Chinese and American authorities have approved the clinical trials of a new drug developed by Zhonghui Biotechnology using CHO cells.

Zhonghui Biotechnology announced that the new drug clinical trial application for the recombinant respiratory syncytial virus (RSV) vaccine developed independently by the group has been approved by the China National Medical Products Administration Drug Evaluation Center. In addition, the IND application for the vaccine in the United States has also been approved by the Food and Drug Administration. RSV is a highly contagious RNA virus that is one of the important pathogens causing respiratory tract infections in infants, the elderly, and immunocompromised individuals. Due to the lack of effective treatment drugs in clinical practice, vaccination has become the preferred clinical solution for RSV prevention and control. The group's recombinant RSV vaccine is developed using CHO cells and can express modified pre-F proteins. Through extensive screening, the group has obtained high-yield monoclonal cell lines capable of stably expressing pre-F proteins. In preclinical studies, it has shown higher levels of pre-F expression, better heat stability, and excellent immunogenicity compared to other recombinant RSV vaccines on the market.