AB&B BIO-TECH-B (02627): Recombinant respiratory syncytial virus vaccine (CHO cells) adjuvant IND approved by China CDE and US FDA.

AB&B BIO-TECH-B (02627) announced that the Group's independently developed recombinant respiratory syncytial virus vaccine (CHO cells) with adjuvant has received approval for new drug clinical trial (IND) application from the Drug Evaluation Center (CDE) of the National Medical Products Administration. In addition, the IND application for this vaccine in the United States has also been approved by the Food and Drug Administration (FDA). Respiratory syncytial virus (RSV) is a highly contagious RNA virus that is one of the major pathogens causing respiratory infections in infants, the elderly, and immunocompromised individuals. Clinically, it mainly presents as symptoms of acute respiratory infections, primarily affecting the lower respiratory tract. Severe cases can be life-threatening. According to data from the Chinese Center for Disease Control and Prevention, from 2009 to 2019, RSV ranked second among the pathogens of acute respiratory infections in adults in China and first in children. Due to the lack of effective treatment drugs in clinical practice, mainly relying on supportive care to deal with acute infections, vaccination has become the preferred clinical solution for RSV prevention and control. The Group's recombinant respiratory syncytial virus vaccine (CHO cells) with adjuvant is developed using CHO cells and can express modified pre-F protein. The Group has obtained high-yield monoclonal cell lines that can stably express pre-F protein through extensive screening. In preclinical studies conducted by the Group, it demonstrated higher levels of pre-F expression, better thermal stability, and excellent immunogenicity compared to the marketed recombinant RSV vaccine. According to previously published results, the expression level of pre-F protein in the marketed recombinant RSV vaccine is between 600mg/L and 800mg/L. In comparison, the pre-F protein produced by the Group's high-yield cell lines is approximately 1,000mg/L to 1,500mg/L. Preclinical studies have shown that after being stored at 40C for 14 days, the activity of the Group's pre-F protein remains above 95%, while the protein activity of the marketed product drops to around 50%. Due to its stability, the Group's product, unlike approved products, is in liquid form rather than lyophilized form. In preclinical immunogenicity tests conducted in mice, the group's investigational vaccine showed significantly higher neutralizing antibody titers than similar marketed products. The Group's toxicity studies and active systemic allergic reaction tests also demonstrated good safety.