特宝生物(688278) - 2025 Q2 - 季度财报

Section I Definitions This section provides definitions of common terms used in the report, ensuring accurate understanding of company names, subsidiaries, reporting periods, and specialized biopharmaceutical terminology Definitions of Common Terms This chapter defines frequently used terms in the report, including company names, subsidiaries, reporting periods, and specialized biopharmaceutical terms like cytokines, PEGylation, clinical research, Class 1 new biological products, innovative drugs, chronic hepatitis B, PEG-interferon (Peginterferon), and hematopoietic growth factors, to ensure accurate understanding of the report's content - The reporting period is defined as January 1, 2025, to June 30, 2025[11] - Peginterferon (Peginterferon alfa-2b injection) is the company's long-acting interferon product[11] - An innovative drug is defined as a drug with a chemical structure, composition, and pharmacological action different from existing drugs, or one not yet marketed in China or abroad[11] Section II Company Profile and Key Financial Indicators This section provides an overview of the company's basic information, contact details, information disclosure, stock summary, and key financial performance indicators for the reporting period I. Company Basic Information Xiamen Amoytop Biotech Co., Ltd. (Amoytop Biotech) is registered at No. 330 Wengjiao Road, Xinyang Industrial Zone, Haicang District, Xiamen, with Sun Li as its legal representative and www.amoytop.com as its official website - The company's full Chinese name is Xiamen Amoytop Biotech Co., Ltd., abbreviated as Amoytop Biotech[14] - The company's legal representative is Sun Li[14] - The company's registered address has been No. 330 Wengjiao Road, Xinyang Industrial Zone, Haicang District, Xiamen since July 21, 2000[14] II. Contact Persons and Information Yang Yiling and Liu Peiyu serve as the Board Secretary (domestic information disclosure representative) and Securities Affairs Representative, respectively, sharing the same contact address, email (ir@amoytop.com), and phone number (0592-6889118) - The Board Secretary (domestic information disclosure representative) is Yang Yiling, and the Securities Affairs Representative is Liu Peiyu[15] - The contact phone number is 0592-6889118, and the email address is ir@amoytop.com[15] III. Information Disclosure and Document Availability Changes The company designates "Securities Times," "China Securities Journal," and "Shanghai Securities News" for information disclosure, www.sse.com.cn as the official website, and the Board of Directors' Office as the location for semi-annual report availability - The company's information disclosure newspapers include "Securities Times," "China Securities Journal," and "Shanghai Securities News"[16] - The website address for publishing the semi-annual report is **www.sse.com.cn**[16](index=16&type=chunk) - The company's semi-annual report is available at the Company's Board of Directors' Office[16] IV. Company Stock/Depositary Receipt Summary The company's A-shares are listed on the STAR Market of the Shanghai Stock Exchange, with stock abbreviation "Amoytop Biotech" and stock code "688278" - The company's stock type is A-shares, and the listing exchange and board is the STAR Market of the Shanghai Stock Exchange[17] - The stock abbreviation is Amoytop Biotech, and the stock code is 688278[17] VI. Key Accounting Data and Financial Indicators In the first half of 2025, the company's operating revenue increased by 26.96% to 1.51 billion yuan, net profit attributable to parent company increased by 40.60% to 428 million yuan, and net cash flow from operating activities surged by 397.97% to 361 million yuan, driven by core product sales growth and improved operational efficiency 2025 Semi-Annual Key Accounting Data | Indicator | Current Period (Jan-Jun) | Prior Period | Period-on-Period Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 1,510,615,117.77 yuan | 1,189,805,069.91 yuan | 26.96 | | Total Profit | 476,272,103.72 yuan | 365,597,546.98 yuan | 30.27 | | Net Profit Attributable to Listed Company Shareholders | 427,894,111.21 yuan | 304,341,868.43 yuan | 40.60 | | Net Profit Attributable to Listed Company Shareholders After Deducting Non-Recurring Gains and Losses | 431,339,041.81 yuan | 330,063,876.52 yuan | 30.68 | | Net Cash Flow from Operating Activities | 360,545,412.47 yuan | 72,403,455.12 yuan | 397.97 | | Net Assets Attributable to Listed Company Shareholders (Period-End) | 2,755,386,861.85 yuan | 2,553,316,291.75 yuan | 7.91 | | Total Assets (Period-End) | 3,209,367,094.56 yuan | 3,050,414,835.58 yuan | 5.21 | 2025 Semi-Annual Key Financial Indicators | Key Financial Indicator | Current Period (Jan-Jun) | Prior Period | Period-on-Period Change (%) | | :--- | :--- | :--- | :--- | | Basic Earnings Per Share (yuan/share) | 1.05 | 0.75 | 40.00 | | Diluted Earnings Per Share (yuan/share) | 1.05 | 0.75 | 40.00 | | Basic Earnings Per Share After Deducting Non-Recurring Gains and Losses (yuan/share) | 1.06 | 0.81 | 30.86 | | Weighted Average Return on Net Assets (%) | 15.61 | 15.21 | Increased by 0.40 percentage points | | Weighted Average Return on Net Assets After Deducting Non-Recurring Gains and Losses (%) | 15.74 | 16.50 | Decreased by 0.76 percentage points | | R&D Investment as Percentage of Operating Revenue (%) | 13.39 | 11.43 | Increased by 1.96 percentage points | - Operating revenue growth is primarily due to the continuous increase in patients treated with the core product Peginterferon[20] - Net profit attributable to the parent company increased mainly due to steady sales revenue growth and improved operational management quality and efficiency[21] - The significant increase in net cash flow from operating activities is primarily due to a substantial increase in cash received from product sales[21] VIII. Non-Recurring Gains and Losses Items and Amounts During the reporting period, the company's total non-recurring gains and losses amounted to -3.44 million yuan, primarily including non-current asset disposal gains/losses, government grants, fair value changes of financial assets, and other non-operating income/expenses 2025 Semi-Annual Non-Recurring Gains and Losses Items and Amounts | Non-Recurring Gains and Losses Item | Amount (yuan) | | :--- | :--- | | Gains and losses from disposal of non-current assets | -213,130.33 | | Government grants recognized in current profit or loss (excluding those closely related to the company's business and granted in accordance with national policies at a fixed standard) | 6,857,825.66 | | Gains and losses from changes in fair value of financial assets and liabilities, and investment income from disposal of financial assets and liabilities | 2,463,832.42 | | Other non-operating income and expenses apart from the above | -20,650,149.81 | | Less: Income tax impact | -8,096,691.46 | | Total | -3,444,930.60 | IX. Companies with Equity Incentive or Employee Stock Ownership Plans May Choose to Disclose Net Profit After Deducting Share-Based Payment Impact The company disclosed net profit after deducting the impact of share-based payments as 448.34 million yuan, a 47.31% increase year-on-year, which is higher than the net profit growth rate before deducting share-based payments Net Profit After Deducting Share-Based Payment Impact | Key Accounting Data | Current Period (Jan-Jun) | Prior Period | Period-on-Period Change (%) | | :--- | :--- | :--- | :--- | | Net profit after deducting share-based payment impact | 448,337,319.59 yuan | 304,341,868.43 yuan | 47.31 | Section III Management Discussion and Analysis This section discusses the company's industry, main business, operational performance, core competencies, and risk factors during the reporting period, highlighting strategic focus, R&D advancements, and management efficiency I. Industry and Main Business Overview During the Reporting Period As an innovative biopharmaceutical enterprise, the company primarily engages in the R&D, production, and sales of recombinant proteins and their long-acting modified drugs, focusing on immune-related cytokine drugs for liver diseases, oncology, and metabolic diseases, maintaining a leading position in PEGylated protein long-acting drugs - The company's main business is the R&D, production, and sales of recombinant proteins and their long-acting modified drugs, with immune-related cytokine drugs as the primary R&D direction[26] - The company has launched six drugs and one electronic pen injector, including Peginterferon, Yipesheng, Peijin, Terlipressin, Terjin, Tercon, and Yusida[26] - The company's industry is "Biological Product Manufacturing (C2761)" within the pharmaceutical manufacturing sector; global drug expenditure is projected to reach $2.4 trillion by 2029, and China's biopharmaceutical market size is expected to reach 1,149.1 billion yuan by 2030[48][51] (I) Main Business, Key Products, and Their Applications The company focuses on the R&D, production, and sales of recombinant proteins and their long-acting modified drugs, with immune-related cytokine drugs at its core, having launched six drugs including Peginterferon (first-line treatment for liver disease), Yipesheng (long-acting growth hormone), and Peijin (long-acting human granulocyte-stimulating factor), and one smart electronic injection pen, Yusida, covering multiple therapeutic areas - Peginterferon is the world's first Y-shaped 40kD PEG-interferon α-2b injection, a first-line antiviral treatment for chronic hepatitis B, with a new indication for "Essential Thrombocythemia" approved for clinical trials[26][28] - Yipesheng is the company's self-developed once-weekly long-acting growth hormone, suitable for children aged 3 and above with growth hormone deficiency, accompanied by the smart electronic injection pen Yusida[28][29][41] - Peijin is the company's self-developed long-acting human granulocyte-stimulating factor, used to reduce the incidence of febrile neutropenia caused by tumor chemotherapy, with a new indication for "reducing the incidence of preeclampsia" approved for clinical trials, and a pre-filled injection pen packaging launched in June 2025[31][33] - Terlipressin (human granulocyte-macrophage stimulating factor), Terjin (human granulocyte-stimulating factor), and Tercon (human interleukin-11) are the company's mature products in the hematology/oncology field, all included in the National Medical Insurance Catalog[34][37][39] (II) Business Model The company adopts an R&D model combining independent and collaborative development, supported by core technology platforms, while optimizing supply chain management, implementing dynamic production plans, upgrading quality management to GMP standards, and establishing a nationwide marketing network through professional academic promotion and self-operated/authorized commercialization - R&D Model: Clinically-driven, adopting a combination of independent R&D and collaborative development, and has established a comprehensive innovative drug R&D system[43] - Procurement and Production Model: Optimized supply chain management, broadened material supply channels, actively conducted domestic substitution research; implemented dynamic production plans, adhering to lean production concepts; benchmarked against European and American GMP standards, integrating QbD concepts to upgrade quality management; deeply implemented digital and intelligent upgrades[44][45] - Marketing Model: Established a nationwide marketing network and professional team, formulated marketing strategies through market research; highly emphasized professional academic promotion; adopted a combination of self-operated and authorized commercial promotion, with direct sales and distribution[46][47] (III) Industry Development Status The company operates in the pharmaceutical manufacturing industry, within a global drug market experiencing continuous growth, particularly in biologics, with China's biopharmaceutical market projected to reach 1,149.1 billion yuan by 2030, driven by supportive policies for innovation and digital transformation - The company's industry is "Biological Product Manufacturing (C2761)" within the pharmaceutical manufacturing sector[48] - IQVIA predicts global drug expenditure will reach $2.4 trillion by 2029, and Evaluate Pharma predicts global prescription drug sales will reach $1.75 trillion by 2030[48] - Frost & Sullivan predicts China's biopharmaceutical market size will reach 1,149.1 billion yuan by 2030, with a compound annual growth rate of approximately 11.2% from 2025-2030[51] - During the reporting period, the state issued multiple policies, such as "Opinions on Comprehensively Deepening the Reform of Drug and Medical Device Regulation and Promoting High-Quality Development of the Pharmaceutical Industry" and "Implementation Plan for Digital and Intelligent Transformation of the Pharmaceutical Industry (2025-2030)," to support innovative drug development and industrial upgrading[51][52] - The pharmaceutical industry is characterized by high technology, high investment, long cycles, and strict regulation, facing multiple barriers in technology, capital, policy, and talent[53] (IV) Company's Industry Position and Development Trends The company is a leading enterprise in China's PEGylated protein long-acting drug field, with core competitiveness in antiviral, hematology/oncology, and endocrine drugs, with Peginterferon leading the market in chronic hepatitis B clinical cure, and new products like Peijin and Yipesheng strengthening its market position - The company is a leading enterprise in China's PEGylated protein long-acting drug field, having established and built various innovative platforms for protein drug expression, long-acting modification, and industrialization[55] - Peginterferon is the first long-acting interferon product with independent intellectual property rights in China, a first-line antiviral treatment for chronic hepatitis B, and its value in improving clinical cure rates and reducing liver cancer risk is recognized by experts[55][57][58] - Approximately 75 million HBV infected individuals in China, with a relatively low antiviral treatment rate, indicating that the number of treated patients will increase with expanded indications in the future[56] - The company has four listed products in the hematology/oncology drug field (rhG-CSF, YPEG-rhG-CSF, rhGM-CSF, rhIL-11), forming a "short-acting + long-acting" synergistic portfolio, all included in the National Medical Insurance Catalog[61][62] - Yipesheng is the company's self-developed new generation long-acting growth hormone, providing a "safe, effective, and convenient" treatment solution for children with growth hormone deficiency, consolidating the company's leading edge in PEGylated long-acting protein drugs[64] II. Discussion and Analysis of Operations In the first half of 2025, the company focused on immunology and metabolism, achieving robust growth with operating revenue of 1.51 billion yuan (up 26.96%) and net profit attributable to parent company of 428 million yuan (up 40.60%) through increased R&D investment and improved management efficiency, while expanding technology platforms and R&D pipelines - In the first half of 2025, the company's operating revenue was 1.51 billion yuan, a year-on-year increase of 26.96%; net profit attributable to listed company shareholders was 428 million yuan, a year-on-year increase of 40.60%[65] - Net cash flow from operating activities was 361 million yuan, a year-on-year increase of 397.97%[65] - The company focuses on the immunology and metabolism fields, with the core mission of solving clinical disease problems and strengthening product differentiation[64][65] (I) Focusing on Clinical Needs, Continuously Exploring Treatment Solutions for Major Diseases The company continues to focus on chronic hepatitis B clinical cure, conducting multiple research and public welfare projects based on Peginterferon, such as "Everest" and "Strong Shield," to accumulate evidence, enhance recognition of Peginterferon's role in improving cure rates and reducing liver cancer risk, and drive sales and profit growth, while also launching the self-developed long-acting growth hormone Yipesheng - The company continuously focuses on chronic hepatitis B clinical cure, conducting multiple research and public welfare projects such as "Everest," "Oasis," and "Strong Shield" to explore optimal treatment regimens[66] - Research evidence on the core product Peginterferon's role in improving chronic hepatitis B clinical cure rates and significantly reducing liver cancer incidence risk has been further recognized by experts and patients, driving both revenue and profit growth[67] - The self-developed National Class 1 new drug, long-acting growth hormone product Yipesheng (Yipesheng Growth Hormone Injection), was approved for marketing at the end of May 2025, completing the company's product matrix[68] (II) Deploying Innovative Technologies, Expanding Technology Platforms and R&D Pipeline Adhering to a "customer-centric, clinical-need-oriented" innovation philosophy, the company expanded multiple technology platforms, including gene therapy, through the acquisition of certain assets from Jiutian Bio, establishing three core technology platforms for PEGylated recombinant protein modification, protein drug production, and drug screening/optimization, with several R&D projects progressing steadily - The company, through its wholly-owned subsidiary Bosai Gene, acquired certain assets from gene therapy company Jiutian Bio, expanding multiple technology platforms including gene therapy[70] - Three core technology platforms have been established: PEGylated recombinant protein modification, protein drug production, and drug screening and optimization, with expansion into nucleic acid drugs and adeno-associated virus (AAV) gene therapy[70] - Yipesheng Growth Hormone Injection has been approved for marketing; YPEG-EPO is preparing for Phase III clinical trials; Human Interferon α2b Nasal Spray and ACT300 have completed Phase I clinical trials; AK0706 and ACT500 are in Phase I clinical trials; ACT50 and ACT60 projects are undergoing pharmaceutical and preclinical research[85][92][93][94][95] (III) Enhancing Management Efficiency, Driving High-Quality Enterprise Development The company promotes high-quality development by strengthening strategic management, optimizing organizational efficiency, and improving its risk prevention and control system, building a full-process closed-loop management system for strategy, focusing on process construction and digital transformation for organizational efficiency, and deepening company-wide risk and compliance management - At the strategic management level, the company, with the "Lighthouse" project as its抓手, builds and improves a full-process closed-loop management system for strategic planning, decoding, execution, and evaluation[73] - At the organizational efficiency level, the company focuses on process construction and digital transformation, actively promoting digital and intelligent upgrades, and exploring the application of AI in the biopharmaceutical field[73] - At the risk prevention and control level, the company deepens company-wide risk management and compliance management concepts, building a full-chain closed-loop risk management system, with a focus on production safety, information security, and compliant operations[74] III. Analysis of Core Competencies During the Reporting Period The company's core competencies lie in its innovation, organizational strength, product portfolio, and brand influence, driven by continuous R&D investment, advanced technology platforms, efficient management, a competitive product pipeline in key therapeutic areas, and a strong market reputation built over nearly three decades - The company's core competencies include innovation, organizational strength, product portfolio, and brand influence[76][77][78][80] - Innovation: Guided by "clinical value orientation," building an "innovation-driven—resource assurance—achievement transformation" system, possessing three core technology platforms: PEGylated recombinant protein modification, drug screening and optimization, and protein drug production[76] - Product portfolio: In the liver disease field, Peginterferon is the world's first Y-shaped 40kD PEGylated long-acting interferon α-2b injection; in the metabolic disease field, Yipesheng is a new generation long-acting growth hormone; in the oncology field, Peijin has a longer drug half-life and lower drug dosage[79][80] - Brand influence: Nearly three decades of deep cultivation in the biopharmaceutical field, with multiple products widely recognized in clinical applications, earning numerous honors such as "First Prize of Fujian Provincial Science and Technology Progress Award" and "Top 50 Biopharmaceutical Companies in China's Pharmaceutical Market 2024"[80][81][82] (I) Core Competency Analysis The company's core competencies are innovation, organizational strength, product portfolio, and brand influence, with innovation stemming from continuous R&D and three core technology platforms; organizational strength enhanced by process, digitalization, and talent development; product portfolio reflected in differentiated offerings across liver disease, oncology, and metabolic diseases; and brand influence accumulated through years of dedication and numerous accolades - Innovation: Guided by "clinical value orientation," building an "innovation-driven—resource assurance—achievement transformation" system, possessing three core technology platforms: PEGylated recombinant protein modification, drug screening and optimization, and protein drug production[76] - Organizational strength: Focused on process construction, empowered by digitalization, talent supply chain, and incentive mechanisms, to enhance organizational efficiency[77][78] - Product portfolio: Built a core competitive product portfolio in liver disease, oncology, metabolic diseases, etc., such as Peginterferon, Yipesheng, and Peijin[78][79][80] - Brand influence: Nearly three decades of deep cultivation in the biopharmaceutical field, with multiple products widely recognized in clinical applications, and winning numerous honors, enhancing industry influence and market recognition[80][81][82] (III) Core Technologies and R&D Progress The company has established and maintained advanced core technology platforms for PEGylated recombinant protein modification, protein drug production, and drug screening/optimization, focusing on R&D and industrialization of recombinant proteins and their long-acting modified drugs. During the reporting period, Yipesheng Growth Hormone Injection was approved, YPEG-EPO entered Phase III clinical preparation, and R&D investment totaled 202.29 million yuan, a 48.77% increase year-on-year - The company's core technologies include PEGylated recombinant protein modification platform technology, protein drug production platform technology, and drug screening and optimization platform technology, all maintaining advanced levels[83][84][85] - During the reporting period, Yipesheng Growth Hormone Injection has been approved for marketing; YPEG-EPO is preparing for Phase III clinical trials; Human Interferon α2b Nasal Spray and ACT300 have completed Phase I clinical trials; AK0706 and ACT500 are in Phase I clinical trials; ACT50 and ACT60 projects are undergoing pharmaceutical and preclinical research[85][92][93][94][95] R&D Investment | Indicator | Current Period (yuan) | Prior Period (yuan) | Change (%) | | :--- | :--- | :--- | :--- | | Expensed R&D Investment | 174,802,367.14 | 113,910,835.09 | 53.46 | | Capitalized R&D Investment | 27,493,627.34 | 22,065,251.23 | 24.60 | | Total R&D Investment | 202,295,994.48 | 135,976,086.32 | 48.77 | | Total R&D Investment as Percentage of Operating Revenue (%) | 13.39 | 11.43 | Increased by 1.96 percentage points | | Capitalization Ratio of R&D Investment (%) | 13.59 | 16.23 | Decreased by 2.64 percentage points | - This period, 2 new invention patent applications, 1 design patent, and 9 trademarks were obtained[86][87] IV. Risk Factors The company faces multiple risks, including core competency risks (technological upgrades, insufficient patent exclusivity, R&D failure, ineffective technology commercialization), operational risks (drug bidding/price reduction, raw material supply, Peginterferon sales growth below expectations, quality control, production safety), financial risks (tax policy changes, increased bad debt from accounts receivable), and industry risks (talent loss, policy changes) - Core competency risks include technological upgrades and iterations, insufficient exclusivity of technology licenses or authorizations, R&D failure, and inability to effectively commercialize technological achievements[97][98] - Operational risks include failure to win drug bids or price reductions, raw material supply risks, risk of Peginterferon sales not growing as expected, drug quality control risks, and production safety risks[100][101] - Financial risks include tax incentive policy changes and increased bad debt from accounts receivable[103] - Industry risks include talent loss risk and industry policy risk[104] - The company will continue to increase R&D investment, improve intellectual property protection, optimize supply chain management, and strengthen product quality control to mitigate risks[99][102][103][104] (I) Core Competency Risks The company faces core competency risks such as rapid technological upgrades, insufficient patent exclusivity, R&D failures, and ineffective technology commercialization, which could lead to reduced product competitiveness and lower-than-expected returns on R&D investment - Life science and drug research fields are rapidly advancing, and revolutionary technologies may emerge to impact existing drugs[97] - Technology patent licenses or authorizations may be invalid or lack exclusivity, failing to effectively protect core technologies and products[97] - New drug R&D is long, capital-intensive, and high-risk, potentially failing due to key technical challenges, clinical study failures, or regulatory changes[98] - R&D achievements may not be timely commercialized or listed products may fail to meet market access thresholds, affecting returns on prior R&D investment[98] (II) Operational Risks The company's operations face risks including failure to win drug centralized procurement bids or price reductions, raw material supply disruptions, Peginterferon sales growth below expectations, improper drug quality control, and production safety incidents, all of which could directly impact sales revenue, production operations, and market position - Failure to win bids or price reductions in centralized drug procurement may lead to decreased sales revenue and net profit[100] - Disruption or quality issues with key raw material supplies may impact business[100] - Sales of core product Peginterferon may not grow continuously if the clinical cure concept for hepatitis B is not widely adopted or if evidence for combination therapies is insufficient[100] - Drug production processes are complex, and quality incidents may occur in raw material procurement, production control, storage, and transportation[101] - Safety production incidents may occur during production due to natural disasters, equipment failures, or operational errors[102] (III) Financial Risks The company faces financial risks from changes in tax incentive policies and increased bad debt from accounts receivable; adjustments to high-tech enterprise tax incentives or failure to maintain certification would impact future performance, while expanding sales may increase accounts receivable and bad debt risk if customer credit deteriorates - The company and its wholly-owned subsidiaries enjoy high-tech enterprise tax incentives, applying a 15% corporate income tax rate; changes in policy or failure to maintain certification will impact performance[103] - As sales scale expands, total accounts receivable may increase, potentially leading to bad debt risk if customer credit deteriorates[103] (IV) Industry Risks The company faces industry risks from talent loss and policy changes; intense competition for talent in the biopharmaceutical sector could lead to technical staff turnover, while reforms and adjustments in healthcare policies may significantly impact market supply/demand, business models, R&D, and drug pricing - Intense talent competition in the biopharmaceutical industry may lead to loss of technical personnel and instability in R&D teams if the company cannot maintain competitiveness[104] - National healthcare system reforms and industry policy adjustments may significantly impact market supply and demand, business models, R&D, and drug prices[104] (V) Macro-Environmental Risks The company's industry is influenced by macroeconomic and pharmaceutical industry policies, with economic cycle fluctuations, industry policy changes, and international political situations (especially US-China trade uncertainties) potentially adversely affecting its operations - The company's industry is comprehensively influenced by macroeconomic policies and pharmaceutical industry policies[105] - Cyclical fluctuations in economic development, changes in industry policies, and international political situations (especially US-China trade uncertainties) may impact the company's production and operations[105] (VI) Other Significant Risks As the company expands, there is a risk of management and internal control issues if operational management, financial management, and internal control systems fail to adapt to the increased scale - Company expansion may lead to management and internal control risks if operational management, financial management, and internal control systems do not adapt in a timely manner[106] V. Key Operating Performance During the Reporting Period In the first half of 2025, the company achieved operating revenue of 1.51 billion yuan (up 26.96%) and net profit attributable to parent company of 428 million yuan (up 40.60%), primarily driven by core product Peginterferon sales growth and improved operational management efficiency, maintaining a stable asset-liability structure and positive investment and subsidiary operations 2025 Semi-Annual Key Operating Data | Indicator | Amount (10,000 yuan) | Year-on-Year Growth (%) | | :--- | :--- | :--- | | Operating Revenue | 151,061.51 | 26.96 | | Net Profit Attributable to Listed Company Shareholders | 42,789.41 | 40.60 | | Net Profit Attributable to Listed Company Shareholders After Deducting Non-Recurring Gains and Losses | 43,133.90 | 30.68 | | Net Assets Attributable to Listed Company Shareholders (Period-End) | 275,538.69 | 7.91 (compared to end of previous year) | - Operating revenue growth is primarily due to the continuous increase in patients treated with the core product Peginterferon[109] - Net cash flow from operating activities increased by 397.97% year-on-year, mainly due to a significant increase in cash received from product sales[109] (I) Main Business Analysis During the reporting period, the company's operating revenue increased by 26.96%, and operating costs increased by 34.27%. Sales, administrative, and R&D expenses all increased, with R&D expenses showing the largest increase at 53.46%. Net cash flow from operating activities significantly grew by 397.97% Analysis of Changes in Financial Statement Items | Item | Current Period (yuan) | Prior Period (yuan) | Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 1,510,615,117.77 | 1,189,805,069.91 | 26.96 | | Operating Cost | 106,031,437.95 | 78,969,264.18 | 34.27 | | Selling Expenses | 598,906,025.59 | 499,725,604.87 | 19.85 | | Administrative Expenses | 140,327,604.73 | 119,448,645.33 | 17.48 | | Financial Expenses | -2,622,877.31 | -1,424,410.08 | Not applicable | | R&D Expenses | 174,802,367.14 | 113,910,835.09 | 53.46 | | Net Cash Flow from Operating Activities | 360,545,412.47 | 72,403,455.12 | 397.97 | | Net Cash Flow from Investing Activities | 53,217,700.92 | -30,207,891.89 | Not applicable | | Net Cash Flow from Financing Activities | -246,782,310.72 | -170,183,806.98 | Not applicable | - Operating revenue growth is primarily due to the continuous increase in patients treated with the core product Peginterferon[109] - R&D expense growth is mainly due to the orderly progress of various R&D projects, increased personnel costs and patent licensing fees, and increased share-based payment expenses[109] (III) Analysis of Assets and Liabilities At the end of the reporting period, the company's monetary funds and notes receivable significantly increased, with total assets growing by 5.21%. Trading financial assets and accounts receivable decreased. Intangible assets substantially increased due to Yipesheng's marketing approval, with a corresponding decrease in development expenditures. On the liability side, short-term borrowings and lease liabilities increased, while taxes payable decreased Changes in Asset and Liability Status | Item Name | Period-End Balance (yuan) | Period-End Balance as % of Total Assets | Prior Period-End Balance (yuan) | Prior Period-End Balance as % of Total Assets | Period-End Amount Change vs. Prior Period-End (%) | | :--- | :--- | :--- | :--- | :--- | :--- | | Monetary Funds | 528,973,264.73 | 16.48 | 371,821,698.43 | 12.19 | 42.27 | | Trading Financial Assets | 150,590,535.23 | 4.69 | 289,963,952.73 | 9.51 | -48.07 | | Notes Receivable | 116,918,551.61 | 3.64 | 37,027,868.80 | 1.21 | 215.76 | | Prepayments | 85,322,794.70 | 2.66 | 38,768,166.49 | 1.27 | 120.08 | | Construction in Progress | 249,974,576.13 | 7.79 | 181,556,607.69 | 5.95 | 37.68 | | Intangible Assets | 294,393,826.70 | 9.17 | 170,848,518.30 | 5.6 | 72.31 | | Development Expenditures | 94,002,988.54 | 2.93 | 208,891,692.66 | 6.85 | -55.00 | | Short-Term Borrowings | 9,904,541.66 | 0.31 | - | - | Not applicable | | Accounts Payable | 87,785,897.27 | 2.74 | 60,140,756.18 | 1.97 | 45.97 | | Taxes Payable | 31,443,277.65 | 0.98 | 69,764,523.07 | 2.29 | -54.93 | | Lease Liabilities | 14,142,678.24 | 0.44 | 3,268,065.07 | 0.11 | 332.75 | - The increase in monetary funds is primarily due to increased cash collection and redemption of matured wealth management products during the reporting period[111] - The significant increase in intangible assets is primarily due to Yipesheng's marketing approval, with its related development expenditures transferred to intangible assets[111] (IV) Investment Status Analysis During the reporting period, the company's investment amounted to 29.99 million yuan, a year-on-year decrease of 40.83%. Key investment activities included increasing the registered capital of Xiamen Zhimou Investment Co., Ltd. and Xiamen Songyi Health Management Co., Ltd., and establishing a new wholly-owned subsidiary, Beijing Anmuduo Kang Internal Medicine Clinic Co., Ltd. Fair value measured financial assets totaled 207 million yuan at period-end Investment Amount During the Reporting Period | Indicator | Amount (yuan) | | :--- | :--- | | Investment amount for the current period | 29,990,000.00 | | Investment amount for the prior period | 50,684,348.29 | | Change (%) | -40.83% | - The company and its subsidiaries made external investments or capital increases, including increasing the registered capital of Xiamen Zhimou Investment Co., Ltd. and Xiamen Songyi Health Management Co., Ltd.[117] - A new wholly-owned subsidiary, Beijing Anmuduo Kang Internal Medicine Clinic Co., Ltd., was established with a registered capital of 9.99 million yuan[117] Financial Assets Measured at Fair Value | Asset Category | Period-End Amount (yuan) | | :--- | :--- | | Other | 207,353,420.16 | | Total | 207,353,420.16 | (VI) Analysis of Major Holding and Participating Companies The company's major holding subsidiaries include Xiamen Bosai Gene Transcription Technology Co., Ltd., Xiamen Zhimou Investment Co., Ltd., and Xiamen Songyi Health Management Co., Ltd., with Bosai Gene showing outstanding performance in medical research and experimentation, achieving a net profit of 93.30 million yuan. Beijing Anmuduo Kang Internal Medicine Clinic Co., Ltd. was newly established during the reporting period Financial Performance of Major Subsidiaries | Company Name | Main Business | Registered Capital (yuan) | Total Assets (yuan) | Net Assets (yuan) | Operating Revenue (yuan) | Net Profit (yuan) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Xiamen Bosai Gene Transcription Technology Co., Ltd. | Medical research and experimentation | 42,000,000.00 | 493,626,908.13 | 481,179,028.82 | 122,177,476.75 | 93,299,482.70 | | Xiamen Zhimou Investment Co., Ltd. | Investment activities with own funds | 40,000,000.00 | 26,895,402.83 | 26,895,402.83 | / | -133,233.21 | | Xiamen Songyi Health Management Co., Ltd. | Health consulting services | 40,000,000.00 | 21,289,436.55 | 21,207,258.33 | / | -559,905.63 | | Beijing Anmuduo Kang Internal Medicine Clinic Co., Ltd. | Medical services; pharmaceutical retail, etc. | 9,990,000.00 | 12,511,315.30 | 2,049,143.73 | / | -950,856.27 | - Beijing Anmuduo Kang Internal Medicine Clinic Co., Ltd. was newly established during the reporting period[123] Section IV Corporate Governance, Environment, and Society This section covers changes in the company's directors, supervisors, senior management, and core technical personnel, profit distribution plans, equity incentive plans, environmental information disclosure, and efforts in poverty alleviation and rural revitalization I. Changes in Directors, Supervisors, Senior Management, and Core Technical Personnel During the reporting period, there were no changes in the company's directors, supervisors, senior management, or core technical personnel - During the reporting period, there were no changes in the company's directors, supervisors, senior management, and core technical personnel[126] II. Profit Distribution or Capital Reserve Conversion Plan The company has not proposed any profit distribution or capital reserve conversion to share capital plan for this semi-annual period - The proposed profit distribution or capital reserve conversion to share capital plan for this semi-annual period is "None"[126] III. Status and Impact of Company Equity Incentive Plans, Employee Stock Ownership Plans, or Other Employee Incentive Measures The company approved and implemented the 2024 Restricted Stock Incentive Plan in August and September 2024, granting restricted shares to incentive recipients, with relevant details disclosed in temporary announcements - On August 21, 2024, the company's Board of Directors and Supervisory Board approved the "Proposal on the Company's <2024 Restricted Stock Incentive Plan (Draft)> and its Summary" and other related proposals[127] - On September 25, 2024, the company's Board of Directors and Supervisory Board approved the "Proposal on Granting Restricted Shares to Incentive Recipients of the 2024 Restricted Stock Incentive Plan for the First Time" and other related proposals[127] IV. Environmental Information of Listed Companies and Their Major Subsidiaries Included in the List of Enterprises Required to Disclose Environmental Information by Law The company is included in the list of enterprises required to disclose environmental information by law, and its environmental information has been disclosed on the Fujian Provincial Department of Ecology and Environment system - The company is included in the list of enterprises required to disclose environmental information by law, with 1 enterprise listed[129] - The environmental information disclosure report can be found on the Fujian Provincial Department of Ecology and Environment - Fujian Provincial Enterprise Environmental Information Disclosure System[129] V. Specific Progress in Consolidating Poverty Alleviation Achievements and Rural Revitalization The company actively fulfills its social responsibilities through various public welfare projects, including educational assistance ("Qizhen Education Micro-Fund") and health assistance (chronic hepatitis B clinical cure projects like "Everest," "Oasis," "Sprout," "Bamboo Shoot"), contributing to poverty alleviation and rural revitalization, with the "Everest" project exceeding its target by achieving 10,240 clinical cures - The company supports the "Qizhen Education Micro-Fund" to carry out educational assistance in the Liangshan Yi Autonomous Prefecture, Sichuan[129] - The company continuously focuses on the diagnosis and treatment of chronic hepatitis B patients, supporting multiple public welfare projects such as "Everest," "Oasis," "Weiming," and "Sprout" for chronic hepatitis B treatment research[129] - As of the end of May 2025, the "China Chronic Hepatitis B Clinical Cure (Everest) Project" has achieved 10,240 clinical cures, with a 33.8% HBsAg clearance rate at 48 weeks for patients treated for over 36 weeks, exceeding the target[129] - The company supports the "Little Bamboo Shoot" Children's Health Care Public Welfare Project, aiming to improve scientific understanding of children's growth and development and provide medical assistance[130] Section V Significant Matters This section details the fulfillment of commitments, absence of illegal guarantees, integrity status of the company and its controlling shareholders, major related-party transactions, significant contracts, and the progress of raised funds utilization I. Fulfillment of Commitments The company's actual controllers, directors, senior management, and shareholders holding 5% or more of shares have strictly fulfilled all commitments related to the initial public offering, including share lock-up, reduction, price stabilization, fraudulent issuance repurchase, immediate return compensation, information disclosure authenticity, avoidance of horizontal competition, and standardization of related-party transactions, with no violations during the reporting period - Actual controllers Yang Ying, Sun Li, and Lan Chun, as well as company directors, senior management, and core technical personnel, committed to share lock-up periods before the initial public offering, with clear provisions on reduction prices, quantities, and information disclosure[132][134][136][138] - The company and actual controllers committed to a price stabilization plan, including company share repurchases, actual controller share increases, and director/senior management share increases[147] - The company and actual controllers committed to initiating share repurchase procedures in case of fraudulent issuance[147] - The company committed to measures such as strengthening raised fund management, actively implementing fundraising projects, strengthening operational efficiency, reducing operating costs, and strengthening investor return mechanisms to compensate for diluted immediate returns[147][148] - Actual controllers committed to avoiding horizontal competition and standardizing related-party transactions[151][152] III. Illegal Guarantees During the reporting period, the company had no illegal guarantees - During the reporting period, the company had no illegal guarantees[154] IX. Explanation of the Integrity Status of the Company, its Controlling Shareholder, and Actual Controller During the Reporting Period During the reporting period, the company and its actual controllers operated with integrity and complied with laws and regulations, with no unfulfilled obligations from effective court judgments or overdue large debts - During the reporting period, the company and its actual controllers operated with integrity and complied with laws and regulations[155] - There were no unfulfilled obligations from effective court judgments or overdue large debts[155] X. Significant Related-Party Transactions During the reporting period, the company had no significant related-party transactions related to daily operations, asset/equity acquisitions or disposals, joint external investments, or related-party creditor-debtor relationships - During the reporting period, the company had no related-party transactions related to daily operations[156] - During the reporting period, the company had no related-party transactions involving asset or equity acquisition or disposal[156] - During the reporting period, the company had no significant related-party transactions involving joint external investments[157] - During the reporting period, the company had no related-party creditor-debtor relationships[157] XI. Significant Contracts and Their Fulfillment The company fulfilled several significant contracts during the reporting period, including R&D cooperation agreements with Aligos Therapeutics, Inc. for nucleic acid technology in hepatitis treatment, an exclusive license agreement with Suzhou Connect Biopharmaceuticals Co., Ltd. for a biologic product, a technology license and development cooperation agreement with Tengji (Xiamen) Biomedical Technology Co., Ltd. for NM6606, and an asset acquisition agreement by wholly-owned subsidiary Bosai Gene with Skyline Therapeutics Limited, all aimed at expanding treatment solutions for hepatitis, non-alcoholic fatty liver disease, and liver fibrosis - The company signed a nucleic acid technology research cooperation and development agreement with Aligos Therapeutics, Inc. for hepatitis treatment, obtaining exclusive option for the China region, and has paid $7 million in advance and research cooperation funds[157][158] - The company signed an exclusive license agreement with Suzhou Connect Biopharmaceuticals Co., Ltd., obtaining permanent exclusive license rights for a biologic product (KN069) in the non-alcoholic fatty liver disease field, and has paid an upfront payment of 20 million yuan[159] - The company signed an NM6606 technology license and development cooperation agreement with Tengji (Xiamen) Biomedical Technology Co., Ltd., obtaining an exclusive license to develop, register, and commercialize a single drug product for liver fat metabolism and liver fibrosis-related diseases in China, and has paid an upfront payment and development milestone payments totaling 20 million yuan[160] - Wholly-owned subsidiary Bosai Gene signed an asset acquisition agreement with Skyline Therapeutics Limited (Jiutian Cayman), with a transaction price including a merger consideration of $15 million and development and sales milestone payments up to $43 million, completed on July 29, 2025[161] XII. Progress of Raised Funds Utilization The company's initial public offering raised a total of 383.16 million yuan, with a net amount of 330.45 million yuan. As of the end of the reporting period, a cumulative 332.41 million yuan has been invested, reaching 100.60% of the planned investment. The funds were primarily used for protein drug production expansion and R&D center construction, new drug R&D projects, and chronic hepatitis B clinical cure research projects, all of which are under construction or R&D, with actual investments exceeding committed amounts Overall Utilization of Raised Funds | Source of Raised Funds | Total Raised Funds (yuan) | Net Raised Funds (yuan) | Total Committed Investment in Prospectus or Offering Document (yuan) | Cumulative Raised Funds Invested as of Period-End (yuan) | Cumulative Raised Funds Investment Progress as of Period-End (%) | | :--- | :--- | :--- | :--- | :--- | :--- | | Initial Public Offering | 383,160,000.00 | 330,446,320.00 | 330,446,320.00 | 332,413,775.64 | 100.60 | Detailed Utilization of Fundraising Projects | Project Name | Committed Investment (yuan) | Cumulative Raised Funds Invested as of Period-End (yuan) | Investment Progress (%) | Date Project Expected to Reach Usable State | | :--- | :--- | :--- | :--- | :--- | | Protein Drug Production Expansion and R&D Center Construction Project | 199,400,920.00 | 205,206,157.72 | 102.91 | December 2025 | | New Drug R&D Project | 101,685,400.00 | 97,457,585.89 | 95.84 | December 2025 | | Chronic Hepatitis B Clinical Cure Research Project | 29,360,000.00 | 29,750,032.03 | 101.33 | December 2025 | - Funds for the "Protein Drug Production Expansion and R&D Center Construction Project" and "Chronic Hepatitis B Clinical Cure Research Project" exceeding committed investment came from interest income and cash management gains generated by raised funds[165] Section VI Share Changes and Shareholder Information This section details the company's share capital changes, shareholder structure, top ten shareholders, actual controllers, and the shareholding status of directors, supervisors, senior management, and core technical personnel I. Share Capital Changes During the reporting period, there were no changes in the company's total ordinary share capital or share capital structure - During the reporting period, there were no changes in the company's total ordinary share capital or share capital structure[169] II. Shareholder Information As of the end of the reporting period, the company had 8,439 ordinary shareholders. Among the top ten shareholders, Yang Ying held 33.94%, Tonghua Dongbao Pharmaceutical Co., Ltd. held 16.03%, and Sun Li held 8.00%. The actual controllers are Yang Ying and Sun Li, with Sun Li and Cai Zhihua being a married couple, and Yang Ying's daughter married to Sun Li's son - As of the end of the reporting period, the total number of ordinary shareholders was 8,439 households[170] Top Ten Shareholders' Shareholdings | Shareholder Name | Period-End Shareholding (shares) | Percentage (%) | Shareholder Nature | | :--- | :--- | :--- | :--- | | Yang Ying | 138,077,266 | 33.94 | Domestic Natural Person | | Tonghua Dongbao Pharmaceutical Co., Ltd. | 65,200,114 | 16.03 | Domestic Non-State-Owned Legal Person | | Sun Li | 32,539,237 | 8.00 | Domestic Natural Person | | Cai Zhihua | 11,428,121 | 2.81 | Domestic Natural Person | | China Merchants Bank Co., Ltd. - Huaxia SSE STAR Market 50 ETF | 8,948,945 | 2.20 | Other | | Zheng Shanxian | 7,505,000 | 1.84 | Domestic Natural Person | | Industrial and Commercial Bank of China Co., Ltd. - E Fund SSE STAR Market 50 ETF | 6,737,726 | 1.66 | Other | | Zuo Zhonghong | 5,073,884 | 1.25 | Domestic Natural Person | | Yang Yinxiang | 3,501,834 | 0.86 | Domestic Natural Person | | Zhang Chao | 3,466,759 | 0.85 | Domestic Natural Person | - The company's actual controllers are Yang Ying and Sun Li; Sun Li and Cai Zhihua are a married couple, and Yang Ying's daughter is married to Sun Li's son[175] - Tonghua Dongbao Pharmaceutical Co., Ltd. transferred some shares via agreement on May 22, 2025, with a shareholding ratio of 10.33% after the transfer[175] III. Information on Directors, Supervisors, Senior Management, and Core Technical Personnel During the reporting period, no changes in shareholdings of the company's directors, supervisors, senior management, and core technical personnel were disclosed, nor were they granted any equity incentives - During the reporting period, no changes in shareholdings for the company's directors, supervisors, senior management, and core technical personnel were disclosed[177] - During the reporting period, the company's directors, supervisors, senior management, and core technical personnel were not granted any equity incentives[177] IV. Changes in Controlling Shareholder or Actual Controller During the reporting period, there were no changes in the company's controlling shareholder or actual controller - During the reporting period, there were no changes in the company's controlling shareholder or actual controller[177] Section VII Bond-Related Information This section confirms the absence of company bonds (including corporate bonds), non-financial enterprise debt financing instruments, and convertible corporate bonds during the reporting period I. Company Bonds (Including Corporate Bonds) and Non-Financial Enterprise Debt Financing Instruments During the reporting period, the company had no company bonds (including corporate bonds) or non-financial enterprise debt financing instruments - During the reporting period, the company had no company bonds (including corporate bonds) or non-financial enterprise debt financing instruments[179] II. Convertible Corporate Bonds During the reporting period, the company had no convertible corporate bonds - During the reporting period, the company had no convertible corporate bonds[179] Section VIII Financial Report This section presents the company's unaudited semi-annual financial statements for 2025, including consolidated and parent company balance sheets, income statements, cash flow statements, and statements of changes in owners' equity, along with detailed notes on accounting policies, tax items, and financial statement items I. Audit Report This semi-annual report has not been audited - This semi-annual report is unaudited[4] II. Financial Statements This chapter 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, operating results, and cash flows at the end of the reporting period - Financial statements include the consolidated balance sheet, parent company balance sheet, consolidated income statement, parent company income statement, consolidated cash flow statement, parent company cash flow statement, consolidated statement of changes in owners' equity, and parent company statement of changes in owners' equity[181][184][188][192][194][198][201][211] Consolidated Balance Sheet As of June 30, 2025, the company's consolidated total assets were 3.21 billion yuan, a 5.21% increase from the end of the previous year; consolidated total liabilities were 454 million yuan, a 9.08% decrease; and owners' equity attributable to the parent company was 2.76 billion yuan, a 7.91% increase Key Consolidated Balance Sheet Data (June 30, 2025) | Item | Period-End Balance (yuan) | Period-Beginning Balance (yuan) | | :--- | :--- | :--- | | Monetary Funds | 528,973,264.73 | 371,821,698.43 | | Trading Financial Assets | 150,590,535.23 | 289,963,952.73 | | Notes Receivable | 116,918,551.61 | 37,027,868.80 | | Accounts Receivable | 635,184,771.86 | 771,496,539.39 | | Inventories | 321,192,181.10 | 263,546,426.51 | | Total Current Assets | 1,869,679,350.53 | 1,827,090,165.08 | | Fixed Assets | 518,267,612.47 | 496,526,291.01 | | Construction in Progress | 249,974,576.13 | 181,556,607.69 | | Intangible Assets | 294,393,826.70 | 170,848,518.30 | | Total Assets | 3,209,367,094.56 | 3,050,414,835.58