中慧生物-B(02627) - 2025 - 中期业绩

Interim Results Announcement Overview Financial Summary The company's unaudited interim results show significant revenue growth, a shift from gross loss to profit, and a markedly narrowed loss for the period Financial Highlights | Metric | 2025 (RMB in thousands) | 2024 (RMB in thousands) | Change | | :--- | :--- | :--- | :--- | | Revenue | 71,123 | 6,978 | 919.2% Increase | | Cost of Sales | (10,342) | (12,599) | 18.3% Decrease | | Gross Profit (Loss) | 60,781 | (5,621) | From Loss to Profit | | R&D Expenses | (98,848) | (99,865) | 1.0% Decrease | | Loss for the Period | (121,518) | (155,807) | 22.0% Decrease | | Loss per Share - Basic and Diluted (RMB Yuan) | (0.34) | (0.43) | 20.9% Decrease | Management Discussion and Analysis Business Review and Outlook The company focuses on R&D, manufacturing, and commercialization of innovative vaccines, achieving significant progress with its core product and advancing multiple pipeline candidates - The company, founded in 2015 and headquartered in China, is dedicated to the R&D, manufacturing, and commercialization of innovative vaccines and traditional vaccines using new technologies[5] - As of the announcement date, the company has two core products: the Quadrivalent Influenza Virus Subunit Vaccine and the investigational Lyophilized Human Rabies Vaccine[5] - The company also has 11 other vaccine candidates covering multiple disease areas, all of which are or are expected to be classified as Category II vaccines in China[5] Overview The company, a Chinese vaccine firm founded in 2015, focuses on R&D, manufacturing, and commercialization of innovative vaccines, with two core products and 11 other candidates in its pipeline Product Pipeline | Product | Indication | Development Stage | Expected Near-Term Milestone | | :--- | :--- | :--- | :--- | | Quadrivalent Influenza Virus Subunit Vaccine (3 years and older) | Influenza | NDA Approved | Complete post-approval safety study in Q4 2025 | | Quadrivalent Influenza Virus Subunit Vaccine (6-35 months) | Influenza | Phase III completed, NDA accepted | Obtain NDA approval in Q3 2025 | | Quadrivalent Influenza Virus Subunit Vaccine (Adjuvanted) (65 years and older) | Influenza | Pre-clinical | Initiate Phase I clinical trial in Q4 2025 | | Trivalent Influenza Virus Subunit Vaccine (3 years and older) | Influenza | NDA accepted | Obtain NDA approval in Q3 or Q4 2025 | | Trivalent Influenza Virus Subunit Vaccine (6-35 months) | Influenza | NDA accepted | Obtain NDA approval in Q3 or Q4 2025 | | Trivalent Influenza Virus Subunit Vaccine (Adjuvanted) (65 years and older) | Influenza | Pre-clinical | Initiate Phase I clinical trial in Q4 2025 | | Lyophilized Human Rabies Vaccine (Human Diploid Cell) | Rabies | Phase I completed | Initiate Phase III clinical trial in Q3 2025 | | PPSV23 | Invasive pneumococcal disease | Pre-clinical | Initiate Phase III clinical trial in Q4 2025 or Q1 2026 | | Recombinant Zoster Vaccine (CHO Cell) | Shingles | Phase I enrollment and initial safety report completed, Phase II enrollment completed | Complete Phase I clinical trial in H1 2026 | | Recombinant RSV Vaccine (CHO Cell) | RSV LRTI | IND Approved (NMPA/FDA) | Initiate Phase I clinical trial in Q1 2026 | | RSV-mRNA Vaccine | RSV LRTI | Pre-clinical | Submit pre-IND application in Q3 or Q4 2025 | | mRNA Mpox Vaccine | Mpox | Pre-clinical | Submit pre-IND application in Q4 2025 | | PCV24 | Invasive pneumococcal disease | Pre-clinical | Submit pre-IND application in Q1 2026 | | Varicella Vaccine, Live | Varicella | Pre-clinical | Submit pre-IND application in Q1 2026 | | Adsorbed Tetanus Toxoid Vaccine | Tetanus | Pre-clinical | Submit pre-IND application in Q4 2025 | Core Products The company's core products include the approved Quadrivalent Influenza Virus Subunit Vaccine and the clinical-stage Lyophilized Human Rabies Vaccine (Human Diploid Cell) - The company cannot guarantee the successful development or marketing of its core products, and shareholders and potential investors are advised to exercise caution[11] Quadrivalent Influenza Virus Subunit Vaccine The Quadrivalent Influenza Virus Subunit Vaccine (Huirconxin®) was approved by the NMPA in May 2023, becoming China's first and only approved vaccine of its kind - The Quadrivalent Influenza Virus Subunit Vaccine received NDA approval from the NMPA in May 2023 for use in individuals aged three and above, making it the first and only approved vaccine of its kind in China[8] - The company began commercialization in September 2023, and as of June 30, 2025, all units were self-produced[8] - The vaccine for the 6-35 month age group has completed Phase III clinical trials, with its NDA accepted by the NMPA in June 2024 and approval expected in Q3 2025[9] Lyophilized Human Rabies Vaccine (Human Diploid Cell) The investigational Lyophilized Human Rabies Vaccine (Human Diploid Cell) has completed Phase I trials with good safety and is preparing for Phase III trials - The investigational rabies vaccine, developed based on WHO-recommended human diploid cells, has completed Phase I clinical trials and demonstrated a favorable safety profile[10] - The company has obtained IND approvals for three immunization schedules: Essen, Zagreb, and the simplified four-injection regimen[10] - As of the announcement date, the company has begun preparations for the Phase III clinical trial, which is expected to be initiated in Q3 2025[10] Our Other Pipeline Products The company's other pipeline products cover various diseases including influenza, pneumococcal disease, shingles, RSV, mpox, varicella, and tetanus Trivalent Influenza Virus Subunit Vaccine The Trivalent Influenza Virus Subunit Vaccine is designed to provide protection consistent with WHO-recommended strains for the 2024-2025 Northern Hemisphere influenza season - The Trivalent Influenza Virus Subunit Vaccine aims to protect against two influenza A viruses and one influenza B virus, aligning with WHO recommendations for the 2024-2025 Northern Hemisphere season[12] - The vaccine leverages the mature formulation of the approved quadrivalent vaccine, simply omitting one influenza B subtype during preparation[12] - The NDA for use in individuals aged 3 years and above and those aged 6-35 months was accepted by the NMPA in September 2024[12] 23-valent Pneumococcal Polysaccharide Vaccine (PPSV23) The company is developing a PPSV23 candidate for individuals aged two and above, which has shown strong immunogenicity and improved safety through process enhancements - The investigational PPSV23 induced a strong immunogenic response in subjects aged two and above in a Phase I clinical trial[13] - The company has significantly improved the manufacturing process by replacing ethanol precipitation with ion-exchange column chromatography to enhance product safety[13] Recombinant Zoster Vaccine (CHO Cell) The company is developing a recombinant zoster vaccine with a proprietary dual-adjuvant for individuals aged 40 and above, which has entered Phase II trials - The investigational recombinant zoster vaccine uses a proprietary dual-adjuvant and is intended for individuals aged 40 and above[14] - Pre-clinical animal studies showed a stronger cell-mediated immune response, potentially translating to enhanced protective efficacy[14] - A Phase I trial was initiated in February 2025, followed by the initiation of a Phase II trial in July 2025[14] 24-valent Pneumococcal Conjugate Vaccine (PCV24) The company is developing a PCV24 vaccine to provide broader protection against 24 serotypes of pneumococcus, utilizing a single carrier protein for cost-effective production - The investigational PCV24 vaccine is designed to protect a broader population, including infants under two years of age[15] - It targets 24 serotypes of pneumococcus, significantly reducing the risk of invasive disease[15] - The vaccine uses a single carrier protein, CRM197, to ensure a consistent immune response while simplifying production and maintaining cost-effectiveness[15] Recombinant RSV Vaccine (CHO Cell) The company is developing a recombinant RSV vaccine using CHO cells for adults, which has received IND approval from both the NMPA and FDA - The investigational recombinant RSV vaccine is developed using CHO cells to express a modified pre-F protein[16] - It aims to protect adults, including pregnant women, from acute RSV infection and related severe lower respiratory tract illness[16] - The vaccine received IND approval from both the NMPA and the FDA in August 2025[16] RSV-mRNA Vaccine The company's investigational RSV-mRNA vaccine for adults aged 60 and above is currently in pre-clinical studies - The investigational RSV-mRNA vaccine is intended for individuals aged 60 and above to prevent acute RSV infection and related severe lower respiratory tract illness[17] - It utilizes synthetic mRNA designed to encode the RSV pre-F protein, encapsulated in lipid nanoparticles (LNPs)[17] - As of the announcement date, the vaccine candidate is undergoing pre-clinical studies[17] mRNA Mpox Vaccine The company is developing an mRNA mpox vaccine for individuals aged 18 and above, which is currently in pre-clinical studies - The investigational mRNA mpox vaccine is a next-generation prophylactic vaccine formulated using a quadrivalent orthopoxvirus antigen and the mRNA-LNP technology platform[18] - It is intended for the prevention of mpox in individuals aged 18 and above[18] - As of the announcement date, the vaccine candidate is undergoing pre-clinical studies[18] Varicella Vaccine, Live The company is developing a live attenuated varicella vaccine for susceptible individuals aged 12 months or older, having completed the establishment of cell and virus seed banks - The investigational live attenuated varicella vaccine is intended for healthy, varicella-susceptible individuals aged 12 months or older[19] - It is produced by propagating the Oka strain of VZV in human diploid cells (MRC-5) and is lyophilized with a stabilizer[19] - The company has completed the establishment of the cell banks and virus seed banks for the vaccine candidate[19] Adsorbed Tetanus Toxoid Vaccine The company is developing a tetanus toxoid vaccine and has completed process scale-up development and pilot-scale production - The investigational adsorbed tetanus toxoid vaccine is designed to induce protective antitoxin antibodies through immunization[20] - The company has completed the process scale-up development and three pilot-scale production batches of the drug substance for the vaccine candidate[20] R&D The company possesses strong R&D capabilities led by an experienced team and supported by three comprehensive vaccine development platforms - The R&D team is led by experienced scientists including Dr Ze Chen (Chief Scientist) and Dr Yelin Xiong (Head of mRNA vaccine research and polysaccharide conjugation technology platforms)[21] - As of June 30, 2025, 46.1% of the in-house R&D team held a Ph.D. or master's degree[21] - The company has established platforms for genetic engineering and protein expression, mRNA vaccine research, and adjuvant development, supplemented by unique proprietary technologies[22] Manufacturing All commercial and clinical trial vaccines are produced at the Taizhou headquarters' Production Campus No. 1, with capacity expansion underway - All Quadrivalent Influenza Virus Subunit Vaccine products and investigational vaccines for clinical trials are manufactured at Production Campus No. 1 in Taizhou[23] - Production Campus No. 1 currently has three operational production lines: influenza vaccine (4.0 million doses/year), rabies vaccine (5.0 million doses/year), and pneumococcal vaccine (15.0 million doses/year)[23] - The company is constructing Production Campus No. 2 (for influenza vaccine expansion) and Production Campus No. 3 (for recombinant protein vaccines) at its headquarters[23] Commercialization The company sells its quadrivalent influenza vaccine directly to CDCs, achieving market access in 30 provinces and adoption by over 1,100 district/county CDCs - The Quadrivalent Influenza Virus Subunit Vaccine is sold directly to CDCs, with market access in 30 provinces and selection by over 1,100 district and county-level CDCs[24] - An in-house sales and marketing team has been established, supplemented by third-party marketing service providers[24] - The marketing strategy is led by academic promotion with a focus on special populations such as pregnant women and patients with chronic diseases[24] Intellectual Property As of June 30, 2025, the company held 190 patents in China and had no significant ongoing intellectual property legal proceedings - As of June 30, 2025, the company owned 190 patents in China, including 37 invention patents and 153 utility model patents[25] - The core product, the Quadrivalent Influenza Virus Subunit Vaccine, is protected by 12 registered patents, while the rabies vaccine has 5 registered patents[25] - For the six months ended June 30, 2025, the company was not involved in any material IP legal proceedings or received any material claims of IP infringement[25] Employees and Remuneration As of June 30, 2025, the company had 583 employees in China, with a compensation plan including salary, bonuses, and equity incentives - As of June 30, 2025, the Group had 583 employees, all located in China[26] - The Group's employee remuneration package includes salaries, bonuses, and equity-based incentives, and an employee incentive scheme has been adopted[26] - For the six months ended June 30, 2025, the Group did not experience any material labor disputes or strikes that could have a significant adverse effect on its business[26] Future Outlook The company plans to advance clinical trials, enrich its vaccine pipeline, upgrade technology platforms, and expand into international markets - Efficiently advance post-approval studies and clinical trials for core products[30] - Accelerate the development of other vaccine candidates that address unmet clinical needs to enrich the vaccine pipeline[30] - Further strengthen manufacturing and commercialization capabilities, and enter international markets to enhance the commercial value of vaccine candidates[30] Financial Review For the six months ended June 30, 2025, the company's revenue grew significantly, gross profit turned positive, and net loss narrowed considerably Analysis of Major Items in Operating Performance During the period, revenue surged due to increased vaccine sales, gross profit turned positive, and the net loss narrowed despite higher selling and listing expenses Revenue Revenue for the six months ended June 30, 2025, surged to RMB71.1 million from RMB7.0 million in the prior-year period, driven by increased vaccine sales | Period | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Y-o-Y Change | | :--- | :--- | :--- | :--- | | Revenue | 71,123 | 6,978 | 919.2% Increase | - The substantial increase in revenue was primarily attributable to the gradual increase in sales of the Quadrivalent Influenza Virus Subunit Vaccine[28] Cost of Sales Cost of sales for the six months ended June 30, 2025, decreased by 18.3% to RMB10.3 million, mainly due to enhanced inventory management | Period | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Y-o-Y Change | | :--- | :--- | :--- | :--- | | Cost of Sales | (10,342) | (12,599) | 18.3% Decrease | - The decrease in cost of sales was mainly consistent with enhanced inventory management[29] Gross Profit and Gross Profit Margin For the six months ended June 30, 2025, the company shifted from a gross loss of RMB5.6 million to a gross profit of RMB60.8 million, with the margin improving to 85.5% | Period | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Change | | :--- | :--- | :--- | :--- | | Gross Profit (Loss) | 60,781 | (5,621) | From Loss to Profit | | Gross Profit Margin | 85.5% | (80.0%) | Significant Improvement | Other Income Other income for the six months ended June 30, 2025, decreased by 65.7% to RMB5.7 million due to a one-off government subsidy received in the prior-year period | Period | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Y-o-Y Change | | :--- | :--- | :--- | :--- | | Other Income | 5,651 | 16,623 | 65.7% Decrease | - The decrease was mainly due to a one-off government subsidy received in the same period of 2024 related to the NDA approval of the Quadrivalent Influenza Virus Subunit Vaccine[32] R&D Expenses R&D expenses for the six months ended June 30, 2025, remained relatively stable at RMB98.8 million, a slight decrease from the prior-year period | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Y-o-Y Change | | :--- | :--- | :--- | :--- | | Total | 98,848 | 99,865 | 1.0% Decrease | | Staff Costs | 29,490 | 29,669 | 0.6% Decrease | | Trial and Testing Expenses | 8,517 | 18,894 | 54.9% Decrease | | Depreciation and Amortization | 22,928 | 16,462 | 39.3% Increase | | Material Costs | 19,538 | 14,056 | 39.0% Increase | | Share-based Payments | 5,298 | 9,004 | 41.1% Decrease | - R&D expenses primarily consist of staff costs for R&D personnel, trial and testing expenses, depreciation and amortization, and R&D material costs[33] Selling Expenses Selling expenses for the six months ended June 30, 2025, increased by 91.5% to RMB47.3 million due to intensified product promotion efforts | Period | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Y-o-Y Change | | :--- | :--- | :--- | :--- | | Selling Expenses | 47,319 | 24,736 | 91.5% Increase | - The increase was mainly due to higher marketing expenses resulting from intensified product promotion efforts in 2025[36] Administrative Expenses Administrative expenses for the six months ended June 30, 2025, decreased by 17.6% to RMB26.2 million, primarily due to the vesting and forfeiture of share awards | Period | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Y-o-Y Change | | :--- | :--- | :--- | :--- | | Administrative Expenses | 26,232 | 31,819 | 17.6% Decrease | - The decrease was mainly due to the continuous vesting of share awards and the forfeiture of unvested share awards granted to employees who left the company[37] Listing Expenses For the six months ended June 30, 2025, the company incurred approximately RMB11.0 million in expenses related to its H-share listing on the Stock Exchange | Period | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Y-o-Y Change | | :--- | :--- | :--- | :--- | | Listing Expenses | 10,955 | – | New | Finance Costs Finance costs for the six months ended June 30, 2025, increased by 32.1% to RMB10.3 million, mainly due to higher interest expenses from increased borrowings | Period | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Y-o-Y Change | | :--- | :--- | :--- | :--- | | Finance Costs | 10,302 | 7,785 | 32.1% Increase | - The increase was primarily due to higher interest expenses on bank borrowings resulting from an increase in borrowings during the period[39] Loss for the Period The loss for the six months ended June 30, 2025, narrowed by 22.0% to RMB121.5 million, reflecting the net effect of changes in operating performance items | Period | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Y-o-Y Change | | :--- | :--- | :--- | :--- | | Loss for the Period | (121,518) | (155,807) | 22.0% Decrease | Analysis of Major Items in Financial Position As of June 30, 2025, inventories increased significantly to meet demand, while trade receivables decreased due to active collection efforts Inventories As of June 30, 2025, inventories increased by 86.3% to RMB107.7 million to meet growing product demand | Date | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Inventories | 107,743 | 57,809 | 86.3% Increase | - The increase in inventories was to meet the growing demand for products[41] Trade Receivables As of June 30, 2025, trade receivables decreased by 48.0% to RMB148.2 million due to active collection of outstanding balances | Date | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Trade Receivables | 148,171 | 284,905 | 48.0% Decrease | - The decrease was mainly due to the company's active collection of outstanding trade receivables[42] Trade and Other Payables As of June 30, 2025, trade and other payables decreased slightly by 0.4% to RMB456.1 million, mainly due to the settlement of certain trade payables | Date | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Trade and Other Payables | 456,108 | 458,031 | 0.4% Decrease | - The decrease was mainly due to the settlement of certain trade payables during the six months ended June 30, 2025[43] Liquidity and Capital Resources Cash was primarily used for R&D, vaccine production, and campus construction, funded by equity financing, bank borrowings, and operating cash flow - Cash usage was mainly related to the R&D of vaccine candidates, production and launch of the quadrivalent influenza vaccine, and construction of production campuses[45] - Funding sources were primarily through equity financing, bank borrowings, and cash generated from operations[45] - Net cash inflow from operating activities was RMB0.2 million, a significant improvement from the RMB107.9 million outflow in the same period of 2024[45] | Date | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | 108,427 | 132,194 | Net Current Liabilities As of June 30, 2025, net current liabilities increased by 16.3% to RMB480.3 million to support R&D, production, and promotional activities | Date | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | Change | | :--- | :--- | :--- | :--- | | Net Current Liabilities | (480,253) | (413,142) | 16.3% Increase | - The increase was mainly due to a decrease in cash and an increase in borrowings to support ongoing product R&D, as well as the production and promotion of the quadrivalent influenza vaccine[46] Indebtedness As of June 30, 2025, total borrowings increased to support operations, while lease liabilities decreased and amounts due to shareholders were settled Borrowings As of June 30, 2025, total borrowings increased to RMB907.8 million to support operational needs and the construction of production campuses | Date | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | Change | | :--- | :--- | :--- | :--- | | Total Borrowings | 907,797 | 809,536 | 12.1% Increase | - The increase in borrowings was mainly to support our operational needs and the construction of production campuses[47] Lease Liabilities As of June 30, 2025, total lease liabilities decreased to RMB8.7 million due to the termination of certain leases during the period | Date | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | Change | | :--- | :--- | :--- | :--- | | Total Lease Liabilities | 8,700 | 49,300 | 82.3% Decrease | - The decrease in lease liabilities was mainly due to the termination of certain leases during the six months ended June 30, 2025[48] Amounts Due to Shareholders As of June 30, 2025, the RMB27.7 million borrowings from two controlling shareholders had been settled - As of June 30, 2025, borrowings of RMB27.7 million from two controlling shareholders, Mr An Youcai and Mr He Yiming, had been settled[49] Third-party Loans As of June 30, 2025, the company had a new third-party loan of RMB16.1 million, bearing interest at 3% per annum and repayable on demand - As of June 30, 2025, the company's third-party loan of RMB16.1 million was recorded under trade and other payables, bearing interest at 3% per annum and repayable on demand[50] Pledge of Assets As of June 30, 2025, the company's pledged assets amounted to RMB145.3 million, a slight decrease from December 31, 2024 | Date | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | Change | | :--- | :--- | :--- | :--- | | Pledged Assets | 145,300 | 149,300 | 2.7% Decrease | Gearing Ratio As of June 30, 2025, the gearing ratio increased slightly to 0.98 times, mainly due to operating losses during the period | Date | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Gearing Ratio | 0.98 times | 0.91 times | Slight Increase | - The increase in the gearing ratio was mainly due to operating losses for the six months ended June 30, 2025[52] Capital Expenditure and Capital Commitments Capital expenditure for the six months ended June 30, 2025, was RMB47.0 million, with capital commitments of RMB353.0 million mainly for production facilities | Period | Six months ended June 30, 2025 (RMB in thousands) | Six months ended June 30, 2024 (RMB in thousands) | Change | | :--- | :--- | :--- | :--- | | Capital Expenditure | 47,000 | 141,000 | 66.7% Decrease | | Date | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | Change | | :--- | :--- | :--- | :--- | | Capital commitments contracted but not provided for | 353,000 | 378,100 | 6.7% Decrease | - The company plans to use approximately HK$20.2 million of the proceeds from the Global Offering to upgrade production facilities and equipment for its vaccines[53] Contingent Liabilities As of June 30, 2025, the company did not have any material contingent liabilities - As of June 30, 2025, the Company did not have any material contingent liabilities[54] Foreign Exchange Risk During the reporting period, the company did not face significant foreign exchange risk, and its operations were not materially affected by currency fluctuations - During the reporting period, the company did not face significant foreign exchange risk, and our operations were not materially affected by any exchange rate fluctuations[55] Material Investments and Material Acquisitions and Disposals of Subsidiaries, Associates and Joint Ventures For the six months ended June 30, 2025, the company had no material investments or material acquisitions or disposals of subsidiaries, associates, and joint ventures - For the six months ended June 30, 2025, the Company had no material investments and/or material acquisitions or disposals of subsidiaries, associates and joint ventures[56] Condensed Consolidated Financial Statements Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income For the six months ended June 30, 2025, revenue grew substantially to RMB71,123 thousand, gross profit turned positive, and the net loss narrowed For the six months ended June 30 | Metric | 2025 (RMB in thousands) | 2024 (RMB in thousands) | | :--- | :--- | :--- | | Revenue | 71,123 | 6,978 | | Cost of sales | (10,342) | (12,599) | | Gross profit (loss) | 60,781 | (5,621) | | Other income | 5,651 | 16,623 | | R&D expenses | (98,848) | (99,865) | | Selling expenses | (47,319) | (24,736) | | Administrative expenses | (26,232) | (31,819) | | Listing expenses | (10,955) | – | | Finance costs | (10,302) | (7,785) | | Loss and total comprehensive expense for the period | (121,518) | (155,807) | | Loss per share – basic and diluted (RMB Yuan) | (0.34) | (0.43) | Condensed Consolidated Statement of Financial Position As of June 30, 2025, total assets less current liabilities stood at RMB597,686 thousand, with increased inventory and decreased trade receivables As at June 30, 2025 | Metric | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Non-current assets | | | | Property, plant and equipment | 938,266 | 944,690 | | Right-of-use assets | 52,157 | 86,091 | | Intangible assets | 24,706 | 25,660 | | Other receivables and prepayments | 62,810 | 60,861 | | Total non-current assets | 1,077,939 | 1,117,302 | | Current assets | | | | Inventories | 107,743 | 57,809 | | Trade receivables | 148,171 | 284,905 | | Cash and cash equivalents | 108,427 | 132,194 | | Total current assets | 379,627 | 495,537 | | Current liabilities | | | | Trade and other payables | 439,692 | 441,615 | | Borrowings | 401,014 | 347,524 | | Total current liabilities | 859,880 | 908,679 | | Net current liabilities | (480,253) | (413,142) | | Total assets less current liabilities | 597,686 | 704,160 | | Non-current liabilities | | | | Borrowings | 506,783 | 462,012 | | Lease liabilities | 4,233 | 42,127 | | Total non-current liabilities | 564,028 | 557,573 | | Net assets | 33,658 | 146,587 | | Total equity | 33,658 | 146,587 | Notes to the Condensed Consolidated Financial Statements Basis of Preparation The condensed consolidated financial statements are prepared in accordance with IAS 34 "Interim Financial Reporting" and the applicable disclosure requirements of the Hong Kong Stock Exchange Listing Rules - The condensed consolidated financial statements have been prepared in accordance with International Accounting Standard 34 "Interim Financial Reporting" issued by the IASB and the applicable disclosure requirements of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited[60] Principal Accounting Policies The financial statements are prepared on the historical cost basis, except for certain financial instruments measured at fair value, with accounting policies consistent with those in the Prospectus - The condensed consolidated financial statements have been prepared on the historical cost basis, except for certain financial instruments which are measured at fair values[61] - The accounting policies and methods of computation used in the condensed consolidated financial statements for the six months ended June 30, 2025 are the same as those presented in "Appendix I - Accountant's Report" to the Prospectus[61] Revenue from Contracts with Customers For the six months ended June 30, 2025, all revenue from contracts with customers, totaling RMB71,123 thousand, was derived from vaccine sales in Mainland China at a point in time Revenue Analysis | Type/Market/Timing | Six months ended June 30, 2025 (RMB in thousands) | Six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Sales of vaccine products | 71,123 | 6,978 | | Mainland China | 71,123 | 6,978 | | At a point in time | 71,123 | 6,978 | Segment Information The company operates as a single operating segment, with all business activities and non-current assets located in China - The Group has only one single operating segment[63] - As at June 30, 2025, all non-current assets were located in China[64] Other Income Other income for the six months ended June 30, 2025, was RMB5,651 thousand, primarily from government grants and bank interest, a decrease from the prior year Breakdown of Other Income | Item | Six months ended June 30, 2025 (RMB in thousands) | Six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Government grants - income related | 4,925 | 14,778 | | Government grants - asset related | 422 | 1,349 | | Bank interest income | 122 | 359 | | Others | 182 | 137 | | Total | 5,651 | 16,623 | - Income-related government grants are mainly awarded as incentives for the Group's R&D activities[66] Other Gains and Losses For the six months ended June 30, 2025, the company recorded other gains of RMB5,654 thousand, primarily from the termination and modification of leases Breakdown of Other Gains and Losses | Item | Six months ended June 30, 2025 (RMB in thousands) | Six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Fair value changes on financial assets at FVTPL | 10 | 239 | | Gain (loss) on disposal of property, plant and equipment | 175 | (4) | | Gain on termination and modification of leases | 5,469 | – | | Total | 5,654 | 235 | Loss Per Share For the six months ended June 30, 2025, the basic and diluted loss per share narrowed to RMB0.34 from RMB0.43 in the prior-year period Calculation of Loss Per Share | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | | Loss for the period attributable to owners of the Company for basic loss per share calculation (RMB in thousands) | (121,518) | (155,807) | | Weighted average number of ordinary shares for basic loss per share calculation (in thousands) | 360,000 | 360,000 | | Loss per share – basic and diluted (RMB Yuan) | (0.34) | (0.43) | Trade Receivables As of June 30, 2025, net trade receivables decreased significantly to RMB148,171 thousand, with a notable shift in the aging profile Trade Receivables Summary | Date | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Trade receivables from contracts with customers | 148,224 | 285,019 | | Less: Allowance for expected credit losses | (53) | (114) | | Net | 148,171 | 284,905 | Aging Analysis of Trade Receivables | Aging | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | 1 to 90 days | 38,881 | 50,066 | | 91 to 180 days | 742 | 216,095 | | 181 to 270 days | 22,889 | 13,007 | | 271 to 365 days | 78,697 | 219 | | Over 1 year | 6,962 | 5,518 | | Total | 148,171 | 284,905 | Trade and Other Payables As of June 30, 2025, total trade and other payables were RMB456,108 thousand, including a new third-party loan of RMB16,054 thousand Breakdown of Trade and Other Payables | Item | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Payables for raw materials and services | 89,383 | 98,385 | | Payables for acquisition of property, plant and equipment | 132,443 | 159,706 | | Payables for marketing activities | 111,563 | 109,929 | | Payroll and welfare payables | 42,141 | 33,500 | | Third-party loans | 16,054 | – | | Total | 456,108 | 458,031 | Aging Analysis of Trade Payables | Aging | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | 1 to 30 days | 55,545 | 74,465 | | 31 days to 1 year | 33,838 | 23,920 | | Total | 89,383 | 98,385 | Borrowings As of June 30, 2025, total borrowings increased to RMB907,797 thousand, including new bank loans under supplier financing arrangements Breakdown of Borrowings | Item | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Bank borrowings | 895,212 | 809,536 | | Bank borrowings under supplier financing arrangements | 12,585 | – | | Total | 907,797 | 809,536 | Analysis of Borrowings | Item | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Bank borrowings – unsecured and unguaranteed | 452,863 | 384,030 | | Bank borrowings – secured and unguaranteed | 454,934 | 375,551 | | Bank borrowings – unsecured and guaranteed | – | 49,955 | | Total | 907,797 | 809,536 | | Less: current portion | (401,014) | (347,524) | | Non-current portion | 506,783 | 462,012 | Other Information Interim Dividend The Board of Directors has recommended that no interim dividend be paid for the reporting period - During the reporting period, the Board recommended not to declare any interim dividend[73] Purchase, Sale or Redemption of the Company's Listed Securities As the company was not listed during the reporting period, the relevant disclosure is not applicable, and no securities were repurchased since the listing date - Disclosure of details on the purchase, sale, or redemption of the Company's listed securities is not applicable as the Company was not yet listed on the Stock Exchange during the reporting period[74] - From the Listing Date up to the date of this announcement, neither the Company nor any of its subsidiaries had purchased, sold or redeemed any of the Company's listed securities[74] Events After the Reporting Period Subsequent to the reporting period, the company was listed on the Stock Exchange, raised approximately HK$431.4 million, and achieved key clinical and regulatory milestones Listing on the Stock Exchange The company was successfully listed on the Stock Exchange on August 11, 2025, raising total proceeds of approximately HK$431.4 million - On August 11, 2025, the Company was successfully listed on the Stock Exchange after completing the issuance of 33,442,600 H Shares at a price of HK$12.90 per Share[75] - The total proceeds from the Listing amounted to approximately HK$431.4 million[75] - The Group will utilize the net proceeds in accordance with the intended purposes set out in the "Future Plans and Use of Proceeds" section of the Prospectus[75] Clinical Trials In July 2025, the company completed the initial safety report for the Phase I trial of its recombinant zoster vaccine and subsequently initiated the Phase II trial - We completed the initial safety report for the Phase I clinical trial of our investigational recombinant zoster vaccine in July 2025[76] - We subsequently commenced the Phase II clinical trial for the investigational recombinant zoster vaccine in July 2025[76] IND Approval On August 15, 2025, the IND application for the company's self-developed recombinant RSV vaccine (CHO Cell) was approved by both the NMPA and the US FDA - On August 15, 2025, the CDE approved the IND application for our self-developed recombinant RSV vaccine (CHO Cell)[77] - In addition, our IND application in the United States has also been approved by the FDA[77] Compliance with the Corporate Governance Code The company has complied with the Corporate Governance Code since its listing, with the exception of the chairman and CEO roles being held by the same individual - The Company has adopted corporate governance practices based on the principles and code provisions set out in the Corporate Governance Code since the Listing Date[79] - From the Listing Date up to the date of this announcement, the Company has complied with the applicable code provisions of the Corporate Governance Code, with the exception of code provision C.2.1[79] - The Board believes that having Mr An Youcai serve as both Chairman and General Manager is in the best interests of the Group for effective management, with sufficient safeguards to ensure a balance of power[79] Compliance with the Model Code The company has adopted the Model Code for securities transactions by directors and supervisors, who have all confirmed their compliance since the listing date - The Company has adopted the Model Code as its code of conduct for regulating securities transactions by its Directors, Supervisors, and employees with access to inside information since its listing[80] - Following specific inquiries made by the Board, all Directors and Supervisors have confirmed their compliance with the provisions of the Model Code from the Listing Date up to the date of this announcement[80] Continuing Disclosure Obligations under the Listing Rules The company has no other disclosure obligations under Listing Rules 13.20, 13.21, and 13.22 beyond what is disclosed in this announcement - Save as disclosed in this announcement, the Company does not have any other disclosure obligations under Rules 13.20, 13.21 and 13.22 of the Listing Rules[81] Changes in Information of Directors, Supervisors and Chief Executive Since the prospectus publication, independent non-executive Director Mr Chan Shing Biu ceased to be an independent director of another company, with no other material changes - Our independent non-executive Director, Mr Chan Shing Biu, ceased to be an independent director of Dongguan Huayue Semiconductor Technology Co, Ltd with effect from August 2025[82] Sufficient Public Float The company has maintained the required minimum public float of 25% as stipulated by the Listing Rules since its listing date - Based on information available to the Company and to the best knowledge of the Directors, the Company has maintained the public float as required by the Listing Rules from the Listing Date up to the date of this announcement[83] Review of Interim Financial Information The Group's interim financial statements for the six months ended June 30, 2025, have been reviewed by the independent auditor, Deloitte Touche Tohmatsu - The condensed consolidated interim financial statements of the Group for the six months ended June 30, 2025 have been reviewed by the Company's independent auditor, Deloitte Touche Tohmatsu, in accordance with International Standard on Review Engagements 2410[84] Audit Committee The Audit Committee, chaired by Ms Li Xiaoqing, has reviewed the unaudited interim financial statements and confirmed their compliance with applicable standards - The Audit Committee currently consists of independent non-executive Directors Ms Li Xiaoqing, Mr Li Xiangming and Mr Cheng Qianwen, with Ms Li Xiaoqing serving as the chairlady[85] - The Audit Committee has reviewed the Group's unaudited condensed interim consolidated financial statements for the reporting period and confirmed their compliance with all applicable accounting standards, laws, and regulations[85] Publication of Interim Report The interim results announcement is available on the websites of the Stock Exchange and the company, with the interim report to follow in due course - The interim results announcement is published on the website of the Stock Exchange at http://www.hkexnews.hk and on the Company's website at http://www.abbbio.com[86](index=86&type=chunk) - The interim report of the Company for the six months ended June 30, 2025 will be dispatched to the Shareholders and published on the above websites in due course as required[86] Definitions, Abbreviations and Technical Glossary Definitions This section provides definitions for key terms used throughout the report, including company-specific, regulatory, and financial terminology - Provides definitions for key terms used in the report, such as "Core Product(s)" referring to products used to qualify under Chapter 18A of the Listing Rules[88] - "Reporting Period" refers to the six months ended June 30, 2025[89] Abbreviations This section lists the full names for abbreviations used in the report, including regulatory bodies and health organizations - Lists the full names for abbreviations used in the report, such as "CDC" for Center for Disease Control and Prevention and "FDA" for the U.S. Food and Drug Administration[91] Technical Glossary This section explains specialized technical terms related to vaccinology, biotechnology, and clinical trials used in the report - Provides explanations for technical terms in vaccinology, biotechnology, and clinical trials, such as "IND" for Investigational New Drug or an application for a new drug for clinical study[92] - Explains the definitions and purposes of different clinical trial phases (Phase I, II, III)[92][93] - Defines different types of vaccines and related diseases, such as "valent" referring to the number of microbial species a vaccine is designed to protect against[93]