Ab&B Bio-Tech-B(02627)

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中慧生物-B(02627) - 2025 - 中期业绩
2025-08-28 08:31
[Interim Results Announcement Overview](index=1&type=section&id=%E4%B8%AD%E6%9C%9F%E6%A5%AD%E7%B8%BE%E5%85%AC%E5%91%8A%E6%A6%82%E8%A6%BD) [Financial Summary](index=1&type=section&id=%E8%B2%A1%E5%8B%99%E6%91%98%E8%A6%81) 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](index=1&type=section&id=%E7%AE%A1%E7%90%86%E5%B1%A4%E8%A8%8E%E8%AB%96%E5%8F%8A%E5%88%86%E6%9E%90) [Business Review and Outlook](index=1&type=section&id=%E6%A5%AD%E5%8B%99%E5%9B%9E%E9%A1%A7%E5%8F%8A%E5%B1%95%E6%9C%9B) 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](index=5&type=chunk) - 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](index=5&type=chunk) - 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](index=5&type=chunk) [Overview](index=1&type=section&id=%E6%A6%82%E8%A6%BD) 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](index=3&type=section&id=%E6%A0%B8%E5%BF%83%E7%94%A2%E5%93%81) 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](index=11&type=chunk) [Quadrivalent Influenza Virus Subunit Vaccine](index=3&type=section&id=%E5%9B%9B%E5%83%B9%E6%B5%81%E6%84%9F%E7%97%85%E6%AF%92%E4%BA%9E%E5%96%AE%E4%BD%8D%E7%96%AB%E8%8B%97) 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](index=8&type=chunk) - The company began commercialization in September 2023, and as of June 30, 2025, all units were self-produced[8](index=8&type=chunk) - 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](index=9&type=chunk) [Lyophilized Human Rabies Vaccine (Human Diploid Cell)](index=3&type=section&id=%E5%87%8D%E4%B9%BE%E4%BA%BA%E7%94%A8%E7%8B%82%E7%8A%AC%E7%97%85%E7%96%AB%E8%8B%97%EF%BC%88%E4%BA%BA%E4%BA%8C%E5%80%8D%E9%AB%94%E7%B4%B0%E8%83%9E%EF%BC%89) 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](index=10&type=chunk) - The company has obtained IND approvals for three immunization schedules: Essen, Zagreb, and the simplified four-injection regimen[10](index=10&type=chunk) - 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](index=10&type=chunk) [Our Other Pipeline Products](index=4&type=section&id=%E6%88%91%E5%80%91%E7%9A%84%E5%85%B6%E4%BB%96%E5%9C%A8%E7%A0%94%E7%94%A2%E5%93%81) The company's other pipeline products cover various diseases including influenza, pneumococcal disease, shingles, RSV, mpox, varicella, and tetanus [Trivalent Influenza Virus Subunit Vaccine](index=4&type=section&id=%E4%B8%89%E5%83%B9%E6%B5%81%E6%84%9F%E7%97%85%E6%AF%92%E4%BA%9E%E5%96%AE%E4%BD%8D%E7%96%AB%E8%8B%97) 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](index=12&type=chunk) - The vaccine leverages the mature formulation of the approved quadrivalent vaccine, simply omitting one influenza B subtype during preparation[12](index=12&type=chunk) - 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](index=12&type=chunk) [23-valent Pneumococcal Polysaccharide Vaccine (PPSV23)](index=4&type=section&id=23%E5%83%B9%E8%82%BA%E7%82%8E%E7%90%83%E8%8F%8C%E5%A4%9A%E7%B3%96%E7%96%AB%E8%8B%97(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](index=13&type=chunk) - The company has significantly improved the manufacturing process by replacing ethanol precipitation with ion-exchange column chromatography to enhance product safety[13](index=13&type=chunk) [Recombinant Zoster Vaccine (CHO Cell)](index=4&type=section&id=%E9%87%8D%E7%B5%84%E5%B8%B6%E7%8B%80%E7%9A%B0%E7%96%B9%E7%96%AB%E8%8B%97%EF%BC%88CHO%E7%B4%B0%E8%83%9E%EF%BC%89) 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](index=14&type=chunk) - Pre-clinical animal studies showed a stronger cell-mediated immune response, potentially translating to enhanced protective efficacy[14](index=14&type=chunk) - A **Phase I trial was initiated in February 2025**, followed by the initiation of a Phase II trial in July 2025[14](index=14&type=chunk) [24-valent Pneumococcal Conjugate Vaccine (PCV24)](index=5&type=section&id=24%E5%83%B9%E8%82%BA%E7%82%8E%E7%90%83%E8%8F%8C%E7%B5%90%E5%90%88%E7%96%AB%E8%8B%97(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](index=15&type=chunk) - It targets **24 serotypes of pneumococcus**, significantly reducing the risk of invasive disease[15](index=15&type=chunk) - The vaccine uses a **single carrier protein, CRM197**, to ensure a consistent immune response while simplifying production and maintaining cost-effectiveness[15](index=15&type=chunk) [Recombinant RSV Vaccine (CHO Cell)](index=5&type=section&id=%E9%87%8D%E7%B5%84RSV%E7%96%AB%E8%8B%97%EF%BC%88CHO%E7%B4%B0%E8%83%9E%EF%BC%89) 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](index=16&type=chunk) - It aims to protect adults, including pregnant women, from acute RSV infection and related severe lower respiratory tract illness[16](index=16&type=chunk) - The vaccine received **IND approval from both the NMPA and the FDA** in August 2025[16](index=16&type=chunk) [RSV-mRNA Vaccine](index=5&type=section&id=RSV-mRNA%E7%96%AB%E8%8B%97) 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](index=17&type=chunk) - It utilizes synthetic mRNA designed to encode the RSV pre-F protein, encapsulated in lipid nanoparticles (LNPs)[17](index=17&type=chunk) - As of the announcement date, the vaccine candidate is undergoing **pre-clinical studies**[17](index=17&type=chunk) [mRNA Mpox Vaccine](index=5&type=section&id=mRNA%E7%8C%B4%E7%97%98%E7%96%AB%E8%8B%97) 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](index=18&type=chunk) - It is intended for the prevention of mpox in individuals aged 18 and above[18](index=18&type=chunk) - As of the announcement date, the vaccine candidate is undergoing **pre-clinical studies**[18](index=18&type=chunk) [Varicella Vaccine, Live](index=5&type=section&id=%E6%B0%B4%E7%97%98%E6%B8%9B%E6%AF%92%E6%B4%BB%E7%96%AB%E8%8B%97) 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](index=19&type=chunk) - It is produced by propagating the Oka strain of VZV in human diploid cells (MRC-5) and is lyophilized with a stabilizer[19](index=19&type=chunk) - The company has completed the establishment of the **cell banks and virus seed banks** for the vaccine candidate[19](index=19&type=chunk) [Adsorbed Tetanus Toxoid Vaccine](index=6&type=section&id=%E5%90%B8%E9%99%84%E7%A0%B4%E5%82%B7%E9%A2%A8%E9%A1%9E%E6%AF%92%E7%B4%A0%E7%96%AB%E8%8B%97) 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](index=20&type=chunk) - The company has completed the **process scale-up development and three pilot-scale production batches** of the drug substance for the vaccine candidate[20](index=20&type=chunk) [R&D](index=6&type=section&id=%E7%A0%94%E7%99%BC) 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](index=21&type=chunk) - As of June 30, 2025, **46.1% of the in-house R&D team held a Ph.D. or master's degree**[21](index=21&type=chunk) - The company has established platforms for genetic engineering and protein expression, mRNA vaccine research, and adjuvant development, supplemented by unique proprietary technologies[22](index=22&type=chunk) [Manufacturing](index=7&type=section&id=%E7%94%9F%E7%94%A2%E8%A3%BD%E9%80%A0) 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](index=23&type=chunk) - 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](index=23&type=chunk) - 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](index=23&type=chunk) [Commercialization](index=7&type=section&id=%E5%95%86%E6%A5%AD%E5%8C%96) 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](index=24&type=chunk) - An in-house sales and marketing team has been established, supplemented by third-party marketing service providers[24](index=24&type=chunk) - The marketing strategy is led by academic promotion with a focus on special populations such as pregnant women and patients with chronic diseases[24](index=24&type=chunk) [Intellectual Property](index=7&type=section&id=%E7%9F%A5%E8%AD%98%E7%94%A2%E6%AC%8A) 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](index=25&type=chunk) - The core product, the Quadrivalent Influenza Virus Subunit Vaccine, is protected by 12 registered patents, while the rabies vaccine has 5 registered patents[25](index=25&type=chunk) - 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](index=25&type=chunk) [Employees and Remuneration](index=8&type=section&id=%E5%83%B1%E5%93%A1%E5%8F%8A%E8%96%AA%E9%85%AC) 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](index=26&type=chunk) - The Group's employee remuneration package includes salaries, bonuses, and equity-based incentives, and an employee incentive scheme has been adopted[26](index=26&type=chunk) - 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](index=26&type=chunk) [Future Outlook](index=8&type=section&id=%E6%9C%AA%E4%BE%86%E5%B1%95%E6%9C%9B) 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](index=30&type=chunk) - Accelerate the development of other vaccine candidates that address unmet clinical needs to enrich the vaccine pipeline[30](index=30&type=chunk) - Further strengthen manufacturing and commercialization capabilities, and enter international markets to enhance the commercial value of vaccine candidates[30](index=30&type=chunk) [Financial Review](index=8&type=section&id=%E8%B2%A1%E5%8B%99%E5%9B%9E%E9%A1%A7) 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](index=8&type=section&id=%E7%B6%93%E7%87%9F%E6%A5%AD%E7%B8%BE%E4%B8%BB%E8%A6%81%E9%A0%85%E7%9B%AE%E5%88%86%E6%9E%90) 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](index=8&type=section&id=%E6%94%B6%E5%85%A5) 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](index=28&type=chunk) [Cost of Sales](index=8&type=section&id=%E9%8A%B7%E5%94%AE%E6%88%90%E6%9C%AC) 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](index=29&type=chunk) [Gross Profit and Gross Profit Margin](index=9&type=section&id=%E6%AF%9B%E5%88%A9%E5%8F%8A%E6%AF%9B%E5%88%A9%E7%8E%87) 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](index=9&type=section&id=%E5%85%B6%E4%BB%96%E6%94%B6%E5%85%A5) 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](index=32&type=chunk) [R&D Expenses](index=9&type=section&id=%E7%A0%94%E7%99%BC%E9%96%8B%E6%94%AF) 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](index=33&type=chunk) [Selling Expenses](index=9&type=section&id=%E9%8A%B7%E5%94%AE%E9%96%8B%E6%94%AF) 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](index=36&type=chunk) [Administrative Expenses](index=10&type=section&id=%E8%A1%8C%E6%94%BF%E9%96%8B%E6%94%AF) 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](index=37&type=chunk) [Listing Expenses](index=10&type=section&id=%E4%B8%8A%E5%B8%82%E9%96%8B%E6%94%AF) 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](index=10&type=section&id=%E8%B2%A1%E5%8B%99%E6%88%90%E6%9C%AC) 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](index=39&type=chunk) [Loss for the Period](index=10&type=section&id=%E6%9C%9F%E5%85%A7%E8%99%A7%E6%90%8D) 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](index=10&type=section&id=%E8%B2%A1%E5%8B%99%E7%8B%80%E6%B3%81%E4%B8%BB%E8%A6%81%E9%A0%85%E7%9B%AE%E5%88%86%E6%9E%90) As of June 30, 2025, inventories increased significantly to meet demand, while trade receivables decreased due to active collection efforts [Inventories](index=10&type=section&id=%E5%AD%98%E8%B2%A8) 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](index=41&type=chunk) [Trade Receivables](index=10&type=section&id=%E8%B2%A1%E6%98%93%E6%87%89%E6%94%B6%E6%AC%BE%E9%A0%85) 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](index=42&type=chunk) [Trade and Other Payables](index=10&type=section&id=%E8%B2%A1%E6%98%93%E5%8F%8A%E5%85%B6%E4%BB%96%E6%87%89%E4%BB%98%E6%AC%BE%E9%A0%85) 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](index=43&type=chunk) [Liquidity and Capital Resources](index=11&type=section&id=%E6%B5%81%E5%8B%95%E8%B3%87%E9%87%91%E5%8F%8A%E8%B3%87%E6%9C%AC%E8%B3%87%E6%BA%90) 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](index=45&type=chunk) - Funding sources were primarily through equity financing, bank borrowings, and cash generated from operations[45](index=45&type=chunk) - 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](index=45&type=chunk) | Date | June 30, 2025 (RMB in thousands) | December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | 108,427 | 132,194 | [Net Current Liabilities](index=11&type=section&id=%E6%B5%81%E5%8B%95%E8%B2%A0%E5%82%B5%E6%B7%A8%E9%A1%8D) 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](index=46&type=chunk) [Indebtedness](index=11&type=section&id=%E5%82%B5%E5%8B%99) As of June 30, 2025, total borrowings increased to support operations, while lease liabilities decreased and amounts due to shareholders were settled [Borrowings](index=11&type=section&id=%E5%80%9F%E6%AC%BE) 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](index=47&type=chunk) [Lease Liabilities](index=12&type=section&id=%E7%A7%9F%E8%B3%83%E8%B2%A0%E5%82%B5) 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](index=48&type=chunk) [Amounts Due to Shareholders](index=12&type=section&id=%E6%87%89%E4%BB%98%E8%82%A1%E6%9D%B1%E6%AC%BE%E9%A0%85) 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](index=49&type=chunk) [Third-party Loans](index=12&type=section&id=%E7%AC%AC%E4%B8%89%E6%96%B9%E8%B2%B8%E6%AC%BE) 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](index=50&type=chunk) [Pledge of Assets](index=12&type=section&id=%E8%B3%87%E7%94%A2%E6%8A%B5%E6%8A%BC) 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](index=12&type=section&id=%E8%B3%87%E7%94%A2%E8%B2%A0%E5%82%B5%E6%AF%94%E7%8E%87) 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](index=52&type=chunk) [Capital Expenditure and Capital Commitments](index=12&type=section&id=%E8%B3%87%E6%9C%AC%E6%94%AF%E5%87%BA%E5%8F%8A%E8%B3%87%E6%9C%AC%E6%89%BF%E6%93%94) 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](index=53&type=chunk) [Contingent Liabilities](index=13&type=section&id=%E6%88%96%E7%84%B6%E8%B2%A0%E5%82%B5) 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](index=54&type=chunk) [Foreign Exchange Risk](index=13&type=section&id=%E8%B2%A8%E5%B9%A3%E9%A2%A8%E9%9A%AA) 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](index=55&type=chunk) [Material Investments and Material Acquisitions and Disposals of Subsidiaries, Associates and Joint Ventures](index=13&type=section&id=%E9%87%8D%E5%A4%A7%E6%8A%95%E8%B3%87%E5%8F%8A%E9%87%8D%E5%A4%A7%E6%94%B6%E8%B3%BC%E5%8F%8A%E5%87%BA%E5%94%AE%E9%99%84%E5%B1%AC%E5%85%AC%E5%8F%B8%E3%80%81%E8%81%AF%E7%87%9F%E5%85%AC%E5%8F%B8%E5%8F%8A%E5%90%88%E7%87%9F%E4%BC%81%E6%A5%AD) 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](index=56&type=chunk) [Condensed Consolidated Financial Statements](index=14&type=section&id=%E7%B0%A1%E6%98%8E%E7%B6%9C%E5%90%88%E8%B2%A1%E5%8B%99%E5%A0%B1%E8%A1%A8) [Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=14&type=section&id=%E7%B0%A1%E6%98%8E%E7%B6%9C%E5%90%88%E6%90%8D%E7%9B%8A%E5%8F%8A%E5%85%B6%E4%BB%96%E5%85%A8%E9%9D%A2%E6%94%B6%E7%9B%8A%E8%A1%A8) 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](index=15&type=section&id=%E7%B0%A1%E6%98%8E%E7%B6%9C%E5%90%88%E8%B2%A1%E5%8B%99%E7%8B%80%E6%B3%81%E8%A1%A8) 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](index=17&type=section&id=%E7%B0%A1%E6%98%8E%E7%B6%9C%E5%90%88%E8%B2%A1%E5%8B%99%E5%A0%B1%E8%A1%A8%E9%99%84%E8%A8%BB) [Basis of Preparation](index=17&type=section&id=%E7%B7%A8%E8%A3%BD%E5%9F%BA%E6%BA%96) 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](index=60&type=chunk) [Principal Accounting Policies](index=17&type=section&id=%E4%B8%BB%E8%A6%81%E6%9C%83%E8%A8%88%E6%94%BF%E7%AD%96) 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](index=61&type=chunk) - 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](index=61&type=chunk) [Revenue from Contracts with Customers](index=17&type=section&id=%E5%AE%A2%E6%88%B6%E5%90%88%E7%B4%84%E6%94%B6%E5%85%A5) 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](index=18&type=section&id=%E5%88%86%E9%83%A8%E8%B3%87%E6%96%99) 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](index=63&type=chunk) - As at June 30, 2025, all non-current assets were located in China[64](index=64&type=chunk) [Other Income](index=18&type=section&id=%E5%85%B6%E4%BB%96%E6%94%B6%E5%85%A5) 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](index=66&type=chunk) [Other Gains and Losses](index=18&type=section&id=%E5%85%B6%E4%BB%96%E6%94%B6%E7%9B%8A%E5%8F%8A%E8%99%A7%E6%90%8D) 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](index=19&type=section&id=%E6%AF%8F%E8%82%A1%E8%99%A7%E6%90%8D) 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](index=19&type=section&id=%E8%B2%A1%E6%98%93%E6%87%89%E6%94%B6%E6%AC%BE%E9%A0%85) 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](index=20&type=section&id=%E8%B2%A1%E6%98%93%E5%8F%8A%E5%85%B6%E4%BB%96%E6%87%89%E4%BB%98%E6%AC%BE%E9%A0%85) 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](index=21&type=section&id=%E5%80%9F%E6%AC%BE) 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](index=22&type=section&id=%E5%85%B6%E4%BB%96%E4%BF%A1%E6%81%AF) [Interim Dividend](index=22&type=section&id=%E4%B8%AD%E6%9C%9F%E8%82%A1%E6%81%AF) 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](index=73&type=chunk) [Purchase, Sale or Redemption of the Company's Listed Securities](index=22&type=section&id=%E8%B3%BC%E8%B2%B7%E3%80%81%E5%87%BA%E5%94%AE%E6%88%96%E8%B4%96%E5%9B%9E%E6%9C%AC%E5%85%AC%E5%8F%B8%E4%B8%8A%E5%B8%82%E8%AD%89%E5%88%B8) 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](index=74&type=chunk) - 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](index=74&type=chunk) [Events After the Reporting Period](index=22&type=section&id=%E5%A0%B1%E5%91%8A%E6%9C%9F%E5%BE%8C%E4%BA%8B%E9%A0%85) 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](index=22&type=section&id=%E5%9C%A8%E8%81%AF%E4%BA%A4%E6%89%80%E4%B8%8A%E5%B8%82) 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](index=75&type=chunk) - The total proceeds from the Listing amounted to approximately **HK$431.4 million**[75](index=75&type=chunk) - 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](index=75&type=chunk) [Clinical Trials](index=22&type=section&id=%E8%87%A8%E5%BA%8A%E8%A9%A6%E9%A9%97) 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](index=76&type=chunk) - We subsequently commenced the **Phase II clinical trial** for the investigational recombinant zoster vaccine in July 2025[76](index=76&type=chunk) [IND Approval](index=22&type=section&id=IND%E6%89%B9%E5%87%86) 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](index=77&type=chunk) - In addition, our IND application in the United States has also been approved by the **FDA**[77](index=77&type=chunk) [Compliance with the Corporate Governance Code](index=22&type=section&id=%E9%81%B5%E5%AE%88%E4%BC%81%E6%A5%AD%E7%AE%A1%E6%B2%BB%E5%AE%88%E5%89%87) 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](index=79&type=chunk) - 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](index=79&type=chunk) - 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](index=79&type=chunk) [Compliance with the Model Code](index=23&type=section&id=%E9%81%B5%E5%AE%88%E6%A8%99%E6%BA%96%E5%AE%88%E5%89%87) 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](index=80&type=chunk) - 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](index=80&type=chunk) [Continuing Disclosure Obligations under the Listing Rules](index=23&type=section&id=%E6%A0%B9%E6%93%9A%E4%B8%8A%E5%B8%82%E8%A6%8F%E5%89%87%E8%A6%8F%E5%AE%9A%E7%9A%84%E6%8C%81%E7%BA%8C%E6%8A%AB%E9%9C%B2%E7%BE%A9%E5%8B%99) 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](index=81&type=chunk) [Changes in Information of Directors, Supervisors and Chief Executive](index=23&type=section&id=%E8%91%A3%E4%BA%8B%E3%80%81%E7%9B%A3%E4%BA%8B%E5%8F%8A%E6%9C%80%E9%AB%98%E8%A1%8C%E6%94%BF%E4%BA%BA%E5%93%A1%E8%B3%87%E6%96%99%E4%B9%8B%E8%AE%8A%E6%9B%B4) 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](index=82&type=chunk) [Sufficient Public Float](index=24&type=section&id=%E5%85%AC%E7%9C%BE%E6%8C%81%E8%82%A1%E9%87%8F%E5%85%85%E8%B6%B3) 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](index=83&type=chunk) [Review of Interim Financial Information](index=24&type=section&id=%E5%AF%A9%E9%96%B1%E4%B8%AD%E6%9C%9F%E8%B2%A1%E5%8B%99%E8%B3%87%E6%96%99) 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](index=84&type=chunk) [Audit Committee](index=24&type=section&id=%E5%AF%A9%E8%A8%88%E5%A7%94%E5%93%A1%E6%9C%83) 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](index=85&type=chunk) - 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](index=85&type=chunk) [Publication of Interim Report](index=24&type=section&id=%E5%88%8A%E7%99%BC%E4%B8%AD%E6%9C%9F%E5%A0%B1%E5%91%8A) 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](index=86&type=chunk) [Definitions, Abbreviations and Technical Glossary](index=24&type=section&id=%E9%87%8B%E7%BE%A9%E3%80%81%E7%B8%AE%E7%95%A5%E8%A9%9E%E5%8F%8A%E6%8A%80%E8%A1%93%E8%A9%9E%E5%BD%99%E8%A1%A8) [Definitions](index=25&type=section&id=%E9%87%8B%E7%BE%A9) 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](index=88&type=chunk) - **"Reporting Period"** refers to the six months ended June 30, 2025[89](index=89&type=chunk) [Abbreviations](index=27&type=section&id=%E7%B8%AE%E7%95%A5%E8%A9%9E) 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](index=91&type=chunk) [Technical Glossary](index=27&type=section&id=%E6%8A%80%E8%A1%93%E8%A9%9E%E5%BD%99%E8%A1%A8) 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](index=92&type=chunk) - Explains the definitions and purposes of different clinical trial phases (Phase I, II, III)[92](index=92&type=chunk)[93](index=93&type=chunk) - 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](index=93&type=chunk)
生物科技股多数下跌,云康集团跌超14%,腾盛博药跌超8%
Ge Long Hui· 2025-08-19 07:29
Group 1 - The majority of Hong Kong biotech stocks experienced declines, with notable drops in several companies [1] - Specifically, Gilead Sciences fell by 15.06%, while Yunkang Group and Pigeon BioPharma dropped over 14% and 9% respectively [2] - Other companies such as China Antibody and Jiahua Bio also saw declines exceeding 7% [1][2] Group 2 - The latest market prices and total market capitalizations for the affected companies include: - Gilead Sciences at 15.510 with a market cap of 14.946 billion - Yunkang Group at 2.300 with a market cap of 1.429 billion - Pigeon BioPharma at 31.760 with a market cap of 12.258 billion - Tengsheng BioPharma at 2.210 with a market cap of 1.590 billion - China Antibody at 3.210 with a market cap of 4.371 billion - Jiahua Bio at 4.460 with a market cap of 2.347 billion [2]
港股生物科技股多数下跌,云康集团跌超14%,腾盛博药跌超8%
Ge Long Hui A P P· 2025-08-19 06:10
Summary of Key Points Core Viewpoint - The Hong Kong biotechnology sector experienced a significant decline, with most stocks falling sharply, indicating a bearish trend in the market [1]. Company Performance - **Gilead Sciences (歌礼制药-B)**: Decreased by 15.06%, latest price at 15.510, market cap at 14.946 billion [2]. - **Yunkang Group (云康集团)**: Fell by 14.18%, latest price at 2.300, market cap at 1.429 billion [2]. - **PAG Pharmaceuticals (派格生物医药-B)**: Dropped by 9.15%, latest price at 31.760, market cap at 12.258 billion [2]. - **Tengsheng Boao (腾盛博药-B)**: Declined by 8.30%, latest price at 2.210, market cap at 1.590 billion [2]. - **China Antibody (中国抗体-B)**: Decreased by 7.49%, latest price at 3.210, market cap at 4.371 billion [2]. - **Jiahua Biotech (嘉和生物-B)**: Fell by 7.08%, latest price at 4.460, market cap at 2.347 billion [2]. - **Sillod Pharmaceuticals (思路迪医药股份)**: Dropped by 6.06%, latest price at 7.910, market cap at 2.042 billion [2]. - **Tiger Med (泰格医药)**: Decreased by 5.73%, latest price at 54.250, market cap at 46.711 billion [2]. - **Kangji Medical (加科思-B)**: Fell by 5.69%, latest price at 8.120, market cap at 6.404 billion [2]. - **WuXi AppTec (药明巨诺-B)**: Dropped by 5.14%, latest price at 5.720, market cap at 2.382 billion [2]. - **Three Leaf Clover Biotech (三叶草生物-B)**: Decreased by 5.13%, latest price at 0.740, market cap at 0.960 billion [2]. - **Yiming Oncology (宜明昂科-B)**: Fell by 4.76%, latest price at 12.810, market cap at 5.218 billion [2]. - **Junshi Biosciences (君实生物)**: Decreased by 4.69%, latest price at 34.540, market cap at 35.462 billion [2]. - **Zhonghui Biotech (中慧生物-B)**: Fell by 4.39%, latest price at 51.150, market cap at 20.125 billion [2]. - **Zhaoyan New Drug (昭衍新药)**: Decreased by 4.38%, latest price at 23.140, market cap at 17.343 billion [2].
19万人打新,超额认购逾4000倍 中慧生物港交所上市首日盘中涨近170%
Mei Ri Jing Ji Xin Wen· 2025-08-18 13:45
Core Viewpoint - 中慧生物 successfully listed on the Hong Kong Stock Exchange, achieving a remarkable first-day increase of 157.98% from its opening price, reflecting strong investor interest in innovative biotech companies [1][2] Company Overview - 中慧生物 was established in 2015, focusing on the research, manufacturing, and commercialization of innovative vaccines, including two core products and 11 other vaccines in development [2] - The core product "慧尔康欣" is China's first and only approved quadrivalent influenza virus subunit vaccine, while another core product, a freeze-dried human rabies vaccine, is expected to enter phase III clinical trials in Q3 2023 [2][3] Market Performance - The company attracted significant investment prior to its listing, with over 19,000 investors participating in the public offering, resulting in an oversubscription of over 4000 times and a total subscription amount exceeding 200 billion HKD [2][3] - 中慧生物's dark market performance also set a record, with a rise of approximately 160%, making it the top-performing new stock of the year [3] Financial Performance - For the years 2023, 2024, and Q1 2025, 中慧生物 reported revenues of 52.168 million, 260 million, and 4.13 million CNY respectively, with R&D expenditures of 283 million, 206 million, and 46.514 million CNY, resulting in losses of 425 million, 259 million, and 87.317 million CNY [4] - The company explained that its revenue is seasonally concentrated from July to September, leading to lower first-quarter revenues [4] Industry Context - The pricing of "慧尔康欣" is set at 319 CNY per dose, which is higher than the industry average, as the average bidding price for influenza vaccines in China has decreased from 126 CNY in 2022 to 125 CNY in 2023, and is projected to drop to 93 CNY in 2024 [5] - Despite challenges such as low vaccination rates and price competition, 中慧生物 sees significant growth potential, with the Chinese influenza vaccine market projected to grow from 2 billion CNY in 2019 to 7 billion CNY in 2024, reflecting a compound annual growth rate of 28.7% [5]
19万人打新 超额认购逾4000倍 中慧生物港交所上市首日盘中涨近170%
Mei Ri Jing Ji Xin Wen· 2025-08-18 13:44
Company Overview - 中慧生物-B successfully listed on the Hong Kong Stock Exchange on August 11, with an opening price of 33.0 HKD per share, marking a significant increase of 157.98% by the end of the trading day [2][3] - The company focuses on the research, manufacturing, and commercialization of innovative vaccines, including its core products: the first approved quadrivalent influenza vaccine in China and a freeze-dried rabies vaccine currently in clinical trials [3][5] Financial Performance - 中慧生物 reported revenues of 52.168 million HKD, 260 million HKD, and 4.13 million HKD for the years 2023, 2024, and the first quarter of 2025, respectively, with corresponding R&D expenditures of 283 million HKD, 206 million HKD, and 46.514 million HKD [5] - The company experienced losses of 425 million HKD, 259 million HKD, and 87.317 million HKD during the same periods [5] Market Dynamics - The company’s core product, the慧尔康欣 vaccine, is priced at 319 HKD per dose, which is above the industry average, while the average bidding price for influenza vaccines in China has decreased from 126 HKD in 2022 to 125 HKD in 2023, and is projected to drop to 93 HKD in 2024 [5] - Despite challenges such as price competition and low vaccination rates, 中慧生物 sees significant growth potential, with the Chinese influenza vaccine market projected to grow from 2 billion HKD in 2019 to 7 billion HKD by 2024, reflecting a compound annual growth rate of 28.7% [6] Investor Interest - The company attracted substantial investor interest during its IPO, with over 19,000 participants and an oversubscription rate exceeding 4000 times, leading to a total subscription amount exceeding 200 billion HKD [4] - The dark market performance prior to the official listing also set a record, with a rise of approximately 160%, making it the top-performing new stock of the year [4]
中慧生物-B重磅产品中美双获批,有望填补RSV疫苗市场空白
Zhi Tong Cai Jing· 2025-08-18 06:53
Core Viewpoint - Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. (referred to as "Zhonghui Biotech") has achieved a significant milestone in its research and development by obtaining IND approval for its recombinant respiratory syncytial virus (RSV) vaccine from the National Medical Products Administration (NMPA) in China, which has also received clinical approval from the FDA in the United States, marking the first dual approval for the company [1][5]. Group 1: Company Developments - The RSV vaccine developed by Zhonghui Biotech and its subsidiary, Yihui Biotechnology (Shanghai) Co., Ltd., is designed to prevent lower respiratory tract infections caused by RSV [1][6]. - The vaccine utilizes innovative technology with fully independent intellectual property rights and employs a pre-F antigen sequence that exhibits high stability, allowing for long-term storage at 2-8°C without freeze-drying [7][8]. - The company has established a comprehensive commercial product and R&D pipeline, with its core product, a quadrivalent influenza virus subunit vaccine, already approved and used in over 30 provinces in China [8]. Group 2: Market Potential - The global RSV drug market, including treatment and prevention, is projected to grow from $1.8 billion in 2020 to $12.8 billion by 2030, with a compound annual growth rate (CAGR) of 21.4% [6]. - The high incidence of RSV infections globally is creating a significant market opportunity, especially as there are currently no approved RSV vaccines in the domestic market [6][7]. - The successful IND approval for Zhonghui Biotech's RSV vaccine positions the company to fill a gap in the domestic RSV prevention market, potentially leading to substantial growth and market returns [7][8].
异动盘点0818|声通科技早盘涨近30%,机器人概念股涨幅居前;迅雷美股涨超26%,应用材料跌超14%
贝塔投资智库· 2025-08-18 04:16
Group 1: Hong Kong Stocks - Ascentage Pharma-B (06855) opened over 5% higher after receiving FDA and EMA approval for its drug, Lisenglitazone, for high-risk MDS in Phase III clinical trials [1] - Haijia Medical (06078) fell over 5% following a profit warning, expecting a mid-term net profit decline of approximately 34% to 39% due to factors like centralized procurement and increased depreciation from new hospitals [1] - Hua Hong Semiconductor (01347) dropped over 6% as it announced plans to acquire a controlling stake in Shanghai Huali Microelectronics to address industry competition [1] - Zhonghui Biotech-B (02627) rose over 8% after receiving IND approval for its recombinant respiratory syncytial virus vaccine in both the US and China [1] - NetDragon (00777) surged over 10% after forming a strategic alliance with Zhongke Wenge to promote AI technologies abroad [1] - Great Wall Motors (02333) increased over 12% following the completion of its factory in Brazil, with an initial production capacity of 30,000 vehicles per year [1] - Yuewen Group (00772) rose over 20% as its first-half performance exceeded expectations, benefiting from growth in licensing business and steady performance of short dramas [1] Group 2: Other Notable Stocks - Huirui Group (00806) increased over 8% after reporting first-half results that met market expectations and is applying for MRF mutual recognition for other products [2] - Soundon Technology (02495) surged nearly 30% after announcing a projected net profit exceeding 50 million yuan for the first half, marking a turnaround from losses [2] - Robotics concept stocks saw significant gains, with Jinshang Machine Tool (01651) up over 11% and Lijin Technology (00558) up over 3% [2] Group 3: US Stocks - Intel (INTC.US) rose 2.93% amid reports of negotiations with the Trump administration for government investment to support domestic manufacturing [3] - Hesai Technology (HSAI.US) increased 9.73% after reporting over 50% year-on-year revenue growth for Q2 2025 [3] - UnitedHealth (UNH.US) surged 11.98% following Berkshire Hathaway's new investments in the company [3] - NIO (NIO.N) rose 8.09% as it announced the upcoming launch of its new ES8 model [4] - Xunlei (XNET.US) continued to rise by 26.53% after reporting a 30.6% year-on-year revenue increase for Q2 2025 [5]
港股异动 中慧生物-B(02627)涨超7% 重组呼吸道合胞病毒疫苗IND申请中美双报获批
Jin Rong Jie· 2025-08-18 03:46
Group 1 - The core point of the article is that Zhonghui Biotech-B (02627) has seen a stock increase of over 7%, currently trading at 50.6 HKD with a transaction volume of 13.64 million HKD, following the approval of its IND application for a recombinant respiratory syncytial virus vaccine by both the National Medical Products Administration (NMPA) in China and the FDA in the United States [1][2]. Group 2 - The company announced that its recombinant respiratory syncytial virus vaccine (CHO cells) utilizes CHO cells to express modified pre-F proteins, achieving a stable high-yield monoclonal cell line that expresses pre-F proteins at higher levels than existing marketed RSV vaccines [1]. - In preclinical studies, the vaccine demonstrated better thermal stability and superior immunogenicity compared to currently available recombinant RSV vaccines [1].
中慧生物-B(02627.HK)盘中涨逾9% 重组呼吸道合胞病毒疫苗IND申请获中国及美国批准
Jin Rong Jie· 2025-08-18 02:24
Core Viewpoint - Zhonghui Biotech-B (02627.HK) has received approval for its self-developed recombinant respiratory syncytial virus vaccine from both the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA) [1] Group 1 - The company's stock price increased by over 9% shortly after market opening, currently up by 6.3%, trading at HKD 50.15 [1] - The vaccine is developed using CHO cell technology and is in the clinical trial phase [1] - The approval from the NMPA and FDA marks a significant milestone for the company in its vaccine development efforts [1]
中慧生物-B涨超7% 重组呼吸道合胞病毒疫苗IND申请中美双报获批
Zhi Tong Cai Jing· 2025-08-18 01:52
Core Viewpoint - Zhonghui Biotech-B (02627) shares rose over 7% following the announcement of the approval of its IND application for a recombinant respiratory syncytial virus vaccine by both the National Medical Products Administration (NMPA) in China and the FDA in the United States [1] Group 1 - Zhonghui Biotech's stock increased by 7.25%, reaching HKD 50.6, with a trading volume of HKD 13.6446 million [1] - The company announced that its self-developed recombinant respiratory syncytial virus vaccine (CHO cell) has received IND approval from the NMPA and the FDA [1] - The vaccine utilizes CHO cells to express modified pre-F proteins and has shown higher pre-F expression levels, better thermal stability, and superior immunogenicity compared to existing RSV vaccines in preclinical studies [1]