CSPC PHARMA (01093) has received clinical trial approval in the United States for its recombinant respiratory syncytial virus vaccine (SYS6057).

CSPC PHARMA (01093) announced that its developed preventive biological product, the Class I new drug recombinant respiratory syncytial virus vaccine (SYS6057), has been approved by the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States. Previously, this product had obtained approval for clinical trials from the National Medical Products Administration (NMPA) of China on July 30, 2026. This product is the second recombinant protein vaccine developed by the group to obtain clinical trial approval, consisting of the respiratory syncytial virus (RSV) pre-fusion F (Pre-F) protein antigen and the group's independently developed second-generation nano adjuvant system. Compared to previous products, this adjuvant uses a different nano carrier, exhibiting unique physicochemical properties and immunological activity. Through the optimization of this adjuvant system, the product can induce high-titer neutralizing antibodies and robust cellular immune responses against RSV simultaneously, providing unique immunoprotective advantages. Preclinical studies have shown that the product has good safety and efficacy. The approved clinical indication is for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 and above. This approval for clinical trials lays a solid foundation for the group's subsequent development of recombinant protein vaccines and adjuvant products and marks a new stage of rapid development for the group's vaccine research and development pipeline.