CSPC Group (01093): Recombinant shingles vaccine (SYS 6052) approved for clinical trials in the US

Zhitongcaijing · 1d ago

Zhitong Finance App News, Shiyao Group (01093) issued an announcement. The recombinant shingles vaccine (SYS 6052), a class 1 new drug for preventive biological products developed by the Group, has been approved by the US Food and Drug Administration (FDA) and can carry out related clinical studies in the US. Previously, the product was approved by China's National Drug Administration (NMPA) to conduct clinical trials in China in July 2026.

This product is the company's first recombinant protein vaccine product approved for clinical trials. It consists of 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 immunity and cellular immune responses, providing more diverse prevention options for the applicable population. Preclinical studies have shown that the product has good safety and efficacy.

The approved clinical indications are adults aged 50 and above to prevent shingles and its complications. The approval of this US clinical trial is another important achievement achieved by 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.