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健友股份(603707) - 健友股份第五届董事会第十四次会议决议公告
2025-08-28 09:21
本次会议由董事长唐咏群先生主持。本次会议召集、召开符合《中华人民共 和国公司法》及有关法律、法规和《公司章程》的规定。 二、董事会会议审议情况 会议审议并通过了如下议案: (一)审议通过了《关于公司 2025 年半年度报告及其摘要》的议案 本议案经公司董事会审计委员会事先审议通过。 | 证券代码:603707 | 证券简称:健友股份 | 公告编号:2025-065 | | --- | --- | --- | | 债券代码:113579 | 债券简称:健友转债 | | 南京健友生化制药股份有限公司 第五届董事会第十四次会议决议公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担个别及连带责任。 一、董事会会议召开情况 南京健友生化制药股份有限公司(以下简称"公司")第五届董事会第十四 次会议的通知已于 2025 年 8 月 18 日以电话及电子邮件的方式向各位董事发出, 会议于 2025 年 8 月 28 日上午 9 点整在公司会议室召开。会议应到董事 6 人,实 到董事 5 人,其中独立董事 1 人。独立董事崔国庆先生因个人原因无法出席 ...
健友股份(603707.SH)上半年净利润2.86亿元,同比下降29.32%
Ge Long Hui A P P· 2025-08-28 09:05
Core Viewpoint - The company reported a decline in both revenue and net profit for the first half of 2025 compared to the previous year [1] Financial Performance - The company achieved operating revenue of 1.98 billion yuan, a year-on-year decrease of 7.60% [1] - The net profit attributable to shareholders of the listed company was 286 million yuan, down 29.32% year-on-year [1] - The net profit attributable to shareholders after deducting non-recurring gains and losses was 260 million yuan, reflecting a year-on-year decline of 29.46% [1] - Basic earnings per share were reported at 0.18 yuan [1]
健友股份(603707) - 2025 Q2 - 季度财报
2025-08-28 08:45
Section I Definitions [Definitions of Common Terms](index=4&type=section&id=%E5%B8%B8%E7%94%A8%E8%AF%8D%E8%AF%AD%E9%87%8A%E4%B9%89) This chapter defines key terms like company names, subsidiaries, and industry concepts (e.g., CDMO, CRO) for clear report understanding - Reporting Period: Refers to **January 1, 2025, to June 30, 2025**[15](index=15&type=chunk) - Company, This Company, Genor Biopharma: Refers to Nanjing Genor Biopharmaceutical Co., Ltd[15](index=15&type=chunk) - CDMO: Contract Development and Manufacturing Organization, which adds customized R&D services for related products based on CMO[15](index=15&type=chunk) Section II Company Profile and Key Financial Indicators [I. Company Information](index=5&type=section&id=%E4%B8%80%E3%80%81%E5%85%AC%E5%8F%B8%E4%BF%A1%E6%81%AF) This section provides basic registration details for Nanjing Genor Biopharmaceutical Co., Ltd., including its Chinese name, abbreviation, foreign name, and legal representative - Company's Chinese Name: Nanjing Genor Biopharmaceutical Co., Ltd[17](index=17&type=chunk) - Company's Legal Representative: Tang Yongqun[17](index=17&type=chunk) [II. Contact Persons and Information](index=5&type=section&id=%E4%BA%8C%E3%80%81%E8%81%94%E7%B3%BB%E4%BA%BA%E5%92%8C%E8%81%94%E7%B3%BB%E6%96%B9%E5%BC%8F) This section lists the contact details for the company's Board Secretary and Securities Affairs Representative, facilitating communication with investors and relevant parties - Board Secretary: Huang Xiwei, Contact Number: **025-86990789**[18](index=18&type=chunk) - Securities Affairs Representative: Qian Xiaojie, Contact Number: **025-86990789**[18](index=18&type=chunk) [III. Overview of Basic Information Changes](index=5&type=section&id=%E4%B8%89%E3%80%81%E5%9F%BA%E6%9C%AC%E6%83%85%E5%86%B5%E5%8F%98%E6%9B%B4%E7%AE%80%E4%BB%8B) This section details the company's registered address, office address, and postal code, noting no historical changes to the registered address during the reporting period - Company's Registered Address: MA010-1, Nanjing High-tech Development Zone, Jiangsu Province[19](index=19&type=chunk) - Historical Changes to Company's Registered Address: None[19](index=19&type=chunk) [IV. Overview of Information Disclosure and Document Custody Location Changes](index=5&type=section&id=%E5%9B%9B%E3%80%81%E4%BF%A1%E6%81%AF%E6%8A%AB%E9%9C%B2%E5%8F%8A%E5%A4%87%E7%BD%AE%E5%9C%B0%E7%82%B9%E5%8F%98%E6%9B%B4%E6%83%85%E5%86%B5%E7%AE%80%E4%BB%8B) This section specifies the company's designated newspapers for information disclosure, the website for semi-annual reports, and the report custody location, with no changes during the reporting period - Company's Selected Information Disclosure Newspapers: China Securities Journal, Shanghai Securities News[20](index=20&type=chunk) - Website Address for Semi-Annual Report Publication: **http://www.sse.com.cn**[20](index=20&type=chunk) [V. Company Stock Profile](index=5&type=section&id=%E4%BA%94%E3%80%81%E5%85%AC%E5%8F%B8%E8%82%A1%E7%A5%A8%E7%AE%80%E5%86%B5) This section provides basic information about the company's stock, including its type, listing exchange, stock abbreviation, and code - Stock Type: A-share[21](index=21&type=chunk) - Stock Listing Exchange: Shanghai Stock Exchange[21](index=21&type=chunk) - Stock Abbreviation: Genor Biopharma, Stock Code: **603707**[21](index=21&type=chunk) [VII. Key Accounting Data and Financial Indicators](index=5&type=section&id=%E4%B8%83%E3%80%81%E5%85%AC%E5%8F%B8%E4%B8%BB%E8%A6%81%E4%BC%9A%E8%AE%A1%E6%95%B0%E6%8D%AE%E5%92%8C%E8%B4%A2%E5%8A%A1%E6%8C%87%E6%A0%87) This section presents the company's key accounting data and financial indicators for the first half of 2025, showing a decline in operating revenue and total profit due to increased marketing expenses in North America and revenue structure adjustments Key Accounting Data for H1 2025 | Key Accounting Data | Current Period (Jan-Jun) | Prior Period | YoY Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 1,979,845,467.48 | 2,142,658,737.40 | -7.60 | | Total Profit | 310,160,900.73 | 459,667,961.20 | -32.53 | | Net Profit Attributable to Shareholders of Listed Company | 286,267,552.30 | 405,017,591.60 | -29.32 | | Net Profit Attributable to Shareholders of Listed Company After Deducting Non-Recurring Gains and Losses | 260,058,164.36 | 368,651,769.63 | -29.46 | | Net Cash Flow from Operating Activities | 410,413,411.47 | 606,437,423.32 | -32.32 | | Net Assets Attributable to Shareholders of Listed Company (End of Current Period) | 6,605,634,468.16 | 6,491,670,118.25 | 1.76 | | Total Assets (End of Current Period) | 9,692,178,185.14 | 9,509,950,363.94 | 1.92 | Key Financial Indicators for H1 2025 | Key Financial Indicators | Current Period (Jan-Jun) | Prior Period | YoY Change (%) | | :--- | :--- | :--- | :--- | | Basic Earnings Per Share (yuan/share) | 0.18 | 0.25 | -28.00 | | Diluted Earnings Per Share (yuan/share) | 0.18 | 0.25 | -28.00 | | Basic Earnings Per Share After Deducting Non-Recurring Gains and Losses (yuan/share) | 0.16 | 0.23 | -30.43 | | Weighted Average Return on Net Assets (%) | 4.34 | 6.91 | -2.57 | | Weighted Average Return on Net Assets After Deducting Non-Recurring Gains and Losses (%) | 3.94 | 6.29 | -2.35 | - Total profit decreased by **32.53%** year-on-year, and basic earnings per share after deducting non-recurring gains and losses decreased by **30.43%**, primarily due to increased marketing and promotion expenses for North American market expansion in 2025[25](index=25&type=chunk) - Net cash flow from operating activities decreased by **32.32%** year-on-year, mainly due to a reduction in current period cash collection from sales caused by revenue structure adjustments[25](index=25&type=chunk) [IX. Non-Recurring Gains and Losses Items and Amounts](index=6&type=section&id=%E4%B9%9D%E3%80%81%E9%9D%9E%E7%BB%8F%E5%B8%B8%E6%80%A7%E6%8D%9F%E7%9B%8A%E9%A1%B9%E7%9B%AE%E5%92%8C%E9%87%91%E9%A2%9D) This section details the company's non-recurring gains and losses for the first half of 2025, totaling **26.21 million yuan**, primarily from disposal of non-current assets, government grants, and fair value changes of financial assets Non-Recurring Gains and Losses Items and Amounts for H1 2025 | Non-Recurring Gains and Losses Item | Amount (yuan) | Notes (if applicable) | | :--- | :--- | :--- | | Disposal gains and losses of non-current assets | 3,435,128.39 | Disposal of fixed assets | | Government grants included in current profit and loss | 9,030,522.81 | See Note 67, Other Income, Section VII, Consolidated Financial Statements Notes | | Fair value changes and disposal gains/losses of financial assets and liabilities held by non-financial enterprises, excluding effective hedge accounting related to normal business operations | 21,778,026.64 | Mainly gains from settled forward foreign exchange and foreign exchange options | | Other non-operating income and expenses apart from the above | -1,781,797.04 | | | Less: Income tax impact | 6,252,492.86 | | | Total | 26,209,387.94 | | Section III Management Discussion and Analysis [I. Industry and Main Business Overview During the Reporting Period](index=7&type=section&id=%E4%B8%80%E3%80%81%E6%8A%A5%E5%91%8A%E6%9C%9F%E5%86%85%E5%85%AC%E5%8F%B8%E6%89%80%E5%B1%9E%E8%A1%8C%E4%B8%9A%E5%8F%8A%E4%B8%BB%E8%90%A5%E4%B8%9A%E5%8A%A1%E6%83%85%E5%86%B5%E8%AF%B4%E6%98%8E) This section details the company's pharmaceutical manufacturing industry background, global and Chinese market trends, policy environment, and core business areas including heparin preparations, non-heparin sterile injectables, CDMO, and biological drug innovation [ (I) Industry to which the Company Belongs During the Reporting Period](index=7&type=section&id=%EF%BC%88%E4%B8%80%EF%BC%89%E3%80%81%E6%8A%A5%E5%91%8A%E6%9C%9F%E5%86%85%E5%85%AC%E5%8F%B8%E6%89%80%E5%B1%9E%E8%A1%8C%E4%B8%9A) The pharmaceutical manufacturing industry, a strategic sector, sees continuous demand growth driven by an aging population and the Healthy China strategy, but faces pressures from volume-based procurement, intensified market competition, and rising costs; the global pharmaceutical market is growing steadily, with innovative drugs and biosimilars as key drivers, and the Chinese market leads in growth rate - China's pharmaceutical manufacturing industry is undergoing a critical transformation, with sustained market demand but facing pressures from normalized volume-based procurement, homogenized competition in innovative drugs, and rising costs[32](index=32&type=chunk) - The global pharmaceutical market is projected to exceed **$1.7 trillion** in 2024, with an annual growth rate of **6-7%**, driven primarily by innovative drugs and biosimilars[33](index=33&type=chunk) - China's pharmaceutical market growth rate reached **7.5%**, double the global average, with innovative drugs accounting for over **30%** for the first time[33](index=33&type=chunk) [ (II) Company's Main Business Operations During the Reporting Period](index=10&type=section&id=%EF%BC%88%E4%BA%8C%EF%BC%89%E3%80%81%E6%8A%A5%E5%91%8A%E6%9C%9F%E5%86%85%E5%85%AC%E5%8F%B8%E4%B8%BB%E8%90%A5%E4%B8%9A%E5%8A%A1%E6%83%85%E5%86%B5) The company's main business encompasses sterile injectables, heparin APIs, CDMO, and biological drug innovation, aiming to become a global multi-product injectable supplier with a rich product pipeline, active global market expansion, and CDMO services supporting Chinese pharmaceutical companies' internationalization - The company is a pharmaceutical enterprise integrating drug R&D, production, and sales, actively developing chemical and biological drugs, with a product pipeline covering cardiovascular, neurological, anesthetic, and anti-tumor preparations[38](index=38&type=chunk) - The company and its subsidiaries hold over **100** overseas drug registration approvals and over **30** Chinese drug registration approvals[40](index=40&type=chunk) - The heparin API business provides cash flow, serving as the foundation for the company's domestic and international sterile injectable expansion[46](index=46&type=chunk) - The company established a biopharmaceutical division, including protein design and drug delivery system platforms, aiming to become an innovative, international, world-class biopharmaceutical enterprise[47](index=47&type=chunk) [II. Discussion and Analysis of Operations](index=17&type=section&id=%E4%BA%8C%E3%80%81%E7%BB%8F%E8%90%A5%E6%83%85%E5%86%B5%E7%9A%84%E8%AE%A8%E8%AE%BA%E4%B8%8E%E5%88%86%E6%9E%90) In the first half of 2025, the company's operating revenue and net profit attributable to the parent company decreased year-on-year, yet it significantly increased R&D investment by **126.55%** and actively expanded its global market presence through independent R&D, collaborative development, and product acquisitions to enrich its pipeline and enhance global operational capabilities and commercial partnerships - In the first half of 2025, the company achieved operating revenue of **1,979.85 million yuan**, a year-on-year decrease of **7.60%**, and net profit attributable to the parent company of **286.27 million yuan**, a year-on-year decrease of **29.32%**[48](index=48&type=chunk) - During the reporting period, the company's R&D investment was **432.52 million yuan**, accounting for **21.85%** of operating revenue, an increase of **126.55%** compared to the same period last year[48](index=48&type=chunk) - The company obtained approvals from the US FDA and China NMPA for multiple drugs, including Liraglutide Injection and Rocuronium Bromide Injection, further expanding its injectable sales pipeline in the US[48](index=48&type=chunk) - The company has nearly **100** products operating in the North American market, making it one of the most comprehensive injectable suppliers in the region[50](index=50&type=chunk) - The company plans to develop Europe into its most important overseas market region outside of the US market[51](index=51&type=chunk) [III. Analysis of Core Competitiveness During the Reporting Period](index=19&type=section&id=%E4%B8%89%E3%80%81%E6%8A%A5%E5%91%8A%E6%9C%9F%E5%86%85%E6%A0%B8%E5%BF%83%E7%AB%9E%E4%BA%89%E5%8A%9B%E5%88%86%E6%9E%90) The company's core competitiveness stems from a strong R&D team and global R&D center collaboration, an efficient standardized registration system, multiple FDA-audited production lines, a high-standard quality system compliant with global pharmaceutical regulations, and a global presence with proprietary channels ensuring rapid market penetration - The company has over **500** R&D personnel, including more than **100** with master's and doctoral degrees, and globally renowned Chinese FDA quality experts[53](index=53&type=chunk) - The company has established three collaborative R&D centers (Nanjing, Chengdu, North America, Israel) both domestically and internationally, adopting a division of labor model that significantly improves R&D efficiency and reduces costs[53](index=53&type=chunk) - The company operates **12** production lines approved by the US FDA, featuring reliable equipment, advanced technology, and high automation[59](index=59&type=chunk) - The company's production quality system complies with pharmaceutical regulatory requirements in China, the US, Japan, the EU, and other regulated markets[61](index=61&type=chunk) - Meitheal, as a localized injectable pharmaceutical company in North America, possesses capabilities in sterile injectable registration, quality control, and marketing, with established resources in the North American heparin sales channels[63](index=63&type=chunk) [IV. Major Operating Conditions During the Reporting Period](index=23&type=section&id=%E5%9B%9B%E3%80%81%E6%8A%A5%E5%91%8A%E6%9C%9F%E5%86%85%E4%B8%BB%E8%A6%81%E7%BB%8F%E8%90%A5%E6%83%85%E5%86%B5) This section analyzes the company's major financial statement item changes during the reporting period, including operating revenue, costs, expenses, and cash flows, and details the asset and liability status, particularly the composition and restricted status of overseas assets Financial Statement Related Item Fluctuation Analysis | Item | Current Period Amount (yuan) | Prior Period Amount (yuan) | Change (%) | Explanation of Change | | :--- | :--- | :--- | :--- | :--- | | Operating Revenue | 1,979,845,467.48 | 2,142,658,737.40 | -7.60 | Injectable sales grew, while API and CDMO sales declined, overall stable | | Operating Cost | 1,237,682,262.89 | 1,280,548,179.82 | -3.35 | Due to expanded injectable sales scale | | Selling Expenses | 185,425,186.94 | 142,748,472.46 | 29.90 | Increase in sales personnel salaries and new business promotion fees | | Administrative Expenses | 117,579,188.83 | 86,149,857.37 | 36.48 | Increase in management personnel salaries and asset amortization | | Financial Expenses | 46,979,284.98 | 16,164,600.01 | 190.63 | Increase in exchange losses due to exchange rate fluctuations | | R&D Expenses | 142,140,345.92 | 174,338,210.56 | -18.47 | R&D investment focused on development expenditures | | Net Cash Flow from Operating Activities | 410,413,411.47 | 606,437,423.32 | -32.32 | Increased proportion of injectable sales, leading to longer collection cycles compared to raw materials | | Net Cash Flow from Investing Activities | 131,299,335.55 | -1,391,496,121.10 | 109.44 | Increase in funds recovered from investments, while cash paid for investments decreased | | Net Cash Flow from Financing Activities | 20,745,946.39 | 715,805,541.21 | -97.10 | Decrease in cash received from borrowings | Asset and Liability Status Changes | Item Name | Amount at End of Current Period (yuan) | Proportion of Total Assets at End of Current Period (%) | Amount at End of Prior Year (yuan) | Proportion of Total Assets at End of Prior Year (%) | Change from Prior Year End (%) | Explanation | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Monetary Funds | 1,372,256,494.35 | 14.16 | 1,024,384,215.58 | 10.77 | 33.96 | Due to collection of payments and maturity of wealth management products at period-end | | Trading Financial Assets | 591,503,977.00 | 6.10 | 1,055,442,297.60 | 11.10 | -43.96 | Due to maturity of wealth management products at period-end | | Accounts Receivable | 1,276,851,921.30 | 13.17 | 909,300,844.30 | 9.56 | 40.42 | Due to new accounts receivable from sales at period-end | | Right-of-Use Assets | 26,543,583.98 | 0.27 | 11,380,530.90 | 0.12 | 133.24 | Due to increased long-term lease liabilities of subsidiaries during the period | | Development Expenditures | 735,988,037.65 | 7.59 | 458,547,105.54 | 4.82 | 60.50 | Due to new development investments during the period | | Non-Current Liabilities Due Within One Year | 530,530,518.37 | 5.47 | 8,208,736.77 | 0.09 | 6,363.00 | Due to reclassification of bonds due within one year at period-end | | Bonds Payable | 0.00 | 0.00 | 519,993,374.81 | 5.47 | -100.00 | Due to reclassification of bonds due within one year at period-end | - Overseas assets amounted to **3,260.27 million yuan**, accounting for **32.06%** of total assets[70](index=70&type=chunk) Major Overseas Asset Information | Overseas Asset Name | Reason for Formation | Operating Model | Current Period Operating Revenue (million yuan) | Current Period Net Profit (million yuan) | | :--- | :--- | :--- | :--- | :--- | | Meitheal Pharmaceuticals,Inc. | Business combination under non-common control | R&D and Sales | 1,136.90 | -19.42 | | Hong Kong Genor Industrial Co., Ltd. | Established by setup | Import and Export | 1,136.89 | 35.67 | | Emerge Bioscience PTE. LTD. | Established by setup | Import and Export | 121.33 | 18.57 | Restricted Assets at Period-End | Item | Book Value at Period-End (yuan) | Reason for Restriction | | :--- | :--- | :--- | | Monetary Funds | 5,499,273.30 | Margin deposits and pledged certificates of deposit | | Fixed Assets | 32,344,103.74 | Mortgaged buildings for loans | | Intangible Assets | 9,130,587.65 | Land use rights mortgaged for loans | [ (IV) Investment Status Analysis](index=25&type=section&id=%EF%BC%88%E5%9B%9B%EF%BC%89%E6%8A%95%E8%B5%84%E7%8A%B6%E5%86%B5%E5%88%86%E6%9E%90) This section primarily discloses the company's financial assets measured at fair value, including structured deposits, wealth management products, and equity investments, and lists the beginning and end book values of securities investments and fair value change gains/losses Financial Assets Measured at Fair Value | Asset Category | Beginning Balance (million yuan) | Fair Value Change Gains/Losses for Current Period (million yuan) | Purchases for Current Period (million yuan) | Sales/Redemptions for Current Period (million yuan) | Ending Balance (million yuan) | | :--- | :--- | :--- | :--- | :--- | :--- | | Financial assets at fair value through profit or loss | 1,055.44 | 4.39 | 847.07 | 1,315.32 | 591.50 | | Receivables financing | 10.74 | - | 17.46 | 17.20 | 11.00 | | Total | 1,066.19 | 4.39 | 864.53 | 1,332.52 | 602.51 | - The company holds shares in Jiuyuan Gene (02566.HK), with an ending book value of **17.78 million yuan** and fair value change losses of **0.08 million yuan** for the current period[76](index=76&type=chunk) [ (VI) Analysis of Major Holding and Participating Companies](index=27&type=section&id=%EF%BC%88%E5%85%AD%EF%BC%89%E4%B8%BB%E8%A6%81%E6%8E%A7%E8%82%A1%E5%8F%82%E8%82%A1%E5%85%AC%E5%8F%B8%E5%88%86%E6%9E%90) This section discloses the financial information of Meitheal Pharmaceuticals, Inc., a major subsidiary with over 10% impact on the company's net profit, showing its current period operating revenue of **1,136.90 million yuan** but a net loss of **19.42 million yuan** Major Subsidiary Financial Information | Company Name | Company Type | Main Business | Registered Capital (million yuan) | Total Assets (million yuan) | Net Assets (million yuan) | Operating Revenue (million yuan) | Operating Profit (million yuan) | Net Profit (million yuan) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Meitheal Pharmaceuticals,Inc. | Subsidiary | Development, manufacturing, procurement, and sales of injectable drugs | 0.49 | 1,968.14 | -57.97 | 1,136.90 | -19.42 | -19.42 | [V. Other Disclosure Matters](index=28&type=section&id=%E4%BA%94%E3%80%81%E5%85%B6%E4%BB%96%E6%8A%AB%E9%9C%B2%E4%BA%8B%E9%A1%B9) This section details significant risks the company may face, including industry policy risks, product quality control risks, raw material price fluctuation risks, changes in the heparin preparation market landscape, force majeure risks, exchange rate risks, volume-based procurement risks, and drug R&D failure risks, along with corresponding countermeasures - Industry Policy Risks: Increased government regulation of the pharmaceutical industry, normalized volume-based procurement, and medical insurance cost control compress profit margins; US tariffs on Chinese pharmaceutical products pose a challenge[79](index=79&type=chunk) - Product Quality Control Risks: Major heparin drug markets enforce strict cGMP standards, requiring high product efficacy and safety[79](index=79&type=chunk) - Raw Material Price Fluctuation Risks: Price volatility of crude heparin and other raw materials significantly impacts the company's production costs and operating performance[81](index=81&type=chunk) - Heparin Preparation Market Landscape Change Risks: A few international leading enterprises dominate most market share, and changes in market structure may affect the company's sales[81](index=81&type=chunk) - Exchange Rate Risks: The company's overseas business is primarily settled in US dollars, and a significant appreciation of the RMB could lead to exchange losses[83](index=83&type=chunk) - Volume-Based Procurement Risks: If the company's main heparin preparation products fail to win bids, its domestic market share may decline[83](index=83&type=chunk) - Drug R&D Failure and Underperformance Risks: Biological and innovative drug R&D cycles are long and risky, with potential for failure or underperformance upon market launch[83](index=83&type=chunk) Section IV Corporate Governance, Environment, and Society [I. Changes in Directors, Supervisors, and Senior Management](index=31&type=section&id=%E4%B8%80%E3%80%81%E5%85%AC%E5%8F%B8%E8%91%A3%E4%BA%8B%E3%80%81%E7%9B%91%E4%BA%8B%E3%80%81%E9%AB%98%E7%BA%A7%E7%AE%A1%E7%90%86%E4%BA%BA%E5%91%98%E5%8F%98%E5%8A%A8%E6%83%85%E5%86%B5) During the reporting period, there were no changes in the company's directors, supervisors, or senior management [II. Profit Distribution or Capital Reserve Conversion Plan](index=31&type=section&id=%E4%BA%8C%E3%80%81%E5%88%A9%E6%B6%A6%E5%88%86%E9%85%8D%E6%88%96%E8%B5%84%E6%9C%AC%E5%85%AC%E7%A7%AF%E9%87%91%E8%BD%AC%E5%A2%9E%E9%A2%84%E6%A1%88) The company's semi-annual profit distribution or capital reserve conversion plan is not applicable, with no distribution or conversion made - Whether to distribute or convert: No[87](index=87&type=chunk) - Number of bonus shares per 10 shares (shares): **0**[87](index=87&type=chunk) - Dividend per 10 shares (yuan) (tax inclusive): **0**[87](index=87&type=chunk) [III. Company Equity Incentive Plans, Employee Stock Ownership Plans, or Other Employee Incentive Measures and Their Impact](index=31&type=section&id=%E4%B8%89%E3%80%81%E5%85%AC%E5%8F%B8%E8%82%A1%E6%9D%83%E6%BF%80%E5%8A%B1%E8%AE%A1%E5%88%92%E3%80%81%E5%91%98%E5%B7%A5%E6%8C%81%E8%82%A1%E8%AE%A1%E5%88%92%E6%88%96%E5%85%B6%E4%BB%96%E5%91%98%E5%B7%A5%E6%BF%80%E5%8A%B1%E6%8E%AA%E6%96%BD%E7%9A%84%E6%83%85%E5%86%B5%E5%8F%8A%E5%85%B6%E5%BD%B1%E5%93%8D) During the reporting period, the company had no disclosed equity incentive matters with no subsequent progress or changes, nor any undisclosed or progressing incentive situations from temporary announcements [IV. Environmental Information of Listed Companies and Their Major Subsidiaries Included in the List of Enterprises Required to Disclose Environmental Information by Law](index=31&type=section&id=%E5%9B%9B%E3%80%81%E7%BA%B3%E5%85%A5%E7%8E%AF%E5%A2%83%E4%BF%A1%E6%81%AF%E4%BE%9D%E6%B3%95%E6%8A%AB%E9%9C%B2%E4%BC%81%E4%B8%9A%E5%90%8D%E5%8D%95%E7%9A%84%E4%B8%8A%E5%B8%82%E5%85%AC%E5%8F%B8%E5%8F%8A%E5%85%B6%E4%B8%BB%E8%A6%81%E5%AD%90%E5%85%AC%E5%8F%B8%E7%9A%84%E7%8E%AF%E5%A2%83%E4%BF%A1%E6%81%AF%E6%83%85%E5%86%B5) The company and two major subsidiaries (Nanjing Genor Biopharmaceutical Co., Ltd., Nanjing Genor Pharmaceutical Co., Ltd., and Genor Pharma Co., Ltd.) are included in the list of enterprises required to disclose environmental information by law, with corresponding inquiry indexes provided - Number of enterprises included in the list of enterprises required to disclose environmental information by law: **3**[87](index=87&type=chunk) - Including Nanjing Genor Biopharmaceutical Co., Ltd., Nanjing Genor Pharmaceutical Co., Ltd., and Genor Pharma Co., Ltd[87](index=87&type=chunk) [V. Specific Information on Consolidating Poverty Alleviation Achievements, Rural Revitalization, and Other Work](index=31&type=section&id=%E4%BA%94%E3%80%81%E5%B7%A9%E5%9B%BA%E6%8B%93%E5%B1%95%E8%84%B1%E8%B4%AB%E6%94%BB%E5%9D%9A%E6%88%90%E6%9E%9C%E3%80%81%E4%B9%A1%E6%9D%91%E6%8C%AF%E5%85%B4%E7%AD%89%E5%B7%A5%E4%BD%9C%E5%85%B7%E4%BD%93%E6%83%85%E5%86%B5) During the reporting period, the company had no specific information to disclose regarding consolidating poverty alleviation achievements, rural revitalization, or other related work Section V Important Matters [I. Fulfillment of Commitments](index=32&type=section&id=%E4%B8%80%E3%80%81%E6%89%BF%E8%AF%BA%E4%BA%8B%E9%A1%B9%E5%B1%A5%E8%A1%8C%E6%83%85%E5%86%B5) This section discloses the fulfillment of various commitments made by the company's actual controllers, shareholders, related parties, and the company during initial public offerings and refinancing, including share lock-ups, compensation measures, resolution of horizontal competition, and related party transactions, all of which were strictly fulfilled during the reporting period - Controlling shareholders and actual controllers Tang Yongqun and Xie Juhua committed not to transfer or entrust others to manage their shares within **36 months** from the company's listing date, a commitment that has been strictly fulfilled[90](index=90&type=chunk) - Controlling shareholders and actual controllers Tang Yongqun and Xie Juhua, and Ding Ying, committed not to overstep their authority in interfering with the company's operations or infringing upon the interests of the listed company, a commitment that has been strictly fulfilled[90](index=90&type=chunk) - Controlling shareholders and actual controllers committed to resolving horizontal competition, ensuring they do not engage in businesses that compete with the issuer's existing operations, a commitment that has been strictly fulfilled[91](index=91&type=chunk) - Controlling shareholders and actual controllers committed to resolving related party transactions, striving to avoid and reduce related party transactions with Genor Biopharma and its subsidiaries, a commitment that has been strictly fulfilled[92](index=92&type=chunk) [II. Non-Operating Fund Occupation by Controlling Shareholders and Other Related Parties During the Reporting Period](index=37&type=section&id=%E4%BA%8C%E3%80%81%E6%8A%A5%E5%91%8A%E6%9C%9F%E5%86%85%E6%8E%A7%E8%82%A1%E8%82%A1%E4%B8%9C%E5%8F%8A%E5%85%B6%E4%BB%96%E5%85%B3%E8%81%94%E6%96%B9%E9%9D%9E%E7%BB%8F%E8%90%A5%E6%80%A7%E5%8D%A0%E7%94%A8%E8%B5%84%E9%87%91%E6%83%85%E5%86%B5) During the reporting period, there was no non-operating fund occupation by controlling shareholders or other related parties of the company [III. Irregular Guarantees](index=37&type=section&id=%E4%B8%89%E3%80%81%E8%BF%9D%E8%A7%84%E6%8B%85%E4%BF%9D%E6%83%85%E5%86%B5) During the reporting period, the company did not provide any external guarantees in violation of decision-making procedures [IV. Semi-Annual Report Audit Status](index=38&type=section&id=%E5%9B%9B%E3%80%81%E5%8D%8A%E5%B9%B4%E6%8A%A5%E5%AE%A1%E8%AE%A1%E6%83%85%E5%86%B5) This semi-annual report has not been audited; the company has re-appointed Grant Thornton Certified Public Accountants (Special General Partnership) as its auditor for 2025, for a one-year term - This semi-annual report has not been audited[8](index=8&type=chunk) - The company has re-appointed Grant Thornton Certified Public Accountants (Special General Partnership) as its auditor for 2025[97](index=97&type=chunk) [VII. Major Litigation and Arbitration Matters](index=38&type=section&id=%E4%B8%83%E3%80%81%E9%87%8D%E5%A4%A7%E8%AF%89%E8%AE%BC%E3%80%81%E4%BB%B2%E8%A3%81%E4%BA%8B%E9%A1%B9) During the reporting period, the company had no major litigation or arbitration matters [IX. Explanation of the Integrity Status of the Company, its Controlling Shareholder, and Actual Controller During the Reporting Period](index=38&type=section&id=%E4%B9%9D%E3%80%81%E6%8A%A5%E5%91%8A%E6%9C%9F%E5%86%85%E5%85%AC%E5%8F%B8%E5%8F%8A%E5%85%B6%E6%8E%A7%E8%82%A1%E8%82%A1%E4%B8%9C%E3%80%81%E5%AE%9E%E9%99%85%E6%8E%A7%E5%88%B6%E4%BA%BA%E8%AF%9A%E4%BF%A1%E7%8A%B6%E5%86%B5%E7%9A%84%E8%AF%B4%E6%98%8E) During the reporting period, the company, its controlling shareholder, and actual controller had no unfulfilled obligations determined by effective court legal documents or large overdue debts, maintaining a good integrity status - The company, its controlling shareholder, and actual controller had no unfulfilled obligations determined by effective court legal documents or large overdue debts[97](index=97&type=chunk) [X. Major Related Party Transactions](index=38&type=section&id=%E5%8D%81%E3%80%81%E9%87%8D%E5%A4%A7%E5%85%B3%E8%81%94%E4%BA%A4%E6%98%93) This section discloses daily operating related party transactions that were previously announced in temporary announcements with no subsequent progress or changes during the reporting period, primarily concerning the progress of a licensing agreement and related party transaction signed by a subsidiary with Xentria - The progress announcement regarding the licensing agreement and related party transaction signed by the company's subsidiary with Xentria has been disclosed in temporary announcements, with no subsequent progress or changes[98](index=98&type=chunk) [XI. Major Contracts and Their Fulfillment](index=40&type=section&id=%E5%8D%81%E4%B8%80%E3%80%81%E9%87%8D%E5%A4%A7%E5%90%88%E5%90%8C%E5%8F%8A%E5%85%B6%E5%B1%A5%E8%A1%8C%E6%83%85%E5%86%B5) This section details the company's major guarantees executed and outstanding during the reporting period, primarily involving guarantees for working capital loans provided to its subsidiaries Nanjing Jianzhi Ziming Pharmaceutical Trade Co., Ltd. and Hong Kong Genor Industrial Co., Ltd., with the total guarantee amount representing **7.98%** of the company's net assets Company's Total Guarantee Amount | Indicator | Amount (yuan) | | :--- | :--- | | Total guarantee amount for subsidiaries during the reporting period | 1,272,247,077.49 | | Total outstanding guarantee amount for subsidiaries at period-end (B) | 527,074,249.59 | | Total guarantee amount (A+B) | 527,074,249.59 | | Proportion of total guarantee amount to company's net assets (%) | 7.98 | - The company provided guarantees for working capital loans applied by its subsidiaries Nanjing Jianzhi Ziming Pharmaceutical Trade Co., Ltd. and Hong Kong Genor Industrial Co., Ltd., involving China Merchants Bank, CITIC Bank, Industrial Bank, Agricultural Bank of China, and Zheshang Bank[104](index=104&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) Section VI Share Changes and Shareholder Information [I. Share Capital Changes](index=45&type=section&id=%E4%B8%80%E3%80%81%E8%82%A1%E6%9C%AC%E5%8F%98%E5%8A%A8%E6%83%85%E5%86%B5) During the reporting period, there were no changes in the company's total share capital or share structure - During the reporting period, there were no changes in the company's total share capital or share structure[109](index=109&type=chunk) [II. Shareholder Information](index=45&type=section&id=%E4%BA%8C%E3%80%81%E8%82%A1%E4%B8%9C%E6%83%85%E5%86%B5) As of the end of the reporting period, the company had **23,853** common shareholders; this section details the shareholdings of the top ten shareholders and top ten unrestricted common shareholders, with Xie Juhua, Jiangsu Coastal Development Group Co., Ltd., and TANG YONGQUN identified as major shareholders - Total number of common shareholders at the end of the reporting period: **23,853**[110](index=110&type=chunk) Top Ten Shareholders' Shareholdings | Shareholder Name | Shares Held at Period-End (shares) | Proportion (%) | Pledged, Marked, or Frozen Shares (shares) | | :--- | :--- | :--- | :--- | | Xie Juhua | 439,682,951 | 27.21 | 0 | | Jiangsu Coastal Development Group Co., Ltd. | 344,164,989 | 21.30 | 0 | | TANG YONGQUN | 319,885,249 | 19.80 | 42,841,500 | | Huang Xiwei | 70,654,217 | 4.37 | 0 | - Xie Juhua is the mother of TANG YONGQUN, and TANG YONGQUN and Xie Juhua signed a concerted action agreement on March 30, 2011[113](index=113&type=chunk) [III. Information on Directors, Supervisors, and Senior Management](index=47&type=section&id=%E4%B8%89%E3%80%81%E8%91%A3%E4%BA%8B%E3%80%81%E7%9B%91%E4%BA%8B%E5%92%8C%E9%AB%98%E7%BA%A7%E7%AE%A1%E7%90%86%E4%BA%BA%E5%91%98%E6%83%85%E5%86%B5) This section discloses the changes in shareholdings of the company's current and former directors, supervisors, and senior management during the reporting period, showing no changes in the shareholdings of key management personnel Changes in Shareholdings of Directors, Supervisors, and Senior Management | Name | Position | Shares Held at Beginning of Period (shares) | Shares Held at End of Period (shares) | Change in Shares During Reporting Period (shares) | | :--- | :--- | :--- | :--- | :--- | | Tang Yongqun | Chairman, General Manager | 319,885,249 | 319,885,249 | 0 | | Xie Juhua | Director | 439,682,951 | 439,682,951 | 0 | | Huang Xiwei | Director, Deputy General Manager, Board Secretary | 70,654,217 | 70,654,217 | 0 | | Liu Zuqing | Chairman of the Supervisory Board | 149,256 | 149,256 | 0 | | Wu Guiping | Deputy General Manager | 381,703 | 381,703 | 0 | | Qian Xiaojie | Financial Controller | 72,150 | 72,150 | 0 | Section VII Bond-Related Information [II. Convertible Corporate Bonds](index=48&type=section&id=%E4%BA%8C%E3%80%81%E5%8F%AF%E8%BD%AC%E6%8D%A2%E5%85%AC%E5%8F%B8%E5%80%BA%E5%88%B8%E6%83%85%E5%86%B5) This section details the basic information of the company's "Genor Convertible Bonds" and "Genor 20 Convertible Bonds," including bondholders, guarantors, changes in convertible bonds, cumulative conversion to shares, historical adjustments to conversion prices, and the company's debt and credit status during the reporting period - The company publicly issued **503.19 million yuan** of "Genor Convertible Bonds" (bond code **113579**) on April 23, 2020[117](index=117&type=chunk) - The company publicly issued **780.00 million yuan** of "Genor 20 Convertible Bonds" (bond code **113614**) on December 17, 2020[118](index=118&type=chunk)[119](index=119&type=chunk) - As of the end of the reporting period, "Genor Convertible Bonds" had **2,375** holders, with an outstanding bond amount of **502.46 million yuan**[120](index=120&type=chunk)[123](index=123&type=chunk) - "Genor Convertible Bonds" cumulatively converted to **18,035** shares, accounting for **0.001%** of the company's total shares issued before conversion[124](index=124&type=chunk) - The latest conversion price for "Genor Convertible Bonds" is **24.34 yuan/share**, adjusted on May 6, 2025[127](index=127&type=chunk) - The company's current asset-liability ratio is reasonable, and its credit status is good; convertible bonds will be repaid through share conversion or cash flow generated from operations after issuance[128](index=128&type=chunk) Section VIII Financial Report [I. Audit Report](index=51&type=section&id=%E4%B8%80%E3%80%81%E5%AE%A1%E8%AE%A1%E6%8A%A5%E5%91%8A) This semi-annual report has not been audited - This semi-annual report has not been audited[8](index=8&type=chunk) [II. Financial Statements](index=51&type=section&id=%E4%BA%8C%E3%80%81%E8%B4%A2%E5%8A%A1%E6%8A%A5%E8%A1%A8) This section provides the company's consolidated and parent company balance sheets, income statements, cash flow statements, and statements of changes in owners' equity for the first half of 2025, comprehensively reflecting the company's financial position at the end of the reporting period and its operating results, cash flows, and changes in owners' equity during the reporting period [Consolidated Balance Sheet](index=51&type=section&id=%E5%90%88%E5%B9%B6%E8%B5%84%E4%BA%A7%E8%B4%9F%E5%80%BA%E8%A1%A8) As of June 30, 2025, the company's consolidated total assets were **9.69 billion yuan**, an increase of **1.92%** from the end of the previous year; consolidated total liabilities were **3.09 billion yuan**, an increase of **2.26%**; and total owners' equity attributable to the parent company was **6.61 billion yuan**, an increase of **1.76%** Consolidated Balance Sheet Key Data | Item | June 30, 2025 (yuan) | December 31, 2024 (yuan) | Change (%) | | :--- | :--- | :--- | :--- | | Total Assets | 9,692,178,185.14 | 9,509,950,363.94 | 1.92 | | Total Liabilities | 3,090,064,852.75 | 3,021,793,728.13 | 2.26 | | Total Owners' Equity Attributable to Parent Company | 6,605,634,468.16 | 6,491,670,118.25 | 1.76 | [Parent Company Balance Sheet](index=53&type=section&id=%E6%AF%8D%E5%85%AC%E5%8F%B8%E8%B5%84%E4%BA%A7%E8%B4%9F%E5%80%BA%E8%A1%A8) As of June 30, 2025, the parent company's total assets were **8.33 billion yuan**, a decrease of **3.03%** from the end of the previous year; total liabilities were **2.26 billion yuan**, a decrease of **10.62%**; and total owners' equity was **6.07 billion yuan**, an increase of **0.13%** Parent Company Balance Sheet Key Data | Item | June 30, 2025 (yuan) | December 31, 2024 (yuan) | Change (%) | | :--- | :--- | :--- | :--- | | Total Assets | 8,326,910,592.93 | 8,587,262,533.32 | -3.03 | | Total Liabilities | 2,256,588,334.70 | 2,524,618,721.45 | -10.62 | | Total Owners' Equity | 6,070,322,258.23 | 6,062,643,811.87 | 0.13 | [Consolidated Income Statement](index=55&type=section&id=%E5%90%88%E5%B9%B6%E5%88%A9%E6%B6%A6%E8%A1%A8) In the first half of 2025, the company's consolidated total operating revenue was **1.98 billion yuan**, a year-on-year decrease of **7.60%**; consolidated net profit was **286.26 million yuan**, a year-on-year decrease of **29.32%**; and net profit attributable to parent company shareholders was **286.27 million yuan**, a year-on-year decrease of **29.32%** Consolidated Income Statement Key Data | Item | H1 2025 (yuan) | H1 2024 (yuan) | Change (%) | | :--- | :--- | :--- | :--- | | Total Operating Revenue | 1,979,845,467.48 | 2,142,658,737.40 | -7.60 | | Total Operating Costs | 1,746,936,316.91 | 1,709,296,538.69 | 2.20 | | Total Profit | 310,160,900.73 | 459,667,961.20 | -32.53 | | Net Profit | 286,261,726.17 | 405,014,750.62 | -29.32 | | Net Profit Attributable to Parent Company Shareholders | 286,267,552.30 | 405,017,591.60 | -29.32 | | Basic Earnings Per Share (yuan/share) | 0.18 | 0.25 | -28.00 | [Parent Company Income Statement](index=57&type=section&id=%E6%AF%8D%E5%85%AC%E5%8F%B8%E5%88%A9%E6%B6%A6%E8%A1%A8) In the first half of 2025, the parent company's operating revenue was **1.30 billion yuan**, a year-on-year increase of **44.18%**; parent company net profit was **177.09 million yuan**, a year-on-year increase of **46.00%** Parent Company Income Statement Key Data | Item | H1 2025 (yuan) | H1 2024 (yuan) | Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 1,304,692,831.77 | 904,933,628.92 | 44.18 | | Operating Profit | 197,152,404.09 | 124,564,268.23 | 58.28 | | Total Profit | 195,409,566.11 | 124,530,769.49 | 56.92 | | Net Profit | 177,088,611.49 | 121,297,380.96 | 46.00 | [Consolidated Cash Flow Statement](index=59&type=section&id=%E5%90%88%E5%B9%B6%E7%8E%B0%E9%87%91%E6%B5%81%E9%87%8F%E8%A1%A8) In the first half of 2025, the company's net cash flow from operating activities was **410.41 million yuan**, a year-on-year decrease of **32.32%**; net cash flow from investing activities was **131.30 million yuan**, a year-on-year increase of **109.44%**; and net cash flow from financing activities was **20.75 million yuan**, a year-on-year decrease of **97.10%** Consolidated Cash Flow Statement Key Data | Item | H1 2025 (yuan) | H1 2024 (yuan) | Change (%) | | :--- | :--- | :--- | :--- | | Net Cash Flow from Operating Activities | 410,413,411.47 | 606,437,423.32 | -32.32 | | Net Cash Flow from Investing Activities | 131,299,335.55 | -1,391,496,121.10 | 109.44 | | Net Cash Flow from Financing Activities | 20,745,946.39 | 715,805,541.21 | -97.10 | | Net Increase in Cash and Cash Equivalents | 630,060,379.77 | -73,560,339.54 | - | | Cash and Cash Equivalents at Period-End | 1,366,757,221.05 | 820,624,887.05 | 66.54 | [Parent Company Cash Flow Statement](index=60&type=section&id=%E6%AF%8D%E5%85%AC%E5%8F%B8%E7%8E%B0%E9%87%91%E6%B5%81%E9%87%8F%E8%A1%A8) In the first half of 2025, the parent company's net cash flow from operating activities was **207.84 million yuan**, a year-on-year decrease of **61.38%**; net cash flow from investing activities was **404.01 million yuan**, a year-on-year increase of **192.08%**; and net cash flow from financing activities was **-510.62 million yuan**, a year-on-year decrease of **60.50%** Parent Company Cash Flow Statement Key Data | Item | H1 2025 (yuan) | H1 2024 (yuan) | Change (%) | | :--- | :--- | :--- | :--- | | Net Cash Flow from Operating Activities | 207,836,157.78 | 536,798,186.48 | -61.38 | | Net Cash Flow from Investing Activities | 404,007,215.37 | -439,919,934.45 | 192.08 | | Net Cash Flow from Financing Activities | -510,621,673.41 | -318,174,521.73 | -60.50 | | Net Increase in Cash and Cash Equivalents | 85,163,649.19 | -228,939,203.57 | - | | Cash and Cash Equivalents at Period-End | 176,677,490.09 | 249,996,395.37 | -29.29 | [Consolidated Statement of Changes in Owners' Equity](index=62&type=section&id=%E5%90%88%E5%B9%B6%E6%89%80%E6%9C%89%E8%80%85%E6%9D%83%E7%9B%8A%E5%8F%98%E5%8A%A8%E8%A1%A8) This section presents the changes in the company's consolidated owners' equity for the first half of 2025, including the impact of net profit, other comprehensive income, owners' contributions, and profit distribution on equity - The total comprehensive income attributable to parent company owners for the current period was **283.37 million yuan**[153](index=153&type=chunk) - Owners' contributions and capital reductions for the current period resulted in a decrease of **10.22 million yuan** in owners' equity attributable to the parent company[153](index=153&type=chunk) - Profit distribution for the current period resulted in a decrease of **161.56 million yuan** in owners' equity attributable to the parent company[154](index=154&type=chunk) [Parent Company Statement of Changes in Owners' Equity](index=70&type=section&id=%E6%AF%8D%E5%85%AC%E5%8F%B8%E6%89%80%E6%9C%89%E8%80%85%E6%9D%83%E7%9B%8A%E5%8F%98%E5%8A%A8%E8%A1%A8) This section presents the changes in the parent company's owners' equity for the first half of 2025, including the impact of net profit, owners' contributions, and profit distribution on equity - The total comprehensive income for the current period was **177.09 million yuan**[171](index=171&type=chunk) - Owners' contributions and capital reductions for the current period resulted in a decrease of **10.22 million yuan** in owners' equity[171](index=171&type=chunk) - Profit distribution for the current period resulted in a decrease of **161.56 million yuan** in owners' equity[171](index=171&type=chunk) [III. Company Basic Information](index=74&type=section&id=%E4%B8%89%E3%80%81%E5%85%AC%E5%8F%B8%E5%9F%BA%E6%9C%AC%E6%83%85%E5%86%B5) This section introduces the company's historical evolution, industry nature, main business scope, registered and actual operating locations, and other basic information, noting that the company's total share capital as of June 30, 2025, was **1,615.63 million shares** - The company was established through the overall restructuring of Nanjing Genor Biochemical Pharmaceutical Co., Ltd. and listed on the Shanghai Stock Exchange in July 2017[167](index=167&type=chunk)[168](index=168&type=chunk) - As of June 30, 2025, the company's total share capital was **1,615.63 million shares**[169](index=169&type=chunk) - The company belongs to the pharmaceutical manufacturing industry, with a main business scope including pharmaceutical wholesale, production, retail, procurement agency services, technology import and export, technology R&D, and promotion[170](index=170&type=chunk) [IV. Basis for Preparation of Financial Statements](index=75&type=section&id=%E5%9B%9B%E3%80%81%E8%B4%A2%E5%8A%A1%E6%8A%A5%E8%A1%A8%E7%9A%84%E7%BC%96%E5%88%B6%E5%9F%BA%E7%A1%80) This section states that the company's financial statements are prepared on a going concern basis, adhere to enterprise accounting standards, and demonstrate the ability to continue operations for at least 12 months - The company's financial statements are prepared on a going concern basis, recognizing and measuring transactions and events in accordance with the "Enterprise Accounting Standards - Basic Standards" and specific accounting standards issued by the Ministry of Finance[173](index=173&type=chunk) - The company possesses the ability to continue as a going concern for at least **12 months** from the end of the reporting period, with no significant matters affecting its going concern ability[174](index=174&type=chunk) [V. Significant Accounting Policies and Accounting Estimates](index=75&type=section&id=%E4%BA%94%E3%80%81%E9%87%8D%E8%A6%81%E4%BC%9A%E8%AE%A1%E6%94%BF%E7%AD%96%E5%8F%8A%E4%BC%9A%E8%AE%A1%E4%BC%B0%E8%AE%A1) This section details the significant accounting policies and estimates followed by the company in preparing its financial statements, covering business combinations, consolidated financial statements, financial instruments, inventories, fixed assets, intangible assets, revenue recognition, government grants, and explains the accounting policy changes for the current period - The company has formulated several specific accounting policies and estimates for revenue recognition and other transactions and events, based on its actual production and operating characteristics and relevant enterprise accounting standards[175](index=175&type=chunk) - The company classifies financial assets into three categories: measured at amortized cost, measured at fair value through other comprehensive income, and measured at fair value through profit or loss[199](index=199&type=chunk) - The company performs impairment accounting for financial assets measured at amortized cost and financial assets classified as measured at fair value through other comprehensive income, based on expected credit losses[214](index=214&type=chunk) - Company revenue recognition principles: Domestic sales are recognized upon customer receipt and absence of explicit return claims; export sales are recognized upon departure from port or dispatch, based on trade terms (FOB, CIF, EXW)[265](index=265&type=chunk) - Effective January 1, 2025, the company changed its accounting policy to recognize revenue upon customer receipt (logistics system receipt record/customer acknowledgment of receipt) and absence of explicit return claims[282](index=282&type=chunk) [VI. Taxes](index=103&type=section&id=%E5%85%AD%E3%80%81%E7%A8%8E%E9%A1%B9) This section discloses the main tax categories and applicable tax rates for the company and its subsidiaries, including VAT, urban maintenance and construction tax, education surcharges, corporate income tax, and profits tax, and details the high-tech enterprise income tax preferential policies and export tax rebate policies enjoyed by the company Main Tax Categories and Tax Rates | Tax Category | Tax Basis | Tax Rate | | :--- | :--- | :--- | | Value-Added Tax | Output tax minus deductible input tax, or sales amount | 13%, export goods subject to exemption, offset, and refund management; 1%, 3%, 5%, 6%, 9% | | Urban Maintenance and Construction Tax | Payable VAT | 7.00% | | Education Surcharges | Payable VAT | 5.00% | | Corporate Income Tax | Taxable income | 15%, 25%, 21%, 17% | | Profits Tax | Assessable profits | 16.50% | - The parent company and its subsidiaries Genor Pharma Co., Ltd. and Nanjing Genor Pharmaceutical Co., Ltd. enjoy high-tech enterprise income tax benefits, taxed at a **15%** rate[284](index=284&type=chunk)[287](index=287&type=chunk)[288](index=288&type=chunk) - The company's exported heparin sodium is exempt from VAT at the export sales stage and is eligible for a **13%** tax rebate to offset and refund VAT paid at the procurement stage[286](index=286&type=chunk)[287](index=287&type=chunk) [VII. Notes to Consolidated Financial Statement Items](index=104&type=section&id=%E4%B8%83%E3%80%81%E5%90%88%E5%B9%B6%E8%B4%A2%E5%8A%A1%E6%8A%A5%E8%A1%A8%E9%A1%B9%E7%9B%AE%E6%B3%A8%E9%87%8A) This section provides detailed notes for each major item in the consolidated financial statements, including monetary funds, trading financial assets, accounts receivable, inventories, fixed assets, intangible assets, short-term borrowings, bonds payable, deferred income, explaining the composition, reasons for changes, and related accounting treatments for each item - The ending balance of monetary funds was **1.37 billion yuan**, of which **190 million yuan** was deposited overseas[290](index=290&type=chunk) - The ending balance of trading financial assets was **592 million yuan**, primarily comprising structured deposits, wealth management products, and equity investments[294](index=294&type=chunk) - The ending book value of accounts receivable was **1.28 billion yuan**, with **27.36 million yuan** provided for bad debts based on credit risk characteristics[301](index=301&type=chunk)[304](index=304&type=chunk) - The ending book value of inventories was **3.39 billion yuan**, mainly including raw materials, work-in-progress, and finished goods, with an inventory impairment provision of **564 million yuan**[334](index=334&type=chunk)[337](index=337&type=chunk) - The ending book value of fixed assets was **1.03 billion yuan**, with accumulated depreciation of **811 million yuan** and impairment provisions of **212 million yuan**[350](index=350&type=chunk) - The ending balance of bonds payable (Genor Convertible Bonds) was reclassified to non-current liabilities due within one year, resulting in an ending balance of **0 yuan**[403](index=403&type=chunk)[404](index=404&type=chunk) [VIII. Research and Development Expenses](index=155&type=section&id=%E5%85%AB%E3%80%81%E7%A0%94%E5%8F%91%E6%94%AF%E5%87%BA) This section discloses the company's R&D expenditures during the reporting period, with total R&D expenditure of **438.68 million yuan**, including **142.14 million yuan** expensed and **290.38 million yuan** capitalized, primarily for insulin series projects and Fosfomycin for Injection R&D Expenditure Information | Item | Current Period Amount (yuan) | Prior Period Amount (yuan) | | :--- | :--- | :--- | | Employee Compensation | 47,653,216.56 | 51,282,717.28 | | Direct Input Costs | 366,680,858.97 | 103,708,505.88 | | Depreciation and Amortization | 16,083,157.47 | 27,491,924.79 | | Other Related Expenses | 2,105,989.20 | 8,437,985.62 | | Collaborative R&D Fees | 6,156,396.00 | 13,897,260.00 | | Total | 438,679,618.20 | 204,818,393.57 | | Of which: Expensed R&D Expenditure | 142,140,345.92 | 174,338,210.56 | | Capitalized R&D Expenditure | 290,382,876.28 | 16,582,923.01 | - Important capitalized R&D projects include insulin series projects and Fosfomycin for Injection, with capitalization criteria based on obtaining clinical approval and company evaluation[469](index=469&type=chunk) [IX. Changes in Consolidation Scope](index=156&type=section&id=%E4%B9%9D%E3%80%81%E5%90%88%E5%B9%B6%E8%8C%83%E5%9B%B4%E7%9A%84%E5%8F%98%E6%9B%B4) During the reporting period, there were no changes in the consolidation scope due to business combinations under non-common control, business combinations under common control, reverse acquisitions, disposal of subsidiaries, or other reasons [X. Equity in Other Entities](index=157&type=section&id=%E5%8D%81%E3%80%81%E5%9C%A8%E5%85%B6%E4%BB%96%E4%B8%BB%E4%BD%93%E4%B8%AD%E7%9A%84%E6%9D%83%E7%9B%8A) This section discloses the composition of the company's enterprise group, including the registered location, business nature, shareholding percentage, and acquisition method of major subsidiaries, and lists the key financial information of the important non-wholly-owned subsidiary Meitheal Pharmaceuticals, Inc Enterprise Group Composition | Subsidiary Name | Main Operating Location | Registered Capital (million yuan) | Business Nature | Shareholding (%) Direct | Shareholding (%) Indirect | Acquisition Method | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Nanjing Genor Pharmaceutical Co., Ltd. | Nanjing | 20.69 | Production and Sales | 70 | 30 | Established by setup | | Hong Kong Genor Industrial Co., Ltd. | Hong Kong | 0.01 | Import and Export | 100 | - | Established by setup | | Genor Pharma Co., Ltd. | Chengdu | 612.42 | Production and Sales | - | 100 | Business combination under non-common control | | Meitheal Pharmaceuticals,inc. | USA | 0.49 | R&D and Sales | - | 99.97 | Business combination under non-common control | Important Non-Wholly-Owned Subsidiary Meitheal Pharmaceuticals, Inc. Financial Information | Subsidiary Name | Minority Shareholder Holding (%) | Current Period Profit/Loss Attributable to Minority Shareholders (yuan) | Minority Shareholder Equity Balance at Period-End (yuan) | | :--- | :--- | :--- | :--- | | Meitheal Pharmaceuticals,inc. | 0.03% | -5,826.13 | -3,521,135.77 | | Subsidiary Name | Current Period Operating Revenue (million yuan) | Current Period Net Profit (million yuan) | Current Period Total Comprehensive Income (million yuan) | Current Period Operating Activities Cash Flow (million yuan) | | :--- | :--- | :--- | :--- | :--- | | Meitheal Pharmaceuticals,inc. | 1,136.90 | -19.42 | -25.51 | 52.62 | [XI. Government Grants](index=160&type=section&id=%E5%8D%81%E4%B8%80%E3%80%81%E6%94%BF%E5%BA%9C%E8%A1%A5%E5%8A%A9) This section discloses the company's government grant-related liability items and government grants recognized in current profit and loss during the reporting period, primarily deferred income related to assets and government grants related to income Liability Items Involving Government Grants | Financial Statement Item | Beginning Balance (yuan) | New Grants for Current Period (yuan) | Included in Other Income for Current Period (yuan) | Ending Balance (yuan) | Related to Assets/Income | | :--- | :--- | :--- | :--- | :--- | :--- | | Deferred Income | 84,625,869.56 | 3,210,000.00 | 5,214,415.34 | 82,621,454.22 | Related to assets | Government Grants Included in Current Profit and Loss | Type | Current Period Amount (yuan) | Prior Period Amount (yuan) | | :--- | :--- | :--- | | Related to Assets | 5,214,415.34 | 4,654,459.30 | | Related to Income | 1,825,092.84 | 36,929,848.44 | | Total | 7,039,508.18 | 44,125,446.97 | [XII. Risks Related to Financial Instruments](index=161&type=section&id=%E5%8D%81%E4%BA%8C%E3%80%81%E4%B8%8E%E9%87%91%E8%9E%8D%E5%B7%A5%E5%85%B7%E7%9B%B8%E5%85%B3%E7%9A%84%E9%A3%8E%E9%99%A9) This section analyzes the market risks (exchange rate risk, interest rate risk), credit risk, and liquidity risk faced by the company, explains the risk management strategies adopted, and discloses the company's hedging activities for risk management - The company's production and operations are primarily denominated and settled in RMB, posing minimal exchange rate risk; there are no financial liabilities with floating interest rates, resulting in low interest rate risk[479](index=479&type=chunk)[480](index=480&type=chunk) - The company mitigates credit risk from receivables by selecting creditworthy customers, controlling credit limits, implementing credit approvals, and making bad debt provisions[480](index=480&type=chunk) - The company maintains sufficient cash and cash equivalents to manage liquidity risk, and management considers liquidity risk to be low[481](index=481&type=chunk)[482](index=482&type=chunk) - The company engages in hedging activities, such as signing forward foreign exchange contracts, to mitigate foreign exchange market risk and reduce the adverse impact of significant exchange rate fluctuations on its operations[484](index=484&type=chunk) [XIII. Disclosure of Fair Value](index=163&type=section&id=%E5%8D%81%E4%B8%89%E3%80%81%E5%85%AC%E5%85%81%E4%BB%B7%E5%80%BC%E7%9A%84%E6%8A%AB%E9%9C%B2) This section discloses the fair value of the company's assets and liabilities measured at fair value at the end of the period, classified by fair value measurement hierarchy, primarily including trading financial assets and receivables financing Fair Value of Assets and Liabilities Measured at Fair Value at Period-End | Item | Level 1 Fair Value Measurement (yuan) | Level 2 Fair Value Measurement (yuan) | Level 3 Fair Value Measurement (yuan) | Total (yuan) | | :--- | :--- | :--- | :--- | :--- | | (I) Trading Financial Assets | 17,777,995.53 | 573,725,981.47 | - | 591,503,977.00 | | (VI) Receivables Financing | - | - | 11,002,858.87 | 11,002,858.87 | | Total Assets Continuously Measured at Fair Value | 17,777,995.53 | 573,725,981.47 | 11,002,858.87 | 602,506,835.87 | | (VI) Trading Financial Liabilities | - | - | 1,391,093.87 | 1,391,093.87 | | Total Liabilities Continuously Measured at Fair Value | - | - | 1,391,093.87 | 1,391,093.87 | - Level 2 fair value measurement items primarily consist of open-ended net value wealth management products purchased by the company, with fair value calculated based on bank-published net values[489](index=489&type=chunk) - Level 3 fair value measurement items primarily include bank wealth management products (future cash flows predicted using expected return rates) and bank acceptance bills receivable (fair value determined by face amount)[490](index=490&type=chunk) [XIV. Related Parties and Related Party Transactions](index=165&type=section&id=%E5%8D%81%E5%9B%9B%E3%80%81%E5%85%B3%E8%81%94%E6%96%B9%E5%8F%8A%E5%85%B3%E8%81%94%E4%BA%A4%E6%98%93) This section discloses the company's subsidiaries, joint ventures, and other related parties, as well as related party transactions that occurred during the reporting period, including purchases and sales of goods, entrusted R&D, and related party guarantees - Information on the company's subsidiaries is detailed in Note X, 1[493](index=493&type=chunk) - The company's significant joint venture is PeKo Limited, with the company holding a **50%** stake[493](index=493&type=chunk) - Other related parties include companies controlled by the actual controller Xie Juhua (Scitakos Bioscience, Sai Xun Bioscience, Scitakos Bioscience) and companies over which significant influence is exerted (Xentria)[493](index=493&type=chunk) - During the current period, entrusted R&D related party transactions with Xentria amounted to **143.17 million yuan**[495](index=495&type=chunk) - The company, as guarantor, provided multiple guarantees for its subsidiaries Nanjing Jianzhi Ziming Pharmaceutical Trade Co., Ltd. and Hong Kong Genor Industrial Co., Ltd.; some guarantees have been fulfilled, while others are ongoing[497](index=497&type=chunk) - Key management personnel compensation for the current period was **2.70 million yuan**[500](index=500&type=chunk) [XV. Share-Based Payment](index=169&type=section&id=%E5%8D%81%E4%BA%94%E3%80%81%E8%82%A1%E4%BB%BD%E6%94%AF%E4%BB%98) This section discloses the company's cash-settled share-based payment information, including fair value determination methods, key parameters, and cumulative liability amounts, and lists the share-based payment expenses for the current period - The fair value of the company's cash-settled share-based payment liabilities is determined using the Black-Scholes option pricing model[502](index=502&type=chunk) - The cumulative liability amount arising from cash-settled share-based payments is **137.75 million yuan**[502](index=502&type=chunk) - Cash-settled share-based payment expenses for the current period amounted to **2.48 million yuan**, primarily for core management, technical, and business personnel[504](index=504&type=chunk) [XVI. Commitments and Contingencies](index=170&type=section&id=%E5%8D%81%E5%85%AD%E3%80%81%E6%89%BF%E8%AF%BA%E5%8F%8A%E6%88%96%E6%9C%89%E4%BA%8B%E9%A1%B9) As of the end of the reporting period, the company had no significant commitments or contingencies requiring disclosure [XVII. Post-Balance Sheet Events](index=170&type=section&id=%E5%8D%81%E4%B8%83%E3%80%81%E8%B5%84%E4%BA%A7%E8%B4%9F%E5%80%BA%E8%A1%A8%E6%97%A5%E5%90%8E%E4%BA%8B%E9%A1%B9) From the end of the reporting period to the date of approval for issuance of the financial report, the company had no significant non-adjusting events, profit distribution information, sales returns, or other post-balance sheet events requiring disclosure [XVIII. Other Significant Matters](index=171&type=section&id=%E5%8D%81%E5%85%AB%E3%80%81%E5%85%B6%E4%BB%96%E9%87%8D%E8%A6%81%E4%BA%8B%E9%A1%B9) During the reporting period, the company had no prior period accounting error corrections, significant debt restructurings, asset exchanges, annuity plans, discontinued operations, segment information, or other significant transactions and events that would impact investor decisions [XIX. Notes to Major Items in Parent Company Financial Statements](index=172&type=section&id=%E5%8D%81%E4%B9%9D%E3%80%81%E6%AF%8D%E5%85%AC%E5%8F%B8%E8%B4%A2%E5%8A%A1%E6%8A%A5%E8%A1%A8%E4%B8%BB%E8%A6%81%E9%A1%B9%E7%9B%AE%E6%B3%A8%E9%87%8A) This section provides detailed notes for major items in the parent company's financial statements, including accounts receivable, other receivables, long-term equity investments, operating revenue and costs, and investment income, explaining the composition, reasons for changes, and related accounting treatments for each item - The parent company's ending book value of accounts receivable was **2.20 billion yuan**, with **2.29 million yuan** provided for bad debts based on credit risk characteristics[509](index=509&type=chunk)[511](index=511&type=chunk) - The parent company's ending book value of other receivables was **1.57 billion yuan**, primarily intercompany balances, with a bad debt provision of **0.07 million yuan**[515](index=515&type=chunk)[520](index=520&type=chunk)[522](index=522&type=chunk) - The parent company's ending book value of long-term equity investments was **367 million yuan**, primarily investments in subsidiaries, with no increase or decrease during the current period[528](index=528&type=chunk)[529](index=529&type=chunk) Parent Company Operating Revenue and Operating Costs | Item | Current Period Revenue (yuan) | Current Period Cost (yuan) | Prior Period Revenue (yuan) | Prior Period Cost (yuan) | | :--- | :--- | :--- | :--- | :--- | | Main Business | 1,302,794,259.19 | 1,024,135,344.01 | 902,430,143.30 | 671,867,467.62 | | Other Businesses | 1,898,572.58 | 2,874,871.69 | 2,503,485.62 | 2,130,063.28 | | Total | 1,304,692,831.77 | 1,027,010,215.70 | 904,933,628.92 | 673,997,530.90 | - The parent company's investment income for the current period primarily originated from wealth management product gains, amounting to **8.37 million yuan**[535](index=535&type=chunk) [XX. Supplementary Information](index=181&type=section&id=%E4%BA%8C%E5%8D%81%E3%80%81%E8%A1%A5%E5%85%85%E8%B5%84%E6%96%99) This section provides supplementary information for the company's first half of 2025, including the detailed statement of non-recurring gains and losses, return on net assets, and earnings per share Detailed Statement of Non-Recurring Gains and Losses for H1 2025 | Item | Amount (yuan) | Explanation | | :--- | :--- | :--- | | Disposal gains and losses of non-current assets | 3,435,128.39 | Disposal of fixed assets | | Government grants included in current profit and loss | 9,030,522.81 | See Note 67, Other Income, Section VII, Consolidated Financial Statements Notes | | Fair value changes and disposal gains/losses of financial assets and liabilities held by non-financial enterprises, excluding effective hedge accounting related to normal business operations | 21,778,026.64 | Mainly gains from settled forward foreign exchange and foreign exchange options | | Other non-operating income and expenses apart from the above | -1,781,797.04 | | | Less: Income tax impact | 6,252,492.86 | | | Total | 26,209,387.94 | | Return on Net Assets and Earnings Per Share | Profit for the Reporting Period | Weighted Average Return on Net Assets (%) | Basic Earnings Per Share | Diluted Earning
健友股份(603707) - 健友股份关于召开2025年半年度业绩说明会的公告
2025-08-28 08:43
| 证券代码:603707 | 证券简称:健友股份 | 公告编号:2025-069 | | --- | --- | --- | | 债券代码:113579 | 债券简称:健友转债 | | 南京健友生化制药股份有限公司 投资者可于 2025 年 09 月 03 日(星期三)至 09 月 09 日(星期二)16:00 前登录 上 证 路 演 中 心 网 站 首 页 点 击 " 提 问 预 征 集 " 栏 目 或 通 过 公 司 邮 箱 nkf-pharma@nkf-pharma.com.cn 进行提问。公司将在说明会上对投资者普遍关 注的问题进行回答。 南京健友生化制药股份有限公司(以下简称"公司")于 2025 年 8 月 29 日 发布公司 2025 年半年度报告,为便于广大投资者更全面深入地了解公司 2025 年半年度经营成果、财务状况,公司计划于 2025 年 09 月 10 日(星期三)上午 10:00-11:00 举行公司 2025 年半年度业绩说明会,就投资者关心的问题进行交 流。 一、说明会类型 本次投资者说明会以网络文字互动形式召开,公司将针对 2025 年半年度的 经营成果及财务指标的具体情况 ...
健友股份(603707) - 健友股份关于自主变更会计政策的公告
2025-08-28 08:43
| 证券代码:603707 | 证券简称:健友股份 | 公告编号:2025-068 | | --- | --- | --- | | 债券代码:113579 | 债券简称:健友转债 | | 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担个别及连带责任。 一、本次会计政策变更概述 南京健友生化制药股份有限公司(以下简称"公司")拟根据公司实际情况 自主对收入确认条件进行相关会计政策变更的修订。 公司于 2025 年 08 月 28 日召开第五届董事会第十四次会议、第五届监事会 第十次会议,审议通过了《关于公司自主变更会计政策的议案》,本次自主变更 会计政策事项对公司财务状况、经营成果和现金流量无重大影响,不涉及以前年 度的追溯调整,无需提交公司股东大会审议。 二、会计政策变更的具体情况 1、变更原因 随着公司信息化管理工作的不断推进,ERP 信息管理系统正式上线运行,细 化了各项指标管控,进一步提升了公司存货管理水平和管理效率。为了提高收入 确认条件与 ERP 信息管理系统的适配性,公司将内销收入确认条件变更为"以 客户签收货物(物流系统签 ...
健友股份:2025年上半年净利润2.86亿元,同比下降29.32%
Xin Lang Cai Jing· 2025-08-28 08:40
健友股份公告,2025年上半年营业收入19.8亿元,同比下降7.60%。净利润2.86亿元,同比下降 29.32%。 ...
南京健友生化制药股份有限公司 关于获得美国FDA盐酸尼卡地平注射液药品注册批件的公告
Group 1 - The company has received FDA approval for its Nicardipine Hydrochloride Injection, 25 mg/10mL (2.5 mg/mL) under ANDA number 216819, which is expected to positively impact its business performance [1][3] - The reference product for Nicardipine Hydrochloride Injection is held by HIKMA INTL PHARMS, which was approved for marketing in the U.S. on July 24, 2008 [1] - Currently, there are seven companies, including HIKMA INTL PHARMS, AM REGENT, and RK PHARMA, that have marketed this product in the U.S., while there is no such product available in the domestic market [1] Group 2 - The company has invested approximately RMB 18.35 million in the research and development of Nicardipine Hydrochloride Injection [2] - The newly approved product is expected to be launched in the U.S. soon, which is anticipated to have a positive effect on the company's operating performance [3]
中国石化:拟5亿元-10亿元回购公司A股股份丨公告精选
Buyback and Shareholder Actions - Sinopec plans to repurchase A-shares with a total fund of no less than RMB 5 billion and no more than RMB 10 billion, potentially reducing its registered capital [1] - Hengbang Mining intends to reduce its stake in the Hong Kong-listed company, WanGuo Gold, by up to 40 million shares, representing approximately 3.69% of WanGuo's total share capital [5] Product Approvals and Market Launches - Wantai Biological's nine-valent HPV vaccine has received the batch release certificate, marking its official market launch and enhancing the company's product lineup [1] - Changchun High-tech's subsidiary has received acceptance for the clinical trial application of GenSci143, a dual-specific antibody drug, which may provide new treatment options for certain tumors [7] Financial Performance - Hongxin Electronics reported a 15.01% increase in revenue to RMB 3.494 billion and a 9.85% rise in net profit to RMB 53.99 million for the first half of 2025 [2] - Sanwei Xinan experienced a net loss of RMB 29.39 million in the first half of 2025, despite a 15.19% increase in revenue to RMB 195 million [3] Corporate Developments - TianTan Bio received a commitment from its controlling shareholder to resolve new competition issues arising from a recent acquisition [4] - Feilu Co. announced a potential change in control, leading to a temporary suspension of its stock trading [8] Investment and Expansion - Jinbei Electric's subsidiary has signed a purchase agreement for a factory in Europe, marking significant progress in establishing its European production base [1] - Shengshi Technology plans to establish a wholly-owned subsidiary to integrate AI and humanoid robot technology with innovative toy products, investing RMB 10 million [6]
健友股份(603707) - 健友股份关于获得美国FDA盐酸尼卡地平注射液药品注册批件的公告
2025-08-21 08:30
| 证券代码:603707 | 证券简称:健友股份 | 公告编号:2025-064 | | --- | --- | --- | | 债券代码:113579 | 债券简称:健友转债 | | 南京健友生化制药股份有限公司 关于获得美国FDA盐酸尼卡地平注射液 药品注册批件的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担个别及连带责任。 南京健友生化制药股份有限公司(以下简称"健友股份"或"公司")于近日收 到美国食品药品监督管理局(以下简称"美国 FDA")签发的盐酸尼卡地平注射 液,25 mg/10mL (2.5 mg/mL)(ANDA 号:216819)批准信,现将相关情况公告 如下: 一、药品的基本情况 二、药品其他相关情况 公司于 2025 年 08 月 20 日获得美国 FDA 的通知,公司向美国 FDA 申报的 盐酸尼卡地平注射液,25 mg/10mL (2.5 mg/mL) 的 ANDA 申请获得批准。 经查询,美国境内,目前有包括 HIKMA INTL PHARMS,AM REGENT, RK PHARMA等 7家产品 ...
健友股份:获得美国FDA盐酸尼卡地平注射液药品注册批件
Mei Ri Jing Ji Xin Wen· 2025-08-21 08:25
Core Viewpoint - The company, Jianyou Co., Ltd. (603707.SH), has received FDA approval for its Nicardipine Hydrochloride Injection, which is expected to positively impact its business performance [1] Group 1: Product Approval - The FDA has issued an approval letter for Nicardipine Hydrochloride Injection, 25mg/10mL (2.5mg/mL) under ANDA number 216819 [1] - The approved drug is indicated for the short-term treatment of hypertension when oral therapy is not feasible [1] Group 2: Investment and Market Impact - The company has invested approximately RMB 18.3543 million in the research and development of this project [1] - The newly approved product is set to be launched in the U.S. market soon, which is anticipated to have a positive effect on the company's operating performance [1]