CSPC Pharma Wins FDA Nod to Initiate U.S. Trials for First Recombinant Herpes Zoster Vaccine

Bulletin Express
Sep 29

CSPC Pharmaceutical Group Limited (CSPC Pharma) has received clearance from the U.S. Food and Drug Administration (FDA) to begin clinical trials of its Class 1 innovative prophylactic biological candidate, SYS6052, a recombinant herpes zoster vaccine targeting adults aged 50 and above.

The product combines varicella-zoster virus glycoprotein E antigen with a proprietary nano-adjuvant platform engineered in-house. Pre-clinical studies showed robust humoral and cellular immune responses alongside a favorable safety profile, according to the company’s voluntary announcement dated 29 September 2026.

SYS6052 is CSPC Pharma’s first recombinant protein vaccine to reach the clinical-trial stage. The FDA authorization follows approval from China’s National Medical Products Administration in July 2026, positioning the group to conduct parallel development in two major regulatory jurisdictions.

Management described the U.S. clearance as a “solid foundation” for the global rollout of its prophylactic vaccine portfolio, underscoring CSPC Pharma’s broader push into recombinant protein vaccines.

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