CSPC PHARMA (01093) has announced that its Class 1 preventive biological product, the recombinant shingles vaccine (SYS 6052), has received approval from the US Food and Drug Administration (FDA) to conduct related clinical research in the United States.

Previously, the product obtained approval from China's National Medical Products Administration (NMPA) in July 2026 to carry out clinical trials in China.

The product is the company's first recombinant protein vaccine to be approved for clinical trials. It is composed of the varicella-zoster virus gE protein antigen and a novel nano-adjuvant system independently developed by the group.

By optimizing the antigen and nano-adjuvant system, the product induces strong humoral and cellular immune responses, providing more diversified preventive options for the applicable population. Preclinical studies have shown that the product has good safety and efficacy.

The approved clinical indication is for adults aged 50 and above, to prevent shingles and its complications.

The approval of this US clinical trial marks another important achievement for the group in the field of recombinant protein vaccines, laying a solid foundation for the global development of preventive vaccine products, including the recombinant shingles vaccine.