On December 19th, Aimei Vaccine announced that its two major single product vaccine new technology routes, suspension cultured MDCK cell influenza vaccine and second-generation high-efficiency adsorption tetanus vaccine, have both obtained the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration. These are two significant developments made by the Emmy vaccine during the intensive declaration period, which are expected to bring new growth points.

According to the announcement, currently all influenza vaccines listed in China are produced using chicken embryo technology, and no cell-based influenza vaccine has been approved for market. The MDCK cell influenza vaccine approved for clinical use has significantly improved product quality and safety compared to traditional chicken embryo influenza split vaccines.

The MDCK cells developed by Aimei have characteristics such as easy cultivation, fast proliferation, and susceptibility to influenza virus. By culturing influenza virus on a large scale in MDCK cells, higher yields, more stable product quality, and lower production costs can be achieved. In addition, the product has strong ability to respond to viral mutations and does not contain ovalbumin, significantly reducing the risk of allergies.

Compared with MDCK cell influenza vaccines developed by other domestic manufacturers, Aimei products use suspension culture for cell culture, which can be cultured on a large scale in bioreactors with low pollution risk and easy large-scale industrial production.

Based on the development of the second-generation high-efficiency adsorbed tetanus vaccine, Aimei is actively promoting the research and development of adsorbed cell-free pertussis HIB combination vaccines, namely quadruple vaccines, pentavalent vaccines, and other multi valent vaccines. Among them, the quadruple vaccine is used to prevent invasive infections caused by pertussis, diphtheria, tetanus, and Haemophilus influenzae type b, and has the advantages of reducing the number of injections for infants and young children, enhancing parental and infant vaccination compliance.

The two heavyweight single product vaccines announced by Emmy Vaccines have been approved for clinical trials, marking a new stage in their development and laying the foundation for subsequent clinical trials and commercialization of vaccine products. According to Zhuoshi Consulting, it is estimated that by 2030, the market size of influenza vaccines in China will be about 20 billion yuan, and the multi valent vaccines representing industry trends are expected to have a domestic market size of about 10 billion yuan. Therefore, the new technology route of suspended cultivation of MDCK cell influenza vaccine and the launch of quadruple vaccine will further improve the product lineup of Emmy vaccine, which is conducive to enriching the product line, consolidating the industry position, and achieving sustained high-speed growth in performance.

In addition, 2024 is a year of intensive application for Emmy vaccines' heavyweight products. The company's 13 valent combined pneumonia vaccine has been accepted for listing, and the iterative serum-free rabies vaccine has also submitted a pre registration application for listing, which is expected to bring stable revenue growth to the company.