Double-strain influenza vaccine Phase I clinical trial initiated, AB&B BIO-TECH-B(02627) continues to enrich vaccine pipeline layout.

Recently, Jiangsu Zhonghuiyuantong Biotechnology Co., Ltd. (hereinafter referred to as "Zhonghui Biology") and its subsidiary Yihui Biotechnology (Shanghai) Co., Ltd. (hereinafter referred to as "Yihui Biology") jointly applied for a new type of drug, "Influenza Virus Subunit Vaccine (Adjuvant)" and "Quadrivalent Influenza Virus Subunit Vaccine (Adjuvant)", have successfully launched Phase I clinical trials in the Hubei region. Influenza, as an extremely infectious respiratory disease, has long been severely underestimated in terms of its potential public health burden and social impact. Data from the World Health Organization (WHO) show that globally, there are approximately 3 to 5 million severe cases of influenza-related illnesses each year. In China, between 2010 and 2015, the annual excess mortality due to respiratory diseases caused by influenza was as high as about 88,000 cases. It is worrisome that the overall vaccination rate for influenza vaccines in China is still at a low level. For example, in the 2022-2023 influenza season, the vaccination rate was only 3.84%, far from forming an effective immune barrier. Influenza prevention and control still face serious challenges. Among populations susceptible to influenza, infants and the elderly are at a higher risk due to their relatively weaker immune function, making them more prone to complications. WHO position papers and the "Technical Guidelines for Influenza Vaccine Vaccination in China" published by the Chinese Center for Disease Control and Prevention both emphasize that annual influenza vaccination is the most cost-effective measure to prevent influenza, significantly reducing the risk of influenza infection and severe complications. It is worth noting that the quadrivalent influenza virus subunit vaccine has been included in the latest version of the "Technical Guidelines for Influenza Vaccine Vaccination in China (2025-2026)" by the Chinese Center for Disease Control and Prevention, explicitly recommended for individuals aged 6 months and above, further consolidating its position in influenza immunization strategies. It is understood that the "Influenza Virus Subunit Vaccine with Adjuvant" entering Phase I clinical trials this time is developed by AB&B BIO-TECH-B (02627) in response to different populations' vaccination needs and WHO recommendations for influenza vaccines, using the company's mature platform technology and novel adjuvants to develop a vaccine with adjuvants suitable for the elderly population aged 65 and above. The drug formulation is an injectable solution, administered by intramuscular injection into the deltoid muscle of the upper arm, with a low dose group receiving 0.25ml per dose and a high dose group receiving 0.5ml per dose, with a total of one dose administered on day 0. The purpose of this trial is to evaluate the safety of the influenza virus subunit vaccine (adjuvant) in individuals aged 65 and above. Preclinical studies have shown that the influenza virus subunit vaccine with adjuvants can significantly increase antibody levels and neutralizing antibody titers in the body, with significant advantages in enhancing immune response capabilities, providing the optimal choice for the elderly to combat influenza. In addition to the elderly population, Zhonghui Biology is also actively advancing clinical studies of the vaccine in pregnant women. As of now, relevant studies have made progress in the midterm stage. If the subsequent results are positive, Zhonghui Biology's Hircontrine is expected to become China's first influenza vaccine specifically for pregnant women, and will further expand to infants aged 0-6 months, filling the current gap in influenza immune protection in this age group. Public information shows that Zhonghui Biology is a technology company dedicated to the research, development, manufacturing, and commercialization of innovative vaccines and traditional vaccines using new technological approaches. In recent years, the company has increased its investment in research and development and has obtained clinical approval for products including recombinant herpes zoster vaccine (CHO cells), adjuvanted influenza virus subunit vaccine, and freeze-dried human rabies vaccine (human diploid cells), with several innovative vaccine pipelines being simultaneously promoted at the Shanghai and Taizhou R&D centers and pilot platforms. In terms of industrial layout, the company has the capacity for large-scale production. The Phase I base covers approximately 68 acres, with internationally advanced influenza seed liquid and formulation GMP production lines already established, and has obtained vaccine production permits and experimental animal use permits. The Phase II and Phase III plans involve an additional 104 acres of land, which will be used for industrialized production of the full product line. As the first quadrivalent influenza subunit vaccine in China to achieve full population coverage, Zhonghui Biology's quadrivalent influenza virus subunit vaccine, which commercialized in September 2023, has maintained a 100% approval rate due to its outstanding safety and immunogenicity performance. With the continuous enrichment of the company's product matrix and steady progress in capacity construction, Zhonghui Biology is expected to further consolidate its competitive advantage in the high-growth vaccine track, providing strong support for long-term sustainable development.