China's first quadrivalent subunit influenza vaccine for all populations has been approved, and AB&B BIO-TECH-B is about to commercialize it on a large scale

On September 3rd, Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. (referred to as "Zhonghui Biology") announced that its Class I new drug quadrivalent influenza virus subunit vaccine (trade name: Huiruankangxin® HRK-X) has received approval from the National Medical Products Administration (NMPA) of China for its supplementary application, marking a significant breakthrough in the commercialization process of this product. This approval expands the vaccine's applicable population from the original 3 years and older to include all age groups from 6 months and older, covering infants, children, adults, and the elderly, especially providing a safer and more ideal vaccination option for infants aged 6 to 35 months. As a result, this vaccine becomes the first and currently the only quadrivalent influenza virus subunit vaccine approved for full dosage across all populations in China. As a Class I new drug for preventive biological products in China, this vaccine has entered the preliminary review list for the commercial insurance innovative drug directory in August this year, and it is the only vaccine product selected in the list, indicating its significant rarity. It is expected to effectively fill the corresponding market gap after its launch. Currently, influenza viruses remain one of the important respiratory pathogens threatening public health. Data shows that influenza is a contributing factor to five of the top ten causes of death globally, with seasonal outbreaks leading to 3 million to 5 million severe cases and 290,000 to 650,000 respiratory disease-related deaths each year, posing a continuous threat to human health. Research from the CDC in the United States shows that vaccination against influenza can reduce the likelihood of seeking medical care by 40% to 60%, and it has clear effects in alleviating symptoms and preventing hospitalization. However, the vaccination rate for influenza in China has long been at a low level, with an overall vaccination rate of only between 3% and 3.84%, far below that of developed countries such as the United States, Japan, and Australia (approximately 50% to 60%). In contrast, there is a huge unmet demand and development potential in China's influenza vaccine market. Currently, the mainstream products in the domestic market are second-generation inactivated influenza vaccines, while the "subunit" influenza vaccine developed by Zhonghui Biology belongs to the third-generation technology route. It further optimizes the production process based on inactivated vaccines, extracting only the effective antigen components from the virus surface—hemagglutinin (HA) and neuraminidase (NA), significantly improving antigen purity and reducing impurity content, thus having obvious advantages in safety, immune efficacy, and overall quality. Huiruankangxin® from Zhonghui Biology is prepared using the components recommended by the World Health Organization for the 2025-2026 Northern Hemisphere seasonal influenza vaccine, providing broad protection against four strains of viruses: H1N1, H3N2, and type B BV, BY. Multiple quality control standards exceed the requirements of the Chinese and European Pharmacopoeias, reaching an internationally advanced level. According to Zhitong Finance APP, a large amount of clinical data has confirmed its excellent safety, as it does not contain antibiotics or preservatives, thereby reducing the risk of allergies from the source. Experimental results show that the incidence of local adverse reactions in infants is 54% of that of traditional inactivated vaccines, the fever response in children aged 3 to 8 years is only 46% of that of the control group, and the overall adverse reactions in adults have also significantly decreased. Huiruankangxin® achieves uniform dosage forms, allowing the same specification to be administered to all individuals aged 6 months and older without distinguishing between children's and adults' doses, greatly enhancing vaccination convenience and medical management efficiency. In addition, the isotonic formulation and five-faceted minimally invasive needle technology used in this product effectively reduce injection pain (by 33%) and bleeding rate (by 21%), significantly improving vaccination compliance among infants, the elderly, and frail populations According to public information, AB&B BIO-TECH is a technology company dedicated to the research, development, manufacturing, and commercialization of innovative vaccines and traditional vaccines using new technological methods. In recent years, the company has continuously increased its investment in research and development. Approved clinical products include recombinant herpes zoster vaccine (CHO cells), adjuvanted influenza virus subunit vaccine, and freeze-dried human rabies vaccine (human diploid cells), among others. Additionally, several innovative vaccine pipelines are being advanced simultaneously at the research and development centers and pilot testing platforms in Shanghai and Taizhou. In terms of industrialization, the company has already established large-scale production capabilities. The first-phase base covers approximately 68 acres and has built international-level GMP production lines for influenza raw materials and formulations, obtaining vaccine production licenses and experimental animal use licenses. The second and third phases are planned to add 104 acres of land for the industrial production of the entire product line. From a market perspective, AB&B BIO-TECH is expected to catalyze the release of its heavyweight products in the short term, while in the medium to long term, it has multiple innovative vaccine reserves, already possessing sustainable growth momentum. Against the backdrop of low penetration rates and high growth potential in the influenza vaccine market, AB&B BIO-TECH is expected to benefit from both industry growth and market share enhancement, enjoying dual high-growth dividends