New stock information | Zhonghui Biologics submits application to Hong Kong Stock Exchange with core products including quadrivalent influenza virus subunit vaccine and lyophilized human rabies vaccine under development.

On January 23, Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. (Zhonghui Biotech) submitted an application for listing on the main board of the Hong Kong Stock Exchange, with CITIC SEC and CMB International as joint sponsors. According to the prospectus, Zhonghui Biotech was established in 2015 and is a vaccine company headquartered in China, dedicated to the research and development, manufacturing, and commercialization of innovative vaccines and traditional vaccines using new technological methods. Currently, Zhonghui Biotech has two core products, namely a quadrivalent influenza virus subunit vaccine and an investigational freeze-dried human rabies vaccine. Zhonghui Biotech's quadrivalent influenza virus subunit vaccine is a significant technological upgrade to traditional viral split vaccines, offering a product with high antigen purity and low risk of adverse reactions. It was approved by the National Medical Products Administration for use in individuals aged three and above in May 2023, under the trade name Huerkangxin. It is the first and only quadrivalent influenza virus subunit vaccine approved in China as of the last feasible date (January 15, 2025). The company began commercialization after the vaccine was approved, generating revenues of approximately RMB 217.2 million for the nine months ended September 30, 2024. The company has also 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 National Medical Products Administration in June 2024. The investigational freeze-dried human rabies vaccine being developed by Zhonghui Biotech uses human diploid cells, which the World Health Organization recommends as one of the safest cell substrates for producing viral vaccines. It demonstrated good safety in Phase I clinical trials already completed and is expected to commence Phase III clinical trials in the second or third quarter of 2025. In addition to the two core products, Zhonghui Biotech's product pipeline includes another 11 investigational vaccines covering various disease areas with vaccination needs. Other investigational products include a trivalent influenza virus subunit vaccine, a 23-valent pneumococcal polysaccharide vaccine (PPSV23), a recombinant herpes zoster vaccine (CHO cells). Apart from the aforementioned products, the company is also developing a 24-valent pneumococcal conjugate vaccine (PCV24) for pneumonia prevention; mRNA and recombinant vaccines for preventing respiratory syncytial virus (RSV) infection; an mRNA monkeypox vaccine; a live attenuated varicella vaccine; and an adsorbed tetanus toxoid vaccine. In terms of production, as of the last feasible date, all quadrivalent influenza virus subunit vaccine products and investigational vaccines used in clinical trials by Zhonghui Biotech were manufactured at the company's first production park located at its headquarters in Taizhou. The first production park has a building area exceeding 48,000 square meters and is equipped with advanced equipment and machinery, including bioreactors, large centrifuges, ultrafiltration systems, large purification systems, and product filling and packaging production lines. The first production park currently has three operational production lines (including one for influenza vaccine production with an annual designed capacity of 4 million doses of quadrivalent and trivalent influenza virus subunit vaccines; one for rabies vaccine production with an annual designed capacity of 5 million doses of rabies vaccine; and one for pneumococcal vaccine production with an annual designed capacity of 15 million doses of PPSV23 and PCV24). In 2023 and the nine months ended September 30, 2024, the company produced 1.2 million and 1.8 million doses of the quadrivalent influenza virus subunit vaccine, with utilization rates of 30.2% and 61.0%, respectively. As of the last feasible date, the second influenza vaccine production line at Zhonghui Biotech's first production park is undergoing process validation. The annual designed capacity of the second influenza vaccine production line is the same as the existing influenza vaccine production line. The commencement of production for the second influenza vaccine production line is expected by the end of 2026. In terms of finances, Zhonghui Biotech achieved revenues of approximately RMB 52.168 million in 2023, RMB 4.532 million in the nine months ended September 30, 2023, and RMB 217.185 million in the nine months ended September 30, 2024.