康希诺(688185) - 2025 Q2 - 季度财报

Definitions This section provides explanations for key terms used throughout the report, ensuring clarity and consistent understanding of the content Definitions of Common Terms This chapter defines key terms, entities, subsidiaries, and vaccine-related professional terminology used in the report for clear understanding - Defined core entities such as CanSinoBIO, the Group, Controlling Shareholder, and Actual Controller[10] - Listed multiple subsidiary names and their relationships, such as Wanbo Bio, CanSino Pharma, CanSino Canada, etc[10] - Explained the meanings of various vaccine products (e.g., MCV4, PCV13i, Ad5-nCoV) and vaccine technologies (e.g., conjugate vaccines, mRNA vaccines)[10][11] Company Profile and Key Financial Indicators This section provides an overview of the company's basic information and key financial performance metrics Basic Company Information This section introduces the basic information of CanSino Biologics Inc., including its Chinese name, abbreviation, English name, legal representative, registered and office addresses, website, and email address - Company's Chinese name: 康希诺生物股份公司 (CanSino Biologics Inc.), abbreviation: 康希诺 (CanSinoBIO)[14] - Legal Representative: XUEFENG YU[14] - Registered address: West Biopharmaceutical Park, No. 185 South Street, West Zone, Tianjin Economic-Technological Development Area[14] Contact Person and Information This section provides the contact information for the company's Board Secretary and Securities Affairs Representative, including names, addresses, phone numbers, fax numbers, and email addresses - Board Secretary: Cui Jin[15] - Securities Affairs Representative: Sun Chang[15] - Contact number: 022-58213766[15] Brief Introduction to Information Disclosure and Document Storage Location Changes This section specifies the designated newspapers and website for company information disclosure, as well as the location for storing semi-annual reports - Information disclosure newspapers: China Securities Journal, Shanghai Securities News, Securities Times[16] - Website for publication: Shanghai Stock Exchange website (www.sse.com.cn)[16](index=16&type=chunk) Overview of Company Shares/Depositary Receipts This section outlines the company's stock listing status, including the listing exchanges, stock abbreviations, and codes for A-shares and H-shares - A-shares: STAR Market of Shanghai Stock Exchange, abbreviation CanSinoBIO, code 688185[17] - H-shares: Main Board of The Stock Exchange of Hong Kong Limited, abbreviation CanSino Biologics, code 06185[17] Key Accounting Data and Financial Indicators This section discloses the company's key accounting data and financial indicators for the reporting period, explaining the significant narrowing of net loss, revenue growth, improved gross margin, and positive operating cash flow Company Key Accounting Data and Financial Indicators | Indicator | Current Reporting Period (Jan-Jun) | Prior Year Period | Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 382,329,923.55 yuan | 303,431,446.47 yuan | 26.00 | | Net Profit Attributable to Shareholders of Listed Company | -13,485,410.57 yuan | -225,373,885.84 yuan | Not applicable (narrowed by 94.02%) | | Net Cash Flow from Operating Activities | 11,276,684.23 yuan | -214,243,635.34 yuan | Not applicable (turned to net inflow) | | Comprehensive Gross Margin | 82.54% | 69.86% | Increased by 12.68 percentage points | | R&D Investment as % of Operating Revenue | 48.03% | 81.85% | Decreased by 33.82 percentage points | - Net loss narrowed by 94.02% year-on-year, primarily due to increased sales revenue of MenQuadra®, government grants and international special fund support, improved comprehensive gross margin, and cost reduction measures[20] - Net cash flow from operating activities turned from net outflow to net inflow, mainly due to increased domestic sales of quadrivalent meningococcal conjugate vaccine and strengthened accounts receivable collection management[21] - R&D investment decreased by 26.06% year-on-year, mainly due to R&D resource integration, efficiency improvement, and focus on high-potential projects[22] Non-Recurring Gains and Losses Items and Amounts This section lists the non-recurring gains and losses items and their amounts for the reporting period, totaling 72,415,473.31 yuan Non-Recurring Gains and Losses Items and Amounts | Non-Recurring Gains and Losses Item | Amount (yuan) | | :--- | :--- | | Gains or losses from disposal of non-current assets | 84,718.58 | | Government grants recognized in current profit or loss (excluding those closely related to the company's main business and granted in accordance with national policies) | 23,069,569.00 | | Gains or losses from changes in fair value of financial assets and liabilities held by non-financial enterprises, and disposal gains or losses | 19,551,615.24 | | Other non-operating income and expenses apart from the above | -147,907.24 | | Other gains and losses that meet the definition of non-recurring gains and losses | 41,346,921.96 | | Less: Income tax impact | 11,489,444.23 | | Total | 72,415,473.31 | Management Discussion and Analysis This section provides a comprehensive discussion and analysis of the company's operations, financial condition, and future outlook Explanation of the Company's Industry and Main Business During the Reporting Period This section elaborates on the company's main business, listed products, R&D pipeline, operating model, and the overall situation, technical barriers, market position, and future development trends of the vaccine industry (I) Main Business, Products, or Services CanSinoBIO, as an innovative vaccine enterprise, has listed products covering meningitis, pneumonia, COVID-19, and other vaccines, and possesses a rich R&D pipeline, including DTcP and recombinant polio vaccines - Listed products include: MCV4 MenQuadra® (quadrivalent meningococcal conjugate vaccine), PCV13i PNEUMOCON® (13-valent pneumococcal conjugate vaccine), MCV2 Menactra® (meningococcal A and C polysaccharide conjugate vaccine), Ad5-nCoV Convidecia® (recombinant novel coronavirus vaccine), inhaled COVID-19 vaccine Convidecia® Air, and Ad5-EBOV (recombinant Ebola virus disease vaccine)[30][31] - R&D pipeline covers: DTcP for infants and young children, Tdcp for adolescents and adults, PBPV (pneumococcal), recombinant polio vaccine, recombinant zoster vaccine, DTcP-Hib-MCV4 combination vaccine, inhaled tuberculosis booster vaccine, etc., which are in NDA, clinical, or preclinical stages[32] (II) Main Business Model The company primarily adopts an R&D model combining independent research with external cooperation, standardized procurement, production strictly adhering to national access regulations, and a sales model expanding marketing networks through self-built teams and partners - R&D Model: Primarily independent R&D, supplemented by technical cooperation with domestic and international universities and research institutions[33] - Procurement Model: Standardized procurement by the supply chain procurement department based on production plans and bills of materials, with strict approval and system management[34] - Production Model: Adheres to the strict access regulations of the "Vaccine Administration Law of the People's Republic of China," with self-built high-standard facilities compliant with GMP requirements for production[35] - Sales Model: Established a commercial operations center, expanded its self-built commercialization team, and collaborated with professional partners for promotion to increase market penetration[36] (III) Industry Overview The vaccine industry, characterized by high R&D and stringent quality control, shows global growth and increasing Chinese market share, with the company leveraging innovation, policy support, and market expansion for competitive advantage - The vaccine industry has long R&D cycles, high investment, significant risks, and higher safety requirements than therapeutic drugs, with production generally not allowed to be outsourced (except in special circumstances)[37][49][50] - The global human vaccine market (excluding COVID-19 vaccines) grew from $37.2 billion in 2019 to $51.7 billion in 2023, projected to reach $86.2 billion by 2032[39][40] - The Chinese human vaccine market (excluding COVID-19 vaccines) grew from RMB 53.5 billion in 2019 to RMB 120.5 billion in 2023, projected to reach RMB 343.1 billion by 2032[45] - The company holds a competitive advantage in the meningococcal conjugate vaccine market with products like MenQuadra®, while PCV13i PNEUMOCON®'s approval further enriches its product portfolio, and the DTcP vaccine for infants and young children received priority review status[52] - National policies support vaccine innovation, industry consolidation is evident, innovative vaccines are evolving towards multi-component, multi-valent, novel adjuvants, and personalized vaccines, the domestic adult vaccine market is ripe for development, vaccine internationalization extends across the value chain, and digital and intelligent applications hold significant potential[53][54][55][56][57][58] Discussion and Analysis of Operations During the reporting period, the company achieved significant progress in meningococcal vaccine commercialization, 13-valent pneumococcal conjugate vaccine approval, component DTaP vaccine combination advancements, clinical trials for recombinant polio vaccine and inhaled tuberculosis booster vaccine, as well as technological innovation and international cooperation - Meningococcal polysaccharide conjugate vaccines MenQuadra® and Menactra® generated sales revenue of approximately 364 million yuan, a year-on-year increase of 38.43%; the applicable age range for MCV4 is proposed to be expanded to 6 years old[60] - The 13-valent pneumococcal conjugate vaccine PCV13i PNEUMOCON® obtained its drug registration certificate, utilizing dual-carrier technology, positioned as a high-end self-paid vaccine, expected to enrich the product portfolio and enhance marketing efficiency[61][62] - Progress in component DTaP vaccine product portfolio: DTcP for infants and young children received priority review status; Tdcp for adolescents and adults completed Phase II/III clinical trial site work; DTcP-Hib-MCV4 combination vaccine received clinical trial approval; adsorbed tetanus vaccine was accepted for review, and an exclusive commercialization cooperation was reached with Grand Pharma Life Sciences[63][64] - Recombinant polio vaccine initiated Phase I/II clinical trials in Indonesia and received funding from the Gates Foundation[65] - Inhaled tuberculosis booster vaccine received clinical trial approval in Indonesia, with potential to stimulate pulmonary immune response[66] - The project "Key Technologies and Industrialization of Polysaccharide-Protein Conjugate Vaccines" won the First Prize of Tianjin Science and Technology Progress Award; the mRNA technology platform developed a novel ionizable sterol lipid (ISL) three-component lipid nanoparticle (ISL-3C-LNP) delivery system[67] - Advanced the registration and commercialization of quadrivalent meningococcal conjugate vaccine in Southeast Asia, the Middle East, North Africa, and South America, with MCV4 already obtaining registration certificate in Indonesia[68] Analysis of Core Competencies During the Reporting Period CanSinoBIO's core competencies are reflected in its mature technology platforms and R&D system, innovative vaccine product pipeline covering a vast market, international standard vaccine production capacity and quality management system, scaled and comprehensive commercialization team, proactive internationalization strategy, and experienced scientists and management team - Possesses five major technology platforms: viral vector, synthetic vaccine, protein structure design and VLP assembly, mRNA, and formulation and administration, providing fundamental technical support for R&D pipeline expansion[69] - An innovative and rich vaccine product pipeline will cover a vast domestic market, benefiting from increased demand for non-EPI vaccines driven by an aging population and rising consumption levels[70][71] - Owns international standard vaccine production capacity and quality management system, with facility design, construction, and operation all adhering to international standards, ensuring vaccine quality and safety[72] - Has a scaled and comprehensively covered self-built and promotion team, enhancing product penetration and market share through academic and marketing activities[73] - Actively expands international markets and enhances international competitiveness by accumulating experience through overseas commercialization and cooperation of COVID-19 vaccines[74] - Founders and core technical personnel have an average of over 25 years of experience in the biopharmaceutical industry, and the management team possesses internationally leading product R&D, production, and commercialization experience[75] (III) Core Technologies and R&D Progress The company has built five advanced technology platforms: viral vector, synthetic vaccine, protein structure design and VLP assembly, mRNA, and formulation and administration. During the reporting period, it obtained multiple invention patents and continuously advanced R&D projects, though total R&D investment decreased by 26.06% year-on-year, mainly due to improved R&D efficiency and resource focus 1. Core Technologies, Their Advanced Nature, and Changes During the Reporting Period CanSinoBIO has established five advanced technology platforms: viral vector, synthetic vaccine, protein structure design and VLP assembly, mRNA, and formulation and administration. These platforms synergistically provide a solid foundation for the company's vaccine R&D and allow for flexible adjustments to R&D strategies based on market changes - Viral Vector Vaccine Technology: Established mature viral vector packaging, high cell density production process technology, and analytical characterization techniques[76][77] - Synthetic Vaccine Technology: Possesses polysaccharide antigen production, carrier protein production, and polysaccharide-protein conjugation technologies, which can effectively reduce epitope inhibition caused by carriers[78] - Protein Structure Design and VLP Assembly Technology: Capable of predicting advanced protein structures from DNA sequences and has developed expression technology for multi-subunit VLPs[79] - mRNA Technology: Developed a universal mRNA process, characterized by short R&D cycles and easy scale-up[80] - Formulation and Administration Technology: Committed to vaccine formulation research, products are free of phenol and preservatives, and has established formulation process, novel adjuvant, and delivery system development technologies[81] 2. R&D Achievements During the Reporting Period During the reporting period, the company obtained 2 invention patent authorizations in China, including an atomization cup and its application in atomized inhalation drug delivery, and an ionizable lipid for nucleic acid delivery, its LNP composition, and vaccine - Obtained 2 invention patents during the reporting period, with a cumulative total of 38 invention patents[82] - Patent name: An atomization cup and its application in atomized inhalation drug delivery (ZL202211532751.9)[81] - Patent name: An ionizable lipid for nucleic acid delivery, its LNP composition, and vaccine (ZL202310045868.2)[81] 3. R&D Investment Table Total R&D investment during the reporting period was 183,616,878.59 yuan, a year-on-year decrease of 26.06%, mainly due to R&D resource integration, efficiency improvement, and the acceptance of the capitalized R&D project PCV13i R&D Investment | Indicator | Current Period (Jan-Jun) | Prior Year Period | Change (%) | | :--- | :--- | :--- | :--- | | Expensed R&D Investment | 147,795,239.10 yuan | 185,902,946.70 yuan | -20.50 | | Capitalized R&D Investment | 35,821,639.49 yuan | 62,440,825.30 yuan | -42.63 | | Total R&D Investment | 183,616,878.59 yuan | 248,343,772.00 yuan | -26.06 | | Total R&D Investment as % of Operating Revenue | 48.03% | 81.85% | Decreased by 33.82 percentage points | - R&D investment decreased mainly due to: R&D resource integration, efficiency improvement, focusing on high-potential projects; PCV13i project received NDA approval, leading to reduced R&D investment related to Phase III clinical trials[84] 4. R&D Project Status The company's R&D projects cover multiple vaccine varieties including DTaP, polio, pneumonia, tetanus, Haemophilus influenzae, meningococcal, tuberculosis, and zoster, with several projects having entered clinical trial or NDA stages, representing significant total and cumulative investment - DTcP for infants and young children: Drug registration application accepted and officially granted priority review status[87] - Recombinant polio vaccine: Phase I/II clinical trials initiated in Indonesia, and domestic drug clinical trial approval notice obtained[87] - PCV13i: New drug application approval granted by the National Medical Products Administration[87] - DTcP-Hib-MCV4 combination vaccine: Drug clinical trial approval notice obtained[87] - Total R&D project investment: 163,435,352.47 yuan for the current period, cumulative investment of 1,947,401,037.41 yuan[87] 5. R&D Personnel Information At period-end, the company had 208 R&D personnel (18.65% of total), with increased average compensation and a workforce primarily holding master's and bachelor's degrees R&D Personnel Basic Information | Indicator | Current Period | Prior Year Period | | :--- | :--- | :--- | | Number of company R&D personnel (persons) | 208 | 306 | | % of R&D personnel in total company headcount | 18.65 | 26.63 | | Average R&D personnel compensation (ten thousand yuan) | 18.21 | 13.87 | - R&D personnel education composition: Master's degrees account for 53.37%, bachelor's degrees for 35.10%[89] Risk Factors The company faces financial risks such as operating losses, core competencies being replaced by new technologies, intensified market competition, exchange rate fluctuations, and asset impairment, as well as industry and macroeconomic risks from changes in vaccine industry regulatory policies and unfavorable macroeconomic environments - Risk of operating losses: Despite narrowed losses, R&D investment and commercialization still require substantial funds; if projects or sales fall short of expectations, the company may still incur operating losses[90] - Risk to core competencies: The emergence of revolutionary new technologies or technological iterations in the vaccine field, if not promptly addressed by the company, could lead to product replacement and impact market competitiveness[91] - Operating risk: The vaccine industry is highly competitive, and the company faces competitive pressure from large multinational corporations and domestic vaccine enterprises[92] - Financial risks: Exchange rate fluctuations may lead to exchange losses; changes in market environment may lead to asset impairment[93][94] - Industry risk: The vaccine industry is strictly regulated by national and local regulatory authorities, and changes in the policy environment may adversely affect the company's operations[95] - Macroeconomic environment risk: A slowdown in the overall growth of the biopharmaceutical industry or negative public events may lead to slower market demand growth[96] Key Operating Performance During the Reporting Period During the reporting period, operating revenue grew by 26.00%, net loss narrowed by 94.02% due to MenQuadra® sales and improved margins, and the asset-liability structure optimized with reduced short-term borrowings (I) Main Business Analysis Operating revenue increased by 26.00%, primarily driven by rising sales revenue of MenQuadra®. Operating costs decreased by 27.01%, and comprehensive gross margin improved to 82.54%. Selling expenses increased by 39.00%, comparable to the revenue growth rate. Administrative and R&D expenses both decreased, while financial expenses fluctuated due to exchange losses and decreased interest income. Operating cash flow turned into a net inflow - Operating revenue: 382,329,923.55 yuan, a year-on-year increase of 26.00%, mainly due to the continuous increase in MenQuadra® market share[98] - Operating cost: 66,747,025.13 yuan, a year-on-year decrease of 27.01%; comprehensive gross margin was 82.54%, a year-on-year increase of 12.68 percentage points[99] - Selling expenses: 156,342,581.06 yuan, a year-on-year increase of 39.00%, comparable to the growth rate of meningococcal vaccine product sales revenue[99] - Administrative expenses: 72,329,276.04 yuan, a year-on-year decrease of 13.39%, mainly due to continuous optimization of resource allocation and implementation of cost reduction and efficiency improvement measures[99] - Financial expenses: 17,095,365.87 yuan, compared to -21,269,758.75 yuan in the prior year period, mainly due to exchange losses from foreign currency exchange rate fluctuations and a year-on-year decrease in deposit interest income[100] - Net cash flow from operating activities: 11,276,684.23 yuan, turning from a net outflow in the prior year period to a net inflow in the current reporting period[101] (III) Analysis of Assets and Liabilities At period-end, total assets and net assets slightly decreased; non-current assets due within one year and intangible assets increased, while short-term borrowings decreased and contract liabilities and non-current liabilities due within one year increased - Total assets: 7,705,027,166.59 yuan, a decrease of 3.18% from the beginning of the year[21] - Net assets attributable to shareholders of the listed company: 4,903,403,666.21 yuan, a decrease of 0.13% from the beginning of the year[21] - Non-current assets due within one year: 321,257,500.00 yuan, a year-on-year increase of 100%, mainly due to reclassification of time deposits[103] - Intangible assets: 198,286,530.23 yuan, a year-on-year increase of 71.70%, mainly due to the transfer of related development expenditures after the PCV13i project obtained NDA approval[103] - Short-term borrowings: 81,424,070.22 yuan, a year-on-year decrease of 78.42%, mainly due to increased sales revenue and collection amounts supplementing operating funds, reducing loan scale[103] - Contract liabilities: 45,037,740.75 yuan, a year-on-year increase of 206.64%, mainly due to increased advance receipts for technical services and technology transfer fees[104] - Non-current liabilities due within one year: 933,693,566.41 yuan, a year-on-year increase of 75.73%, mainly due to optimizing financing structure and increasing the proportion of long-term borrowings held[104] - Major asset restrictions: Fixed assets of 154,856,495.58 yuan pledged as collateral for long-term borrowings, other monetary funds of 29,958,522.62 yuan for foreign exchange management business and letter of guarantee deposits[106] (IV) Analysis of Investment Status During the reporting period, the company had no significant equity investments but disclosed information on financial assets measured at fair value (including trading financial assets, other non-current financial assets, and derivative financial assets), derivative investments, and private equity fund investments Financial Assets Measured at Fair Value | Asset Category | Period-End Amount (yuan) | | :--- | :--- | | Trading financial assets | 1,339,525,105.79 | | Other non-current financial assets | 148,940,936.11 | | Derivative financial assets | 1,400,676.57 | | Total | 1,489,866,718.47 | - Derivative investments for hedging purposes had a period-end book value of 761,137.13 yuan, with actual realized gains of 490,609.40 yuan during the reporting period[111] - Investment in Yuanxi Haihe (Tianjin) Biomedical Industry Investment Fund Partnership (Limited Partnership) was 90,000,000.00 yuan, with an equity ratio of 28.40%, accounted for as other non-current financial assets[115] (VI) Analysis of Major Holding and Participating Companies This section lists the basic information, main business, and financial data of major subsidiaries including CanSinoBIO Shanghai, CanSino Biologics Technology, CanSino Biologics R&D, Bio-Mab Venture, CanSinoBIO Hong Kong, and CanSino International Life Science Major Subsidiary Financial Overview | Company Name | Registered Capital (yuan) | Total Assets (yuan) | Net Profit (yuan) | | :--- | :--- | :--- | :--- | | CanSinoBIO Shanghai | 850,000,000.00 | 864,523,507.81 | 46,698.91 | | CanSino Biologics Technology | 750,000,000.00 | 940,381,876.23 | -38,183,071.09 | | CanSinoBIO Hong Kong | 1 HKD | 66,470,446.40 | 3,189,863.44 | Corporate Governance, Environment, and Society This section covers the company's governance structure, environmental responsibilities, and social contributions Profit Distribution or Capital Reserve Conversion Plan During the reporting period, the company had no profit distribution plan or capital reserve conversion to share capital plan - Whether to distribute or convert: No[121] Status and Impact of Company Equity Incentive Plans, Employee Stock Ownership Plans, or Other Employee Incentive Measures The second lock-up period of the company's 2023 A-share employee stock ownership plan expired on May 8, 2025, with some shares sold through centralized bidding, and 114,685 shares remaining - The second lock-up period of the 2023 A-share employee stock ownership plan expired on May 8, 2025[123] - As of the end of the reporting period, the remaining number of shares held under this employee stock ownership plan was 114,685 shares[123] Environmental Information of Listed Companies and Their Major Subsidiaries Included in the List of Enterprises Required to Disclose Environmental Information by Law The company and its subsidiary CanSino Biologics (Shanghai) Co., Ltd. are included in the list of enterprises required to disclose environmental information by law, with inquiry indexes provided - Number of enterprises included in the list of enterprises required to disclose environmental information by law: 2[124] - Enterprise names: CanSino Biologics Inc., CanSino Biologics (Shanghai) Co., Ltd[124] Significant Matters This section details important events and issues affecting the company, including commitments, litigation, related party transactions, and use of raised funds Fulfillment of Commitments The company's actual controller, shareholders, related parties, and the company itself have made multiple commitments regarding share lock-up, fraudulent issuance, truthfulness of the prospectus, dilution of immediate returns, and restrictive measures for non-fulfillment, all of which were strictly adhered to during the reporting period - Controlling shareholder and actual controller committed not to transfer shares within 36 months from the date of A-share listing[127] - The company committed that the prospectus contains no false records, misleading statements, or major omissions, and assumes individual and joint legal liabilities[144] - The company committed to increase R&D efforts, strictly control product quality, accelerate commercialization, expedite the use of raised funds, and improve profit distribution policies to mitigate the dilution of immediate returns[149][150] - All committing parties pledged to bear corresponding legal responsibilities for any breach of commitments and to implement restrictive measures such as public explanation, apology, cessation of salary/cash dividends, and non-transferability of shares[153][154][155] Significant Litigation and Arbitration Matters In March 2024, Belcher filed a lawsuit in Brazil seeking approximately 219 million yuan in damages, which the company is actively defending, believing the probability of winning is low - Plaintiff: Belcher Farmaceutica Ltda. (Belcher)[157] - Claim: Payment of lost profits and moral damages totaling approximately 167 million Brazilian Reals (approximately 219 million yuan)[157] - Company's response: Engaged a professional legal team to actively respond; based on legal opinion, the company has a strong defense position, but the probability of winning is low, and no provision for contingent liabilities has been recognized[160] Explanation of the Integrity Status of the Company, its Controlling Shareholder, and Actual Controller During the Reporting Period During the reporting period, the company, its controlling shareholder, and actual controller had no unfulfilled effective court judgments or large overdue debts, indicating a good integrity status - During the reporting period, the company, its controlling shareholder, and actual controller maintained a good integrity status, with no unfulfilled effective court judgments or overdue debts[158] Significant Related Party Transactions During the reporting period, the company had related party creditor-debtor transactions with its associate, Shanghai Pharma CanSino, providing a loan of 36,320,100.00 yuan, which has been fully impaired - Related party creditor-debtor: The company provided a loan of 36,320,100.00 yuan to Shanghai Pharma CanSino[162] - Impact: The recoverability of the aforementioned loan is uncertain, and the Group has fully provided for impairment[162] - The product transfer and technology license agreement proposed to be signed between the company and Shanghai Pharma CanSino has been terminated[163] Significant Contracts and Their Performance The company has multiple property lease contracts and provided a joint liability guarantee of 790 million yuan to its wholly-owned subsidiary CanSino Biologics Technology, representing 9.45% of the company's net assets - The company has multiple property lease contracts, with lease terms ranging from 2 to 9 years[168] - The company provided a joint liability guarantee of 790 million yuan to its wholly-owned subsidiary CanSino Biologics Technology, with a term of 10 years[169] - The company's total guarantee amount accounts for 9.45% of its net assets[169] Explanation of Progress in Use of Raised Funds The company's IPO raised 4.98 billion yuan net, with 94.83% cumulatively invested by period-end; some projects are delayed, and idle funds are used for cash management (I) Overall Use of Raised Funds The net amount of raised funds from the initial public offering was 4,979,465,107.65 yuan. As of the end of the reporting period, a cumulative total of 4,721,902,890.43 yuan has been invested, representing an investment progress of 94.83% - Total raised funds from initial public offering: 5,200,808,000.00 yuan[171] - Net raised funds: 4,979,465,107.65 yuan[171] - Cumulative invested amount as of the end of the reporting period: 4,721,902,890.43 yuan[171] - Investment progress: 94.83%[171] (II) Details of Raised Fund Investment Projects Raised fund investment projects such as the Innovative Vaccine Industrial Park Project and R&D Projects for Vaccines Under Development are progressing, with some projects delayed due to construction urgency and slower R&D progress. The PCV13i project has received new drug application approval, and related development expenditures have been transferred to intangible assets - Innovative Vaccine Industrial Park Project budget: 2,244,695,000.00 yuan, with a cumulative investment of 866,444,371.98 yuan as of the end of the reporting period, representing an investment progress of 78.77%, expected to complete preliminary construction by the end of 2026[173] - R&D Projects for Vaccines Under Development budget: 150,000,000.00 yuan, with a cumulative investment of 125,993,410.80 yuan as of the end of the reporting period, representing an investment progress of 84.00%, with some projects delayed until completion of investment by December 2025[173][174][175] - PCV13i project has received new drug application approval from the National Medical Products Administration, and related development expenditures have been transferred to intangible assets[173] (III) Other Circumstances Regarding the Use of Raised Funds During the Reporting Period The company uses temporarily idle raised funds, up to a maximum of 550 million yuan, for cash management, investing in highly secure, liquid, and principal-guaranteed investment products - The company uses a maximum of 550 million yuan of temporarily idle raised funds for cash management[179] - The cash management balance at the end of the reporting period was 294.5 million yuan[179] Share Changes and Shareholder Information This section provides details on changes in the company's share capital and information about its shareholders 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[182] Shareholder Information As of the end of the reporting period, the total number of ordinary shareholders was 17,486. Among the top ten shareholders, HKSCC NOMINEES LIMITED held the highest proportion at 39.55%, with Tao Zhu, Xuefeng Yu, and others as major shareholders - Total number of ordinary shareholders as of the end of the reporting period: 17,486 households[183] Top Ten Shareholders' Shareholding | Shareholder Name | Period-End Shareholding (shares) | Proportion (%) | Shareholder Nature | | :--- | :--- | :--- | :--- | | HKSCC NOMINEES LIMITED | 97,857,297 | 39.55 | Overseas Legal Person | | Tao Zhu | 17,984,200 | 7.27 | Domestic Natural Person | | XUEFENG YU | 17,974,200 | 7.26 | Overseas Natural Person | | DONGXU QIU | 17,114,200 | 6.92 | Overseas Natural Person | | HELEN HUIHUA MAO | 9,206,828 | 3.72 | Overseas Natural Person | | CHAMPDEN | 6,000,000 | 2.42 | Overseas Legal Person | | Shanghai Qianxi Yi | 3,474,600 | 1.40 | Domestic Non-State-Owned Legal Person | | Shanghai Qianxi Rui | 3,299,475 | 1.33 | Domestic Non-State-Owned Legal Person | | Advanced Manufacturing Industry Investment Fund (Limited Partnership) | 1,472,195 | 0.59 | Domestic Non-State-Owned Legal Person | | Sun Ge | 1,403,742 | 0.57 | Domestic Natural Person | - XUEFENG YU, Tao Zhu, DONGXU QIU, HELEN HUIHUA MAO, and CHAMPDEN are parties acting in concert[186] Bond-Related Information This section provides information regarding the company's bonds and other debt financing instruments Corporate Bonds (Including Enterprise Bonds) and Non-Financial Enterprise Debt Financing Instruments During the reporting period, the company had no corporate bonds or non-financial enterprise debt financing instruments - During the reporting period, the company had no corporate bonds or non-financial enterprise debt financing instruments[190] 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[190] Financial Report This section presents the company's financial statements and related notes, offering a detailed view of its financial performance and position Financial Statements This section presents the consolidated and parent company financial statements for H1 2025, including balance sheets, income statements, cash flow statements, and statements of changes in equity, detailing financial position and performance - As of June 30, 2025, consolidated total assets were 7,705,027,166.59 yuan, and total equity attributable to parent company owners was 4,903,403,666.21 yuan[195] - For the first half of 2025, consolidated total operating revenue was 382,329,923.55 yuan, and net profit attributable to parent company shareholders was -13,485,410.57 yuan[202][204] - For the first half of 2025, consolidated net cash flow from operating activities was 11,276,684.23 yuan[209] - For the first half of 2025, total equity attributable to parent company owners decreased by 6,467,987.52 yuan[217] Company Overview CanSino Biologics Inc. was established in 2009, converted to a joint-stock company in 2017, and listed on the Hong Kong Stock Exchange in 2019 and the Shanghai STAR Market in 2020, primarily engaged in the R&D, production, and commercialization of human vaccine products - The company was established as Tianjin CanSino Biologics Inc. on January 13, 2009, and converted into a joint-stock company on February 13, 2017[225] - The company was listed on the Main Board of The Stock Exchange of Hong Kong Limited on March 28, 2019, and on the STAR Market of the Shanghai Stock Exchange on August 13, 2020[225] - The company and its subsidiaries are primarily engaged in the R&D, production, and commercialization of human vaccine products[225] Basis of Preparation of Financial Statements The financial statements are prepared on a going concern basis, adhering to the Accounting Standards for Business Enterprises issued by the Ministry of Finance and relevant regulations, and the company's ability to continue as a going concern for the next 12 months has been assessed - The company's financial statements are prepared on a going concern basis[226] - The Group implements the Accounting Standards for Business Enterprises and relevant regulations issued by the Ministry of Finance[226] - The Group assessed its ability to continue as a going concern for the 12 months from June 30, 2025, and found no significant doubts regarding its going concern ability[227] Significant Accounting Policies and Estimates This section details the company's accounting policies and estimates for financial instruments, inventories, long-term equity investments, fixed assets, construction in progress, intangible assets, impairment of long-term assets, revenue recognition, government grants, deferred income tax assets/liabilities, and leases, also explaining key assumptions and uncertainties - Financial instruments: Classified and measured based on the business model for managing financial assets and contractual cash flow characteristics, with loss provisions recognized based on expected credit losses[243][250] - Inventories: Measured at the lower of cost and net realizable value, with impairment provisions considering factors such as inventory shelf life and future demand forecasts for vaccine products[278][283] - Intangible assets: Include land use rights, non-patent technologies, software, etc., amortized over their estimated useful lives; internal research and development expenditures are capitalized when specific conditions are met[301][308] - Revenue recognition: Revenue is recognized when performance obligations in the contract are satisfied, i.e., when the customer obtains control of the related goods or services, at the transaction price allocated to that performance obligation[326][327] - Key assumptions and uncertainties in accounting estimates: Inventory impairment provisions, fair value of equity instrument investments, deferred income tax, return liabilities, impairment of long-term assets, etc., involve significant management judgment and estimation[344][345][347][348][349] Taxation This section discloses the company's main tax categories and rates, including value-added tax, enterprise income tax, and urban maintenance and construction tax. The company and some subsidiaries enjoy high-tech enterprise income tax preferential policies, and export goods are subject to "exemption, offset, and refund" tax policies - Main tax categories: Value-added tax (applicable rates of 13%, 6%, and 3% based on sales amount), enterprise income tax (based on taxable income), urban maintenance and construction tax (7% of actual paid turnover tax), education surcharge (3% of actual paid turnover tax), local education surcharge (2% of actual paid turnover tax)[351] - Enterprise income tax preferences: The company and CanSino Biologics Technology apply an enterprise income tax rate of 15%; Bio-Mab Venture qualifies as a small-profit enterprise and applies a rate of 20%[352][353] - Value-added tax policy: Export business applies a 13% tax refund rate; domestic sales of Convidecia®, Menactra®, and MenQuadra® are subject to simplified collection, applying a 3% collection rate[354][355] Notes to Consolidated Financial Statement Items This section provides detailed notes on the period-end and beginning balances, and current period changes for consolidated financial statement items including assets, liabilities, equity, income, and expenses - Monetary funds period-end balance: 1,612,398,072.27 yuan, of which restricted funds are 29,958,522.62 yuan[360] - Trading financial assets period-end balance: 1,339,525,105.79 yuan, primarily structured deposits and wealth management products[358] - Accounts receivable period-end book value: 660,325,856.11 yuan, with bad debt provision of 44,228,016.61 yuan[364] - Inventories period-end book value: 339,753,884.05 yuan, with inventory impairment provision of 407,181,868.69 yuan[391] - Non-current assets due within one year period-end balance: 321,257,500.00 yuan, primarily time deposits[395] - Intangible assets period-end book value: 198,286,530.23 yuan, with an increase of 89,138,104.27 yuan from internal R&D during the current period[426] - Short-term borrowings period-end balance: 81,424,070.22 yuan, a significant decrease from the beginning of the period[445] - Contract liabilities period-end balance: 45,037,740.75 yuan, a significant increase from the beginning of the period[452] - Long-term borrowings period-end balance: 864,431,404.93 yuan, with some borrowings pledged as collateral for fixed assets[467][472] - Current period operating revenue: 382,329,923.55 yuan, operating cost: 66,747,025.13 yuan[497] - Current period other income: 69,656,509.27 yuan, primarily government grants and Gates Foundation grants[511] - Current period investment income: 16,542,248.28 yuan, compared to -64,392,982.86 yuan in the prior period, mainly due to wealth management product income and investment losses from associates[510][512] - Net cash flow from operating activities: 11,276,684.23 yuan[533] Research and Development Expenses Total R&D investment was 183.62 million yuan, with 147.80 million expensed and 35.82 million capitalized; several projects are in Phase III or NDA stages and have begun capitalization R&D Expenditure | Item | Current Period Amount (yuan) | | :--- | :--- | | Total R&D Investment | 183,616,878.59 | | Of which: Expensed R&D Expenditure | 147,795,239.10 | | Capitalized R&D Expenditure | 35,821,639.49 | - Important capitalized R&D projects include DTcP for infants and young children, MCV4 age expansion research, MCV4 overseas, adsorbed tetanus vaccine, Tdcp for adolescents and adults, etc., all of which have entered Phase III clinical trials or NDA stages and have begun capitalization[546] Changes in Consolidation Scope During the current reporting period, the wholly-owned subsidiary CanSino Pharma completed its deregistration on May 15, 2025, which did not have a significant impact on the financial statements - The company's wholly-owned subsidiary CanSino Pharma completed its deregistration on May 15, 2025[549] - This matter did not have a significant impact on the financial statements[549] Interests in Other Entities This section details the company's equity interests in various subsidiaries and its investment in the associate Tianjin Qianxi - The company owns multiple wholly-owned subsidiaries including Wanbo Bio, CanSino Canada, CanSino Singapore, CanSino Hong Kong, CanSino Shanghai, CanSino Biologics Technology, CanSino Biologics R&D, CanSino Switzerland, CanSino Pharma, Bio-Mab Venture, and CanSino International Life Science[551] - Investment in the associate Tianjin Qianxi has a book value of 2,058,438.26 yuan[556] Government Grants During the reporting period, the company recognized 27.67 million yuan in government and Gates Foundation grants as current profit or loss Government Grants Recognized in Current Profit or Loss | Type | Current Period Amount (yuan) | | :--- | :--- | | Other income | 27,668,067.51 | | Total | 27,668,067.51 | - The period-end balance of liability items related to government grants and Gates Foundation grants was 240,300,312.76 yuan[558] Risks Related to Financial Instruments The company faces market risks (foreign exchange risk, interest rate risk, other price risks), credit risk, and liquidity risk. The company has established risk management systems and manages these risks through hedging, monitoring interest rate levels, assessing credit risk, and monitoring funding needs - Foreign exchange risk: Primarily arises from USD and HKD denominated assets and liabilities; a 5% appreciation or depreciation of RMB against USD could increase/decrease net loss by approximately 1,708,427.11 yuan; a 5% appreciation or depreciation of RMB against HKD could increase/decrease net loss by approximately 11,795,313.93 yuan[563][564] - Interest rate risk: Primarily arises from floating-rate financial liabilities; if the interest rate on floating-rate borrowings rises or falls by 50 basis points, the Group's net loss would increase or decrease by approximately 7,822,761.89 yuan[565] - Credit risk: Primarily arises from monetary funds, financial assets measured at amortized cost, and financial assets measured at fair value with changes recognized in current profit or loss; counterparties are mostly reputable institutions, and financial assets are regularly assessed and provisions for losses are made[569][570] - Liquidity risk: Managed by continuously monitoring short-term and long-term funding needs and ensuring sufficient cash reserves and readily convertible marketable securities[571] Disclosure of Fair Value This section discloses period-end fair values of financial assets and liabilities, categorized by Level 1, 2, and 3, including trading, derivative, and other non-current financial assets, with explanations of valuation techniques - As of June 30, 2025, total assets continuously measured at fair value were 1,489,866,718.47 yuan, and total liabilities were 639,539.44 yuan[577] - Level 3 fair value measurement items include structured deposits, option foreign exchange contracts, unlisted equity investments, and unlisted fund investments, valued using discounted cash flow method, option pricing models, market approach, and asset-based approach[579][580] - As of June 30, 2025, unlisted equity investments originally classified as Level 2, having been held for over one year, were reclassified from Level 2 to Level 3, with an amount of 36,553,900.00 yuan, based on market approach valuation instead of recent transaction prices[582] Related Parties and Related Party Transactions This section discloses related party transactions with associate Shanghai Pharma CanSino and other parties, covering purchases, services, and creditor-debtor relationships - Major related parties include the associate Shanghai Pharma CanSino, as well as Dongfulong Technology Group Co., Ltd., Shanghai Yisi Biomedical Technology Co., Ltd., etc[585][586] - Total related party transactions for purchases of goods/acceptance of services during the current period amounted to 637,624.02 yuan[588] - As of the end of the period, other receivables from the associate Shanghai Pharma CanSino amounted to 71,984,348.39 yuan, for which a full bad debt provision has been made[595] - Key management personnel compensation for the current period amounted to 9,686,991.13 yuan[591] Share-Based Payments This section details the 2023 A-share employee stock ownership plan's implementation, including granted, exercised, unlocked, and forfeited shares, and equity-settled share-based payment expenses - On May 8, 2023, the company granted 277,650 restricted shares to 217 incentive recipients at an exercise price of 61.17 yuan/share[603] - Equity-settled share-based payment expense for the current period was 554,814.66 yuan[608] - The 2023 A-share employee stock ownership plan was fully unlocked by May 2025[606] Commitments and Contingencies The company faces a significant contingent lawsuit in Brazil from Belcher, seeking approximately 219 million yuan in damages, for which no provision has been recognized due to a low probability of economic outflow - In March 2024, the company received a lawsuit from Belcher in a Brazilian court, requesting the company to pay lost profits and moral damages totaling approximately 167 million Brazilian Reals (approximately 219 million yuan)[610] - The company's management believes it is not probable that an outflow of economic benefits will be required to settle this lawsuit, and therefore no provision for contingent liabilities has been recognized for this lawsuit[610] Events After the Balance Sheet Date After the balance sheet date, the company repaid 35 million yuan in bank borrowings, leading to the reclassification of 621.26 million yuan of bank borrowings from current to non-current liabilities - On August 18, 2025, the Group repaid bank borrowings totaling 35,000,000.00 yuan[611] - Following this repayment, bank borrowings totaling 621,258,724.10 yuan were reclassified from current liabilities to non-current liabilities after the period-end[611] Other Significant Matters Wholly-owned subsidiary CanSino Pharma was deregistered on May 15, 2025, with no significant financial impact; the company reports human vaccine R&D, production, and commercialization as its sole operating segment - The company's wholly-owned subsidiary CanSino Pharma completed its deregistration on May 15, 2025, and this matter did not have a significant impact on the financial statements[614] - The Group reports the R&D, production, and commercialization of human vaccine products as its sole operating segment[615] Notes to Key Items in Parent Company Financial Statements This section details period-end and beginning balances, and current period changes for key parent company financial statement items, including accounts receivable, other receivables, and long-term equity investments - Parent company accounts receivable period-end book value: 660,325,856.11 yuan, with bad debt provision of 44,228,016.61 yuan[623] - Parent company other receivables period-end book value: 28,856,003.71 yuan, with bad debt provision of 72,927,169.15 yuan, mainly including intercompany fund advances and related party loans[640][642] - Parent company long-term equity investments period-end book value: 934,622,208.77 yuan, primarily investments in subsidiaries[651] Supplementary Information This section provides a detailed statement of non-recurring gains and losses and data on return on net assets and earnings per share - Total non-recurring gains and losses for the current period amounted to 72,415,473.31 yuan[663] Return on Net Assets and Earnings Per Share | Profit for the Reporting Period | Weighted Average Return on Net Assets (%) | Basic Earnings Per Share (yuan/share) | Diluted Earnings Per Share (yuan/share) | | :--- | :--- | :--- | :--- | | Net profit attributable to ordinary shareholders of the company | -0.27 | -0.05 | -0.05 | | Net profit attributable to ordinary shareholders of the company after deducting non-recurring gains and losses | -1.75 | -0.35 | -0.35 |