信立泰(002294) - 2025 Q2 - 季度财报

Section 1 Important Notice, Table of Contents, and Definitions Important Notice The board, supervisory board, and senior management guarantee the report's accuracy, with no interim dividend distribution planned, and highlight key risks - The company's board of directors, supervisory board, and senior management guarantee the truthfulness, accuracy, and completeness of the semi-annual report content[4] - The company plans not to distribute cash dividends, bonus shares, or convert capital reserves into share capital[6] - Investors should be aware of risks such as R&D failure, price reductions due to policy changes, and rising costs[5] Table of Contents This report's clear directory is divided into nine chapters covering important notices, company profile, management discussion, governance, and financial statements - The report comprises nine main chapters, covering company operations, financials, governance, and significant matters[9] Definitions This section defines common terms used in the report, including company names, regulatory bodies, currency units, and key products, ensuring accurate understanding - "The Company," "Company," or "Salubris" refers to Shenzhen Salubris Pharmaceuticals Co., Ltd[17] - Key products include XINLITAN, XINCHAOTUO, FULITAN®, FULIAN®, ENNALUO®, XINLITING, TAJIA, Maurora®, and others[17] - Innovative biological drugs under research include "Recombinant Human Neuregulin-1-Anti-HER3 Antibody Fusion Protein Injection" (JK07, SAL007)[17] Section 2 Company Profile and Key Financial Indicators Company Profile This section provides Shenzhen Salubris Pharmaceuticals Co., Ltd.'s basic information, including stock details and legal representative, confirming no changes in contact or disclosure methods Company Basic Information | Indicator | Content | | :--- | :--- | | Stock Abbreviation | Salubris | | Stock Code | 002294 | | Listing Exchange | Shenzhen Stock Exchange | | Chinese Name | Shenzhen Salubris Pharmaceuticals Co., Ltd. | | Legal Representative | Ye Yuxiang | - The company's registered address, office address, website, and email address remained unchanged during the reporting period, as detailed in the 2024 annual report[21] Key Accounting Data and Financial Indicators During the reporting period, the company's operating revenue increased by 4.32% to 2.13 billion yuan, and net profit attributable to shareholders grew by 6.10% to 365.08 million yuan Key Accounting Data and Financial Indicators (Current Reporting Period vs. Prior Year Period) | Indicator | Current Period (yuan) | Prior Year Period (yuan) | Year-on-Year Change | | :--- | :--- | :--- | :--- | | Operating Revenue | 2,130,967,669.97 | 2,042,631,367.90 | 4.32% | | Net Profit Attributable to Shareholders of Listed Company | 365,078,698.05 | 344,091,865.40 | 6.10% | | Net Profit Attributable to Shareholders of Listed Company After Deducting Non-Recurring Gains and Losses | 346,830,164.52 | 333,721,199.32 | 3.93% | | Net Cash Flow from Operating Activities | 425,428,003.38 | 533,059,656.76 | -20.19% | | Basic Earnings Per Share (yuan/share) | 0.33 | 0.31 | 6.45% | | Diluted Earnings Per Share (yuan/share) | 0.33 | 0.31 | 6.45% | | Weighted Average Return on Net Assets | 4.19% | 4.29% | -0.10% | | Period-End Indicators | End of Current Period (yuan) | End of Prior Year (yuan) | Change from End of Prior Year | | Total Assets | 10,627,572,107.10 | 10,465,603,624.18 | 1.55% | | Net Assets Attributable to Shareholders of Listed Company | 8,538,957,962.17 | 8,712,145,683.76 | -1.99% | Non-Recurring Gains and Losses Items and Amounts This section details non-recurring gains and losses, totaling 18.25 million yuan, primarily from government grants and entrusted investment income, after tax and minority interest adjustments Non-Recurring Gains and Losses Items and Amounts | Item | Amount (yuan) | | :--- | :--- | | Gains and Losses from Disposal of Non-Current Assets | -2,493,366.43 | | Government Grants Included in Current Period's Gains and Losses | 21,230,136.44 | | Gains and Losses from Entrusted Investment or Asset Management | 7,256,178.64 | | Other Non-Operating Income and Expenses | -4,351,021.71 | | Less: Income Tax Impact | 3,269,108.30 | | Minority Interest Impact (After Tax) | 124,285.11 | | Total | 18,248,533.53 | Section 3 Management Discussion and Analysis Company's Main Business Activities During the Reporting Period The company focuses on R&D, production, and sales of pharmaceuticals and medical devices, with revenue growth, new product approvals, and significant R&D investment in chronic disease areas - The company's business involves the R&D, production, sales, and patent licensing of pharmaceutical and medical device products, with key offerings including cardiovascular drugs and medical devices, cephalosporin antibiotics and raw materials, and orthopedic drugs[31] Reporting Period Key Financial Performance | Indicator | Amount | Year-on-Year Growth | | :--- | :--- | :--- | | Operating Revenue | 2.13 billion yuan | 4.32% | | Net Profit Attributable to Shareholders of Listed Company | 365 million yuan | 6.10% | | R&D Investment | 542 million yuan | 17.89% | | R&D Investment as % of Revenue | 25.43% | - | - XINCHAOTUO and FULIAN® were approved for market launch as scheduled and have passed the preliminary formal review for national medical insurance negotiations[33] - In medical devices, 16,000 Maurora® vertebral artery stents were implanted in the first half of the year, and Salubris Medical achieved operating revenue of 182 million yuan, a year-on-year increase of 32.54%[34] - Key R&D projects are progressing smoothly, including the review of enarodustat and SAL056 for market application, SAL003 completing Phase III clinical trials, JK07 initiating international multi-center clinical trials, SAL0112, SAL0120, SAL0114 entering Phase II clinical trials, SAL0140, JK06 entering Phase I clinical trials, and YOLT-101 receiving implied clinical trial approval[35][36] - The company submitted 4 IND applications for drugs, obtained implied clinical trial approval for 2 products, was granted 31 patents, and filed 136 new patent applications[38] Key R&D Project Status This section lists the company's R&D projects by stage and therapeutic area, showcasing its comprehensive pipeline in chemical drugs, biologics, and medical devices New Drug and Key Project R&D Areas and Progress (by Stage) | Stage | Chemical Drugs | Biologics | | :--- | :--- | :--- | | Pre-IND | SAL0137、SAL0127、SAL0139、SAL0145 | SAL0150、SAL012 | | IND | - | SAL061 | | Phase I | SAL0119、SAL0125、SAL0140、SAL0951（新增适应症）、SAL0132 | SAL023、JK06 | | Phase II | SAL0951（CIA）、SAL0120（高血压、CKD）、SAL0112（糖尿病、肥胖）、SAL0114 | JK07（HFrEF、HFpEF）、JK08 | | Phase III | S086（慢性心衰）、SAL0130 | SAL003 | | Market Application | SAL0951（血透和腹透） | SAL056 | New Drug and Key Project R&D Areas and Progress (by Area) | Area | Chemical Drugs | Biologics | | :--- | :--- | :--- | | Cardiovascular and Related Fields | S086（慢性心衰）、SAL0130、SAL0120（高血压）、SAL0140、SAL0137、SAL0127、SAL0139、SAL0132 | JK07（HFrEF、HFpEF）、SAL003 | | Metabolic | SAL0112（糖尿病、肥胖）、SAL0125、SAL0145 | SAL0150、SAL061 | | Nephrology | SAL0120（CKD）、SAL0951（血透和腹透、CIA） | - | | Anti-tumor | - | JK08、JK06、SAL012 | | Orthopedics | - | SAL056、SAL023 | | Other | SAL0114、SAL0119、SAL0951（新增适应症） | - | - In the first half of 2025, the company obtained marketing approvals for 2 drugs, including XINCHAOTUO and FULIAN®, and had 5 drug/device clinical trial applications, such as SAL0140 and YOLT-101, accepted for review[43][45] Analysis of Core Competencies The company's core strengths include innovation, efficient R&D, a diverse chronic disease pipeline, professional medical promotion, stringent quality control, and resilient supply chain management - The company is driven by innovation, leveraging a nationwide evidence-based medical promotion team, high-standard product quality and services, robust evidence-based medical data, and a comprehensive product pipeline to provide patients with holistic treatment solutions[46] - The company possesses excellent innovation capabilities and efficient R&D management, having established a series of product pipelines in chronic disease areas such as hypertension, heart failure, anticoagulation, lipid-lowering, metabolism, autoimmunity, nephropathy, orthopedics, and oncology[47][48] - The company has built a professional evidence-based medical promotion team, focusing on core cardiovascular therapeutic areas, cultivating brand building, and establishing a strong customer base and positive brand image[49] - The company has established a sound and advanced product lifecycle quality management system, implements internal quality standards higher than national benchmarks, and built a vertically integrated full-产业链 layout to ensure product quality and supply chain resilience[50][51] Analysis of Main Business Operations Operating revenue increased by 4.32% while operating costs decreased by 10.81%, with growth in pharmaceutical preparations and medical devices offsetting a decline in raw material revenue Year-on-Year Changes in Key Financial Data | Indicator | Current Period (yuan) | Prior Year Period (yuan) | Year-on-Year Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Operating Revenue | 2,130,967,669.97 | 2,042,631,367.90 | 4.32% | Minor change | | Operating Cost | 526,057,677.55 | 589,791,689.35 | -10.81% | Minor change | | Selling Expenses | 836,374,719.24 | 740,796,677.23 | 12.90% | Minor change | | Financial Expenses | -8,792,687.14 | -20,919,296.97 | 57.97% | Decrease in interest income and increase in exchange losses | | R&D Investment | 541,982,565.11 | 459,751,651.70 | 17.89% | Minor change | | Net Cash Flow from Operating Activities | 425,428,003.38 | 533,059,656.76 | -20.19% | Minor change | | Net Cash Flow from Investing Activities | -148,515,848.99 | -674,357,491.51 | 77.98% | Increase in recovery of wealth management products, increase in investment payments | | Net Cash Flow from Financing Activities | -522,735,746.69 | -243,151,259.96 | -114.98% | Increase in dividend distribution | Operating Revenue Composition (by Industry, Product, Region) | Category | Item | Current Period Amount (yuan) | Proportion of Operating Revenue | Year-on-Year Change | | :--- | :--- | :--- | :--- | :--- | | By Industry | Pharmaceutical Manufacturing | 1,948,934,133.15 | 91.46% | 2.29% | | | Medical Devices | 182,033,536.82 | 8.54% | 32.54% | | By Product | Raw Materials | 152,791,188.89 | 7.17% | -34.75% | | | Preparations | 1,740,855,372.01 | 81.69% | 6.76% | | | Devices | 182,033,536.82 | 8.54% | 32.54% | | By Region | North China | 331,945,701.99 | 15.58% | -13.85% | | | East China | 942,654,218.87 | 44.24% | 23.84% | | | South China | 320,899,514.62 | 15.06% | 21.47% | | | Other Regions | 535,468,234.49 | 25.13% | -15.27% | Gross Profit Margin of Main Business Operations | Category | Item | Gross Profit Margin | Change in Gross Profit Margin from Prior Year Period | | :--- | :--- | :--- | :--- | | By Industry | Pharmaceutical Manufacturing | 75.61% | 3.58% | | By Product | Raw Materials | 30.61% | 3.20% | | | Preparations | 79.56% | 1.12% | | By Region | North China | 75.07% | 10.81% | | | East China | 77.99% | 4.63% | | | South China | 66.70% | 4.13% | | | Other Regions | 77.60% | -1.88% | Analysis of Assets and Liabilities Total assets increased by 1.55% at period-end, with notable changes in accounts receivable, construction in progress, short-term borrowings, and goodwill, while major assets remain unencumbered Significant Changes in Asset Composition | Item | Amount at End of Current Period (yuan) | Proportion of Total Assets | Change in Proportion | Explanation of Significant Change | | :--- | :--- | :--- | :--- | :--- | | Monetary Funds | 857,063,333.60 | 8.06% | -2.69% | Minor change | | Accounts Receivable | 701,177,232.07 | 6.60% | 1.66% | Increase in accounts receivable to be settled within credit period | | Inventories | 539,623,290.45 | 5.08% | 0.24% | Minor change | | Investment Properties | 4,755,644.60 | 0.04% | -0.25% | Change in asset use due to termination of some property leases | | Construction in Progress | 95,326,868.95 | 0.90% | 0.30% | Increased investment in workshop renovation for medical device subsidiary and Shandong subsidiary | | Short-term Borrowings | 173,873,581.25 | 1.64% | 0.49% | New bank borrowings | | Financial Assets Held for Trading | 389,871,672.59 | 3.67% | -3.34% | Decrease in wealth management products held at period-end | | Non-Current Assets Due Within One Year | 1,083,383,862.37 | 10.19% | 7.29% | Increase in reclassification of large-denomination certificates of deposit due within one year | | Debt Investments | 63,792,416.81 | 0.60% | -2.30% | Reclassification of some large-denomination certificates of deposit to non-current assets due within one year | | Goodwill | 219,486,727.34 | 2.07% | 1.97% | New goodwill arising from the acquisition of Butler Company | | Employee Benefits Payable | 168,569,971.84 | 1.59% | -0.92% | Year-end bonuses accrued at the beginning of the period were paid in the current period | | Other Payables | 659,384,654.78 | 6.20% | 1.39% | Increase in expenses payable | | Deferred Tax Liabilities | 34,590,750.83 | 0.33% | 0.13% | Non-same control business combination formed by acquiring Butler Company, recognized due to asset appraisal appreciation | | Minority Interests | 162,200,344.17 | 1.53% | 1.15% | Medical device subsidiary received capital increase from minority shareholders | - The measurement attributes of the company's main assets did not undergo significant changes during the reporting period[63] - As of the end of the reporting period, the company's main assets were not subject to seizure, detention, freezing, mortgage, pledge, or other restrictions on rights[64] Analysis of Investment Status The company invested 111.58 million yuan during the period, primarily in increasing stakes in Prigine Technology and Butler Biotech, and acquiring equity in Gebijia Molecular Drug Innovation Center Investment Amount During the Reporting Period | Indicator | Amount (yuan) | | :--- | :--- | | Investment Amount During Reporting Period | 111,577,129.00 | | Investment Amount in Prior Year Period | 0 | | Change Rate | - | - The company increased its investment in Prigine Technology (Beijing) Co., Ltd. by 10 million yuan to explore new avenues for innovative drug R&D[66] - Subsidiary Salubris Medical acquired a controlling stake in Butler Biotechnology (Shenzhen) Co., Ltd. through equity transfer, capital increase, and equity swap, paying 71.58 million yuan for equity transfer and 30 million yuan for capital increase[66] - The company acquired a 10% equity stake in Shenzhen Gebijia Molecular Drug Innovation Center Co., Ltd. for 1 yuan, with capital contributions to be made progressively based on operational progress[67] Overall Use of Raised Funds | Indicator | Amount (million yuan) | | :--- | :--- | | Net Amount of Raised Funds | 1,932.07 | | Total Raised Funds Used in Current Period | 30.55 | | Total Raised Funds Used Cumulatively | 1,129.94 | | Proportion of Raised Funds Used at End of Reporting Period | 58.48% | | Total Unused Raised Funds | 791.83 | - Some raised fund investment projects (SAL0107, SAL0108) have been completed, with remaining raised funds of 137.86 million yuan permanently supplementing working capital[79] - The company used temporarily idle raised funds for cash management, with an ending balance of 760 million yuan, generating 5.62 million yuan in income during the reporting period[75] Significant Asset and Equity Disposals The company did not engage in any significant asset or equity disposal activities during the reporting period - The company did not dispose of significant assets during the reporting period[82] - The company did not dispose of significant equity during the reporting period[83] Analysis of Major Holding and Associate Companies This section presents financial data for major subsidiaries and associates, noting Salubris Medical's acquisition of a controlling stake in Butler Biotechnology Major Subsidiary Financial Data (Unit: million yuan) | Company Name | Total Assets | Net Assets | Operating Revenue | Net Profit | | :--- | :--- | :--- | :--- | :--- | | Shandong Salubris Pharmaceuticals Co., Ltd. | 607.80 | 356.03 | 130.75 | 26.74 | | Huizhou Salubris Pharmaceuticals Co., Ltd. | 471.79 | 182.03 | 206.62 | 44.91 | | Salubris (Chengdu) Biotechnology Co., Ltd. | 488.91 | 477.65 | 54.03 | 32.81 | | Salubris (Suzhou) Pharmaceuticals Co., Ltd. | 571.56 | 516.56 | 97.14 | 37.01 | | Shenzhen Salubris Medical Device Co., Ltd. | 1,513.76 | 1,241.45 | 182.03 | 57.37 | | Shenzhen Jianshankang Pharmaceutical Co., Ltd. | 27.96 | 8.93 | 42.24 | 1.90 | | Notai International Co., Ltd. | 833.87 | 813.28 | - | -10.37 | - Butler Biotechnology (Shenzhen) Co., Ltd. was consolidated into Salubris Medical's financial statements through equity transfer and capital increase, aligning with the medical device segment's operational development plan[86] Risks Faced by the Company and Countermeasures The company faces risks from R&D failure, policy-driven price reductions, and rising costs, addressed by strengthening R&D, optimizing product structure, and enhancing supply chain management - R&D failure risk: The pharmaceutical industry's innovative R&D involves high investment, long cycles, and significant risks; despite risk prevention measures, the company still bears the risk of failure[88] - Price reduction risk due to policy changes: Medical insurance cost control and volume-based procurement policies may lead to lower drug tender prices, which the company will address by improving product structure, enhancing product quality, and fostering R&D innovation[89] - Rising cost risk: Increasing raw material, human resource, and environmental protection costs pose continuous pressure, which the company will mitigate by strengthening full-产业链 management, enhancing financial analysis, and promoting automation to control costs[90] Implementation of Market Value Management System and Valuation Enhancement Plan The company has implemented a Market Value Management System to enhance investment value and shareholder returns through innovation, operational quality, and improved investor relations - The company approved the "Proposal on Formulating the Market Value Management System" on March 23, 2025, aiming to enhance investment value and shareholder return capabilities[93] - The company will adhere to innovation-driven development, focus on technological breakthroughs and pipeline布局 in core areas like cardiovascular chronic diseases, strengthen its market value foundation by improving operational quality, and enhance investor relations and the quality and transparency of information disclosure[93] Implementation of 'Quality and Return Dual Enhancement' Action Plan The company actively implements its "Quality and Return Dual Enhancement" action plan, focusing on R&D innovation, core competitiveness, stable performance, and transparent disclosure to boost shareholder value - The company has disclosed its "Quality and Return Dual Enhancement" action plan announcement, actively practicing the development philosophy of "investor-centricity"[95] - During the reporting period, the company continuously strengthened its core competitiveness through R&D innovation and differentiated product布局, achieving high-quality development and dual enhancement of investor returns, based on steady operating performance, long-term stable dividend policy, and transparent and efficient information disclosure[95] Section 4 Corporate Governance, Environment, and Society Changes in Directors, Supervisors, and Senior Management There were no changes in the company's directors, supervisors, or senior management during the reporting period - There were no changes in the company's directors, supervisors, and senior management during the reporting period[97] Profit Distribution and Capital Reserve Conversion to Share Capital During the Reporting Period The company plans no interim cash dividend distribution, bonus shares, or capital reserve conversion to share capital - The company plans not to distribute cash dividends, bonus shares, or convert capital reserves into share capital for the half-year period[98] Implementation of Equity Incentive Plans, Employee Stock Ownership Plans, or Other Employee Incentive Measures No equity incentives were granted by the parent company, the second employee stock ownership plan terminated, the third is in lock-up, and subsidiaries Salubris Medical and Salubris Biotechnology implemented their own equity incentive plans - The company did not implement equity incentives during the reporting period[99] Status of All Valid Employee Stock Ownership Plans During the Reporting Period | Plan Name | Employee Scope | Number of Employees | Total Shares Held (shares) | Proportion of Listed Company's Total Share Capital | Funding Source for Plan Implementation | | :--- | :--- | :--- | :--- | :--- | :--- | | Second Employee Stock Ownership Plan | Directors, Supervisors, Senior Management, and Other Core and Key Employees | Within 150 | 17,503,178 (All sold and terminated) | 0.00% | Employees' Legal Remuneration, Self-Raised Funds | | Third Employee Stock Ownership Plan | Directors, Supervisors, Senior Management, and Other Core and Key Employees | Within 300 | 23,457,523 | 2.10% | Employees' Legal Remuneration, Self-Raised Funds | - All 17,503,178 shares held under the second employee stock ownership plan were sold in batches through block trades or centralized bidding transactions between July 4, 2022, and May 22, 2025, and the plan has been terminated[106] - Holding subsidiary Shenzhen Salubris Medical Device Co., Ltd. plans to implement equity incentives, increasing capital by 34.45 million yuan for 41 incentive recipients to acquire 1.88 million shares, with a service period of 3 years[121] - The company's holding subsidiary Salubris Biotechnology Limited formulated an equity incentive plan, granting stock options to its R&D team, with a cumulative grant of 11,527,184 shares as of April 2025[124] Environmental Information Disclosure The company and its three main subsidiaries are listed as legally required environmental information disclosure enterprises and have complied with disclosure regulations - The listed company and its major subsidiaries have been included in the list of enterprises required to disclose environmental information by law[125] Subsidiaries Included in the List of Enterprises Required to Disclose Environmental Information by Law | No. | Enterprise Name | Query Index for Legally Disclosed Environmental Information Report | | :--- | :--- | :--- | | 1 | Shenzhen Salubris Pharmaceuticals Co., Ltd. Pharmaceutical Factory No. 1 | Guangdong Provincial Department of Ecology and Environment - Enterprise Environmental Information Legal Disclosure System | | 2 | Huizhou Salubris Pharmaceuticals Co., Ltd. | Guangdong Provincial Department of Ecology and Environment - Enterprise Environmental Information Legal Disclosure System | | 3 | Shandong Salubris Pharmaceuticals Co., Ltd. | Enterprise Environmental Information Legal Disclosure System | Social Responsibility The company actively fulfills its social responsibilities by protecting stakeholder rights, ensuring employee welfare, maintaining product quality, promoting environmental sustainability, and engaging in public welfare - The company strictly adheres to laws and regulations, improves its corporate governance structure, safeguards the legitimate rights and interests of all shareholders, especially small and medium investors, and implements prudent financial policies to protect creditors' interests[128][129] - The company strictly complies with the "Labor Law" and "Labor Contract Law," protects employees' legitimate rights and interests, values talent development and career growth, and supports labor unions in carrying out their work according to law[130] - Adhering to the principle of integrity, the company has established a high-standard quality management system to ensure product quality and safety, safeguarding the interests of suppliers, customers, and consumers[131] - The company upholds the HSE policy of "Harmonious Environment, Sustainable Development," has established environmental and energy management systems, and actively implements sustainable development initiatives to address climate change[132][133] - The company actively participates in social welfare, organizes health education activities, disseminates disease prevention knowledge, helps improve grassroots medical care, and has repeatedly engaged in charity clinics, donations, and other public welfare activities[135] Section 5 Significant Matters Commitments During the reporting period, there were no commitments made by the company, its actual controller, shareholders, or related parties that were fulfilled or overdue - During the reporting period, there were no commitments by the company's actual controller, shareholders, related parties, acquirers, or the company itself that were fulfilled or overdue as of the end of the reporting period[137] Fund Occupation and Illegal Guarantees During the reporting period, the company had no non-operating fund occupation by controlling shareholders or related parties, nor any illegal external guarantees - During the reporting period, there was no non-operating fund occupation by controlling shareholders or other related parties of the listed company[138] - The company had no illegal external guarantees during the reporting period[139] Appointment and Dismissal of Accounting Firms The company's semi-annual financial report was not audited - The company's semi-annual report was not audited[140] Bankruptcy and Reorganization Matters The company did not experience any bankruptcy or reorganization-related matters during the reporting period - The company did not experience any bankruptcy or reorganization-related matters during the reporting period[142] Litigation Matters The company had no significant litigation or arbitration matters, only minor contract and labor disputes totaling 3.13 million yuan, which do not impact normal operations - The company had no significant litigation or arbitration matters during the reporting period[143] - During the reporting period, there were 4 contract disputes (involving 2.96 million yuan) and 2 labor disputes (involving 0.16 million yuan), totaling 3.13 million yuan, which did not meet the disclosure threshold for significant litigation[144] Penalties and Rectification The company did not incur any penalties or require rectification during the reporting period - The company had no penalties or rectification situations during the reporting period[145] Significant Related Party Transactions During the reporting period, the company did not engage in any significant related party transactions, including those related to daily operations, asset/equity acquisitions, joint investments, or debt - The company did not engage in related party transactions related to daily operations during the reporting period[146] - The company did not engage in related party transactions involving asset or equity acquisitions or disposals during the reporting period[147] - There were no related party creditor-debtor transactions during the reporting period[150] Significant Contracts and Their Performance This section details the performance of significant contracts, including 0.85 million yuan in operating lease income, a 4 million yuan guarantee by Salubris Medical, and 982.56 million yuan in outstanding entrusted wealth management - During the reporting period, the company generated 0.85 million yuan in operating lease income[156] - Subsidiary Salubris Medical provided a joint and several liability guarantee of 4 million yuan for Butler Biotechnology (Suzhou) Co., Ltd., with a guarantee period of three years from the expiration of the debt performance period stipulated in the credit agreement[158][161] Entrusted Wealth Management Status (Unit: million yuan) | Specific Type | Funding Source | Amount of Entrusted Wealth Management Occurred | Unexpired Balance | | :--- | :--- | :--- | :--- | | Bank Wealth Management Products | Own Funds | 485.00 | 172.56 | | Brokerage Wealth Management Products | Own Funds | 250.41 | 50.00 | | Bank Wealth Management Products | Raised Funds | 910.00 | 760.00 | | Total | - | 1,645.41 | 982.56 | Explanation of Other Significant Matters This section details the company's equity fund investments and Salubris Medical's acquisition of a controlling stake in Butler Biotechnology to streamline equity structure and accelerate business development - The company participated in establishing and investing in several equity investment funds, including Ningbo Meishan Bonded Port Area Wosheng Jingjia Equity Investment Partnership, Shenzhen Futian Tongchuang Weiye Great Health Industry Investment Fund Partnership, Pingtan Comprehensive Experimental Zone Wosheng Huijia Equity Investment Partnership, and Shenzhen Huagai Qianhai Kekong Angel Venture Capital Partnership, primarily targeting the biomedical, medical device, and other major health industries[171][172] - Subsidiary Salubris Medical ultimately holds a 70% equity stake in Butler Biotechnology (Shenzhen) Co., Ltd. through equity transfer, capital increase, and voting rights entrustment, bringing it into the company's consolidated financial statements[173][174][175] - This acquisition aims to streamline the subsidiary's equity structure, integrate resources, achieve complementary advantages, accelerate Butler's clinical progress, and promote the long-term development of the medical device segment[175] Section 6 Share Changes and Shareholder Information Share Changes The company's total share capital remained unchanged, with stable proportions of restricted and unrestricted shares, and completed share buybacks used for employee stock ownership plans Share Changes | Item | Quantity Before This Change (shares) | Proportion Before This Change | Increase/Decrease in This Change (+, -) | Quantity After This Change (shares) | Proportion After This Change | | :--- | :--- | :--- | :--- | :--- | :--- | | I. Restricted Shares | 250,799 | 0.02% | 0 | 250,799 | 0.02% | | II. Unrestricted Shares | 1,114,565,736 | 99.98% | 0 | 1,114,565,736 | 99.98% | | III. Total Shares | 1,114,816,535 | 100.00% | 0 | 1,114,816,535 | 100.00% | - The company has completed two share buyback plans, with all repurchased shares used for subsequent equity incentive or employee stock ownership plans[183][187] - In July 2024, 23,457,523 repurchased shares were transferred to the "Shenzhen Salubris Pharmaceuticals Co., Ltd. - Third Employee Stock Ownership Plan" special account[185] - In June 2021, 17,503,178 repurchased shares were transferred to the "Shenzhen Salubris Pharmaceuticals Co., Ltd. - Second Employee Stock Ownership Plan" special account[190] Number of Shareholders and Shareholding Status As of the reporting period end, the company had 24,019 common shareholders, with Salubris Pharmaceuticals Co., Ltd. as the controlling shareholder holding 56.99% of shares, some of which are pledged - The total number of common shareholders at the end of the reporting period was 24,019 households[194] Shareholding Status of Shareholders Holding 5% or More or Top 10 Shareholders | Shareholder Name | Shareholder Nature | Shareholding Proportion | Number of Shares Held at End of Reporting Period (shares) | Number of Unrestricted Shares Held (shares) | Share Status | Pledged, Marked, or Frozen Quantity (shares) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Salubris Pharmaceuticals Co., Ltd. | Overseas Legal Person | 56.99% | 635,279,380 | 635,279,380 | Pledged | 156,790,000 | | Industrial and Commercial Bank of China Co., Ltd. - China-Europe Healthcare Mixed Securities Investment Fund | Other | 2.35% | 26,162,969 | 26,162,969 | Not applicable | 0 | | Shenzhen Salubris Pharmaceuticals Co., Ltd. - Third Employee Stock Ownership Plan | Other | 2.10% | 23,457,523 | 23,457,523 | Not applicable | 0 | | Shenzhen Runfu Investment Development Co., Ltd. | Domestic Non-State-Owned Legal Person | 1.39% | 15,465,952 | 15,465,952 | Pledged | 7,140,000 | | Hong Kong Securities Clearing Company Limited | Overseas Legal Person | 1.37% | 15,307,308 | 15,307,308 | Not applicable | 0 | | China Construction Bank Co., Ltd. - ICBC Credit Suisse Frontier Healthcare Stock Investment Fund | Other | 1.35% | 15,000,000 | 15,000,000 | Not applicable | 0 | | Central Huijin Asset Management Co., Ltd. | State-Owned Legal Person | 1.26% | 14,066,700 | 14,066,700 | Not applicable | 0 | | National Social Security Fund 114 Portfolio | Other | 0.89% | 9,927,500 | 9,927,500 | Not applicable | 0 | | Wang Guohua | Domestic Natural Person | 0.85% | 9,462,713 | 9,462,713 | Not applicable | 0 | | Agricultural Bank of China Co., Ltd. - CSI 500 ETF | Other | 0.74% | 8,261,390 | 8,261,390 | Not applicable | 0 | Changes in Shareholdings of Directors, Supervisors, and Senior Management There were no changes in the shareholdings of the company's directors, supervisors, or senior management during the reporting period - There were no changes in the shareholdings of the company's directors, supervisors, and senior management during the reporting period[197] Changes in Controlling Shareholder or Actual Controller The company's controlling shareholder and actual controller remained unchanged during the reporting period - The company's controlling shareholder did not change during the reporting period[199] - The company's actual controller did not change during the reporting period[200] Preferred Share Information The company had no preferred shares during the reporting period - The company had no preferred shares during the reporting period[201] Section 7 Bond-Related Information Bond-Related Information The company had no bond-related activities during the reporting period - The company had no bond-related information during the reporting period[203] Section 8 Financial Report Audit Report The company's semi-annual financial report was not audited - The company's semi-annual financial report was not audited[205] 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 - The consolidated balance sheet shows total assets of 10.63 billion yuan, total liabilities of 1.93 billion yuan, and total owners' equity of 8.70 billion yuan at period-end[207][209] - The consolidated income statement shows total operating revenue of 2.13 billion yuan, net profit of 375.37 million yuan, and net profit attributable to parent company shareholders of 365.08 million yuan for the first half of 2025[215][216] - The consolidated cash flow statement shows net cash flow from operating activities of 425.43 million yuan, net cash flow from investing activities of -148.52 million yuan, and net cash flow from financing activities of -522.74 million yuan for the first half of 2025[221] Company Basic Information Shenzhen Salubris Pharmaceuticals Co., Ltd., established in 1998 and listed in 2009, specializes in R&D, production, and sales of pharmaceuticals and medical devices across various therapeutic areas - Shenzhen Salubris Pharmaceuticals Co., Ltd. was registered and established in Shenzhen in November 1998 and listed on the Shenzhen Stock Exchange in 2009[240] - The company's main business involves the R&D, production, and sales of pharmaceutical and medical device products, with key products and R&D projects covering cardiovascular, hypoglycemic, orthopedic, anti-tumor, anti-infective, and other therapeutic areas[240] Basis for Preparation of Financial Statements The financial statements are prepared on a going concern basis, adhering to PRC Accounting Standards for Business Enterprises, with the company confirming its ability to continue operations for at least 12 months - The company's financial statements are prepared on a going concern basis, in accordance with the actual transactions and events, and the "Accounting Standards for Business Enterprises" issued by the Ministry of Finance[241] - The company has the ability to continue as a going concern for at least 12 months from the end of the reporting period[242] Significant Accounting Policies and Estimates This section details the company's key accounting policies and estimates for R&D, manufacturing, and sales of pharmaceuticals and medical devices, covering financial instruments, revenue recognition, R&D capitalization, inventory, fixed assets, intangible assets, and expected credit losses - The company and its subsidiaries are engaged in the R&D, manufacturing, and sales of pharmaceuticals and medical devices, and have formulated specific accounting policies and estimates for transactions and events such as revenue recognition and R&D expenditures in accordance with enterprise accounting standards[243] - Financial instruments are classified as financial assets and liabilities measured at amortized cost, at fair value through other comprehensive income, and at fair value through profit or loss[256][257][259] - Revenue is recognized when the customer obtains control of the related goods or services, at the transaction price allocated to that performance obligation, with specific recognition points determined based on product sales models (academic promotion, agency distribution, direct sales) and intellectual property licensing characteristics[312][313] - R&D expenditures are divided into research and development phases; development phase expenditures are recognized as intangible assets when specific conditions are met, otherwise expensed in the current period. Chemical innovative drugs and biologics formally enter the development phase after obtaining Clinical Trial Approval (IND)[296] Taxation This section details the company's and its subsidiaries' applicable tax types and rates, including VAT, urban maintenance and construction tax, enterprise income tax, and profits tax, highlighting high-tech enterprise tax incentives and R&D expense deductions Major Tax Types and Rates | Tax Type | Tax Base | Tax Rate | | :--- | :--- | :--- | | Value-Added Tax | Value-added amount from sales of goods or provision of services | 13%、9%、6% | | Urban Maintenance and Construction Tax | VAT actually paid according to law | 7%、5% | | Enterprise Income Tax | Taxable income | 25%、20%、15% | | Profits Tax | Assessable profits | 8.25%、16.5% | - Shenzhen Salubris Pharmaceuticals Co., Ltd., Shandong Salubris Pharmaceuticals Co., Ltd., Salubris (Suzhou) Pharmaceuticals Co., Ltd., Salubris (Chengdu) Biotechnology Co., Ltd., and other subsidiaries enjoy a 15% preferential enterprise income tax rate as high-tech enterprises[332][333][334] - The company benefits from the R&D expense super deduction policy (100% additional deduction for expenses not forming intangible assets, 200% amortization for those forming intangible assets) and the advanced manufacturing enterprise VAT additional deduction policy (5%)[334] Notes to Consolidated Financial Statement Items This section provides detailed explanations for consolidated financial statement items, including monetary funds, accounts receivable, goodwill, and operating expenses, clarifying period-end balances, changes, and reasons - Monetary funds at period-end totaled 857 million yuan, with 167 million yuan deposited overseas[337] - Financial assets held for trading at period-end totaled 390 million yuan, a decrease from the beginning of the period, primarily due to a reduction in wealth management products held at period-end[340][59] - Accounts receivable at period-end totaled 701 million yuan, an increase from the beginning of the period, primarily due to an increase in accounts receivable to be settled within the credit period[349][59] - Inventories at period-end totaled 540 million yuan, a slight increase from the beginning of the period, with inventory impairment provisions of 23.19 million yuan[416][420] - Goodwill at period-end had a book original value of 589 million yuan, with an increase of 209 million yuan in the current period, primarily due to new goodwill arising from the acquisition of Butler Company[489][59] - Short-term borrowings at period-end totaled 174 million yuan, an increase from the beginning of the period, primarily due to new bank borrowings in the current period[512][59] - Employee benefits payable at period-end totaled 169 million yuan, a decrease from the beginning of the period, primarily due to the payment of year-end bonuses accrued at the beginning of the period[533][59] - Operating revenue was 2.13 billion yuan, operating cost was 526 million yuan, selling expenses were 836 million yuan, administrative expenses were 140 million yuan, R&D expenses were 235 million yuan, and financial expenses were -8.79 million yuan[215] Research and Development Expenses Total R&D expenditure was 541.98 million yuan, with 235.26 million yuan expensed and 306.72 million yuan capitalized, including significant projects in clinical phases expected to generate future economic benefits R&D Expenditure Status | Item | Amount Incurred in Current Period (yuan) | Amount Incurred in Prior Period (yuan) | | :--- | :--- | :--- | | Direct Input | 153,137,338.05 | 123,500,223.02 | | Employee Compensation | 148,232,226.98 | 144,202,888.20 | | Experiment and Test Fees | 189,738,502.24 | 135,404,711.64 | | Depreciation and Amortization | 25,276,372.37 | 22,462,651.57 | | Other Expenses | 24,501,937.10 | 32,173,070.93 | | Share-Based Payment | 1,096,188.37 | 2,008,106.34 | | Total | 541,982,565.11 | 459,751,651.70 | | Of which: Expensed R&D Expenditure | 235,264,179.60 | 202,275,720.89 | | Capitalized R&D Expenditure | 306,718,385.51 | 257,475,930.81 | - Significant capitalized R&D projects include Project 16 (Phase III clinical, expected completion 2027) and Project 17 (Phase II clinical, expected completion 2028), both expected to generate economic benefits through product sales or licensing[614] Changes in Consolidation Scope The company consolidated Butler Biotechnology (Shenzhen) Co., Ltd. through a non-same control business combination, acquiring 70% equity, resulting in a merger cost of 298.20 million yuan and goodwill of 208.57 million yuan - On April 7, 2025, the company consolidated Butler Biotechnology (Shenzhen) Co., Ltd. through a non-same control business combination, with an equity acquisition ratio of 70.00%[616] Merger Cost and Goodwill | Item | Amount (yuan) | | :--- | :--- | | Total Merger Cost | 298,198,033.81 | | Less: Fair Value Share of Identifiable Net Assets Acquired | 89,623,769.97 | | Goodwill | 208,574,263.84 | - The fair value of the merger cost was determined based on an asset appraisal report, ultimately using the income approach, with the appraised value of Butler's total shareholder equity at the appraisal base date being 409.77 million yuan[622] - The fair value of Butler's equity held before the acquisition date was 61.84 million yuan on the acquisition date[631] Interests in Other Entities This section discloses the company's interests in subsidiaries, joint ventures, and associates, including Salubris Medical as a significant non-wholly owned subsidiary and aggregated financial information for immaterial entities - The company owns multiple subsidiaries, including Shenzhen Salubris Medical Device Co., Ltd., Huizhou Salubris Pharmaceuticals Co., Ltd., and Notai International Co., Ltd[643] Financial Information of Important Non-Wholly Owned Subsidiaries | Subsidiary Name | Minority Shareholding Proportion | Profit/Loss Attributable to Minority Shareholders in Current Period (yuan) | Minority Interests Balance at Period-End (yuan) | | :--- | :--- | :--- | :--- | | Shenzhen Salubris Medical Device Co., Ltd. | 12.64% | 5,801,114.37 | 235,799,375.75 | - The total book value of the company's investments in associates was 289.20 million yuan, with net profit and total comprehensive income attributable to the company based on its shareholding proportion both being -2.67 million yuan for the current period[658] - The company's shareholding in its subsidiary Shenzhen Salubris Medical Device Co., Ltd. changed from 89.7443% to 87.3639%, and its registered capital increased to 115.57 million yuan[650] Government Grants This section discloses government grants received, with a deferred income balance of 122.46 million yuan at period-end, and 34.90 million yuan recognized as current period income Liability Items Involving Government Grants | Accounting Account | Beginning Balance (yuan) | Amount Transferred to Other Income in Current Period (yuan) | Ending Balance (yuan) | Related to Assets/Income | | :--- | :--- | :--- | :--- | :--- | | Deferred Income | 119,962,451.83 | 10,398,641.31 | 109,563,810.52 | Related to Assets | | Deferred Income | 22,075,114.75 | 9,181,013.00 | 12,894,101.75 | Related to Income | | Total | 142,037,566.58 | 19,579,654.31 | 122,457,912.27 | - | Government Grants Included in Current Period's Gains and Losses | Accounting Account | Amount Incurred in Current Period (yuan) | Amount Incurred in Prior Period (yuan) | | :--- | :--- | :--- | | Other Income | 34,778,453.44 | 34,733,779.26 | | Non-Operating Income | 17,985.71 | 1,500.00 | | Financial Expenses | 104,700.00 | - | | Total | 34,901,139.15 | 34,735,279.26 | Risks Related to Financial Instruments The company manages market risks (foreign exchange, interest rate), credit risk, and liquidity risk through various strategies, including hedging, credit limits, and maintaining sufficient cash - The company's main financial instruments include equity investments, monetary funds, accounts receivable, accounts payable, other receivables, and other payables[663] - The company's foreign exchange risk is primarily related to HKD, USD, and EUR, and the foreign currency asset and liability balances at period-end may impact operating performance[664] - Interest rate risk is mainly associated with floating-rate bank borrowings, and the company's policy is to maintain floating rates to achieve risk balance[668] - Credit risk primarily arises from losses on financial assets due to the failure of a counterparty to fulfill its obligations; the company mitigates this risk through credit limits, approval, and monitoring procedures, and by making provisions for bad debts[668] - Liquidity risk is managed by maintaining and monitoring cash and cash equivalents that management deems sufficient[669] - The company transfers bank acceptance bills in accounts receivable financing through endorsement and discounting, and derecognizes them because credit risk and deferred payment risk are minimal, and interest rate risk has been transferred to the bank[672] Fair Value Disclosure This section discloses the fair value of assets and liabilities measured at fair value at period-end, categorized by fair value hierarchy, including financial assets held for trading, debt investments, and equity instrument investments 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) Financial Assets Held for Trading | - | 185,668,123.27 | 248,758,549.32 | 434,426,672.59 | | (II) Other Debt Investments | - | - | 543,177,138.87 | 543,177,138.87 | | (III) Other Equity Instrument Investments | - | - | 237,957,520.63 | 237,957,520.63 | | (VI) Other Non-Current Financial Asset Investments | - | - | 349,517,432.10 | 349,517,432.10 | | (VII) Accounts Receivable Financing | - | - | 63,260,919.15 | 63,260,919.15 | | Total Assets Continuously Measured at Fair Value | - | 185,668,123.27 | 1,442,671,560.07 | 1,628,339,683.34 | - Wealth management products use the expected rate of return to calculate their period-end value as a reasonable estimate of fair value (Level 2)[679] - Level 3 fair value measurement items (such as financial assets held for trading, other equity instrument investments, and accounts receivable financing) use bank appraisal results, investment cost, or face value as reasonable estimates of fair value[680] Related Parties and Related Party Transactions This section identifies the company's parent, ultimate controlling parties, subsidiaries, and other related parties, confirming no significant related party transactions occurred during the reporting period, and discloses key management personnel compensation - The company's parent company is Salubris Pharmaceuticals Co., Ltd., and the ultimate controlling parties are Ye Chenghai, Liao Qingqing, Ye Yuxiang, Ye Yujun, and Chen Zhiming[690][691] - During the reporting period, the company had no related party transactions involving the purchase and sale of goods or the provision and acceptance of services[694] - During the reporting period, the company had no related party entrusted management/contracting, related party leases, related party guarantees, related party fund borrowings, related party asset transfers, or debt restructuring situations[696][700][703][705][707] Key Management Personnel Compensation | Item | Amount Incurred in Current Period (yuan) | | :--- | :--- | | Key Management Personnel Compensation | 3,374,364.55 | Share-Based Payment This section details equity-settled share-based payment arrangements, including stock option grants by Salubris Biotechnology Limited and equity incentives by Salubris Medical, with cumulative costs recognized - The company's holding subsidiary Salubris Biotechnology Limited formulated an equity incentive plan, granting stock options to its R&D team, with a cumulative grant of 11,527,184 shares as of April 2025[719] - Shenzhen Salubris Medical Device Co., Ltd. issued a total of 1.88 million shares to 41 incentive recipients at a price of 18.32 yuan per share, with a service period of 3 years[719] - As of June 30, 2025, the cumulative payment cost and expenses for restricted shares granted under the equity incentive plan totaled 53.08 million yuan[720] Commitments and Contingencies At the end of the reporting period, the company had no significant commitments but noted a contingent liability related to commercial milestone payments for enarodustat to Japan Tobacco, not yet triggered - There were no significant commitments as of the balance sheet date[723] - After the launch of enarodustat, according to the agreement with Japan Tobacco, commercial milestone payments of $20 million, $30 million, $40 million, and $50 million will be made if total net sales first reach $100 million, $200 million, $300 million, and $400 million, respectively, within a twelve-month period[724] - As of the end of the reporting period, enarodustat's net sales had not reached $100 million, and the probability of triggering milestone payments was less than 50%, thus no provision for liabilities was recognized[724] Events After the Balance Sheet Date As of the report date, the company had no significant non-adjusting events, profit distribution, sales returns, or other post-balance sheet events requiring disclosure - As of the report date, there were no other post-balance sheet events requiring disclosure[730] Other Significant Matters The company had no other significant matters, such as prior period accounting error corrections, debt restructuring, asset swaps, annuity plans, or discontinued operations - The company had no other significant matters such as prior period accounting error corrections, debt restructuring, asset swaps, annuity plans, or discontinued operations[732][734][735][737][740] Notes to Parent Company Financial Statement Items This section provides detailed notes for the parent company's financial statement items, including accounts receivable of 645.28 million yuan, other receivables of 469.27 million yuan (including 430 million yuan in subsidiary dividends), and long-term equity investments of 3.94 billion yuan - The parent company's accounts receivable had a book value of 645.28 million yuan at period-end, with 93.14% of accounts receivable being within 1 year (inclusive)[749][750] - The parent company's other receivables had an ending balance of 469.27 million yuan, including 430 million yuan in dividends receivable from subsidiaries[759][767] - The parent company's long-term equity investments had a book value of 3.94 billion yuan at period-end, comprising investments in subsidiaries of 3.89 billion yuan and investments in associates and joint ventures of 54.45 million yuan[792] - The parent company's operating revenue for the current period was 1.79 billion yuan, and operating cost was 569.31 million yuan[801][802] - The parent company's investment income for the current period was 715.25 million yuan, primarily from long-term equity investment income accounted for using the cost method, totaling 700.46 million yuan[804] Section 9 Other Submitted Data Other Significant Social Security Issues The company and its subsidiaries had no other significant social security issues or administrative penalties during the reporting period - The listed company and its subsidiaries had no other significant social security issues[812] - No administrative penalties were incurred during the reporting period[812] Registration Form for Investor Relations Activities During the Reporting Period The company actively engaged in investor relations activities, hosting various institutional investors through online and in-person meetings to discuss operations and strategy - On April 10, April 18, May 14, and other dates in 2025, the company hosted institutional investors, including Fullgoal Fund and Soochow Securities, through online meetings, network platforms, and company meeting rooms to discuss its operational status and development strategy[812] Fund Transactions Between Listed Company and Controlling Shareholder and Other Related Parties This section details non-operating fund transactions with controlling shareholders and related parties, with a period-end balance of 447.45 million yuan, all being routine operational funds within the consolidated scope Fund Transactions Between Listed Company and Controlling Shareholder and Other Related Parties (Unit: million yuan) | Counterparty Name | Nature of Transaction | Beginning Balance | Amount Incurred in Reporting Period | Amount Repaid in Reporting Period | Ending Balance | | :--- | :--- | :--- | :--- | :--- | :--- | | Huizhou Salubris Pharmaceuticals Co., Ltd. | Non-Operating Transaction | 0 | 10.14 | 10.14 | 0 | | Huizhou Salubris Pharmaceuticals Co., Ltd. | Non-Operating Transaction | 0 | 700.00 | 500.00 | 200.00 | | Shandong Salubris Pharmaceuticals Co., Ltd. | Non-Operating Transaction | 0 | 0.06 | 0.06 | 0 | | Shandong Salubris Pharmaceuticals Co., Ltd. | Non-Operating Transaction | 230.00 | 0 | 0 | 230.00 | | Shenzhen Jianshankang Pharmaceutical Co., Ltd. | Non-Operating Transaction | 13.07 | 25.51 | 21.13 | 17.45 | | Total | -- | 243.07 | 735.71 | 531.33 | 447.45 | - All fund transactions are routine operating funds between the company and its consolidated subsidiaries, having undergone internal approval procedures as per the company's internal