艾美疫苗(06660) - 2025 - 中期财报

Company Information This section details changes in the company's board, supervisory committee, and key personnel, along with auditor and contact information Directors, Supervisors, and Committee Members During the reporting period, the company's board, supervisory committee, and various committees saw multiple changes, including the resignations of Non-executive Director Ms. Wang Aijun and Independent Non-executive Director Mr. Ouyang Hui, and the appointments of Ms. Wen Jie, Mr. Jia Shaojun, and Mr. Zhou Xin to different committees - Non-executive Director Ms. Wang Aijun resigned on April 13, 2025[6] - Independent Non-executive Director Mr. Ouyang Hui resigned on April 13, 2025[6] - Ms. Wen Jie was appointed as a member of the Audit Committee and Nomination Committee on April 17, 2025[6] - Mr. Jia Shaojun and Mr. Zhou Xin were appointed as members of the Strategy Committee on April 17, 2025[6] Company Secretary, Authorized Representatives, and Other Key Information Changes occurred in the company's joint company secretary and authorized representatives, with Ms. Lam Wing Chi resigning and Ms. Wong Pui Kiu appointed; the company's auditor is Ernst & Young, and information on its registered office, headquarters, principal place of business in Hong Kong, H-share registrar, and principal bankers was disclosed - Joint Company Secretary Ms. Lam Wing Chi resigned on June 13, 2025, and Ms. Wong Pui Kiu was appointed[8] - Authorized Representative Ms. Lam Wing Chi resigned on June 13, 2025, and Ms. Wong Pui Kiu was appointed[8] - The company's auditor is Ernst & Young[8] - The company's stock code is 06660, and its website is **www.aimbio.com**[10](index=10&type=chunk) Management Discussion and Analysis This section provides an overview of the company's business, R&D pipeline, production capabilities, industry landscape, future prospects, and financial performance for the reporting period Business Overview and Outlook Aim Vaccine, a leading Chinese vaccine enterprise, covers the entire value chain from R&D to commercialization, possessing five major technology platforms and seven R&D teams, with 8 commercialized and 20 pipeline products, including 4 core products expected to launch in 2025, while actively expanding internationally, despite a 4.2% year-on-year revenue decrease in H1 2025 - The company possesses five human vaccine technology platforms: bacterial, viral, genetic engineering, combination, and mRNA[12] - The company has 8 commercialized products for 6 diseases, with sales covering all 31 provinces, municipalities, and autonomous regions in China[12] - The company has 20 R&D vaccine products for 12 disease areas, with 4 core products (13-valent pneumococcal conjugate vaccine, serum-free rabies vaccine, 23-valent pneumococcal polysaccharide vaccine, high-titer human diploid cell rabies vaccine) in the final stages of market launch[13] - In H1 2025, the company's quadrivalent meningococcal polysaccharide vaccine entered the African market, and its rabies vaccine entered the Central American market[16] 2025 H1 Sales Revenue by Product Category | Metric | 2025 (RMB thousands) | 2024 (RMB thousands) | YoY Change (%) | | :--- | :----------------- | :----------------- | :----------- | | Total Vaccine Product Sales Revenue | 514,657 | 537,178 | -4.2% | | Class I Vaccine Sales Revenue | 55,876 | 54,100 | +3.3% | | Class II Vaccine Sales Revenue | 458,781 | 483,078 | -5.0% | Our Products and R&D Pipeline The company has commercialized eight vaccine products, with recombinant hepatitis B vaccine and lyophilized human rabies vaccine being market leaders; its rich R&D pipeline includes multivalent pneumococcal vaccines, iterated rabies vaccines, mRNA RSV, and shingles vaccines, with many products in late-stage clinical trials or marketing application, supported by AI technology and a professional internal R&D team - The company has commercialized eight vaccine products for six disease areas, with recombinant hepatitis B vaccine and lyophilized human rabies vaccine being the main commercialized vaccines[18] - The recombinant hepatitis B vaccine (Hansenula polymorpha) is China's first and only company to achieve stable production and batch release of hepatitis B vaccine using Hansenula polymorpha for antigen expression, possessing a patented process[19] - The lyophilized human rabies vaccine (Vero cell) has long held a leading market position, being the second largest supplier in the rabies vaccine market, maintaining a 100% pass rate in batch release quality reviews for 18 years[22] - The 13-valent pneumococcal conjugate vaccine (PCV13) has submitted a marketing authorization application to the NMPA and completed on-site inspections[26] - The serum-free iterated rabies vaccine has officially submitted a marketing authorization application, with no serum-free rabies vaccines yet approved for market launch globally[31] - Both mRNA RSV vaccine and mRNA shingles vaccine have received clinical trial approvals in China and the United States[35] - The company is currently utilizing AI for vaccine antigen structure and mRNA sequence design, and is exploring AI assistance in vaccine process R&D[39] Our Vaccine Products The company's commercialized products include recombinant hepatitis B vaccine (Hansenula polymorpha, China's only), lyophilized human rabies vaccine (Vero cell, second largest market supplier), inactivated hepatitis A vaccine (human diploid cell), and ACYW135 group meningococcal polysaccharide vaccine (MPSV4), which hold leading market positions and unique advantages, such as the hepatitis B vaccine's patented process and the rabies vaccine's 100% batch release pass rate - The recombinant hepatitis B vaccine (Hansenula polymorpha) is produced using a patented process, free of preservatives, antibiotics, and bovine serum albumin, with an expiry date until May 2032[19] - Since its commercialization in 2007, the lyophilized human rabies vaccine (Vero cell) has maintained a 100% pass rate in batch release quality reviews by the National Institutes for Food and Drug Control[22] - The ACYW135 group meningococcal polysaccharide vaccine (MPSV4) contains no antibiotics or preservatives and has a shelf life of three years, making it the only one of its kind[24] Our R&D Vaccines The company's R&D vaccine pipeline covers pneumonia, rabies, hand-foot-and-mouth disease, influenza, shingles, and RSV, with multiple products in late-stage clinical trials or marketing application, particularly iterated pneumococcal and rabies vaccine series, and innovative mRNA-based vaccines, demonstrating strong R&D capabilities R&D Vaccine Portfolio Overview | Technology Platform | Indication | R&D Vaccine | Development Stage | | :--- | :--- | :--- | :--- | | Bacterial Vaccine | Pneumococcal Disease | 13-valent Pneumococcal Conjugate Vaccine (PCV13) | Marketing Authorization Application Submitted | | | | 20-valent Pneumococcal Conjugate Vaccine (PCV20) | Clinical Trial Application Submitted | | | | 23-valent Pneumococcal Polysaccharide Vaccine (PPSV23) | Pre-marketing Authorization Application Planned for 2025 | | Viral Vaccine | Rabies | Serum-free Iterated Rabies Vaccine | Marketing Authorization Application Submitted | | | | Novel Process High-titer Human Diploid Cell Rabies Vaccine | Phase III Clinical Trials Ongoing | | mRNA Vaccine | Shingles | mRNA Shingles Vaccine | Clinical Trial Approval Obtained (China & US) | | | Respiratory Syncytial Virus Infection | mRNA Respiratory Syncytial Virus (RSV) Vaccine | Clinical Trial Approval Obtained (China & US) | - The Phase III clinical study results for the company's 13-valent pneumococcal conjugate vaccine (PCV13) demonstrated good immunogenicity and safety, meeting clinical endpoints[27] - The serum-free iterated rabies vaccine contains no animal serum, significantly enhancing safety and reducing the probability of adverse reactions[31] - The EV71-CA16 bivalent hand-foot-and-mouth disease vaccine is the world's first R&D vaccine designed to provide immunity against EV71 and CA16 virus strains, being the first to receive clinical approval[38] Vaccine Development Platform Technologies and Internal R&D Team The company possesses five validated human vaccine platform technologies, including mRNA, genetic engineering, and combination vaccines, and utilizes AI to assist in vaccine antigen structure, mRNA sequence design, and process R&D, with an internal R&D team comprising three research institutions and four manufacturing subsidiaries' R&D centers, each with specialized focus - The company possesses five validated human vaccine platform technologies, including mRNA vaccine, genetic engineering vaccine, and combination vaccine technologies[39] - The company is currently utilizing AI for vaccine antigen structure and mRNA sequence design, and is exploring AI