CSPC Pharma (01093) has announced that its preventive biologic Class 1 new drug, the recombinant respiratory syncytial virus (RSV) vaccine (SYS6057), has received approval from the US Food and Drug Administration (FDA) to proceed with clinical trials in the United States.

Prior to this US clearance, the product had already obtained approval from China's National Medical Products Administration (NMPA) to initiate clinical trials on July 30, 2026. This candidate represents the group's second recombinant protein vaccine product to secure clinical trial approval.

The vaccine is composed of the RSV pre-fusion F (Pre-F) protein antigen combined with the group's self-developed second-generation nano-adjuvant system. Compared with previous products, the adjuvant in this candidate employs a different nano-carrier, exhibiting distinctive physicochemical properties and immunological activity.

Through optimization of this adjuvant system, the product can simultaneously induce high-titer neutralizing antibodies against RSV and potent cellular immune responses, offering a unique immune protection advantage. Preclinical studies have demonstrated that the product possesses good safety and efficacy profiles.

The approved clinical indication is for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 years and older. This clinical trial approval lays a solid foundation for the group's subsequent development of recombinant protein vaccines and adjuvant products, marking a significant milestone as the company's vaccine research pipeline enters a phase of rapid advancement.