Completed the expansion of age for the first dose of the vaccine in multiple locations, AB&B BIO-TECH-B (02627) commercialization process is fully accelerated.

This autumn and winter, the influenza epidemic in the Asia-Pacific region is earlier and more severe than in previous years: in Japan, the flu season arrived 5 weeks earlier than last year, with over 9,000 reported cases nationwide from October 6 to 12, which is 2.65 times the number reported during the same period last year. The number of new cases has been increasing for 8 consecutive weeks; during the same period, the percentage of flu-like cases reported by sentinel hospitals in southern provinces of China was 4.1%, significantly higher than the levels during the same period in 2022 and 2024. Reports indicate that the predominant strain in this flu epidemic is type A H3N2, with antigenic drift mutations leading to a decrease in the effectiveness of previous vaccines, and it is more pathogenic to high-risk groups such as children and the elderly, easily causing severe symptoms such as high fever and pneumonia, putting greater pressure on the prevention and control of respiratory infectious diseases this winter. Against this backdrop, the first quadrivalent influenza virus subunit vaccine suitable for the entire population aged 6 months and above in China- Huircon Xin (HRK-X) was expanded to the market at the right time. This vaccine expands the age range to include the entire population aged 6 months and above, which means that high-risk groups for flu such as infants, young children, and the elderly can all receive this vaccine, providing high-quality vaccine protection equivalent to that for adults. Significant safety advantages, tapping into the high-end infant market It is understood that the current influenza vaccines used in China are mainly divided into three categories: split vaccines, subunit vaccines, and live attenuated vaccines. Among them, the subunit process used in Huircon Xin represents a technical path that focuses more on safety and purity. Compared to traditional split vaccines and live attenuated vaccines, the quadrivalent influenza subunit vaccine HRK-X removes impurities such as internal viral proteins and membrane proteins through precise purification processes; the material used to produce one subunit vaccine is extracted from about 5 split vaccines, significantly improving vaccine purity. This technological breakthrough results in fewer adverse reactions, stronger immunogenicity, and is especially suitable for children, the elderly, and individuals with weakened immune systems. Data published in the international journal Vaccine show that the fever reaction in children aged 3-8 years after receiving this quadrivalent influenza subunit vaccine is significantly lower than that in the control group, at only 46% of the control group; the rate of local adverse reactions in infants after vaccination is 54% of the split vaccine in the control group. In addition, this vaccine uses isotonic technology and a five-sided minimally invasive needle, which significantly reduces injection pain by 33% and bleeding rate by 21%, greatly improving the vaccination experience and compliance of special populations such as infants and the elderly. The "Chinese Influenza Vaccine Prevention and Vaccination Technology Guide (2023-2024)" clearly states that subunit vaccines remove internal viral proteins, retaining only the high-purity HA and NA antigen components, which offers better safety compared to split vaccines. It can be said that the launch of Huircon Xin not only fills the market gap for high-end influenza vaccines for infants, but also marks a move towards a safer and more refined direction in the research and application of influenza vaccines in China. Vast market space, subunit vaccines facing structural opportunities As a highly contagious respiratory disease, influenza's health threats and social burdens have long been underestimated by the public. The World Health Organization estimates that globally, severe cases of influenza cause approximately 3 to 5 million deaths each year; from 2010 to 2015, China had an average of about 88,000 excess deaths from respiratory diseases caused by influenza annually, and the influenza vaccination rate in China has long been at a low level, with only 3.84% of the population vaccinated during the 2022-2023 flu season, indicating a serious situation in influenza prevention and control. In terms of market size, the global influenza subunit vaccine market has grown from $4 billion in 2019 to $6 billion in 2023, and is expected to further expand to $14 billion by 2032; it is estimated that the Chinese influenza virus subunit vaccine market will grow rapidly from RMB 700 million in 2024 to RMB 2.9 billion by 2033, with a compound annual growth rate of 18.0%, making it a typical high-growth track. From the market structure perspective, the current domestic influenza vaccine market is still dominated by the second-generation split influenza vaccines, while the "subunit" influenza vaccine developed by AB&B BIO-TECH-B (02627) belongs to the third-generation technology, with significant advantages in safety, immunogenic effect, and overall quality. According to the prospectus of Zhonghui Biology, there are currently 19 influenza vaccines in clinical development in China, including 6 trivalent vaccines (including 4 split vaccines, 1 live attenuated vaccine, and 1 subunit vaccine, namely Zhonghui Biology's trivalent influenza virus subunit vaccine) and 13 quadrivalent vaccines (including 11 split vaccines and 2 subunit vaccines). In terms of research and development progress, it will take some time for competitors' similar products to be launched, while Huircon Xin, as the only domestically approved quadrivalent influenza subunit vaccine for full-dose use in the entire population, stands out for its scarcity and is expected to enjoy a sufficient market monopoly window, providing important opportunities to establish brand awareness and channels. As the peak of the autumn and winter influenza season approaches, Zhonghui Biology's subunit influenza vaccine has completed expansion filings in 26 provinces nationwide and has launched the first dose vaccinations in cities such as Shenyang, Jinan, Shanghai, Wuhan, Kunming, and Fuzhou. Its rapid commercialization capabilities will be a key catalyst for the future performance and value realization of Zhonghui Biology.