CSPC PHARMA (01093): Recombinant Herpes Zoster Vaccine (SYS 6052) Receives Clinical Trial Approval in the United States
CSPC PHARMA (01093) announced that the group's developed Class 1 preventive biological product new drug, recombinant herpes zoster vaccine (SYS 6052), has received approval from the U.S. Food and Drug Administration (FDA) to conduct related clinical research in the United States. Previously, the product was approved by China's National Medical Products Administration (NMPA) in July 2026 to conduct clinical trials in China.
CSPC PHARMA (01093) announced that the Group's developed Category 1 preventive biological product, the recombinant herpes zoster vaccine (SYS 6052), has received approval from the U.S. Food and Drug Administration (FDA) to conduct relevant clinical research in the United States. Previously, the product obtained approval from China's National Medical Products Administration (NMPA) in July 2026 to conduct clinical trials in China.
This product is the Company's first recombinant protein vaccine approved for clinical trials. It consists 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 diverse preventive options for the applicable population. Preclinical studies have shown that the product has a good safety and efficacy profile.
The approved clinical indication is for adults aged 50 and above to prevent herpes zoster and its complications. The approval of this U.S. clinical trial represents another important achievement 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 herpes zoster vaccine.
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