复旦张江(01349) - 2025 - 中期业绩

Company Major Financial Indicators Five-Year Financial Summary The report presents the company's performance and balance sheet over the past five half-years, showing a decrease in revenue and a significant decline in profit for the six months ended June 30, 2025, with total assets and liabilities slightly reduced from year-end 2024 Five-Year Performance Summary (As of June 30 for Six Months) | Indicator (RMB thousands) | 2025 | 2024 | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | :--- | :--- | | Revenue | 390,083 | 408,124 | 522,828 | 271,260 | 399,037 | | Profit/(Loss) for the Period | 5,622 | 70,344 | 68,605 | (36,021) | 65,069 | | Profit Attributable to Equity Holders of the Company | 5,715 | 70,473 | 68,438 | (35,975) | 65,485 | Five-Year Assets and Liabilities Summary | Indicator (RMB thousands) | June 30, 2025 | December 31, 2024 | December 31, 2023 | December 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | :--- | :--- | :--- | | Total Assets | 2,541,453 | 2,586,503 | 2,876,688 | 2,976,007 | 2,781,172 | | Total Liabilities | (261,015) | (281,226) | (518,124) | (722,986) | (591,582) | | Equity Attributable to Equity Holders of the Company | 2,279,821 | 2,304,567 | 2,357,554 | 2,257,102 | 2,192,946 | Key Accounting Data and Financial Indicators During the reporting period, the company's operating revenue decreased by 4.42% year-on-year, while total profit and net profit attributable to shareholders both declined by over 90%, primarily due to increased R&D expenses and a high comparative base from one-time compensation in the prior year, though net cash flow from operating activities grew by 125% Key Accounting Data (RMB) | Key Accounting Data | Current Reporting Period (2025 H1) | Prior Year Period (2024 H1) | YoY Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 390,083,112 | 408,123,863 | -4.42 | | Total Profit | 5,622,200 | 72,186,951 | -92.21 | | Net Profit Attributable to Shareholders of Listed Company | 5,715,142 | 70,473,064 | -91.89 | | Net Cash Flow from Operating Activities | 62,212,859 | 27,649,549 | 125.00 | - Total profit and net profit attributable to parent company shareholders significantly decreased year-on-year, primarily due to increased R&D expenses in the current period and a higher comparative base from one-time compensation and liquidated damages recognized in the prior year due to termination of cooperation with a Ribao Duo® promotion service provider[11] Key Financial Indicators | Key Financial Indicators | Current Reporting Period (2025 H1) | Prior Year Period (2024 H1) | Change | | :--- | :--- | :--- | :--- | | Basic Earnings Per Share (RMB/share) | 0.01 | 0.07 | -85.71% | | Weighted Average Return on Net Assets (%) | 0.25 | 2.99 | Decrease 2.74 percentage points | | R&D Investment as % of Operating Revenue (%) | 45.63 | 38.06 | Increase 7.57 percentage points | Non-Recurring Gains and Losses and Amounts During the reporting period, the company's non-recurring gains and losses totaled approximately RMB 15.21 million, primarily from gains on financial assets like structured deposits and wealth management products, and government subsidies Non-Recurring Gains and Losses Items (RMB) | Non-Recurring Gains and Losses Item | Amount | | :--- | :--- | | Government Subsidies | 6,850,812 | | Gains and Losses from Holding Financial Assets and Liabilities | 8,257,294 | | Gains and Losses from Disposal of Non-Current Assets | 203,055 | | Other Non-Operating Income and Expenses | -103,860 | | Total | 15,206,999 | Financial Review and Management Discussion and Analysis Operating Performance Review During the reporting period, the group's operating revenue decreased by 4% to RMB 390 million, with net profit plummeting by 92% to RMB 5.62 million, primarily due to a high comparative base from one-time gains in the prior year and increased R&D and sales expenses - Operating revenue was approximately RMB 390 million, a 4% year-on-year decrease, with main business revenue primarily from three core products: Aileda® (contributing 49%), Ribao Duo® (contributing 30%), and Fumeida® (contributing 20%)[16][17] - Operating costs increased year-on-year, mainly due to a decrease in Ribao Duo® production volume affected by centralized procurement, leading to higher unit production costs[18] Period Expense Changes | Expense Item (RMB thousands) | Current Reporting Period (2025 H1) | Prior Year Period (2024 H1) | YoY Change | | :--- | :--- | :--- | :--- | | Selling Expenses | 181,910 | 114,493 | +59% | | Administrative Expenses | 20,303 | 23,374 | -13% | | R&D Expenses | 177,976 | 154,593 | +15% | - Net profit was approximately RMB 5.62 million, a 92% year-on-year decrease, with net profit margin falling from 17% in the prior year to 1%, primarily due to compensation and liquidated damages recognized in the prior year from the termination of cooperation with Shanghai Huizheng[25] Liquidity and Financial Resources The group maintains a conservative financial policy, primarily relying on internal resources and IPO proceeds, holding approximately RMB 1.11 billion in cash and cash equivalents as of the reporting period end, with no outstanding bank borrowings or asset pledges - As of June 30, 2025, the group held cash and cash equivalents of RMB 1.106 billion[27] - The group has no outstanding bank borrowings, rendering the debt-to-asset ratio inapplicable, and no assets were pledged at the period end[27][29][31] Significant Investments and Asset Changes The group's most significant long-term equity investment is a 39.5663% stake in Shanghai Handu Pharmaceutical Technology Co., Ltd., with a net book value of approximately RMB 222 million, accounting for 8.72% of total assets, resulting in an investment loss of RMB 2.258 million for the period, with no major asset acquisitions or disposals - The group's long-term equity investment in Handu Pharmaceutical has a net book value of RMB 222 million, accounting for 8.72% of total assets, and the group recognized an investment loss of approximately RMB 2.258 million during the reporting period due to Handu Pharmaceutical's unrealized net loss[35] - The group's 360 ordinary shares of TuHURA Biosciences, Inc., a US Nasdaq-listed company, had a fair value of approximately RMB 5,747 at the end of the reporting period[38] - During the reporting period, the group had no significant acquisitions or disposals of assets, subsidiaries, associates, or joint ventures[39] Analysis of Major Controlled and Invested Companies The report details the financial status of major controlled and invested companies, with Taizhou Fudan-Zhangjiang incurring a net loss of RMB 7.2391 million due to significantly increased R&D expenses, and Handu Pharmaceutical recording a net loss of RMB 5.5960 million Financial Data of Major Controlled and Invested Companies (RMB 10,000) | Company Name | Total Assets | Net Assets | Operating Revenue | Net Profit | | :--- | :--- | :--- | :--- | :--- | | Taizhou Fudan-Zhangjiang | 58,303.47 | 45,547.62 | 9,381.22 | -723.91 | | Fengyi Holdings | 2,132.32 | 2,032.39 | 8.17 | -136.55 | | Shanghai Suyuan Bio | 1,340.38 | 1,214.22 | 210.77 | -182.95 | | Handu Pharmaceutical | 66,531.40 | 52,796.88 | 403.93 | -559.60 | Subscription of Wealth Management Products and Structured Deposits To effectively utilize idle funds, the company subscribed to RMB 1 billion worth of structured deposit products from various banks during the reporting period, all of which matured and yielded approximately RMB 8.26 million in total gains, with no outstanding products at period end - During the reporting period, the company subscribed to a total of RMB 1 billion in structured deposit products using its own idle funds and raised capital[42] - All structured deposit products matured and were redeemed, yielding total gains of approximately RMB 8.26 million during the reporting period[43][44] Business Review and Outlook Industry and Main Business Overview The company specializes in innovative R&D, production, and sales of biopharmaceuticals, focusing on dermatology and oncology with core products Aileda®, Fumeida®, and Ribao Duo®, benefiting from supportive national policies for innovative drugs - The state has intensively introduced multiple policies supporting the development of innovative drugs, including the "Implementation Plan for Full-Chain Support of Innovative Drug Development" and "Several Measures to Support High-Quality Development of Innovative Drugs," providing comprehensive support for industry growth[47][48] - The company's main business products include: Aileda® (Aminolevulinic Acid Hydrochloride for External Use), the world's first photodynamic drug for condyloma acuminatum; Fumeida® (Hemoporfin for Injection), the world's first photodynamic drug for port-wine stains; and Ribao Duo® (Doxorubicin Hydrochloride Liposome Injection), China's first generic version of Doxil for tumor treatment[56][58][59] Discussion and Analysis of Operating Conditions The company's R&D strategy focuses on photodynamic and ADC drugs, with ongoing clinical trials for new indications and novel compounds, while core product sales show mixed performance, and Ribao Duo®'s significant price reduction due to non-中标 in centralized procurement is expected to negatively impact 2025 revenue - R&D strategy focuses on two major areas: Photodynamic drugs, expanding new indications for marketed drugs (e.g., Aileda® for cervical precancerous lesions, acne) and developing intraoperative molecular imaging (IMI) technology for surgical visualization in glioblastoma, bladder cancer, etc.; and Antibody-Drug Conjugates (ADCs), with anti-Trop2 antibody-conjugated SN38 drug (FDA018) in Phase III clinical trials, and multiple ADC projects based on the new linker-drug platform (BB05), such as anti-Her2-BB05 and anti-Trop2-BB05, both in Phase I/II clinical trials[61][62][72][74] YoY Change in Major Product Sales Revenue | Product | YoY Change in Reporting Period | | :--- | :--- | | Aileda® | Increase 2% | | Fumeida® | Decrease 7% | | Ribao Duo® | Decrease 16% | - Significant event: The anti-tumor drug Ribao Duo®, not selected in the national centralized procurement, has seen its market retail price adjusted downwards by no less than 35% since May 1, 2025, which is expected to adversely impact the company's sales revenue for 2025 and subsequent periods[81] Core Competitiveness Analysis The company's core competitiveness stems from its four major technology platforms—gene engineering, photodynamic, nanotechnology, and oral solid dosage—with a strategic focus on photodynamic and ADC drugs, demonstrating strong R&D progress and a robust academic promotion and quality control system, supported by a 14.58% increase in R&D investment - The company possesses four core technology platforms: gene engineering, photodynamic, nanotechnology, and oral solid dosage formulation, with a strategic focus on photodynamic drugs and Antibody-Drug Conjugates (ADCs)[89] Progress of Key R&D Projects | Technology Area | Project Name | Indication | Latest Progress | | :--- | :--- | :--- | :--- | | Photodynamic | Hemoporfin | Port-wine Stains | US Phase II Clinical Study ongoing | | Photodynamic | Aminolevulinic Acid Hydrochloride-CIN | HPV-infected Cervical Diseases | Phase II Clinical Study completed | | Photodynamic | Aminolevulinic Acid Hydrochloride-Glioblastoma | Glioblastoma Surgical Visualization | Confirmatory Clinical Trial enrollment completed | | ADC | Anti-Trop2 Antibody-Conjugated SN38 | Triple-Negative Breast Cancer | Phase III Clinical Study ongoing | | ADC | Anti-Her2 Antibody-Conjugated BB05 | HER2-low Expressing Breast Cancer | Phase II Clinical Study enrollment completed | R&D Investment (RMB) | Indicator | Current Period Amount | Prior Year Period Amount | Change (%) | | :--- | :--- | :--- | :--- | | Expensed R&D Investment | 177,976,257 | 154,592,537 | 15.13 | | Total R&D Investment | 177,976,257 | 155,330,149 | 14.58 | | Total R&D Investment as % of Operating Revenue (%) | 45.63 | 38.06 | Increase 7.57 percentage points | Risk Factors The company faces significant risks including the long, costly, and uncertain nature of new drug R&D, potential loss of core technical personnel, product concentration risk with high reliance on three main products, and intensified drug price reduction risks, particularly for Ribao Duo® after failing centralized procurement - New drug R&D carries high costs, long cycles, and uncertainty risks, where failure to succeed or gain approval for pipeline products will result in losses of prior investments[101] - Product portfolio is relatively concentrated, with dominant products Aileda®, Ribao Duo®, and Fumeida® accounting for a large proportion of total sales revenue, making the company vulnerable to single-product market impacts[103] - Drug price reduction risk intensified: Ribao Duo® was not selected in the tenth batch of national centralized procurement and has been subject to price reductions of no less than 35% since May 1, 2025, with its 2025 annual sales revenue projected to decrease by over 50% year-on-year, potentially leading to a single-product loss[106] Outlook Moving forward, the group will strategically focus on its two advantageous areas: photodynamic technology, with comprehensive investment to solidify its leadership, and Antibody-Drug Conjugates (ADCs), by rapidly advancing competitive projects for R&D and industrialization to expand market scale - The company will strategically focus on two core areas in the future: Photodynamic technology, with comprehensive development from specialized devices to innovative drugs, increasing investment to consolidate industry leadership; and Antibody-Drug Conjugates (ADCs), by rapidly advancing competitive project R&D and industrialization to expand industry scale[109] Corporate Governance and Other Significant Matters Corporate Governance Practices The company has adopted the HKEX Listing Rules' Corporate Governance Code, complying with all principles and provisions during the reporting period, except for the combined roles of Chairman and CEO held by Mr. Zhao Dajun, which the board believes enhances management efficiency at this stage - The company's corporate governance has one deviation: the roles of Chairman and CEO (General Manager) are both held by Mr. Zhao Dajun, without separation of duties, which the board believes is more beneficial for the company's development at this stage[116] Employees and Remuneration As of June 30, 2025, the group had 899 employees, a slight decrease from 913 in the prior year, with total staff costs for the reporting period decreasing to RMB 101.82 million from RMB 117.82 million Employee and Remuneration Overview | Indicator | June 30, 2025 | June 30, 2024 | | :--- | :--- | :--- | | Total Employees | 899 人 | 913 人 | | Staff Costs (RMB) | 101,818,230 元 | 117,815,229 元 | Other Significant Matters During the reporting period, the company adhered to disclosed commitments, with no instances of controlling shareholder fund appropriation, irregular guarantees, or major litigations, while the "Hemoporfin US Registration Project" was extended to December 31, 2025, due to external environmental factors - The net proceeds from A-share issuance amounted to RMB 974 million, with a net balance of RMB 193 million as of January 1, 2025[126] - Due to external environmental factors, the "Hemoporfin US Registration Project" has been delayed, and its implementation period has been adjusted to December 31, 2025[131] Share Capital Changes and Shareholder Information During the reporting period, the company's total share capital and structure remained unchanged, with 19,877 common shareholders at period end, and the top three shareholders being HKSCC NOMINEES LIMITED (24.58%), Shanghai Pharmaceutical Group Co., Ltd. (20.27%), and Xinqi Phase II Venture Capital Enterprise (15.14%) Top Three Shareholders' Holdings | Shareholder Name | Shares Held at Period End (shares) | Percentage (%) | | :--- | :--- | :--- | | HKSCC NOMINEES LIMITED | 254,827,740 | 24.58 | | Shanghai Pharmaceutical Group Co., Ltd. | 210,142,560 | 20.27 | | Xinqi Phase II Venture Capital Enterprise | 156,892,912 | 15.14 | Consolidated Financial Statements Consolidated Balance Sheet As of June 30, 2025, the company's total assets were RMB 2.541 billion, a 1.74% decrease from the beginning of the year, with total liabilities at RMB 261 million, a 7.18% decrease, and equity attributable to parent company shareholders totaling RMB 2.280 billion, a 1.07% decrease Key Data from Consolidated Balance Sheet (RMB) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total Current Assets | 1,593,438,095 | 1,606,778,507 | | Total Non-Current Assets | 948,015,177 | 979,724,116 | | Total Assets | 2,541,453,272 | 2,586,502,623 | | Total Current Liabilities | 229,088,028 | 250,952,140 | | Total Non-Current Liabilities | 31,927,181 | 30,273,378 | | Total Liabilities | 261,015,209 | 281,225,518 | | Total Equity Attributable to Parent Company Shareholders | 2,279,821,312 | 2,304,567,412 | | Total Shareholders' Equity | 2,280,438,063 | 2,305,277,105 | Consolidated Income Statement For the six months ended June 30, 2025, the company's operating revenue was RMB 390.08 million, a 4.4% year-on-year decrease, with operating costs rising 35.3% to RMB 39.77 million, and net profit attributable to parent company shareholders significantly declining by 91.9% to RMB 5.715 million Key Data from Consolidated Income Statement (RMB) | Item | For the 6 Months Ended June 30, 2025 | For the 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | | Operating Revenue | 390,083,112 | 408,123,863 | | Operating Costs | (39,773,796) | (29,399,848) | | Selling Expenses | (181,910,272) | (114,492,701) | | R&D Expenses | (177,976,257) | (154,592,537) | | Total Profit | 5,622,200 | 72,186,951 | | Net Profit | 5,622,200 | 70,344,013 | | Net Profit Attributable to Parent Company Shareholders | 5,715,142 | 70,473,064 | Consolidated Cash Flow Statement During the reporting period, net cash flow from operating activities was RMB 62.21 million, a 125% year-on-year increase, primarily due to increased cash received from sales, while net cash outflow from investing activities was RMB 8.28 million, and cash and cash equivalents at period end totaled RMB 1.106 billion Key Data from Consolidated Cash Flow Statement (RMB) | Item | For the 6 Months Ended June 30, 2025 | For the 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net Cash Flow from Operating Activities | 62,212,859 | 27,649,549 | | Net Cash Flow (Used in)/Generated from Investing Activities | (8,277,485) | 4,326,668 | | Net Cash Flow Used in Financing Activities | (3,638,269) | (5,522,836) | | Net Increase in Cash | 50,205,176 | 26,585,009 | | Cash Balance at Period End | 1,106,490,805 | 1,222,481,006 | Notes to Financial Statements Significant Accounting Policies and Estimates The financial statements are prepared in accordance with China's Accounting Standards for Business Enterprises on a going concern basis, with key policies including expected credit loss model for receivables, weighted average cost for inventory, capitalization of development expenditures under specific conditions, and revenue recognition upon transfer of control, while significant estimates involve useful lives of fixed assets, expected credit losses, and deferred tax asset recognition - The financial statements are prepared in accordance with the Accounting Standards for Business Enterprises issued by the Ministry of Finance of China, with the functional currency being RMB[160][165] - Expenditures in the development phase are capitalized when five conditions are met: technical feasibility, management's intention, future economic benefits, resource availability, and reliable measurement[209] - Revenue recognition principle: Revenue is recognized at the amount of consideration expected to be entitled when the customer obtains control of the related goods or services[216] Notes to Consolidated Financial Statements The notes detail the composition and changes of major consolidated financial statement items, including a significant reversal of accounts receivable impairment provision, the breakdown of R&D expenses, a 59% year-on-year decrease in other income primarily due to reduced government subsidies, and investment income mainly from wealth management products - The provision for doubtful accounts on accounts receivable significantly reversed by RMB 23.837 million from RMB 27.046 million at the beginning of the year, with a period-end balance of RMB 3.209 million[254] Composition of R&D Expenses (RMB) | Item | For the 6 Months Ended June 30, 2025 | For the 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | | Outsourced R&D Expenses | 86,088,902 | 55,618,334 | | Salaries and Wages | 36,390,548 | 43,950,526 | | Data and Material Costs | 20,852,237 | 24,015,533 | | R&D Department Expenses | 18,760,793 | 19,656,393 | | Depreciation Expense | 15,883,777 | 11,351,751 | | Total | 177,976,257 | 154,592,537 | - Investment income was RMB 6.125 million, comprising a loss of RMB 2.132 million from long-term equity investments accounted for under the equity method and RMB 8.257 million from wealth management products[335] Supplementary Information to Financial Statements Return on Net Assets and Earnings Per Share During the reporting period, the weighted average return on net assets (ROE) attributable to common shareholders was 0.25%, a significant decrease from 2.99% in the prior year, with basic earnings per share at RMB 0.01, down from RMB 0.07 Return on Net Assets and Earnings Per Share | Item | Weighted Average Return on Net Assets (%) | Basic Earnings Per Share (RMB) | | :--- | :--- | :--- | | Current Reporting Period (2025 H1) | | | | Net Profit Attributable to Common Shareholders of the Company | 0.25% | 0.01 | | After Deducting Non-Recurring Gains and Losses | -0.41% | (0.01) | | Prior Year Period (2024 H1) | | | | Net Profit Attributable to Common Shareholders of the Company | 2.99% | 0.07 | | After Deducting Non-Recurring Gains and Losses | 1.85% | 0.04 |