中慧生物递交招股书 联席保荐人为中信证券、招银国际
Zheng Quan Shi Bao Wang·2025-01-23 05:30

Company Overview - Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with CITIC Securities and CMB International as joint sponsors [1] - Established in 2015, the company focuses on the research, development, manufacturing, and commercialization of innovative vaccines and traditional vaccines using new technologies [1] - The company has two core products: a quadrivalent influenza virus subunit vaccine and an investigational lyophilized human rabies vaccine [1] Product Details - The quadrivalent influenza virus subunit vaccine, named Huiruankangxin, received approval from the National Medical Products Administration (NMPA) in May 2023 for individuals aged three and above, making it the first and only quadrivalent influenza virus subunit vaccine approved in China as of the last feasible date [1] - The company has submitted a New Drug Application (NDA) for the use of the quadrivalent influenza virus subunit vaccine in children aged 6 to 35 months, which was accepted by the NMPA in June 2024 [1] - The investigational lyophilized human rabies vaccine is developed using human diploid cells, which are recommended by the World Health Organization as one of the safest cell culture substrates for producing viral vaccines [1][4] Clinical Trial Results - In Phase III clinical trials, the quadrivalent influenza virus subunit vaccine demonstrated serum protection rates of 96.56%, 97.98%, 89.41%, and 95.88% for H1N1, H3N2, BV, and BY virus strains, respectively, all exceeding the EU standard of 70.0% [2] - The geometric mean titer (GMT) of neutralizing antibodies induced by the vaccine was significantly higher than that of the control quadrivalent influenza virus split vaccine [2] - The overall incidence of vaccine-related adverse events in participants aged 18 to 64 was lower than that of the control vaccine, with statistically significant differences [2] Market Analysis - The influenza vaccine market in China grew from 2 billion yuan in 2019 to 8.8 billion yuan in 2023, with a compound annual growth rate (CAGR) of 45.1% [3] - The total number of influenza vaccine batches released increased from 30.8 million doses in 2019 to 70.5 million doses in 2023, with projections to reach 19.8 billion yuan by 2032 [3] - The quadrivalent influenza virus subunit vaccine market is expected to grow from 400 million yuan in 2023 to 3.4 billion yuan by 2032, with a CAGR of 27.4% [3] Rabies Vaccine Market - The human rabies vaccine market in China increased from 3.8 billion yuan in 2019 to 8.9 billion yuan in 2023, with a CAGR of 23.9% [4] - The total number of rabies vaccine batches released rose from 58.8 million doses in 2019 to 70.4 million doses in 2023, with expectations to reach 12.5 billion yuan by 2032, reflecting a CAGR of 3.8% from 2023 to 2032 [4] - The investigational rabies vaccine is expected to partially replace traditional vaccines developed using Vero and primary hamster kidney cells [4]

CITIC Securities Co., Ltd.-中慧生物递交招股书 联席保荐人为中信证券、招银国际 - Reportify