Multiple locations have completed the expansion of the age range for initial vaccination, and the commercialization process of AB&B BIO-TECH-B (02627) is accelerating comprehensively.

This autumn and winter, the flu epidemic in the Asia-Pacific region has arrived earlier and stronger 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 6th to 12th, which is 2.65 times the number of reported cases during the same period last year, with weekly new cases 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 in 2022 and 2024. Reports indicate that the dominant strain of the flu epidemic this time is type A H3N2, with antigenic drift mutations leading to a decrease in the efficacy of previous vaccines and stronger pathogenicity in high-risk groups such as children and the elderly, resulting in severe symptoms such as high fever and pneumonia, putting greater pressure on the prevention and control of respiratory infectious diseases this winter. In this context, the launch of the first quadrivalent influenza virus subunit vaccine for all age groups above 6 months old, Heilongxin (HRK-X), in China is timely. This vaccine expands the age range to include the entire population over 6 months old, meaning that high-risk groups for the flu such as infants and the elderly can receive this vaccine, providing high-quality protection with the same technical standards as adult vaccines. Significant safety advantages, tapping into the high-end market for infants and young children It is understood that the flu vaccines currently used in China are mainly divided into three categories: split vaccines, subunit vaccines, and intranasal attenuated vaccines. Among them, the subunit process used in Heilongxin represents a technology path that places more emphasis on safety and purity. Compared to traditional split vaccines and attenuated vaccines, Heilongxin's HRK-X quadrivalent influenza subunit vaccine, with its precise purification process, removes impurities such as internal viral proteins and membrane proteins. It takes about 5 split vaccine raw materials to extract 1 subunit vaccine, significantly improving vaccine purity. This technological breakthrough results in fewer adverse reactions and stronger immunogenicity, making it particularly suitable for children, the elderly, and individuals with weak immune systems. Data published in the international Vaccine journal showed that the incidence of fever reactions in 3-8-year-old children after receiving this quadrivalent influenza subunit vaccine was significantly lower than the control group, at only 46% of the control group; the incidence of local adverse reactions in infants and young children after vaccination was 54% of that for the control group receiving split vaccines. In addition, this vaccine uses isosmotic technology and a five-bevel minimally invasive needle, significantly reducing injection pain by 33% and bleeding by 21%, greatly enhancing the vaccination experience and compliance of special populations such as infants, young children, and the elderly. The "China Influenza Vaccine Prevention and Vaccination Technical Guidelines (2023-2024)" has clearly indicated that from the perspective of vaccine preparation technology, subunit vaccines remove internal viral proteins and retain only purified HA and NA antigen components, showing better safety compared to split vaccines. It can be said that the launch of Heilongxin not only fills the market gap for high-end flu vaccines for infants and young children but also marks the progression of flu vaccine research and application in China towards a safer and more refined direction. Vast market space, subunit vaccines facing structural opportunities As a highly contagious respiratory disease, the health threats and social burdens of the flu have long been underestimated by the public. The World Health Organization estimates that globally, severe cases of the flu cause approximately 3 to 5 million deaths each year. From 2010 to 2015, there were an average of about 88,000 excess deaths each year in China due to respiratory diseases caused by the flu, and the vaccination rate for the flu vaccine in China has been at a low level for a long time. In the 2022-2023 flu season, the vaccination rate in China was only 3.84%, and the situation for flu prevention and control is severe. 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 subunit vaccine market will grow rapidly from RMB 700 million in 2024 to RMB 2.9 billion in 2033, with a compound annual growth rate of 18.0%, representing a typical high-growth track. In terms of market structure, the current domestic influenza vaccine market is still dominated by second-generation ordinary split influenza vaccines, while the "subunit" influenza vaccine developed by AB&B BIO-TECH-B (02627) belongs to the third generation technology route and has significant advantages in safety, immune effects, and overall quality. According to the prospectus of Zhonghui Bioscience, there are currently 19 influenza vaccines in clinical development in China, including 6 trivalent vaccines (4 split vaccines, 1 attenuated vaccine, and 1 subunit vaccine, i.e., the trivalent influenza subunit vaccine of Zhonghui Bioscience) 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 similar products from competitors to enter the market, and Heilongxin, as the only quadrivalent influenza subunit vaccine approved for full dose in the entire population in China, has outstanding scarcity. It is expected to enjoy a sufficient market monopoly window, providing important opportunities for establishing brand awareness and channel network. With the peak of the autumn and winter flu season approaching, this subunit influenza vaccine from Zhonghui Bioscience has completed expansion records in 26 provinces nationwide, and has started first doses in expansion markets such as Shenyang, Jinan, Shanghai, Wuhan, Kunming, and Fuzhou. Its rapid commercialization capability will be a core catalyst for future performance and value realization for Zhonghui Bioscience.