亿帆医药(002019) - 2025 Q2 - 季度财报

Important Notice, Table of Contents, and Definitions This section includes critical disclaimers from management, the report's structural overview, a list of reference documents, and definitions of key terms and entities Important Notice Management assures report accuracy, declares no dividends or capital transfers, and outlines key risks such as international trade, R&D, and goodwill impairment - The company's board of directors, supervisory board, and senior management guarantee the truthfulness, accuracy, and completeness of the semi-annual report, free from false records, misleading statements, or major omissions, and assume individual and joint legal responsibility[4] - The company plans not to distribute cash dividends, issue bonus shares, or convert capital reserves into share capital[5] - No exceptionally significant risks substantially impacting the company's operations occurred during the reporting period, but detailed discussions cover international trade risks, R&D underperformance risks, goodwill impairment risks, exchange rate fluctuation risks, international operation risks, and safety and environmental protection risks[4] Table of Contents This section lists the report's nine main chapters and their starting page numbers, providing an overall structural overview for investors - The report comprises nine main chapters, covering important notices, company profile, management discussion and analysis, corporate governance, significant events, share changes, bond information, financial reports, and other submitted data[7] List of Reference Documents This section lists all publicly disclosed company documents, original announcements, financial statements, and the original semi-annual report text as reference materials for the reporting period - Reference documents include signed and sealed financial statements, all publicly disclosed original company documents and announcements, the original semi-annual report text signed by the legal representative, and other reference materials[9] Definitions This section defines common terms, the company and its main subsidiaries, R&D products (e.g., F-627, F-652), and relevant regulatory bodies (e.g., NMPA, FDA, EMA) to ensure clear understanding of the report content - The report defines abbreviations for the Company, Yifan Pharmaceutical, and its main subsidiaries (e.g., Yifan Bio, Hefei Yifan, Yiyi Bio)[10][11] - F-627 refers to Epegfilgrastim Injection (Yilishu®/Ryzneuta®), and F-652 refers to Recombinant Human Interleukin-22-Fc Fusion Protein, both being self-developed R&D products of the company[11] - NMPA, FDA, and EMA refer to the National Medical Products Administration, the U.S. Food and Drug Administration, and the European Medicines Agency, respectively[11] Company Profile and Key Financial Indicators This section provides an overview of the company's basic information and presents key financial data and performance indicators for the reporting period Company Profile Yifan Pharmaceutical Co., Ltd. (stock code: 002019) is listed on the Shenzhen Stock Exchange, with Cheng Xianfeng as its legal representative, and contact information remained unchanged during the reporting period Company Basic Information | Metric | Content | | :--- | :--- | | Stock Abbreviation | Yifan Pharmaceutical | | Stock Code | 002019 | | Listing Exchange | Shenzhen Stock Exchange | | Chinese Name | Yifan Pharmaceutical Co., Ltd. | | Legal Representative | Cheng Xianfeng | - The company's registered address, office address, website, email, and information disclosure locations remained unchanged during the reporting period, as detailed in the 2024 annual report[15][16] Key Accounting Data and Financial Indicators In H1 2025, operating revenue slightly increased by 0.11% YoY, net profit attributable to shareholders grew by 19.91%, and non-recurring net profit increased by 32.21%, driven by higher innovative drug revenue and increased foreign exchange gains, with operating cash flow surging by 98.99% 2025 Semi-Annual Key Financial Data | Metric | Current Period (RMB) | Prior Period (RMB) | YoY Change | | :--- | :--- | :--- | :--- | | Operating Revenue | 2,635,110,083.18 | 2,632,089,783.35 | 0.11% | | Net Profit Attributable to Shareholders of Listed Company | 303,651,052.46 | 253,226,615.60 | 19.91% | | Net Profit Attributable to Shareholders of Listed Company (Excluding Non-recurring Items) | 237,210,048.08 | 179,419,522.02 | 32.21% | | Net Cash Flow from Operating Activities | 286,097,071.23 | 143,774,218.95 | 98.99% | | Basic Earnings Per Share (RMB/share) | 0.25 | 0.21 | 19.05% | | Diluted Earnings Per Share (RMB/share) | 0.25 | 0.21 | 19.05% | | Weighted Average Return on Net Assets | 3.49% | 2.96% | 0.53% | | Period-end Indicators | Current Period-end (RMB) | Prior Year-end (RMB) | Change from Prior Year-end | | Total Assets | 12,674,139,895.70 | 12,285,788,088.75 | 3.16% | | Net Assets Attributable to Shareholders of Listed Company | 8,771,392,564.72 | 8,521,867,867.56 | 2.93% | - Operating revenue increased by 0.11%, primarily due to a significant increase in revenue from innovative and self-developed drugs, partially offset by a decrease in volume and price of some proprietary pharmaceutical products, and reduced revenue from vitamin products and pharmaceutical promotion services[18] - Net profit attributable to shareholders of the listed company (excluding non-recurring items) increased by 32.21%, mainly driven by higher gross profit from high-value-added innovative and self-developed drugs, increased foreign exchange gains from financial expenses, and reduced credit impairment losses[18] - Net cash flow from operating activities increased by 98.99%, primarily because the increase in cash received from sales of goods and provision of services outpaced the increase in cash paid for purchases of goods and acceptance of services[19] Non-recurring Gains and Losses and Amounts During the reporting period, the company's total non-recurring gains and losses amounted to RMB 66,441,004.38, mainly comprising disposal gains/losses of non-current assets, government grants, fair value changes of financial assets/liabilities, and other non-operating income 2025 Semi-Annual Non-recurring Gains and Losses | Item | Amount (RMB) | Explanation | | :--- | :--- | :--- | | Disposal gains/losses of non-current assets | 3,389,221.12 | Primarily net gains from disposal of intangible assets during the reporting period. | | Government grants recognized in current profit/loss (excluding those with continuous impact) | 64,177,846.31 | Primarily government grants received during the reporting period. | | Fair value changes and disposal gains/losses of financial assets and liabilities | 44,413.44 | Due to revaluation of foreign exchange derivatives at period-end and gains from matured time deposits. | | Other non-operating income and expenses | 1,847,214.24 | | | Less: Income tax impact | 2,565,065.42 | | | Impact on minority interests (after tax) | 452,625.31 | | | Total | 66,441,004.38 | | - Some government grants recognized in current profit/loss (RMB 5,145,150.23) were classified as recurring gains/losses because they are closely related to the company's normal operations, comply with national policies, are enjoyed according to established standards, and have a continuous impact on the company's profit and loss[24] Management Discussion and Analysis This section provides a comprehensive analysis of the company's main business, core competitiveness, financial performance, investment activities, and risk management strategies during the reporting period Main Business Activities During the Reporting Period The company's main business involves R&D, production, sales of pharmaceutical products (biologics, chemical drugs, traditional Chinese medicines), vitamins, and polymer materials, along with drug promotion services; innovative drug sales revenue grew by 169.57%, while vitamin products faced competitive pressure - The company primarily engages in the R&D, production, sales, and promotion services of pharmaceutical products (biologics, chemical drugs, traditional Chinese medicines), vitamins, and polymer materials, operating within the pharmaceutical manufacturing industry[26] - The pharmaceutical industry is undergoing deep adjustments and innovation breakthroughs, with traditional generic drugs facing pressure and innovative drugs experiencing explosive growth; in H1 2025, pharmaceutical manufacturing operating revenue decreased by 1.2% and total profit decreased by 2.8% year-on-year[28][29] - Vitamin B5 and its precursor products hold a high global market share and a leading position, but currently face severe supply-demand imbalance and industry reshuffling[32][37] - The company is one of the few Chinese enterprises to have obtained marketing approval from drug regulatory agencies in China, the U.S., EU, and Brazil for its innovative biological products, possessing a global pharmaceutical marketing and promotion network[34] - In H1 2025, proprietary (including imported) pharmaceutical operating revenue increased by 7.22% year-on-year, and innovative drug sales revenue grew by 169.57%, serving as the core driver for a significant increase in non-recurring net profit margin[38] Company's Main Business The company's main business covers biologics, chemical drugs, traditional Chinese medicines, and vitamin products, with biologics like F-627 (Yilishu®) and recombinant human insulin sold globally, alongside various chemical and traditional Chinese medicines, and leading global sales of Vitamin B5 series products Main Product List | Product Category | Product Name | Sales Region | Indication/Description | | :--- | :--- | :--- | :--- | | Biologic | Epegfilgrastim Injection (F-627) | Global Sales | Reduces incidence of infection in febrile neutropenia caused by chemotherapy | | Biologic | Recombinant Human Insulin Injection | Global Sales | Regulates glucose metabolism, lowers blood sugar | | Chemical Drug | Capecitabine Tablets (Xeloda®) | Domestic Sales | Advanced or metastatic gastric cancer, colorectal cancer, breast cancer | | Chemical Drug | Sodium Hyaluronate Cross-linked with Butanediol Diglycidyl Ether Injection (Yinikang) | Domestic Sales | Knee osteoarthritis | | Traditional Chinese Medicine | Xiao'er Qingqiao Granules | Domestic Sales | Wind-heat tonsillitis, fever, sore throat, etc. | | Vitamin | Vitamin B5 and its precursor | Global Sales | Precursor to Coenzyme A, involved in metabolism, feed/food additive | Industry Development Stage and Company's Industry Position The pharmaceutical industry is in a phase of deep adjustment and innovation, with significant growth in innovative drugs, while the vitamin sector faces supply-demand imbalances; the company holds a prominent position in biologics, small molecules, traditional Chinese medicines, and synthetic biology, particularly in innovative biologics and internationalization - The pharmaceutical industry has entered a phase of deep adjustment and innovation breakthroughs, with traditional generic drugs facing pressure and innovative drugs experiencing explosive growth; the industry as a whole exhibits weak cyclicality and strong defensive characteristics[28][31] - The vitamin industry faces severe supply-demand imbalance and reshuffling, but the company's Vitamin B5 products maintain a leading position in the segmented market[32] - The company has established a full lifecycle system for macromolecular drugs, from new drug discovery to commercial production, and has successfully launched its first innovative biologic, Yilishu, in 34 countries including China, the U.S., EU, and Brazil[34][35] - In the small molecule (chemical drug) sector, the company focuses on a differentiated product chain of 'small, sharp, and special' products, possesses an internationally aligned high-standard production quality management system, and is one of the few domestic enterprises with an integrated international R&D, production, and sales layout for pharmaceuticals[35] - The company owns 13 exclusive traditional Chinese medicine products covered by medical insurance, including Baixuekang (Compound Huangdai Tablets®), an effective drug for treating acute promyelocytic leukemia, which is also listed on the WHO Model List of Essential Medicines[36][37] Key Performance Drivers In H1 2025, the company's performance growth was primarily driven by a 7.22% increase in proprietary pharmaceutical product revenue, especially a 169.57% surge in innovative drug sales, which boosted high-margin business, while Vitamin B5 series products maintained market leadership despite industry competition - In the pharmaceutical preparation business, proprietary (including imported) pharmaceutical operating revenue increased by 7.22% year-on-year, and innovative drug sales revenue grew by 169.57%, serving as the core driver for a significant increase in the company's non-recurring net profit margin[38] - Although Vitamin B5 series products were affected by industry competition, leading to declines in average transaction prices and sales volumes, the company maintained its market-leading position through cost reduction, efficiency improvement, and strengthened management[38] Analysis of Core Competitiveness The company's core competitiveness remained unchanged during the reporting period, with specific details available in the 2024 Annual Report - The company's core competitiveness remained unchanged during the reporting period, as detailed in the 2024 Annual Report[39] Analysis of Main Business In H1 2025, the company achieved operating revenue of RMB 2.635 billion, a 0.11% increase, and net profit attributable to shareholders of RMB 304 million, up 19.91%; pharmaceutical-related revenue accounted for 85.53% of total revenue, with innovative drugs Yilishu® and Yinikang® sales growing by 169.57%, alongside significant progress in biologics commercialization, global operations, BD collaborations, high-quality R&D, and synthetic biology new product development 2025 Semi-Annual Key Financial Indicators | Metric | Amount (RMB 10,000) | YoY Change | | :--- | :--- | :--- | | Operating Revenue | 263,511.01 | 0.11% | | Net Profit Attributable to Shareholders of Listed Company | 30,365.11 | 19.91% | | Net Profit Attributable to Shareholders of Listed Company (Excluding Non-recurring Items) | 23,721.00 | 32.21% | - Pharmaceutical-related operating revenue was RMB 2,253,705,400 (RMB 225,370.54 ten thousand), accounting for 85.53% of the company's total operating revenue; combined sales revenue of innovative drugs Yilishu® and Yinikang® increased by 169.57% year-on-year[41] Advancing Yilishu Commercialization and Biologics Ecosystem Development Yilishu® has completed its first shipment to the U.S. market and is approved for sale in 34 countries, with the company actively pursuing global commercial collaborations and advancing R&D projects like F-652 and N-3C01, while construction of the Shanghai International Innovation Center and Hefei Xinzhu Gene Recombinant Industrial Base progresses significantly - The first self-developed Class I macromolecular innovative biologic, Yilishu®, completed its first shipment to the U.S. market, with a market retail price of USD 4,600 per dose, marking its official entry into the U.S. market[42] - Yilishu® has been approved for marketing and sales in 34 countries, including China, the U.S., EU, and Brazil, with shipments or sales realized in 5 countries[42] - The NMPA approved a supplementary application for Yilishu® to change from 48-hour to 24-hour administration, the EU approved self-injection, and the Japanese partner initiated studies for shorter administration times[43] - The innovative drug N-3C01 project has largely completed preclinical research and will soon submit a clinical application, with potential indications for bladder cancer and pan-solid tumors[44] - The Shanghai International Innovation Center project completed civil engineering and outdoor works, the Hefei Xinzhu Gene Recombinant Industrial Base project's formulation line underwent debugging and validation, and the 1000L bulk drug production line entered the trial production acceptance phase[45] Anchoring Overseas Strategy, Consolidating Domestic and International Sales Systems The company consolidated its domestic and international sales systems into a Global Commercial Business Unit to unify pharmaceutical market operations; overseas pharmaceutical preparation revenue increased by 6.46%, domestic pharmaceutical market revenue grew by 3.57%, and innovative drugs Yilishu® and Yinikang® sales surged by 169.57% - The company merged its domestic and international sales systems, establishing a Global Commercial Business Unit to coordinate business development, product marketing, market planning, sales strategies, and operations for both domestic and international pharmaceutical markets[46] - Overseas pharmaceutical preparations achieved operating revenue of RMB 331,988,900 (RMB 33,198.89 ten thousand), a year-on-year increase of 6.46%[47] - Domestic pharmaceutical market achieved operating revenue of RMB 1,921,716,500 (RMB 192,171.65 ten thousand), a year-on-year increase of 3.57%, with proprietary (including imported) pharmaceuticals achieving operating revenue of RMB 1,768,848,900 (RMB 176,884.89 ten thousand), a year-on-year increase of 7.20%[48] - Combined sales revenue of the two innovative drugs, Yilishu® and Yinikang®, increased by 169.57% year-on-year, showing an accelerating volume trend[48] Integrating Dispersed Resources, Launching Global BD Center The company established a Global BD Center to coordinate product transactions, cross-border negotiations, alliance management, and ecosystem building, strengthening external collaborations; during the reporting period, it signed multiple cooperation agreements in Europe, Malaysia, India, and with Bayer China, and licensed oxytocin nasal spray commercialization in Russia - The company established a Global BD Center, responsible for transaction execution and cross-border negotiations, alliance management and ecosystem building, internationalization, and regional market expansion for products across various business units[50] - On the inbound side, cooperation agreements were signed with Phar OS (Europe), Novugen (Malaysia), and Mankind (India), and an exclusive market promotion right for Bayer's Xofigo® and Nexavar® in mainland China was secured with Bayer China[51] - On the outbound side, a cooperation agreement was signed with Sygardis Rus, LLC (Russia), authorizing them to commercialize oxytocin nasal spray in the Russian market[51] Promoting High-Quality R&D and Production, Supporting Company Transformation and Upgrading The small molecule (traditional Chinese medicine) business unit focuses on high-barrier areas like solid tumors, hematologic tumors, and rare diseases, obtaining four chemical drug registration certificates and submitting two formulation product registration applications; progress was made in traditional Chinese medicine new drug research, and internationalization achieved breakthroughs with Amikacin Sulfate Injection shipped to Italy - Domestic pharmaceutical R&D (chemical drugs) obtained 4 product registration certificates, including Etazocine Hydrobromide Injection, and submitted 2 formulation product registration applications, including Bilastine Oral Solution[52] - The statistical report for the Phase Ib patient study of the Class 1.1 traditional Chinese medicine new drug Duanjin Jiedu Capsule was completed; enrollment and follow-up for the Phase III clinical trial of Compound Yinhua Jiedu Granules for pediatric influenza were completed[53][54] - The ethics approval for the lead unit of the IIT clinical study of Compound Huangdai Tablets for treating advanced recurrent platinum-resistant ovarian cancer patients was obtained, marking a crucial step towards treating ovarian cancer[54] - Breakthrough progress was made in internationalization, with Amikacin Sulfate Injection successfully shipped to the Italian market, and Norepinephrine Bitartrate Injection completing its PIC/S certification on-site inspection[55] Synthetic Biology Sector: Significant Progress in New Product R&D and Construction, B5 Series Products Maintain Leading Edge The synthetic biology business unit increased investment in new product development, with Human Milk Oligosaccharide (HMO) 2'-FL obtaining FDA GRAS certification and 6'-SL obtaining Self-GRAS certification; Vitamin B5 series products maintained market leadership despite industry competition, and construction of the Hangzhou Synthetic Biology Industrial Park Phase I is accelerating - Human Milk Oligosaccharide (HMO) 2'-FL obtained FDA GRAS safety certification, and 6'-SL obtained Self-GRAS certification, with registration efforts in other regions progressing concurrently[56] - Although Vitamin B5 series products were affected by industry competition, leading to declines in average transaction prices and sales volumes, they still maintained a market-leading position[56] - Construction and equipment installation for the four buildings of the Hangzhou Synthetic Biology Industrial Park Phase I project are accelerating[56] Operating Revenue Composition (by Industry) | Industry | Current Period Amount (RMB) | Share of Operating Revenue | Prior Period Amount (RMB) | Share of Operating Revenue | YoY Change | | :--- | :--- | :--- | :--- | :--- | :--- | | Pharmaceutical | 2,253,705,361.70 | 85.53% | 2,167,257,866.51 | 82.34% | 3.99% | | Vitamin | 302,225,793.57 | 11.47% | 375,941,164.06 | 14.28% | -19.61% | | Polymer Materials | 79,178,927.91 | 3.00% | 88,890,752.78 | 3.38% | -10.93% | Operating Revenue Composition (by Product) | Product | Current Period Amount (RMB) | Share of Operating Revenue | Prior Period Amount (RMB) | Share of Operating Revenue | YoY Change | | :--- | :--- | :--- | :--- | :--- | :--- | | Proprietary Pharmaceutical Products (incl. imported) | 1,990,001,955.45 | 75.52% | 1,856,050,098.60 | 70.52% | 7.22% | | Other Pharmaceutical Products | 250,904,572.83 | 9.52% | 242,788,226.46 | 9.22% | 3.34% | | Pharmaceutical Services | 12,798,833.42 | 0.49% | 68,419,541.45 | 2.60% | -81.29% | | Vitamin | 302,225,793.57 | 11.47% | 375,941,164.06 | 14.28% | -19.61% | | Polymer Materials | 79,178,927.91 | 3.00% | 88,890,752.78 | 3.38% | -10.93% | Operating Revenue Composition (by Region) | Region | Current Period Amount (RMB) | Share of Operating Revenue | Prior Period Amount (RMB) | Share of Operating Revenue | YoY Change | | :--- | :--- | :--- | :--- | :--- | :--- | | Domestic | 2,075,408,442.12 | 78.76% | 2,025,625,964.71 | 76.96% | 2.46% | | Overseas | 559,701,641.06 | 21.24% | 606,463,818.64 | 23.04% | -7.71% | Analysis of Non-Core Business The company's non-core business impacted total profit, primarily through investment income (associate losses), fair value changes (foreign exchange derivatives revaluation), asset impairment (inventories and intangible assets), non-operating income (litigation compensation), non-operating expenses (fixed asset disposals), and credit impairment (receivables bad debt provisions), none of which are sustainable Impact of Non-Core Business on Total Profit | Item | Amount (RMB) | Share of Total Profit | Reason for Formation | Sustainable | | :--- | :--- | :--- | :--- | :--- | | Investment Income | -14,370,446.64 | -4.17% | Primarily investment losses recognized from associate losses during the reporting period. | No | | Fair Value Change Gains/Losses | -459,827.92 | -0.13% | Due to revaluation of foreign exchange derivatives at period-end. | No | | Asset Impairment | -11,333,286.25 | -3.29% | Due to impairment losses on inventories and intangible assets recognized during the reporting period. | No | | Non-Operating Income | 2,571,952.61 | 0.75% | Primarily litigation compensation received during the reporting period. | No | | Non-Operating Expenses | 1,193,751.91 | 0.35% | Primarily losses from fixed asset disposals and compensation payments during the reporting period. | No | | Credit Impairment | -23,146,737.30 | -6.72% | Primarily bad debt provisions for receivables recognized based on aging portfolio during the reporting period. | No | | Other Income | 69,741,135.46 | 20.25% | Primarily income-related government grants received during the reporting period. | No | | Asset Disposal Gains | 3,858,234.66 | 1.12% | Primarily net gains from disposal of intangible assets during the reporting period. | No | Analysis of Assets and Liabilities At period-end, total assets were RMB 12.674 billion, up 3.16% from year-end, with construction in progress significantly increasing by 2.43% due to investments in industrial parks and innovation centers; long-term borrowings increased by 0.80%, while non-current liabilities due within one year decreased by 1.48%, and overseas assets constituted 45.67% of net assets Significant Changes in Asset Composition | Item | Current Period-end Amount (RMB) | Share of Total Assets | Prior Year-end Amount (RMB) | Share of Total Assets | Change in Share | Explanation of Significant Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Total Assets | 12,674,139,895.70 | 100% | 12,285,788,088.75 | 100% | 3.16% | | | Construction in Progress | 1,140,989,321.45 | 9.00% | 807,153,241.00 | 6.57% | 2.43% | Due to increased investment in the Vitamin Industrial Park, Gene Recombinant Biopharmaceutical Base Project, and International Innovation Center Project during the reporting period. | | Long-term Borrowings | 747,170,028.46 | 5.90% | 627,163,153.57 | 5.10% | 0.80% | Primarily due to changes in loan structure, new project borrowings, and reclassification to non-current liabilities due within one year during the reporting period. | | Non-current Liabilities Due Within One Year | 389,190,380.76 | 3.07% | 558,892,484.59 | 4.55% | -1.48% | Primarily due to reduced reclassification of long-term borrowings to non-current liabilities due within one year during the reporting period. | - Total overseas assets amounted to RMB 5,745,898,863.19, accounting for 45.67% of the company's net assets, primarily including assets of subsidiaries such as Hong Kong Yifan, Yifan International, and Yiyi Bio[69] - The company's financial assets measured at fair value totaled RMB 85,371,843.49 at period-end, mainly comprising other debt investments and other equity instrument investments; financial liabilities totaled RMB 459,827.92 at period-end, primarily trading financial liabilities (revaluation of foreign exchange derivatives)[71] [Analysis of Investment Status](index=23&type=section