&D, medical device sales, registration and sales of oncology molecular diagnostic products, and related technical services[547][548] Summary Financial Information of Insignificant Associates | Item | Ending Balance/Current Period Amount (RMB) | | :--- | :--- | | Total Investment Carrying Amount | 10,950,220.10 | | Net Profit | -366,210.76 | | Other Comprehensive Income | -635,379.32 | | Total Comprehensive Income | -1,001,590.08 | 11. Government Grants This section details the company's government grant liability items and grants recognized in current profit or loss, including asset-related and revenue-related subsidies Liability Items Involving Government Grants | Account | Beginning Balance (RMB) | New Grants During Current Period (RMB) | Amount Transferred to Other Income During Current Period (RMB) | Ending Balance (RMB) | Asset/Revenue Related | | :--- | :--- | :--- | :--- | :--- | :--- | | Deferred Income | 17,982,060.31 | 364,000.00 | 2,531,685.42 | 15,814,374.89 | Asset-related | Government Grants Recognized in Current Profit or Loss | Account | Amount for Current Period (RMB) | Amount for Prior Period (RMB) | | :--- | :--- | :--- | | Deferred Income - Asset-Related Government Grants | 2,531,685.42 | 1,669,274.88 | | Other Income - Revenue-Related Government Grants | 1,628,149.80 | 6,955,581.97 | 12. Risks Related to Financial Instruments The company manages credit, market (including interest rate and exchange rate), and liquidity risks through various monitoring and matching strategies - Company faces credit risk, market risk (exchange rate risk, interest rate risk, and other price risks), and liquidity risk[564][568] - Company manages credit risk through customer due diligence and credit monitoring[565][566] - Company manages liquidity risk by monitoring cash balances, readily marketable securities, and 12-month cash flow forecasts[567] - Company faces exchange rate risk from USD and EUR denominated financial assets, mitigating it by matching foreign currency receipts and payments[568] Financial Assets Held for Trading | Item | Ending Balance (RMB) | Prior Year-End Balance (RMB) | | :--- | :--- | :--- | | Financial Assets Held for Trading | 242,347,632.37 | 351,885,744.55 | 13. Disclosure of Fair Value This section discloses the fair value of the company's assets and liabilities, with RMB 242 million in financial assets held for trading measured using Level 2 fair value Fair Value of Assets and Liabilities Measured at Fair Value at Period-End | Item | Level 2 Fair Value Measurement (RMB) | Total (RMB) | | :--- | :--- | :--- | | I. Continuous Fair Value Measurement | | | | （I）Financial Assets Held for Trading | 242,347,632.37 | 242,347,632.37 | | Total Assets Continuously Measured at Fair Value | 242,347,632.37 | 242,347,632.37 | - Financial assets held for trading are valued using the market approach, with market interest rates of similar terms and risks as key parameters[576] 14. Related Parties and Related Party Transactions This section identifies the company's controlling shareholder and actual controller, and confirms the absence of significant related party transactions during the reporting period - Company's controlling shareholder is Forward-looking Investment (Hong Kong) Co., Ltd., actual controller is LI-MOU ZHENG[578] - During the reporting period, company accepted RMB 0 in services from Beijing Mingjia Engineering Design Co., Ltd., compared to RMB 148,800 in the prior period[582] - No related party entrusted management/contracting or entrusted out/subcontracting during the reporting period[584][585] - No significant related party guarantees, fund transfers, asset transfers, or debt restructuring during the reporting period[588][589] 15. Share-Based Payments This section details the company's 2023 Restricted Stock Incentive Plan, including repurchases and the total expense recognized for equity-settled share-based payments Overall Share-Based Payment Information | Category of Grantee | Number of Shares Forfeited in Current Period (shares) | Amount Forfeited in Current Period (RMB) | | :--- | :--- | :--- | | Core Management and Core Technical (Business) Backbone | 1,525,825 | 17,958,960.25 | | Total | 1,525,825 | 17,958,960.25 | - Cumulative amount of equity-settled share-based payments recognized in capital reserves is RMB 27,027,112.30[599] - Total expense of equity-settled share-based payments recognized in the current period is RMB 2,730,576.46[599][602] - Company's 2023 Restricted Stock Incentive Plan initially granted 4.3895 million restricted shares to 394 core management and core technical (business) backbone personnel at a grant price of RMB 11.77 per share[599][600] 16. Commitments and Contingencies As of the balance sheet date, the company had no significant commitments or important contingencies requiring disclosure - No significant commitments as of the balance sheet date[602] - No important contingencies requiring disclosure[602] 17. Events After the Balance Sheet Date There were no significant non-adjusting events or profit distribution situations between the balance sheet date and the approval date of the financial report - No significant non-adjusting events between the balance sheet date and the approval date of the financial report[604] - No profit distribution situations between the balance sheet date and the approval date of the financial report[605] 18. Other Significant Matters During the reporting period, the company had no prior period accounting error corrections, debt restructurings, asset exchanges, annuity plans, discontinued operations, segment information, or other significant transactions and matters affecting investor decisions - No prior period accounting error corrections, debt restructurings, asset exchanges, annuity plans, discontinued operations, segment information, or other significant transactions and matters affecting investor decisions during the reporting period[606][608][609][610][612][613] 19. Notes to Parent Company Financial Statement Items This section provides detailed notes for the parent company's key financial statement items, including accounts receivable, long-term equity investments, operating revenue, and investment income - Parent company's accounts receivable ending carrying amount was RMB 632 million, an increase from RMB 538 million at the beginning of the period[616] - Parent company's long-term equity investments ending carrying amount was RMB 82.0564 million, an increase from RMB 78.2038 million at the beginning of the period[643] - Parent company's operating revenue for the current period was RMB 538 million, and operating cost was RMB 59 million[648] - Parent company's investment income for the current period was RMB 0.0132 million, primarily including equity method investment income and wealth management product investment income[652] 20. Supplementary Information This section provides supplementary financial details, including non-recurring gains and losses, net asset return, earnings per share, and confirms no accounting data differences under various standards Detailed Statement of Non-Recurring Gains and Losses for the Current Period | Item | Amount (RMB) | | :--- | :--- | | Gains/Losses from Disposal of Non-Current Assets | -44,133.07 | | Government Subsidies Included in Current Profit/Loss | 4,405,158.18 | | Gains/Losses from Fair Value Changes and Disposal of Financial Assets and Liabilities | 3,856,948.27 | | Other Non-Operating Income and Expenses Apart from the Above | -3,228,330.26 | | Less: Income Tax Impact | 748,446.47 | | Total | 4,241,196.65 | Return on Net Assets and Earnings Per Share | Profit for the Reporting Period | Weighted Average Return on Net Assets | Basic Earnings Per Share (RMB/share) | Diluted Earnings Per Share (RMB/share) | | :--- | :--- | :--- | :--- | | Net Profit Attributable to Common Shareholders of the Company | 9.92% | 0.48 | 0.48 | | Net Profit Attributable to Common Shareholders of the Company After Deducting Non-Recurring Gains and Losses | 9.70% | 0.47 | 0.47 | - No differences in accounting data under domestic and international accounting standards[158][567]