泽璟制药(688266) - 2025 Q2 - 季度财报

Section I Definitions Common Term Definitions This section defines key terms, including company entities, regulatory bodies, and drug classifications, for report clarity - Full company name: Suzhou Zelgen Biopharmaceutical Co., Ltd., abbreviated as Zelgen Biopharma[13] - National Medical Products Administration (NMPA): The national drug regulatory body under the State Administration for Market Regulation[13] - Donafenib Tosylate Tablets (Zepsun®): The company's marketed Class 1 anti-tumor targeted small molecule new drug for unresectable hepatocellular carcinoma and radioactive iodine-refractory differentiated thyroid cancer[14] - Jicacaxtinib Hydrochloride Tablets (Zepuping®): The company's marketed Class 1 JAK small molecule new drug for treating myelofibrosis[14] - ZG006: The company's investigational CD3/DLL3/DLL3 trispecific antibody, a Class 1 therapeutic biological product, approved for clinical trials by China and the FDA[14] Section II Company Profile and Key Financial Indicators I. Company Overview This section outlines basic information about Suzhou Zelgen Biopharmaceutical Co., Ltd., including its name, registered address, and legal representative - Company Chinese name: Suzhou Zelgen Biopharmaceutical Co., Ltd., abbreviated as Zelgen Biopharma[16] - Legal Representative: ZELIN SHENG[16] - Company Registered Address: No. 209 Chenfeng Road, Yushan Town, Kunshan City, Jiangsu Province[16] II. Contact Persons and Information This section provides contact details for the company's Board Secretary and Securities Affairs Representative for investor communication - Board Secretary: Gao Qingping, contact number 0512-57011882[17] - Securities Affairs Representative: Ma Weihao, contact number 0512-57011882[17] III. Information Disclosure and Document Custody Location Changes This section specifies the company's semi-annual report disclosure channels and custody locations for timely investor access - Designated information disclosure newspaper: Shanghai Securities News[18] - Website for semi-annual report: **www.sse.com.cn**[18](index=18&type=chunk) IV. Company Stock/Depositary Receipt Summary This section briefly introduces the company's stock listing, including stock type, exchange, board, ticker symbol, and code - Stock Type: A-shares[19] - Stock Exchange and Board: Shanghai Stock Exchange STAR Market[19] - Stock Abbreviation: Zelgen Biopharma, Stock Code: 688266[19] VI. Key Accounting Data and Financial Indicators Revenue grew 56.07% to 375.65 million yuan, but net loss widened and operating cash flow significantly declined Key Accounting Data (Jan-Jun 2025 vs. Prior Period) | Indicator | Current Period (Jan-Jun) | Prior Period | Period-over-Period Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue (yuan) | 375,650,273.55 | 240,696,731.58 | 56.07 | | Total Profit (yuan) | -77,414,988.02 | -79,493,376.06 | N/A | | Net Profit Attributable to Shareholders of Listed Company (yuan) | -72,803,538.99 | -66,536,070.99 | N/A | | Net Profit Attributable to Shareholders of Listed Company (Excluding Non-recurring Gains and Losses) (yuan) | -102,641,422.42 | -72,371,226.25 | N/A | | Net Cash Flow from Operating Activities (yuan) | -17,020,276.08 | 112,553,063.11 | -115.12 | | Net Assets Attributable to Shareholders of Listed Company (End of Period) (yuan) | 1,176,615,436.44 | 1,253,857,931.48 | -6.16 | | Total Assets (End of Period) (yuan) | 2,999,203,352.04 | 3,004,614,283.98 | -0.18 | Key Financial Indicators (Jan-Jun 2025 vs. Prior Period) | Indicator | Current Period (Jan-Jun) | Prior Period | Period-over-Period Change (%) | | :--- | :--- | :--- | :--- | | Basic Earnings Per Share (yuan/share) | -0.28 | -0.25 | N/A | | Diluted Earnings Per Share (yuan/share) | -0.28 | -0.25 | N/A | | Basic Earnings Per Share (Excluding Non-recurring Gains and Losses) (yuan/share) | -0.39 | -0.27 | N/A | | Weighted Average Return on Net Assets (%) | -5.98 | -4.16 | N/A | | Weighted Average Return on Net Assets (Excluding Non-recurring Gains and Losses) (%) | -8.43 | -4.52 | N/A | | R&D Investment as % of Operating Revenue (%) | 52.31 | 75.26 | Decrease of 22.95 percentage points | - Operating revenue increased by 56.07%, primarily due to increased drug sales, with recombinant human thrombin showing significant sales growth after its inclusion in the National Medical Insurance Drug List[22] - Net loss attributable to shareholders of the listed company slightly increased, mainly due to rising sales and R&D expenses alongside revenue growth[23] - Net cash flow from operating activities decreased by 115.12%, primarily due to differences in installment payments for thrombin marketing authorization fees[23] VIII. Non-recurring Gains and Losses Items and Amounts This section details non-recurring gains and losses, totaling 29.84 million yuan, primarily from government grants and terminated equity incentives Non-recurring Gains and Losses Items and Amounts | Non-recurring Gains and Losses Item | Amount (yuan) | | :--- | :--- | | Gains or losses on disposal of non-current assets | 810.44 | | Government grants recognized in profit or loss for the current period | 22,817,064.89 | | Gains or losses from changes in fair value and disposal of financial assets and liabilities | 800,771.56 | | Share-based payment expenses recognized due to cancellation or modification of equity incentive plans | 10,242,297.78 | | Other non-operating income and expenses | -683,818.74 | | Less: Income tax impact | 3,295,251.89 | | Impact on minority interests (after tax) | 43,990.61 | | Total | 29,837,883.43 | - Total non-recurring gains and losses amounted to 29,837,883.43 yuan, primarily comprising government grants and one-time share-based payment expenses from the termination of an equity incentive plan[25] IX. Net Profit Excluding Share-based Payment Impact (Optional Disclosure) This section discloses net profit after excluding share-based payments, which was -64.74 million yuan, a narrowed loss year-over-year Net Profit Excluding Share-based Payment Impact | Key Accounting Data | Current Period (Jan-Jun) | Prior Period | Period-over-Period Change (%) | | :--- | :--- | :--- | :--- | | Net Profit Excluding Share-based Payment Impact (yuan) | -64,741,191.14 | -76,794,876.67 | N/A | Section III Management Discussion and Analysis I. Industry Overview and Principal Business Operations During the Reporting Period The company's core business involves R&D, production, and sales of chemical and biological new drugs, focusing on oncology, bleeding, hematological, and immune-inflammatory diseases (I) Industry Overview The company operates in pharmaceutical manufacturing, with a pipeline covering oncology and autoimmune diseases, driven by policy and patient needs, facing high technical barriers - The company operates in the 'Pharmaceutical Manufacturing (C27)' sub-category within the 'C Manufacturing' industry[29] - China's oncology drug market is projected to reach USD 129.3 billion by 2034, with a CAGR of 13.7% between 2024 and 2034[31] - China's bispecific antibody drug market is expected to grow rapidly to USD 39.3 billion by 2034, with a CAGR of 59.4%[31] - China's autoimmune disease drug market is projected to grow to USD 35.2 billion by 2034, with a CAGR of 22.7% between 2024 and 2034[34] - The global bispecific antibody market is projected to reach USD 192.6 billion by 2033, with a CAGR of 37.5%[36] - Technical and commercial barriers in the biopharmaceutical industry primarily include R&D innovation, process development and clinical uncertainty, large-scale production, and intellectual property and patent barriers[42] (II) Principal Business Operations Marketed products like Donafenib Tosylate Tablets and Recombinant Human Thrombin are covered by national medical insurance, while the R&D pipeline shows significant progress and international development - Donafenib Tosylate Tablets are approved for first-line treatment of advanced hepatocellular carcinoma and progressive, locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer, with both indications included in the National Medical Insurance Drug List (2023)[53] - Recombinant Human Thrombin is marketed and included in the National Medical Insurance Drug List (2024), being the only recombinant human thrombin produced using recombinant gene technology in China[54] - Jicacaxtinib Hydrochloride Tablets are approved for treating myelofibrosis, marking the first domestically approved JAK inhibitor innovative drug for this indication[55] - Jicacaxtinib for severe alopecia areata is under new drug application technical review; indications for moderate-to-severe atopic dermatitis and ankylosing spondylitis are in Phase III clinical trials[56] - Recombinant Human Thyroid Stimulating Hormone (rhTSH) for injection is under new drug marketing review, potentially becoming the first domestically approved new drug for this indication[57] - ZG006 for injection received CDE Breakthrough Therapy Designation for advanced small cell lung cancer and is about to enter pivotal clinical studies[58] - ZG005, a PD-1/TIGIT bispecific antibody, is among the global leaders in clinical development, with potential indications including hepatocellular carcinoma, neuroendocrine tumors, and cervical cancer[58] (III) Key Operating Models The company employs independent R&D, procurement, production, and sales models, combining in-house R&D with outsourcing, and utilizing both distribution and exclusive marketing partnerships - R&D Model: Operates 3 new drug R&D centers in Kunshan (Jiangsu), Zhangjiang (Shanghai), and California (USA), combining in-house R&D with outsourcing services[60] - Production Model: Possesses two GMP-certified production facilities (4 workshops) capable of producing chemical tablets, capsules, and recombinant protein drug substances and formulations, with a new biopharmaceutical industrialization base expected to be operational by end of 2025[61] - Sales Model: Donafenib Tosylate Tablets and Jicacaxtinib Hydrochloride Tablets use a distribution model; Recombinant Human Thrombin is exclusively marketed by Grand Life Science (Shandong) Co., Ltd.; Recombinant Human Thyroid Stimulating Hormone for injection is exclusively marketed by ATSA, a Swiss subsidiary of Merck KGaA (Germany)[62][63] II. Discussion and Analysis of Operations In H1 2025, the company achieved 56.07% revenue growth to 375.65 million yuan, driven by drug sales and R&D milestones, alongside enhanced corporate governance - During the reporting period, the company achieved operating revenue of 375.65 million yuan, a 56.07% increase year-over-year, primarily due to increased drug sales[64] - Net profit attributable to shareholders of the listed company was -72.80 million yuan, a slight increase in loss compared to the prior period[64] - Donafenib Tosylate Tablets have entered over 1,200 hospitals, covered over 2,200 hospitals, and over 1,000 pharmacies[64] - Recombinant Human Thrombin sales significantly increased after its inclusion in the 2024 National Medical Insurance Drug List, with cumulative access to over 590 hospitals[65] - Jicacaxtinib Hydrochloride Tablets were approved for treating myelofibrosis in May 2025, and its new drug application for severe alopecia areata was also accepted in May 2025[65][66] - Pre-marketing work for Recombinant Human Thyroid Stimulating Hormone (rhTSH) for injection continues, with supplementary research completed and technical review ongoing; an exclusive marketing agreement was signed with Merck KGaA (Germany)[66] - At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the company presented 28 sets of latest clinical research data, including products like ZG006 and ZG005[67] - The company completed the re-election of its third board of directors and the appointment of senior management, revised and improved governance documents like the Articles of Association, and formulated a Market Value Management System[70] III. Analysis of Core Competencies During the Reporting Period The company's core strengths include a differentiated product pipeline, advanced R&D platforms, active international development, and a strong team with independent production capabilities - The company possesses a differentiated and competitive product pipeline, focusing on oncology, bleeding and hematological diseases, and immune-inflammatory diseases, dedicated to developing best-in-class or first-in-class drugs[71] - Donafenib Tosylate Tablets and Recombinant Human Thrombin are both included in the medical insurance catalog; Jicacaxtinib Hydrochloride Tablets is China's first approved domestic JAK inhibitor new drug for myelofibrosis[74][75] - The company has R&D and industrialization platforms for small molecule drugs and complex recombinant protein biologics/antibody new drugs, with ZG006 and ZG005 showing best-in-class potential in clinical studies[76][77] - The company actively pursues international product development, with multiple products including ZG005, ZGGS18, ZGGS15, ZG006, ZG2001, ZG0895, and ZGGS34 having received FDA clinical trial approvals[77] - The company boasts an excellent R&D, industrialization, and sales team, along with independent commercial production capabilities and a superior clinical collaboration system[78] (III) Core Technologies and R&D Progress The company achieved significant R&D progress with Jicacaxtinib Hydrochloride Tablets approval, ZG006 breakthrough therapy designation, and rhTSH regulatory advancements, supported by a 196.50 million yuan R&D investment - The company's core technology platforms include small molecule drug R&D and industrialization, and complex recombinant protein biologic and antibody new drug R&D and industrialization[80] - On May 29, 2025, the company's self-developed Jicacaxtinib Hydrochloride Tablets (Zepuping) were approved for marketing to treat myelofibrosis[80] - The New Drug Application (NDA) for Jicacaxtinib Hydrochloride Tablets for severe alopecia areata was accepted by the National Medical Products Administration[81] - ZG006 for injection was included in the CDE Breakthrough Therapy Designation list for the indication of monotherapy for advanced small cell lung cancer[81] - IND applications for the trispecific antibody ZGGS34 were submitted to CDE and FDA, with the FDA IND application already approved[81] R&D Investment Table | Indicator | Current Period Amount (yuan) | Prior Period Amount (yuan) | Change (%) | | :--- | :--- | :--- | :--- | | Expensed R&D Investment | 196,503,538.35 | 181,154,578.04 | 8.47 | | Capitalized R&D Investment | 0 | 0 | N/A | | Total R&D Investment | 196,503,538.35 | 181,154,578.04 | 8.47 | | Total R&D Investment as % of Operating Revenue (%) | 52.31 | 75.26 | Decrease of 22.95 percentage points | - As of June 30, 2025, the company held 135 authorized invention patents (35 domestic, 100 international), with a cumulative total of 343 invention patent applications[84] - The company's R&D personnel numbered 299, accounting for 30.48% of total employees, including 24 PhDs (8.03%) and 101 Master's degree holders (33.78%)[93] IV. Risk Factors The company faces financial risks from sustained losses and high R&D costs, operational risks from market competition, and industry risks from policy changes and IP protection - The company is not yet profitable and has accumulated uncompensated losses, potentially facing continued losses in the future, unable to distribute cash dividends in the short term, with most working capital relying on external financing[94][95] - The company faces risks of significant performance decline or losses, primarily influenced by various factors in drug R&D, listing, production, marketing, and sales, with the marketing team still under development[97] - Core competency risks include inability to successfully identify or screen new drug candidates, clinical trial progress or results of investigational drugs falling short of expectations, reliance on third parties for contractual obligations, and inability to complete the review and approval process for investigational drugs[99][100][101][102] - Operating risks include intense competition in the pharmaceutical market, underperforming market development for marketed products, and inability to achieve rapid sales volume or market acceptance[105] - Financial risks primarily manifest as the company's continuous reliance on external financing due to high R&D investment and marketing costs[106] - Industry risks include adjustments in pharmaceutical industry regulatory policies, intense competition in innovative drug development, and technological upgrades and iterations[107][108] - Other significant risks include insufficient intellectual property protection or alleged infringement of third-party patents, and the loss of core R&D technical personnel[110][113] V. Key Operating Performance During the Reporting Period Revenue increased 56.07% to 375.65 million yuan, but net loss widened to -72.80 million yuan; operating cash flow decreased 115.12% due to marketing authorization payment differences - During the current reporting period, the company achieved operating revenue of 375.65 million yuan, a 56.07% increase year-over-year, primarily due to increased drug sales[114] - During the current reporting period, net profit attributable to shareholders of the listed company was -72.80 million yuan, a slight increase in loss compared to the prior period, mainly due to increased sales and R&D expenses[114] - At the end of the reporting period, net cash flow from operating activities was -17.02 million yuan, a 115.12% decrease year-over-year, primarily due to differences in installment payments for thrombin marketing authorization fees[114] (I) Analysis of Principal Business Operations Revenue grew 56.07%, but operating costs surged 121.88%; sales and administrative expenses rose, while R&D expenses increased 8.47%; all cash flow activities saw significant decreases Analysis Table of Changes in Financial Statement Items | Item | Current Period Amount (yuan) | Prior Period Amount (yuan) | Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 375,650,273.55 | 240,696,731.58 | 56.07 | | Operating Cost | 38,820,914.93 | 17,495,980.98 | 121.88 | | Sales Expenses | 211,258,113.88 | 120,194,067.03 | 75.76 | | Administrative Expenses | 38,686,242.34 | 26,420,304.17 | 46.43 | | Financial Expenses | -14,026,864.62 | -15,357,661.08 | N/A | | R&D Expenses | 196,503,538.35 | 181,154,578.04 | 8.47 | | Net Cash Flow from Operating Activities | -17,020,276.08 | 112,553,063.11 | -115.12 | | Net Cash Flow from Investing Activities | -62,342,600.36 | 35,587,827.78 | -275.18 | | Net Cash Flow from Financing Activities | 25,912,835.49 | 44,364,792.88 | -41.59 | - Change in operating revenue was primarily due to year-over-year growth in drug sales[116] - Change in operating costs was primarily due to increased sales volume and a higher proportion of thrombin sales, which has a lower gross profit margin[117] - Change in sales expenses was primarily due to increased marketing service fees[118] - Change in administrative expenses was primarily due to increased expenses from the termination of employee equity incentives at US subsidiary GENSUN[118] - Change in net cash flow from operating activities was primarily due to differences in installment payments for exclusive marketing authorization fees for thrombin[118] (III) Analysis of Assets and Liabilities Total assets slightly decreased, and net assets attributable to shareholders decreased 6.16%; other non-current assets significantly increased 737.57%, while long-term borrowings rose 183.42% Changes in Assets and Liabilities (Period-end vs. Prior Year-end) | Item | Current Period-end Amount (yuan) | Prior Year-end Amount (yuan) | Change from Prior Year-end (%) | | :--- | :--- | :--- | :--- | | Notes Receivable | 0 | 324,131.60 | -100.00 | | Right-of-use Assets | 19,141,912.99 | 34,655,845.75 | -44.77 | | Other Non-current Assets | 32,525,329.50 | 3,883,301.93 | 737.57 | | Notes Payable | 17,637,650.00 | 10,208,204.80 | 72.78 | | Advances from Customers | 0 | 15,290.52 | -100.00 | | Contract Liabilities | 524,982.09 | 0 | 100.00 | | Other Payables | 45,457,064.72 | 106,347,910.54 | -57.26 | | Non-current Liabilities Due Within One Year | 23,376,316.37 | 16,166,597.35 | 44.60 | | Long-term Borrowings | 125,699,999.96 | 44,350,969.43 | 183.42 | | Lease Liabilities | 13,140,162.19 | 26,861,235.30 | -51.08 | | Deferred Income Tax Liabilities | 3,673,860.67 | 5,701,419.80 | -35.56 | - Other non-current assets significantly increased by 737.57%, primarily due to increased prepayments for infrastructure and equipment projects[120] - Long-term borrowings increased by 183.42%, primarily due to new acquisition loans[120] - Other payables decreased by 57.26%, primarily due to installment payments for equity transfer fees to minority shareholders of subsidiary GENSUN[120] - Overseas assets amounted to USD 17,392,914.58, accounting for 4.15% of total assets[122] (IV) Analysis of Investment Status This section analyzes the company's investment status, disclosing financial assets measured at fair value, with an ending balance of 33.97 million yuan Financial Assets Measured at Fair Value (Unit: yuan) | Asset Category | Beginning Balance | Fair Value Change Gains/Losses for Current Period | Cumulative Fair Value Changes Recognized in Equity | Impairment Provision for Current Period | Amount Purchased for Current Period | Amount Sold/Redeemed for Current Period | Other Changes | Ending Balance | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Financial Derivatives | 40,500,717.30 | 7,158,600.00 | 0 | 0 | 0 | 0 | 630,575.35 | 33,972,692.65 | | Total | 40,500,717.30 | 7,158,600.00 | 0 | 0 | 0 | 0 | 630,575.35 | 33,972,692.65 | (VI) Analysis of Major Holding and Participating Companies This section lists financial information for Shanghai Zelgen and GENSUN, showing losses for both subsidiaries during the period Major Holding and Participating Companies (Unit: 10,000 yuan) | Company Name | Company Type | Principal 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) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Shanghai Zelgen | Subsidiary | New drug R&D technical consulting, services | 1,000.00 | 6,609.99 | -9.89 | 5,029.34 | -145.45 | -144.71 | | GENSUN | Subsidiary | Innovative antibody drug research | USD 588.8838 | 12,147.61 | -5,122.14 | - | -3,732.01 | -3,533.09 | Section IV Corporate Governance, Environment, and Social Responsibility I. Changes in Directors, Senior Management, and Core Technical Personnel The company completed board re-election and senior management appointments, with several directors and supervisors departing, and the supervisory board abolished - JISHENG WU and Zhang Menghang resigned as directors; RUYI HE, Zhang Binghui, and Huang Fanzhi resigned as independent directors[128] - Cheng Zengjiang, Guan Yamei, and Yuan Hongchang were elected as independent directors[128] - Yi Bihui, Zhang Junchao, and Ren Yuanqi resigned as supervisors; Yi Bihui was elected as an employee representative director, and Zhang Junchao was elected as a director[128] - The company completed adjustments to its corporate governance structure, abolishing the supervisory board, with its functions now exercised by the Board's Audit Committee[70] II. Profit Distribution or Capital Reserve Conversion Plan The company's board of directors resolved that there is no profit distribution or capital reserve conversion plan for the current reporting period - There is no profit distribution plan or capital reserve conversion plan for the current reporting period[129] IV. Environmental Information of Listed Companies and Their Major Subsidiaries The company and its Yuanfeng Road plant are included in the list of enterprises required to disclose environmental information by law - The number of enterprises included in the list of those required to disclose environmental information by law is 1 (referring to the company entity)[131] - Suzhou Zelgen Biopharmaceutical Co., Ltd. and its Yuanfeng Road plant are both included in the list of enterprises required to disclose environmental information by law[131] Section V Significant Matters I. Fulfillment of Commitments All commitments by the company, its actual controllers, shareholders, and related parties, including share lock-ups and non-competition, were strictly fulfilled - Controlling shareholder, actual controller, chairman, general manager, and core technical personnel ZELIN SHENG committed not to transfer shares within 36 months from the company's stock listing date, and not to transfer shares within the first 3 full fiscal years before the company achieves profitability[133] - The company and its actual controller committed that the prospectus contains no false records, misleading statements, or material omissions, and will bear compensation liabilities and share repurchase obligations[141][142] - The actual controller, core technical personnel, and employee shareholding platforms committed to resolve horizontal competition, refraining from engaging in businesses or activities that constitute or may constitute direct or indirect competition with the company's principal business[144][145][146] - The actual controller and employee shareholding platforms committed to resolve related party transactions, minimizing and avoiding related party transactions with the company and its controlled entities, and ensuring they are conducted on fair, equitable, and arm's-length principles[146][147][148] - The actual controller committed to bear supplementary payments for social insurance and housing provident funds, fines, late fees, and other expenses, as well as tax补缴 and related costs[149][150] - The company's directors, senior management, controlling shareholders, and actual controllers committed to diligently implement the company's return enhancement measures, refraining from transferring benefits to other entities or individuals without compensation or under unfair conditions[150][151] VII. Material Litigation and Arbitration Matters The company had no material litigation or arbitration matters during the current reporting period - The company had no material litigation or arbitration matters during the current reporting period[153] XII. Explanation of Progress in Use of Raised Funds Raised funds were utilized smoothly, with 2.08 billion yuan invested; however, the R&D and Production Center Phase II project was extended to December 2026 Overall Use of Raised Funds (Unit: 10,000 yuan) | Source of Raised Funds | Total Raised Funds (10,000 yuan) | Net Raised Funds (10,000 yuan) | Cumulative Raised Funds Invested as of Period-end (10,000 yuan) | Cumulative Investment Progress as of Period-end (%) | Amount Invested in Current Year (10,000 yuan) | | :--- | :--- | :--- | :--- | :--- | :--- | | Initial Public Offering | 202,560.00 | 190,822.08 | 167,780.57 | 87.93 | 6,351.68 | | Private Placement of Shares to Specific Objects | 120,000.00 | 118,193.32 | 40,625.21 | 34.37 | 7,933.61 | | Total | 322,560.00 | 309,015.39 | 208,405.78 | - | 14,285.30 | - The completion date for the 'New Drug R&D and Production Center Phase II Project' has been extended to December 2026[160] - On April 18, 2025, the company's board of directors approved the 'Proposal on Changes, Amount Adjustments, and Addition of Sub-projects for Certain Fundraising Investment Projects,' modifying and adjusting the amounts for some sub-projects within the 'New Drug R&D Project' from both the initial public offering and the 2021 private placement of A-shares[158][161][162] - At the end of the reporting period, the company managed idle raised funds as cash, with an ending balance of 1.148 billion yuan[167] Section VI Share Changes and Shareholder Information I. Changes in Share Capital During the reporting period, there were no changes in the company's total ordinary shares or share capital structure - During the reporting period, there were no changes in the company's total ordinary shares or share capital structure[169] II. Shareholder Information As of period-end, the company had 8,795 ordinary shareholders; ZELIN SHENG was the largest shareholder, with related party relationships disclosed - Total number of ordinary shareholders at the end of the reporting period: 8,795[171] Top Ten Shareholders' Shareholdings (Excluding Shares Lent via Securities Lending) | Shareholder Name | Shares Held at Period-end | Proportion (%) | Shareholder Nature | | :--- | :--- | :--- | :--- | | ZELIN SHENG | 49,910,527 | 18.85 | Overseas Natural Person | | Ningbo Zeao Venture Capital Partnership (Limited Partnership) | 16,500,600 | 6.23 | Other | | Lu Huiping | 12,631,644 | 4.77 | Domestic Natural Person | | JACKIE ZEGI SHENG | 12,292,164 | 4.64 | Overseas Natural Person | | Industrial and Commercial Bank of China Co., Ltd. - Zhong Ou Medical and Health Mixed Securities Investment Fund | 8,166,341 | 3.09 | Other | | Bank of China Co., Ltd. - GF Medical and Healthcare Stock Investment Fund | 5,274,465 | 1.99 | Other | | China Construction Bank Co., Ltd. - ICBC Credit Suisse Frontier Medical Stock Investment Fund | 4,700,000 | 1.78 | Other | | China Construction Bank Co., Ltd. - Huitianfu Innovative Medicine Theme Mixed Securities Investment Fund | 4,268,948 | 1.61 | Other | | Ningbo Jingchen Investment Partnership (Limited Partnership) | 3,904,740 | 1.48 | Other | | China Construction Bank Co., Ltd. - Fullgoal Precision Medicine Flexible Allocation Mixed Securities Investment Fund | 3,424,532 | 1.29 | Other | - ZELIN SHENG and Lu Huiping are parties acting in concert; ZELIN SHENG and JACKIE ZEGI SHENG are siblings[174] III. Information on Directors, Senior Management, and Core Technical Personnel There were no changes in the shareholdings of current and departed directors, senior management, and core technical personnel during the reporting period - There were no changes in the shareholdings of current and departed directors, senior management, and core technical personnel during the reporting period[175] Section VII Bond-Related Information I. Corporate Bonds (Including Enterprise Bonds) and Non-Financial Enterprise Debt Financing Instruments The company had no corporate bonds or non-financial enterprise debt financing instruments during the current reporting period - The company had no corporate bonds (including enterprise bonds) or non-financial enterprise debt financing instruments[179] II. Convertible Corporate Bonds The company had no convertible corporate bonds during the current reporting period - The company had no convertible corporate bonds[179] Section VIII Financial Report I. Audit Report This semi-annual report is unaudited - This semi-annual report is unaudited[6] II. Financial Statements This section presents the company's consolidated and parent company financial statements for H1 2025, reflecting financial position and operating results - The consolidated balance sheet shows that as of June 30, 2025, total assets were 2,999,203,352.04 yuan, total liabilities were 1,822,587,915.60 yuan, and total equity attributable to parent company owners was 1,176,615,436.44 yuan[183] - The consolidated income statement shows that for January-June 2025, total operating revenue was 375,650,273.55 yuan, and net profit attributable to parent company shareholders was -72,803,538.99 yuan[190] - The consolidated cash flow statement shows that for January-June 2025, net cash flow from operating activities was -17,020,276.08 yuan[195] - The parent company balance sheet shows that as of June 30, 2025, total assets were 3,375,115,029.06 yuan, total liabilities were 1,792,223,444.26 yuan, and total owner's equity was 1,582,891,584.80 yuan[186] - The parent company income statement shows that for January-June 2025, operating revenue was 388,593,125.25 yuan, and net profit was -37,049,880.95 yuan[192][193] III. Company Profile This section outlines Suzhou Zelgen Biopharmaceutical Co., Ltd.'s profile, including establishment, listing, registered capital, and business scope - The company was initially established on March 18, 2009, and made its initial public offering and listed on the STAR Market of the Shanghai Stock Exchange in January 2020[209] - As of December 31, 2024, the company's registered capital was 264,708,186.00 yuan[209] - Business scope includes R&D of new drugs, related technical consulting and services; drug production, and sales of self-produced products[209] IV. Basis of Financial Statement Preparation The company's financial statements are prepared on a going concern basis, expecting continued operations due to marketed drugs, R&D pipeline, and strong financing - The company's financial statements are prepared on a going concern basis[210] - The company has three new drugs approved for marketing, multiple innovative drugs in R&D, sufficient working capital, and strong financing capabilities, indicating an expectation of continued operations[211] V. Significant Accounting Policies and Estimates This section details the significant accounting policies and estimates used in preparing financial statements, covering financial instruments, receivables, inventory, R&D, revenue, and leases - The company adheres to the requirements of enterprise accounting standards to accurately and completely reflect its financial position[213] - Financial assets are classified as measured at amortized cost, at fair value through other comprehensive income, or at fair value through profit or loss[227] - For accounts receivable, the simplified approach is adopted, consistently measuring loss allowances at an amount equal to the lifetime expected credit losses[242] - R&D expenditures are divided into research phase expenditures and development phase expenditures; research phase expenditures are expensed as incurred, while development phase expenditures are capitalized when specific conditions are met[271] - Revenue is recognized using the five-step model; drug sales are recognized when customers receive and sign for the drugs, while intellectual property licensing revenue is recognized based on milestone payments and sales royalties[286][292] - Government grants are classified as asset-related or income-related based on relevant government regulations and are recognized and accounted for separately[296] VI. Taxation This section details the company's and its subsidiaries' main tax types and rates, along with applicable tax incentives, including preferential corporate income tax rates Major Tax Categories and Rates | Tax Category | Tax Basis | Tax Rate | | :--- | :--- | :--- | | Value-Added Tax (VAT) | Value-added amount | 13% (sales of goods), 9% (real estate leasing services), 6% (technical services), 3% (small-scale taxpayers), 7.25% (GENSUN sales tax) | | Urban Maintenance and Construction Tax | Amount of turnover tax payable | 7% (Company, Zelgen Biotech, Zhejiang Zelgen), 5% (Shanghai Zelgen) | | Corporate Income Tax | Taxable income | 15% (Company), 20% (Shanghai Zelgen, Zelgen Biotech, Zhejiang Zelgen), 29.84% (GENSUN), 16.5% (Hong Kong Zelgen) | | Education Surcharge | Amount of turnover tax payable | 3% (Company, Zelgen Biotech, Shanghai Zelgen, Zhejiang Zelgen) | | Local Education Surcharge | Amount of turnover tax payable | 2% (Company, Zelgen Biotech, Shanghai Zelgen, Zhejiang Zelgen) | - The company is exempt from VAT for providing technology transfer, technology development, and related technical consulting and services[311] - From January 1, 2023, to December 31, 2027, advanced manufacturing enterprises are allowed to deduct an additional 5% of current deductible input VAT from their payable VAT amount[312] - As a high-tech enterprise, the company enjoys a preferential corporate income tax rate of 15%[313] - Shanghai Zelgen, Zelgen Biotech, and Zhejiang Zelgen qualify as small-profit enterprises, with their taxable income calculated at 25% and corporate income tax paid at a 20% rate[314] VII. Notes to Consolidated Financial Statement Items This section provides detailed notes for consolidated financial statement items, explaining balances, changes, and key influencing factors across various accounts - Cash and bank balances at period-end totaled 2,117,480,591.46 yuan, with 6,206,693.04 yuan held overseas[317] - Trading financial assets at period-end totaled 33,972,692.65 yuan, entirely comprising short-term bank wealth management products of US subsidiary GENSUN[318] - Accounts receivable book value at period-end was 175,399,720.05 yuan, with a bad debt provision rate of 5.00%[325] - Inventory book value at period-end was 164,215,169.54 yuan, with a new inventory impairment provision of 3,358,109.26 yuan for the period, mainly due to trial-produced thrombin nearing its expiration date[350][353] - Construction in progress at period-end totaled 152,531,961.67 yuan, primarily including the R&D and Production Center Phase II project and the post-marketing expansion and outsourced technology transfer project for thrombin[366] - Intangible assets book value at period-end was 40,178,060.57 yuan, including land use rights, patent rights, non-patent technology, and software[373] - Short-term borrowings at period-end totaled 976,363,228.04 yuan, primarily credit loans[392] - Other non-current liabilities at period-end totaled 330,188,680.29 yuan, primarily exclusive marketing authorization fees for recombinant human thrombin[420] - Capital surplus at period-end totaled 3,116,344,427.97 yuan, with the decrease primarily due to a reduction in share premium from the repurchase of shares upon termination of subsidiary GENSUN's employee equity incentive plan[424][425] - Retained earnings at period-end were -2,189,546,023.06 yuan[429] - Operating revenue for the current period was 375,650,273.55 yuan, and operating cost was 38,820,914.93 yuan[432] - Sales expenses for the current period were 211,258,113.88 yuan, a 75.76% increase year-over-year, primarily due to increased marketing service fees[438] - Administrative expenses for the current period were 38,686,242.34 yuan, primarily due to expenses from the termination of employee equity incentives at subsidiary GENSUN[439] - R&D expenses for the current period were 196,503,538.35 yuan, an 8.47% increase year-over-year[440] - Other income for the current period was 27,082,192.48 yuan, primarily government grants[442] - Non-operating expenses for the current period were 683,818.74 yuan, including fines and civil compensation[452] VIII. R&D Expenditures This section details the company's R&D expenditures, totaling 196.50 million yuan (all expensed), with employee compensation and clinical research as primary components R&D Expenditures by Nature of Expense | Item | Current Period Amount (yuan) | Prior Period Amount (yuan) | | :--- | :--- | :--- | | Employee Compensation | 62,480,818.52 | 57,078,660.05 | | Raw Materials, Reagents, and Consumables | 24,730,510.78 | 22,491,358.94 | | Preclinical and Clinical Research | 82,093,653.70 | 75,605,896.74 | | Depreciation and Amortization | 15,942,611.48 | 15,277,833.39 | | Other | 11,255,943.87 | 10,700,828.92 | | Total | 196,503,538.35 | 181,154,578.04 | | Of which: Expensed R&D Investment | 196,503,538.35 | 181,154,578.04 | | Capitalized R&D Investment | 0 | 0 | IX. Changes in Consolidation Scope During the current reporting period, there were no changes in the company's consolidation scope, involving no business combinations or disposals - During the current reporting period, there were no changes in the company's consolidation scope[472] X. Interests in Other Entities This section outlines the company's equity interests in its wholly-owned subsidiaries, noting the termination of GENSUN's employee equity incentive plan Composition of Enterprise Group (Unit: 10,000 yuan) | Subsidiary Name | Principal Place of Business | Registered Capital (10,000 yuan) | Registered Address | Business Nature | Shareholding Ratio (%) Direct | Shareholding Ratio (%) Indirect | Acquisition Method | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Zelgen Biotech | Jiangsu | 100.00 | Suzhou | Drug R&D | 100 | - | Newly Established | | Shanghai Zelgen | Shanghai | 1,000.00 | Shanghai | Drug R&D | 100 | - | Acquisition | | Zhejiang Zelgen | Zhejiang | 500.00 | Lishui | Drug R&D | 100 | - | Newly Established | | Hong Kong Zelgen | Hong Kong | USD 1,270 | Hong Kong | Investment Holding | 100 | - | Newly Established | | GENSUN | California, USA | USD 588.8838 | Delaware, USA | Drug R&D | - | 100 | Acquisition | - On June 25, 2025, subsidiary GENSUN's board of directors approved the termination of GENSUN's 2016 employee equity incentive plan, and the company indirectly holds 100% equity in GENSUN through Hong Kong Zelgen[473] XI. Government Grants This section discloses the company's government grants, with deferred income from grants totaling 7.66 million yuan and 25.18 million yuan recognized as other income Liability Items Involving Government Grants (Unit: yuan) | Financial Statement Item | Beginning Balance | New Grants for Current Period | Amount Recognized as Non-operating Income for Current Period | Amount Transferred to Other Income for Current Period | Other Changes for Current Period | Ending Balance | Asset/Income Related | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Deferred Income | 5,100,000.00 | 23,642,064.89 | 0 | 22,817,064.89 | 0 | 5,925,000.00 | Income Related | | Deferred Income | 4,101,753.31 | 0 | 0 | 2,365,187.22 | 0 | 1,736,566.09 | Asset Related | | Total | 9,201,753.31 | 23,642,064.89 | 0 | 25,182,252.11 | 0 | 7,661,566.09 | - | Government Grants Recognized in Profit or Loss for the Current Period (Unit: yuan) | Item | Current Period Amount | Prior Period Amount | | :--- | :--- | :--- | | Asset Related | 2,365,187.22 | 2,630,582.94 | | Income Related | 22,817,064.89 | 2,335,211.22 | | Total | 25,182,252.11 | 4,965,794.16 | - Total government grants recognized in profit or loss for the current period amounted to 25,182,252.11 yuan, primarily including subsidies for the Blood Center Public Platform and Kunshan Biopharmaceutical Technology Innovation (policy-based funding)[443][477] XII. Risks Related to Financial Instruments The company faces market risks (currency, interest rate), credit risk, and liquidity risk, all managed to be immaterial or low impact - The company's foreign exchange risk primarily relates to its USD bank deposits, but management considers it immaterial[477] - As of June 30, 2025, if the RMB appreciates or depreciates by 10% against foreign currencies, the company's net profit would increase or decrease by 771,247.07 yuan[478] - The company's interest rate risk arises from interest-bearing debts such as bank borrowings and lease liabilities; management believes a 50 basis point change in interest rates would not materially impact total profit and shareholder equity[479][481] - Credit risk primarily stems from losses on financial assets due to the counterparty's failure to fulfill obligations; the company mitigates this risk through credit limit control, credit approval, and provision for bad debts[481] - The company's management believes the liquidity risk undertaken is low and does not materially impact operations and financial statements[482] XIII. Disclosure of Fair Value This section discloses the fair value of the company's assets and liabilities measured at fair value at period-end, with trading financial assets totaling 33.97 million yuan Fair Value of Assets and Liabilities Measured at Fair Value at Period-end (Unit: yuan) | Item | Level 1 Fair Value Measurement | Level 2 Fair Value Measurement | Level 3 Fair Value Measurement | Total | | :--- | :--- | :--- | :--- | :--- | | I. Recurring Fair Value Measurements | - | - | - | - | | (I) Trading Financial Assets | - | - | 33,972,692.65 | 33,972,692.65 | | 1. Financial assets measured at fair value through profit or loss | - | - | - | - | | (1) Debt instrument investments | - | - | 33,972,692.65 | 33,972,692.65 | | Total assets measured at recurring fair value | - | - | 33,972,692.65 | 33,972,692.65 | XIV. Related Parties and Related Party Transactions This section details the company's related parties and transactions, including procurement, leases, key management compensation, and the acquisition of GENSUN minority shares - Key related parties include the Small Nucleic Acid Research Institute (associate shareholder), JACKIE ZEGI SHENG (sibling of ZELIN SHENG), and MIKE C SHENG (son of ZELIN SHENG)[489] - Purchases of goods from the Small Nucleic Acid Research Institute for the current period amounted to 3,072,233.16 yuan[490] - As a lessee, the company leased buildings from the Small Nucleic Acid Research Institute, paying 67,503.80 yuan in rent and incurring 496,351.91 yuan in lease liability interest expenses for the current period[493] - Key management personnel compensation for the current period amounted to 5.16 million yuan[496] - The Small Nucleic Acid Research Institute invested 30 million yuan to purchase relevant instruments and equipment for the Blood Center Public Platform; as of June 30, 2025, the original value of installed and accepted equipment was 26,305,829.08 yuan[497] - The company's wholly-owned subsidiary, Hong Kong Zelgen, acquired a combined 36.43% stake in GENSUN from JACKIE ZEGI SHENG and MIKE C SHENG for a total of USD 32.8887 million, which was fully paid as of June 30, 2025[497] - At period-end, accounts payable to the Small Nucleic Acid Research Institute were 145,177.44 yuan, other payables were 5,293,250.00 yuan, and lease liabilities were 7,160,940.88 yuan[502] XV. Share-based Payment This section discloses equity-settled share-based payments, primarily related to GENSUN's terminated employee equity incentive plan, resulting in a 10.83 million yuan expense - Equity-settled share-based payments are granted to company employees[504] - On June 25, 2025, subsidiary GENSUN's board of directors approved the termination of its 2016 employee equity incentive plan, repurchasing 129,450 vested options for a total of USD 1,508,351.12 (equivalent to 10,828,754.36 yuan)[508] - Equity-settled share-based payment expense recognized for the current period was 10,828,754.36 yuan[508] XVI. Commitments and Contingencies The company had no significant commitments or contingent matters requiring disclosure during the current reporting period - The company had no significant contingent matters requiring disclosure[510] XVII. Post-Balance Sheet Events The company had no significant non-adjusting events, profit distribution, sales returns, or other post-balance sheet events - The company had no significant non-adjusting events, profit distribution, sales returns, or other post-balance sheet events[511] XIX. Notes to Parent Company Financial Statement Items This section provides detailed notes for the parent company's key financial statement items, including accounts receivable, other receivables, long-term equity investments, and operating revenue - Parent company accounts receivable book value at period-end was 239,096,151.72 yuan[514] - Parent company other receivables at period-end totaled 380,868,780.63 yuan, primarily intercompany balances[521][524] - Parent company long-term equity investments at period-end totaled 340,723,685.01 yuan, primarily investments in subsidiaries[534][536] - Parent company operating revenue for the current period was 388,593,125.25 yuan, and operating cost was 49,606,624.68 yuan[538] XX. Supplementary Information This section provides supplementary financial information, including non-recurring gains and losses totaling 29.84 million yuan and basic/diluted EPS of -0.28 yuan/share Detailed Statement of Non-recurring Gains and Losses for the Current Period (Unit: yuan) | Item | Amount | | :--- | :--- | | Gains or losses on disposal of non-current assets | 810.44 | | Government grants recognized in profit or loss for the current period | 22,817,064.89 | | Gains or losses from changes in fair value and disposal of financial assets and liabilities | 800,771.56 | | Share-based payment expenses recognized due to cancellation or modification of equity incentive plans | 10,242,297.78 | | Other non-operating income and expenses | -683,818.74 | | Less: Income tax impact | 3,295,251.89 | | Impact on minority interests (after tax) | 43,990.61 | | Total | 29,837,883.43 | Return on Net Assets and Earnings Per Share | Profit for the Reporting Period | Weighted Average Return on Net Assets (%) | Earnings Per Share Basic EPS | Earnings Per Share Diluted EPS | | :--- | :--- | :--- | :--- | | Net profit attributable to ordinary shareholders of the company | -5.98 | -0.28 | -0.28 | | Net profit attributable to ordinary shareholders of the company (excluding non-recurring gains and losses) | -8.43 | -0.39 | -0.39 |