According to the Zhitong Finance App, Shiyao Group (01093) announced that the recombinant respiratory syncytial virus vaccine (SYS6057), a class 1 new prophylactic biological product developed by the Group, has been approved by the US Food and Drug Administration (FDA) and can conduct clinical trials in the US. Previously, the product was approved for clinical trials by China's National Drug Administration (NMPA) on July 30, 2026.

This product is the Group's second recombinant protein vaccine product approved for clinical trials. It consists of respiratory syncytial virus (RSV) fusion pre-F (Pre-F) protein antigen and a second-generation nano-adjuvant system independently developed by the Group. Compared with previous products, the adjuvants in this product use different nanocarriers, showing unique physico-chemical properties and immune activity. By optimizing this adjuvant system, the product can simultaneously induce high-titer neutralizing antibodies against RSV and potent cellular immune responses, and has unique immune protection advantages. Preclinical studies have shown that the product has good safety and efficacy.

The approved clinical indication is for the prevention of lower respiratory disease (LRTD) caused by RSV in people aged 60 and above. The approval of this clinical trial 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 of the Group's vaccine research and development pipeline.

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