康辰药业(603590) - 2025 Q2 - 季度财报

Important Notice This section provides crucial declarations and disclaimers regarding the semi-annual report's accuracy, audit status, and potential risks Board of Directors, Supervisory Board, and Senior Management Statement The company's Board of Directors, Supervisory Board, and all directors, supervisors, and senior management guarantee the truthfulness, accuracy, and completeness of the semi-annual report and assume legal responsibility - Company's Board of Directors, Supervisory Board, and all directors, supervisors, and senior management guarantee the truthfulness, accuracy, and completeness of the semi-annual report, and bear individual and joint legal liabilities[5] Board Meeting Attendance All company directors attended the Board of Directors meeting - All company directors attended the Board of Directors meeting[6] Report Audit Status This semi-annual report has not been audited - This semi-annual report has not been audited[7] Financial Report Authenticity Statement Company head Liu Jianhua, chief accountant Liu Xiaohan, and head of accounting Wang Jing declare the financial report's truthfulness, accuracy, and completeness - Company head Liu Jianhua, chief accountant Liu Xiaohan, and head of accounting Wang Jing declare the financial report's truthfulness, accuracy, and completeness[7] Profit Distribution Plan There is no profit distribution or capital reserve to share capital increase plan approved by the Board for this reporting period - There is no profit distribution or capital reserve to share capital increase plan approved by the Board for this reporting period[8] Forward-Looking Statement Risk Disclaimer Forward-looking descriptions in this report, such as future plans and development strategies, do not constitute a commitment to investors, who are advised to be aware of investment risks - Forward-looking descriptions in this report, such as future plans, development strategies, and other forward-looking statements, do not constitute a commitment to investors, who are advised to be aware of investment risks[8] Occupation of Funds by Controlling Shareholder and Related Parties The company has no non-operating occupation of funds by controlling shareholders or other related parties - The company has no non-operating occupation of funds by controlling shareholders or other related parties[9] External Guarantees The company has not provided external guarantees in violation of prescribed decision-making procedures - The company has not provided external guarantees in violation of prescribed decision-making procedures[9] Directors' Guarantee of Report Authenticity There is no situation where more than half of the directors cannot guarantee the truthfulness, accuracy, and completeness of the company's disclosed semi-annual report - There is no situation where more than half of the directors cannot guarantee the truthfulness, accuracy, and completeness of the company's disclosed semi-annual report[9] Major Risk Warning The company has detailed potential risks in "Section III Management Discussion and Analysis, V. Other Disclosures, (I) Possible Risks" of this report - The company has detailed potential risks in this report, specifically in "Section III Management Discussion and Analysis, V. Other Disclosures, (I) Possible Risks"[9] Definitions This section defines common terms used in the report, ensuring clear understanding of key concepts Definitions of Common Terms This section provides definitions for common terms used in the report, covering company names, organizational structures, laws, regulations, controlling shareholders, subsidiaries, product names, industry terms, and the reporting period, ensuring clear understanding of the report's content - Company Abbreviation: Konruns Pharmaceutical[14] - Company's Actual Controllers: Liu Jianhua, Wang Xijuan[14] - Main Products: Suling (Batroxobin for Injection), Miacalcic (Salmon Calcitonin Injection and Nasal Spray)[14] - Reporting Period: January 1, 2025, to June 30, 2025[14] Company Profile and Key Financial Indicators This section provides an overview of the company's basic information, contact details, stock profile, and key financial performance indicators for the reporting period Company Information This section outlines the company's basic registration information, including its Chinese name, abbreviation, foreign name, and legal representative, providing identity details for investors - Company Chinese Name: Beijing Konruns Pharmaceutical Co., Ltd[16] - Company Chinese Abbreviation: Konruns Pharmaceutical[16] - Legal Representative: Liu Jianhua[16] Contact Person and Information This section provides contact details for the company's Board Secretary and Securities Affairs Representative, including names, addresses, phone numbers, faxes, and email, for investor communication and inquiries - Board Secretary: Huang Xiaodong[17] - Securities Affairs Representative: Zhang Shina[17] - Contact Number: 010-82898898[17] - Email: ir@konruns.cn[17] Brief Introduction to Changes in Basic Information This section describes the company's registered and office addresses, noting no historical changes during the reporting period, maintaining stability in basic company information - Company Registered Address: No 11 Xingsheng South Road, Economic Development Zone, Miyun District, Beijing[18] - Company Office Address: Building 3, No 7 Courtyard, Science Park Road, Zhongguancun Life Science Park, Changping District, Beijing[18] - No changes occurred during the reporting period[18] Brief Introduction to Changes in Information Disclosure and Document Storage Locations This section lists the company's designated newspapers for information disclosure, the website address for semi-annual reports, and the report storage location, ensuring transparency and accessibility of information - Designated newspapers for information disclosure: China Securities Journal, Shanghai Securities News, Securities Daily, Securities Times[19] - Website address for semi-annual reports: http://www.sse.com.cn[19](index=19&type=chunk) - Company semi-annual report storage location: Building 3, No 7 Courtyard, Science Park Road, Zhongguancun Life Science Park, Changping District, Beijing[19] Company Stock Profile This section provides basic information about the company's stock, including its type, listing exchange, stock abbreviation, and code, clarifying its identity in the capital market - Stock Type: A-share[20] - Stock Listing Exchange: Shanghai Stock Exchange[20] - Stock Abbreviation: Konruns Pharmaceutical[20] - Stock Code: 603590[20] Company's Key Accounting Data and Financial Indicators This section discloses the company's key accounting data and financial indicators for the first half of 2025, showing growth in operating revenue and net profit, but a significant decrease in net cash flow from operating activities 2025 H1 Key Accounting Data | Indicator | Current Period (Jan-Jun) | Prior Year Period | YoY Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 460,869,253.77 | 405,024,853.01 | 13.79 | | Total Profit | 109,767,887.26 | 100,804,286.39 | 8.89 | | Net Profit Attributable to Shareholders of Listed Company | 91,046,083.02 | 79,202,846.22 | 14.95 | | Net Profit Attributable to Shareholders of Listed Company (Excluding Non-Recurring Gains/Losses) | 96,257,444.50 | 74,497,082.33 | 29.21 | | Net Cash Flow from Operating Activities | -11,677,133.72 | 82,117,401.24 | -114.22 | 2025 H1 Key Financial Indicators | Indicator | Current Period (Jan-Jun) | Prior Year Period | YoY Change | | :--- | :--- | :--- | :--- | | Basic Earnings Per Share (Yuan/share) | 0.58 | 0.50 | 16.00 | | Diluted Earnings Per Share (Yuan/share) | 0.58 | 0.50 | 16.00 | | Basic EPS (Excluding Non-Recurring Gains/Losses) (Yuan/share) | 0.61 | 0.47 | 29.79 | | Weighted Average Return on Net Assets (%) | 2.87 | 2.54 | Increased by 0.33 percentage points | | Weighted Average Return on Net Assets (Excluding Non-Recurring Gains/Losses) (%) | 3.04 | 2.39 | Increased by 0.65 percentage points | - Net cash flow from operating activities同比下降 114.22% year-on-year, primarily due to increased cash paid to and on behalf of employees and increased taxes paid compared to the prior year period[23] Non-Recurring Gains and Losses Items and Amounts This section details the company's non-recurring gains and losses items and their amounts for the first half of 2025, totaling -5,211,361.48 yuan, which had an impact on net profit 2025 H1 Non-Recurring Gains and Losses Items | Non-Recurring Gains and Losses Item | Amount (Yuan) | | :--- | :--- | | Gains and losses from disposal of non-current assets | 130,668.15 | | Government grants recognized in current profit or loss | 1,908,885.78 | | Fair value changes and disposal gains/losses from financial assets and liabilities held by non-financial enterprises | 379,689.56 | | Gains and losses from entrusted investments or asset management | 2,538,452.19 | | Other non-operating income and expenses | -11,424,362.67 | | Other gains and losses meeting the definition of non-recurring gains and losses | 356,635.36 | | Less: Income tax impact | -901,291.51 | | Minority interest impact (after tax) | 2,621.36 | | Total | -5,211,361.48 | Net Profit After Deducting Impact of Share-Based Payments This section discloses the company's net profit after deducting the impact of share-based payments, which was 96,998,373.39 yuan for the first half of 2025, a year-on-year increase of 8.06% Net Profit After Deducting Impact of Share-Based Payments | Indicator | Current Period (Jan-Jun) | Prior Year Period | YoY Change (%) | | :--- | :--- | :--- | :--- | | Net Profit After Deducting Impact of Share-Based Payments | 96,998,373.39 | 89,760,145.02 | 8.06 | Management Discussion and Analysis This section provides a comprehensive review of the company's industry, business operations, core competencies, and financial performance during the reporting period Industry and Main Business The company operates in the pharmaceutical manufacturing industry, focusing on hemostasis and perioperative care, bone metabolism, oncology, and metabolic diseases, with key products "Suling" and "Miacalcic," while actively investing in innovative drug R&D - The company operates in the pharmaceutical manufacturing industry, focusing on unmet clinical needs in hemostasis and perioperative care, bone metabolism, oncology, and metabolic diseases[30] - "Suling" (Batroxobin for Injection) is a self-developed national Class 1 innovative drug, used for hemostasis in superficial surgical wounds, featuring "aggregation without thrombosis, balanced reconstruction, efficient hemostasis, and unlimited medical insurance coverage"[33] - "Miacalcic" is a salmon calcitonin product originally developed by Novartis, a polypeptide drug indicated for primary osteoporosis, secondary osteoporosis, and pain caused by bone loss or osteolysis[35] - KC1036 is a self-developed Class 1 innovative chemical drug, demonstrating anti-tumor activity by inhibiting multiple targets like AXL and VEGFR2, showing outstanding efficacy and good safety in advanced esophageal squamous cell carcinoma, rare thymic carcinoma, and pediatric Ewing's sarcoma[37][38][39] - ZY5301 is the only Class 1.2 innovative traditional Chinese medicine product approved by the National Medical Products Administration for "chronic pelvic pain after pelvic inflammatory disease sequelae," with Phase III clinical trials reaching primary endpoints, and is actively pursuing marketing authorization[40][41] - KC1086 is a completely self-developed, potent, highly selective lysine acetyltransferase 6 (KAT6) small molecule inhibitor with a novel structure, intended for the treatment of advanced recurrent or metastatic solid tumors, and has received clinical trial approval[41][42] - The registration application for canine Batroxobin for Injection was accepted in 2023, supplementary research was completed and submitted in Q1 2025, and it is currently in the re-examination and testing phase, aiming to expand into the pet medical market[43] Discussion and Analysis of Operations In the first half of 2025, the company achieved 13.79% year-on-year growth in operating revenue, 14.95% in net profit attributable to the parent, and 29.21% in non-recurring net profit attributable to the parent, indicating continuous improvement in operational quality, driven by strong marketing, R&D advancements, and strategic organizational development 2025 H1 Operating Performance | Indicator | Amount (10,000 Yuan) | YoY Growth (%) | | :--- | :--- | :--- | | Operating Revenue | 46,086.93 | 13.79 | | Net Profit Attributable to Parent Company Owners | 9,104.61 | 14.95 | | Net Profit Attributable to Parent Company Owners (Excluding Non-Recurring Gains/Losses) | 9,625.74 | 29.21 | - Marketing transformation covered 19 provinces, with self-operated regions maintaining high growth, and the sales expense ratio decreased to 44.35%, a year-on-year reduction of 3.49%, continuously improving marketing profitability and efficiency[44] - In R&D, the KC1086 project received clinical tacit approval, and the ZY5301 project advanced to the Pre-NDA critical stage, with cumulative R&D investment of 50.3574 million yuan, accounting for 10.93% of operating revenue[44] - The company deepened agile organizational construction, strengthened incentive mechanisms, and actively promoted R&D and manufacturing to benchmark international standards, exploring overseas cooperation[45] - The company adheres to the "pipeline-first innovation" strategy, through organic innovation and external acquisition, continuously enriching its differentiated product pipeline, with over 12 self-developed projects and over 6 projects under negotiation[46] - The company continues to advance its "digital-driven" strategy, resolving digital bottlenecks and introducing an AI-driven UMU learning platform to enhance the professional capabilities of medical specialists[47][48] Analysis of Core Competencies The company's core competencies are rooted in its integrated R&D platform, "self-operated dominant + alliance collaborative" marketing model, stringent quality control, and an agile, digitally-driven, innovation-focused organizational culture - The company has established a comprehensive, integrated innovation drug R&D core technology platform covering early drug discovery, pharmaceutical process development, pharmacology and toxicology evaluation, clinical research, and product commercialization[49] - The company adheres to innovation-driven and differentiated R&D strategies, focusing on unmet clinical needs in niche areas to avoid homogeneous competition and actively exploring "light blue ocean" markets[50] - Through self-development and external acquisition, the company continuously expands its product pipeline, forming a tiered product pipeline structure including marketed, pre-market, clinical, pre-clinical, and early research projects[52] - The company highly values intellectual property protection, holding 33 effective core invention patents (19 domestic, 14 overseas), with another 14 invention patent applications in substantive examination[53] - The R&D team comprises 98 individuals, accounting for 18.28% of the parent company's headcount, with 96.9% holding bachelor's degrees or higher, including 37 masters and 11 doctors, forming a "four pillars and eight beams" talent echelon[54] - The company has built a self-operated marketing team of over 400 people, transitioning its marketing model from a single alliance to a "self-operated dominant + alliance collaborative" dual-driven approach, and introducing a digital promotion platform to enhance precise marketing capabilities[57] - The company maintains a "quality first" approach in production, and its pharmacovigilance work received commendation from the National Medical Products Administration's Drug Evaluation Center[59] - The company builds an agile organization through flat management, rapid response, efficient collaboration, resource optimization, and employee empowerment to enhance organizational adaptability[60] - The company operates under the philosophy of "digital-driven, pipeline-first innovation, striving for achievement," guided by the "three-high" profile of strivers, integrating a culture of striving with its systems, structures, and mechanisms[61] Main Operating Performance In the first half of 2025, the company achieved operating revenue of 460.8693 million yuan, a 13.79% year-on-year increase; net profit attributable to the parent company owners of 91.0461 million yuan, up 14.95%; and net profit attributable to the parent company owners after deducting non-recurring gains and losses of 96.2574 million yuan, up 29.21% 2025 H1 Main Operating Data | Indicator | Amount (10,000 Yuan) | YoY Growth (%) | | :--- | :--- | :--- | | Operating Revenue | 46,086.93 | 13.79 | | Net Profit Attributable to Parent Company Owners | 9,104.61 | 14.95 | | Net Profit Attributable to Parent Company Owners (Excluding Non-Recurring Gains/Losses) | 9,625.74 | 29.21 | (一) Analysis of Main Business This period saw a 13.79% increase in operating revenue and a 6.75% increase in operating costs, with sales and administrative expenses rising, R&D expenses decreasing by 12.01%, a significant 114.22% drop in net cash flow from operating activities, a positive shift in net cash flow from investing activities, and a substantial reduction in net cash flow from financing activities Financial Statement Item Fluctuation Analysis | Item | Current Period Amount (Yuan) | Prior Year Period Amount (Yuan) | Change Ratio (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 460,869,253.77 | 405,024,853.01 | 13.79 | | Operating Cost | 45,249,089.13 | 42,387,416.16 | 6.75 | | Sales Expenses | 204,384,553.16 | 193,746,682.98 | 5.49 | | Administrative Expenses | 66,697,905.34 | 56,522,302.28 | 18.00 | | Financial Expenses | -450,710.38 | -2,260,888.85 | N/A | | R&D Expenses | 20,498,356.48 | 23,294,981.62 | -12.01 | | Net Cash Flow from Operating Activities | -11,677,133.72 | 82,117,401.24 | -114.22 | | Net Cash Flow from Investing Activities | 243,991,021.27 | -28,379,428.92 | N/A | | Net Cash Flow from Financing Activities | -55,984,605.75 | -1,670,433.70 | N/A | - The change in financial expenses was primarily due to an increase in interest expenses and a decrease in interest income during the reporting period[63] - The change in net cash flow from operating activities was mainly due to increased cash paid to and on behalf of employees and increased taxes paid compared to the prior year period[63] - The change in net cash flow from investing activities was primarily due to an increase in the amount of wealth management products redeemed by the company compared to the prior year period, driven by the wealth management cycle[63] - The change in net cash flow from financing activities was mainly due to dividend payments in the reporting period, which were not paid in the prior year period[63] (三) Analysis of Assets and Liabilities At the end of the reporting period, total assets and net assets attributable to shareholders slightly decreased; significant increases in monetary funds, receivables, prepayments, and other current assets were driven by wealth management redemptions, increased accounts receivable, and prepaid expenses, while other non-current assets significantly decreased due to reduced long-term wealth management products Asset and Liability Status Changes | Item Name | Current Period End Amount (Yuan) | Current Period End % of Total Assets | Prior Year End Amount (Yuan) | Prior Year End % of Total Assets | YoY Change (%) | Explanation | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Monetary Funds | 366,314,713.38 | 9.46 | 189,977,701.84 | 4.85 | 92.82 | Primarily due to redemption of wealth management products during the reporting period | | Receivables | 345,252,441.13 | 8.92 | 251,013,321.48 | 6.40 | 37.54 | Primarily due to increased accounts receivable of subsidiaries during the reporting period | | Prepayments | 11,889,335.14 | 0.31 | 4,712,451.02 | 0.12 | 152.30 | Primarily due to increased prepaid expenses of the company during the reporting period | | Other Current Assets | 156,443,276.99 | 4.04 | 77,586,421.58 | 1.98 | 101.64 | Primarily due to increased large-denomination certificates of deposit maturing within one year at the end of the reporting period | | Other Non-Current Assets | 116,745,575.43 | 3.02 | 415,399,038.20 | 10.60 | -71.90 | Primarily due to a decrease in wealth management products maturing in over one year at the end of the reporting period | | Contract Liabilities | 2,354,059.34 | 0.06 | 6,426,596.76 | 0.16 | -63.37 | Primarily due to a decrease in accrued sales discounts during the reporting period | | Employee Remuneration Payable | 27,962,295.98 | 0.72 | 43,685,764.10 | 1.11 | -35.99 | Primarily due to payment of bonuses accrued at the end of the prior year during the reporting period | | Other Payables | 48,075,538.80 | 1.24 | 71,082,843.44 | 1.81 | -32.37 | Primarily due to a decrease in restricted stock repurchase obligations during the reporting period | | Taxes Payable | 11,977,452.28 | 0.31 | 8,880,929.21 | 0.23 | 34.87 | Primarily due to an increase in VAT payable during the reporting period | - Overseas assets amounted to 1,326,974,719.89 yuan, accounting for 34.27% of total assets, primarily contributed by Fangheng Pharmaceutical International Co., Ltd., which generated 134,325,545.30 yuan in operating revenue and 14,304,370.79 yuan in net profit during this reporting period[66][68] (四) Analysis of Investment Status The company's investment status is primarily reflected in financial assets measured at fair value and private equity fund investments, with total fair value financial assets of 1,180,182,702.56 yuan at period-end, and a cumulative paid-in capital of 112.7778 million yuan in various private equity funds to strengthen its pharmaceutical industry presence Changes in Financial Assets Measured at Fair Value | Asset Category | Beginning Balance (Yuan) | Fair Value Change in Current Period (Yuan) | Cumulative Fair Value Change in Equity (Yuan) | Current Period Purchases (Yuan) | Current Period Sales/Redemptions (Yuan) | Ending Balance (Yuan) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Stocks | 350,282,387.58 | 0 | -51,795,116.34 | 0 | 0 | 298,487,271.24 | | Others | 943,946,917.39 | -163,353.04 | 0 | 530,000,000.00 | 590,000,000.00 | 881,695,431.32 | | Total | 1,294,229,304.97 | -163,353.04 | -51,795,116.34 | 530,000,000.00 | 590,000,000.00 | 1,180,182,702.56 | - The company strengthens its pharmaceutical industry presence and industrial cooperation by participating in multiple private equity funds, including Weifang High-tech Zone Kangsheng Venture Capital Partnership, Nantong Yuanqing Bencao Equity Investment Center, Beijing Jinlun Management Consulting Partnership, and Beijing Jinsheng Management Consulting Partnership, with a total paid-in capital of 112.7778 million yuan[73][74] (六) Analysis of Major Holding and Participating Companies This section details the operating performance of the company's major holding and participating companies, including registered capital, total assets, net assets, operating revenue, and net profit, highlighting Fangheng Pharmaceutical International Co., Ltd.'s contribution of 134.3255 million yuan in operating revenue and 14.3044 million yuan in net profit Major Holding and Participating Companies' Operating Performance | 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) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Hunan Jingxiangyuan Snake Breeding Co., Ltd. | Subsidiary | Breeding | 430.00 | 4,214.67 | 4,063.18 | 310.72 | 203.09 | 199.00 | | Hebei Konruns Pharmaceutical Co., Ltd. | Subsidiary | Under Construction | 10,130.00 | 9,758.06 | 9,468.24 | 0 | -134.79 | -134.79 | | Beijing Konruns Medical Technology Co., Ltd. | Subsidiary | Technology Development, Services | 4,000.00 | 1,407.87 | 1,297.99 | 0 | -60.80 | -60.80 | | Shandong Puhua Pharmaceutical Co., Ltd. | Subsidiary | Under Construction | 4,000.00 | 624.67 | 584.14 | 0 | -30.09 | -30.77 | | Beijing Konruns Biotechnology Co., Ltd. | Subsidiary | Technical Services, Promotion Services | 10,000.00 | 93,300.21 | 87,285.42 | 3,773.58 | 597.90 | 618.03 | | Konruns Pharmaceutical (Hong Kong) Co., Ltd. | Subsidiary | Investment | 3,196.55 | 16,342.74 | 81.19 | 0 | -1.28 | -1.28 | | Konruns Biomedical (Shanghai) Co., Ltd. | Subsidiary | Technical Services, Investment | 90,000.00 | 90,328.31 | 90,328.31 | 0 | -0.48 | -2.93 | | Fangheng Pharmaceutical International Co., Ltd. | Subsidiary | Sales | 0.00 | 116,354.73 | 110,786.74 | 13,432.55 | 1,988.28 | 1,430.44 | | Beijing Aixiwan Medical Technology Co., Ltd. | Subsidiary | Technology Development, Promotion & Product Sales | 500.00 | 499.33 | 246.86 | 0 | 0.06 | 0.06 | | Beijing Konruns Pharmaceutical Enterprise Management Co., Ltd. | Subsidiary | Research and Experimental Development, Technology Development, Promotion | 500.00 | 58.42 | 58.42 | 0 | -3.21 | -3.21 | - Tailing Pharmaceutical International Co., Ltd was renamed Fangheng Pharmaceutical International Co., Ltd on May 16, 2025[76] Other Disclosures This section details nine potential risks, including R&D innovation, market competition, industry policy, talent retention, raw material supply, quality control, environmental protection, safety production, and force majeure, along with corresponding mitigation strategies - The company faces R&D innovation and core competency risks, with countermeasures including attracting international talent, optimizing talent development mechanisms, and activating the R&D team's innovation capabilities[77][78] - The company's main product "Suling" faces market competition risks, with countermeasures including strengthening marketing team execution, intensifying policy research, clarifying unique product application scenarios, and promoting its inclusion in the national essential drug list[79] - "Miacalcic" faces challenges from generic drug evaluations, with countermeasures including accelerating marketing transformation, expanding self-operated regions, strengthening medical project promotion, exploring international markets, and forming product portfolios[80] - The pharmaceutical industry is highly susceptible to national policies; the company will closely monitor policy changes, improve its innovation system, adjust product structure, and strategically enter the essential drug market[81] - To address the risk of core technical (business) personnel loss, the company will focus on organizational capability and talent pipeline development, establish a robust compensation and incentive mechanism, deepen corporate culture, and improve confidentiality systems[82] - To mitigate raw material supply risks, the company will standardize Deinagkistrodon acutus breeding, establish a second breeding base, and increase raw material suppliers[83] - To manage quality control risks, the company will enhance company-wide GMP learning and strengthen quality audits of overseas manufacturers[84] - To address environmental protection risks, the company will adhere to the principle of combining cleaner production with end-of-pipe treatment to build a green pharmaceutical enterprise[85] - To manage safety production risks, the company will integrate GMP into all-round management and improve its quality, safety, environment, energy, and occupational health management systems[87] - To mitigate force majeure risks, the company will establish a sound emergency management system and formulate corresponding measures to minimize impacts[88] Corporate Governance, Environment, and Society This section covers changes in the company's governance structure, including director and senior management appointments, profit distribution plans, and the status of equity incentive and employee stock ownership plans Changes in Directors, Supervisors, and Senior Management During the reporting period, there were changes in the company's directors, supervisors, and senior management, with independent director Li Hongyi resigning and Liu Junyan being elected as an independent director, and Huang Xiaodong appointed as Board Secretary Changes in Directors, Supervisors, and Senior Management | Name | Position Held | Change Type | | :--- | :--- | :--- | | Li Hongyi | Independent Director | Resignation | | Liu Junyan | Independent Director | Election | | Huang Xiaodong | Board Secretary | Appointment | - Mr Li Hongyi resigned from his positions as independent director of the fourth Board of Directors and related committees due to personal reasons, and will no longer hold any positions in the company after his resignation[91] Profit Distribution or Capital Reserve to Share Capital Increase Plan The company's proposed semi-annual profit distribution or capital reserve to share capital increase plan is "none," meaning no distribution or transfer will occur - The company's proposed semi-annual profit distribution or capital reserve to share capital increase plan is "none"[92] Equity Incentive and Employee Stock Ownership Plans During the reporting period, the company approved the repurchase and cancellation of restricted shares granted but not yet unblocked to some incentive recipients, adjusted the repurchase price, and fulfilled the unblocking conditions for the second unblocking period of the 2023 restricted stock incentive plan's initial grant and the first unblocking period of the reserved grant - The company approved the "Proposal on Repurchasing and Cancelling Part of Restricted Shares Granted but Not Yet Unblocked to Certain Incentive Recipients and Adjusting the Repurchase Price"[93] - The unblocking conditions for the second unblocking period of the 2023 restricted stock incentive plan's initial grant and the first unblocking period of the reserved grant have been met[93] - The company's first phase employee stock ownership plan has completed the disposal of all company shares held, and has been fully implemented and terminated[94] Significant Matters This section details the company's fulfillment of commitments, significant related-party transactions, and the progress of its raised capital utilization, including project changes and cash management Fulfillment of Commitments The company's actual controllers, controlling shareholders, and other related parties strictly fulfilled all commitments during the reporting period, including avoiding horizontal competition, standardizing and reducing related-party transactions, and commitments regarding shareholding and reduction intentions - Company's actual controllers Liu Jianhua and Wang Xijuan committed to avoiding horizontal competition and ensuring that they and their controlled enterprises do not participate in any business or activities that compete with the company's operations[98][99] - Liu Jianhua, Wang Xijuan, their close relatives, and their controlled enterprises committed to standardizing and minimizing related-party transactions with the company, ensuring their fairness[100] - Controlling shareholder and actual controller Liu Jianhua and his controlled Puhua Jiyue, as well as Wang Xijuan and her controlled Muren Investment, committed to announcing share reductions three trading days in advance, provided no public commitments have been violated and full compensation liabilities have been borne[103] Significant Related-Party Transactions During the reporting period, the company renewed its office building lease contract with related party Xinhua Jiyue (Beijing) Technology Co., Ltd., and signed a supplementary agreement on March 31, 2025, adjusting the annual rent to 5,129,738.00 yuan - The company renewed a house lease contract with related party Xinhua Jiyue (Beijing) Technology Co., Ltd, leasing floors 2-5 of Building 4, No 7 Courtyard, Science Park Road, Life Science Park, Changping District, Beijing, for a three-year term[105] - Effective April 1, 2025, the rent price was adjusted to 3.50 yuan/square meter/day, with a total annual rent of 5,129,738.00 yuan[105] Progress of Raised Funds Utilization The company's initial public offering raised a total of 973.60 million yuan, with a net amount of 891.425937 million yuan; as of the end of the reporting period, 677.7135 million yuan had been invested, representing a 76.03% progress, with some projects changed or delayed, and idle funds managed as cash Overall Utilization of Raised Funds | Source of Raised Funds | Total Raised Funds (10,000 Yuan) | Net Raised Funds (10,000 Yuan) | Committed Investment (10,000 Yuan) | Cumulative Investment at Period End (10,000 Yuan) | Cumulative Investment Progress at Period End (%) | Amount Invested This Year (10,000 Yuan) | Amount Invested This Year as % of Total Raised Funds | Total Raised Funds with Changed Use (10,000 Yuan) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Initial Public Offering | 97,360.00 | 89,142.5937 | 89,142.5937 | 67,771.35 | 76.03 | 1,225.64 | 1.37 | 39,192.00 | - The "Lorlatinib Hydrochloride API Production Capacity Project" was changed to the "Annual Production of 500kg Anti-tumor API Production Base Project" and delayed until December 2026[112] - Part of the investment plan for the "Innovative Drug R&D and Targeted Anti-tumor Drug Innovation Platform Project" was changed, reducing 311.92 million yuan to fund the R&D of the new raised investment project KC1036[113] - The company managed idle raised funds as cash, with an authorized limit not exceeding 220 million yuan, and the cash management balance at the end of the reporting period was 220 million yuan[117] Share Changes and Shareholder Information This section details the company's share capital stability during the reporting period and provides an overview of its shareholder structure, including major shareholders and their restricted shareholdings Share Capital Changes During the reporting period, there were no changes in the company's total share capital or share structure - During the reporting period, there were no changes in the company's total share capital or share structure[120] Shareholder Information As of the end of the reporting period, the company had 9,970 common shareholders; Liu Jianhua, the largest shareholder with 31.87% of shares, has pledged some of his holdings, while Beijing Muren Investment Management Co., Ltd and Beijing Puhua Jiyue Investment Consulting Center (Limited Partnership) are the second and third largest shareholders, with Liu Jianhua and Wang Xijuan being the actual controllers and acting in concert with their controlled entities - As of the end of the reporting period, the total number of common shareholders was 9,970[120] Top Ten Shareholders' Shareholding | Shareholder Name | Shares Held at Period End (shares) | Percentage (%) | Pledged, Marked, or Frozen Status (shares) | Shareholder Nature | | :--- | :--- | :--- | :--- | :--- | | Liu Jianhua | 50,786,760 | 31.87 | 8,846,840 (Pledged) | Domestic Natural Person | | Beijing Muren Investment Management Co., Ltd. | 16,245,600 | 10.19 | 0 (None) | Domestic Non-State-Owned Legal Person | | Beijing Puhua Jiyue Investment Consulting Center (Limited Partnership) | 9,600,000 | 6.02 | 0 (None) | Other | | Zhang Mingjie | 4,172,200 | 2.62 | 0 (None) | Domestic Natural Person | | Yang Yongkang | 2,017,401 | 1.27 | 0 (None) | Domestic Natural Person | | Xue Xiaohong | 1,466,280 | 0.92 | 0 (None) | Domestic Natural Person | | Agricultural Bank of China Co., Ltd. - Penghua Pharmaceutical Technology Stock Fund | 1,394,400 | 0.88 | 0 (None) | Other | | Bank of China Co., Ltd. - E Fund Medical and Healthcare Industry Mixed Fund | 1,335,601 | 0.84 | 0 (None) | Other | | Bohai Bank Co., Ltd. - CITIC Securities Investment Medical Reform Flexible Allocation Mixed Fund | 1,250,000 | 0.78 | 0 (None) | Other | | Tan Jinqing | 1,054,400 | 0.66 | 0 (None) | Domestic Natural Person | - Liu Jianhua and Wang Xijuan are the actual controllers of the company; Puhua Jiyue is an enterprise controlled by Liu Jianhua, and Muren Investment is an enterprise controlled by Wang Xijuan; Liu Jianhua, Wang Xijuan, Muren Investment, and Puhua Jiyue are parties acting in concert[124] Top Ten Shareholders with Restricted Shares and Restriction Conditions | No. | Name of Shareholder with Restricted Shares | Number of Restricted Shares Held (shares) | Restriction Conditions | | :--- | :--- | :--- | :--- | | 1 | Initial Grant Incentive Recipients of the Company's 2023 Restricted Stock Incentive Plan | 1,589,000 | Equity Incentive Restriction | | 2 | Reserved Grant Incentive Recipients of the Company's 2023 Restricted Stock Incentive Plan | 530,000 | Equity Incentive Restriction | - The initial grant unblocking periods are divided into three phases, with unblocking ratios of 30%, 40%, and 30% respectively; the reserved grant unblocking periods are divided into two phases, with unblocking ratios of 50% each[125] Bond-Related Information This section confirms that the company had no company bonds, non-financial enterprise debt financing instruments, or convertible corporate bonds during the reporting period Corporate Bonds and Non-Financial Enterprise Debt Financing Instruments During the reporting period, the company had no corporate bonds (including enterprise bonds) or non-financial enterprise debt financing instruments - During the reporting period, the company had no corporate bonds (including enterprise bonds) or non-financial enterprise debt financing instruments[129] Convertible Corporate Bonds During the reporting period, the company had no convertible corporate bonds - During the reporting period, the company had no convertible corporate bonds[129] Financial Report This section presents the company's comprehensive financial statements, including balance sheets, income statements, cash flow statements, and statements of changes in owners' equity, along with detailed notes on accounting policies, tax items, and financial instrument risks Financial Statements This section provides the company's consolidated and parent company balance sheets, income statements, cash flow statements, and statements of changes in owners' equity for the first half of 2025, comprehensively presenting the company's financial position, operating results, and cash flow - Financial statements include the Consolidated Balance Sheet, Parent Company Balance Sheet, Consolidated Income Statement, Parent Company Income Statement, Consolidated Cash Flow Statement, Parent Company Cash Flow Statement, Consolidated Statement of Changes in Owners' Equity, and Parent Company Statement of Changes in Owners' Equity[131][134][138][142][145][148][151][153][154][156][158][159][161] Company's Basic Information This section outlines the company's overview, including registered capital, address, headquarters, business scope, and nature of business, and specifies the approval date of the financial statements - Company's registered capital is 159,356,477.00 yuan[162] - Company's business scope includes production of lyophilized powder injections, biochemical APIs, tablets (including anti-tumor drugs); biomedical development and research; technology promotion services; technology transfer, and consulting services[162] - Company's business nature is pharmaceutical manufacturing, engaged in the manufacture of chemical pharmaceutical preparations[162] - These financial statements were approved for issuance by the company's Board of Directors on August 27, 2025[162] Basis of Financial Statement Preparation The company's financial statements are prepared on a going concern basis, adhering to "Enterprise Accounting Standards" and relevant CSRC regulations, and demonstrate at least 12 months of continuous operating capability - The company prepares its financial statements on a going concern basis, in accordance with "Enterprise Accounting Standards" and the China Securities Regulatory Commission's "Information Disclosure Rules for Companies Issuing Securities to the Public No 15 - General Provisions for Financial Reports" (Revised 2023)[163] - The company possesses the ability to continue as a going concern for at least 12 months from the end of this reporting period, with no significant matters affecting its going concern ability[164] Significant Accounting Policies and Accounting Estimates This section details the company's specific accounting policies and estimates for inventory valuation, fixed asset depreciation, biological asset depreciation, intangible asset amortization, long-term deferred expense amortization, revenue recognition, financial instruments, share-based payments, government grants, and deferred income tax, ensuring accuracy and comparability of financial reporting - The company has formulated specific accounting policies and estimates for inventory valuation methods, fixed asset depreciation, biological asset depreciation, intangible asset amortization, long-term deferred expense amortization, revenue recognition methods, and other transactions or events, based on its actual production and operation characteristics[165] - The company classifies financial assets into three categories: measured at amortized cost, measured at fair value through other comprehensive income, and measured at fair value through profit or loss[189] - The company recognizes revenue when it satisfies a performance obligation in the contract, i.e., when the customer obtains control of the related goods, and classifies revenue recognition based on whether performance obligations are satisfied over time or at a point in time[267][270][271] - For self-developed intangible assets, expenditures in the research phase are expensed in the current period, while expenditures in the development phase are capitalized as intangible assets if specific conditions are met simultaneously[248] - For innovative drug and biosimilar R&D projects, R&D expenditures incurred before Phase III clinical trials are expensed, while development phase expenditures after Phase II clinical trials are capitalized under specific circumstances[249] Taxation This section discloses the company's main tax categories and rates, including VAT, urban maintenance and construction tax, education surcharge, local education surcharge, and corporate income tax, noting the company's 15% corporate income tax preferential rate as a high-tech enterprise Main Tax Categories and Rates | Tax Category | Tax Basis | Tax Rate | | :--- | :--- | :--- | | Value-Added Tax | Sales of goods and taxable services calculated according to tax laws, after deducting deductible input VAT | 13%, 9%, 6% | | Urban Maintenance and Construction Tax | Payable turnover tax | 7%, 5% | | Education Surcharge | Payable turnover tax | 3% | | Local Education Surcharge | Payable turnover tax | 2% | | Corporate Income Tax | Taxable income | 25%/16.5%/15%/8.25% | - Beijing Konruns Pharmaceutical Co., Ltd, as a high-tech enterprise, enjoys a 15% preferential corporate income tax rate[291] Notes to Consolidated Financial Statement Items This section provides detailed notes on various consolidated financial statement items, including assets, liabilities, owners' equity, and profit/loss, such as monetary funds, trading financial assets, accounts receivable, inventory, long-term equity investments, fixed assets, construction in progress, intangible assets, accounts payable, employee remuneration payable, deferred income tax, operating revenue and costs, sales expenses, administrative expenses, R&D expenses, financial expenses, and investment income, explaining the reasons for changes Ending Balance of Monetary Funds | Item | Ending Balance (Yuan) | | :--- | :--- | | Bank Deposits | 357,652,840.82 | | Other Monetary Funds | 8,661,872.56 | | Total | 366,314,713.38 | Ending Balance of Trading Financial Assets | Item | Ending Balance (Yuan) | | :--- | :--- | | Wealth Management Products | 391,050,361.08 | | Total | 391,050,361.08 | - The ending book balance of accounts receivable is 375,920,806.15 yuan, of which 20,912,581.55 yuan is provided for bad debts on an individual basis, and 355,008,224.60 yuan is provided for bad debts on a portfolio basis[297][299] - The ending book value of inventory is 69,521,027.12 yuan, primarily comprising raw materials, work-in-progress, finished goods, and goods in transit[330] - The ending book value of long-term equity investments is 48,610,808.32 yuan, mainly investments in associates[338] - The ending book value of fixed assets is 191,098,987.00 yuan, with buildings and structures accounting for 166,125,015.00 yuan[347] - The ending book value of construction in progress is 216,114,155.24 yuan, primarily including the annual production of 500kg anti-tumor API production base project and the innovative oral solid dosage form project[351][354] - The ending book value of intangible assets is 838,008,635.73 yuan, with patent rights accounting for 779,875,874.17 yuan[359] - Operating revenue for the current period was 460,869,253.77 yuan, and operating cost was 45,249,089.13 yuan, with main business revenue primarily from "Suling" and "Miacalcic"[412][414] - Sales expenses for the current period were 204,384,553.16 yuan, administrative expenses were 66,697,905.34 yuan, and R&D expenses were 20,498,356.48 yuan[420][421][422] - Investment income for the current period was 10,015,947.42 yuan, mainly from wealth management product income and dividend income[425] R&D Expenses This section discloses the company's R&D expenditures for the first half of 2025, totaling 50,357,405.82 yuan, comprising 20,498,356.48 yuan in expensed R&D and 29,859,049.34 yuan in capitalized R&D, with key capitalized projects ZY5301 and KC1036 in clinical trial phases R&D Expenses by Nature of Expense | Item | Current Period Amount (Yuan) | Prior Period Amount (Yuan) | | :--- | :--- | :--- | | R&D Personnel Salaries | 27,097,672.34 | 21,861,746.81 | | Direct Input | 8,515,647.64 | 6,662,605.46 | | Depreciation of Fixed Assets | 5,432,794.46 | 6,005,779.89 | | Amortization of Intangible Assets | 221,454.17 | 253,917.30 | | Clinical Trial Fees | 7,225,111.17 | 15,073,857.66 | | Other Expenses | 1,864,726.04 | 1,897,317.21 | | Total | 50,357,405.82 | 51,755,224.33 | | Of which: Expensed R&D | 20,498,356.48 | 23,294,981.62 | | Capitalized R&D | 29,859,049.34 | 28,460,242.71 | Development Expenditures for Capitalized R&D Projects | Project | Beginning Balance (Yuan) | Amount Increased in Current Period (Yuan) | Ending Balance (Yuan) | | :--- | :--- | :--- | :--- | | SLYF | 8,205,299.93 | 2,549,421.52 | 10,754,721.45 | | AH1001 | 10,902,136.90 | 256,284.96 | 11,158,421.86 | | KC1036 | 60,857,430.50 | 19,077,665.13 | 79,935,095.63 | | KC-B173 | 11,920,676.76 | 0 | 11,920,676.76 | | ZY5301 | 141,884,591.20 | 7,975,677.73 | 149,860,268.93 | | Total | 233,770,135.29 | 29,859,049.34 | 263,629,184.63 | - Important capitalized R&D projects such as ZY5301 and KC1036 are both in Phase III clinical research, expected to be completed in 2026 and 2027 respectively[455] Changes in Consolidation Scope During the reporting period, the company had no business combinations involving entities not under common control, business combinations involving entities under common control, reverse acquisitions, or disposals of subsidiaries leading to loss of control - During the reporting period, the company had no business combinations involving entities not under common control, business combinations involving entities under common control, reverse acquisitions, or disposals of subsidiaries leading to loss of control[456][457] Interests in Other Entities This section discloses the company's interests in subsidiaries and associates, including several wholly-owned or controlled subsidiaries, with Beijing Konruns Biotechnology Co., Ltd being a significant non-wholly-owned subsidiary, and total investments in associates amounting to 48,610,808.32 yuan Composition of the Enterprise Group | Subsidiary Name | Main Operating Location | Registered Capital | Business Nature | Shareholding Ratio (%) (Direct) | Acquisition Method | | :--- | :--- | :--- | :--- | :--- | :--- | | Hunan Jingxiangyuan Snake Breeding Co., Ltd. | Hunan | 430.00 10,000 RMB | Breeding | 100.00 | Establishment | | Hebei Konruns Pharmaceutical Co., Ltd. | Hebei | 10,130.00 10,000 RMB | Under Construction | 100.00 | Establishment | | Beijing Konruns Medical Technology Co., Ltd. | Beijing | 4,000.00 10,000 RMB | Technology Development, Services | 85.00 | Establishment | | Shandong Puhua Pharmaceutical Co., Ltd. | Shandong | 4,000.00 10,000 RMB | Under Construction | 100.00 | Establishment | | Beijing Konruns Biotechnology Co., Ltd. | Beijing | 10,000.00 10,000 RMB | Technical Services, Promotion Services | 73.70 | Acquisition | | Konruns Pharmaceutical (Hong Kong) Co., Ltd. | Hong Kong | 3,500.00 10,000 HKD | Investment | 100.00 | Establishment | | Konruns Biomedical (Shanghai) Co., Ltd. | Shanghai | 90,000.00 10,000 RMB | Technical Services, Investment | 73.70 | Establishment | | Fangheng Pharmaceutical International Co., Ltd. | Hong Kong | 1.00 HKD | Sales | 73.70 (Indirect) | Acquisition | | Beijing Aixiwan Medical Technology Co., Ltd. | Beijing | 500.00 10,000 RMB | Technology Development, Promotion & Product Sales | 100.00 | Establishment | | Beijing Konruns Pharmaceutical Enterprise Management Co., Ltd. | Beijing | 500.00 10,000 RMB | Research and Experimental Development, Technology Development, Promotion | 100.00 | Establishment | Key Financial Information of Significant Non-Wholly-Owned Subsidiary (Beijing Konruns Biotechnology Co., Ltd.) | Indicator | Ending Balance (Yuan) | Beginning Balance (Yuan) | Current Period Amount (Yuan) | Prior Period Amount (Yuan) | | :--- | :--- | :--- | :--- | :--- | | Minority Shareholding Ratio (%) | 26.30 | 26.30 | N/A | N/A | | Net Profit Attributable to Minority Shareholders | 5,379,755.46 | N/A | 5,379,755.46 | N/A | | Ending Balance of Minority Interests | 285,093,237.02 | N/A | N/A | N/A | | Operating Revenue | N/A | N/A | 134,325,545.30 | 129,945,385.35 | | Net Profit | N/A | N/A | 20,455,343.97 | 31,197,642.78 | - Total book value of investments in associates is 48,610,808.32 yuan, with a net loss attributable to the company based on its shareholding ratio of -711,455.97 yuan for the current period[463] Government Grants This section discloses the company's government grants for the reporting period, including liability items and grants recognized in current profit or loss, totaling 1,908,885.78 yuan, comprising 1,852,417.24 yuan related to assets and 56,468.54 yuan related to income Liability Items Related to Government Grants | Financial Statement Item | Beginning Balance (Yuan) | New Grants in Current Period (Yuan) | Transferred to Other Income in Current Period (Yuan) | Ending Balance (Yuan) | Related to Asset/Income | | :--- | :--- | :--- | :--- | :--- | :--- | | Deferred Income | 40,475,455.14 | 0 | 1,852,417.24 | 38,623,037.90 | Asset-related | Government Grants Recognized in Current Profit or Loss | Type | Current Period Amount (Yuan) | Prior Period Amount (Yuan) | | :--- | :--- | :--- | | Asset-related | 1,852,417.24 | 1,852,417.24 | | Income-related | 56,468.54 | 81,380.00 | | Total | 1,908,885.78 | 1,933,797.24 | Risks Related to Financial Instruments The company aims to balance risk and return, minimizing negative impacts on operating performance, and manages credit, liquidity, and market risks (including interest rate and foreign exchange risks) through prudent banking, customer credit assessment, ensuring working capital, and primarily RMB-denominated activities - The company's risk management objective is to achieve a balance between risk and return, minimizing negative impacts on operating performance and maximizing the interests of shareholders and other equity investors[468] - The company faces credit risk, liquidity risk, and market risk (including interest rate risk and foreign exchange risk)[468] - Credit risk primarily arises from bank deposits and receivables, controlled by depositing with highly-rated financial institutions and regularly assessing customer credit[468] - Liquidity risk is not significant, as the company's current financial assets can meet working capital needs and capital expenditures[469] - Interest rate risk and foreign exchange risk within market risk are not significant, as major activities are denominated in RMB[469][470] Fair Value Disclosure This section discloses the fair value of the company's assets and liabilities measured at fair value at period-end, totaling 1,180,182,702.56 yuan, with trading financial assets and receivables financing measured at Level 3, other equity instrument investments at Level 1 (stocks) and Lev