By Fineline Cube 
Beijing Luzhu Biotechnology Co., Ltd. (HKG: 2480) announced today that its Phase 1 clinical trial of the recombinant herpes zoster vaccine candidate LZ901 in the United States has been successfully completed. The study enrolled healthy adults aged 40 and older and evaluated both high‑dose (HD) and low‑dose (LD) formulations against placebo.
Clinical Findings
- Safety Profile – The LD arm reported mild, vaccine‑related adverse reactions in 4.35 % of participants, while the HD arm and placebo group experienced no vaccine‑related events.
- Immunogenicity – Both dose levels elicited robust antibody responses, surpassing those observed in the placebo group and meeting the prespecified immunogenicity endpoints.
Strategic Context
- Product Positioning – LZ901 is designed to prevent herpes zoster and its most common complication, post‑herpetic neuralgia, in adults 40 + years old.
- Regulatory Status – The Phase 3 study conducted in China achieved its predefined clinical objectives and produced the expected outcomes. A biologics license application (BLA) for LZ901 has been accepted by China’s National Medical Products Administration (NMPA) and is currently under review.
- Market Opportunity – With rising incidence of shingles among aging populations worldwide, LZ901 could fill a significant unmet need in both Chinese and global markets.
Commercial Outlook
Luzhu Biotechnology plans to leverage the U.S. Phase 1 data to support its global regulatory strategy, with a view to submitting a BLA to the U.S. Food and Drug Administration (FDA) following the completion of Phase 2/3 trials. The company’s partnership network and robust manufacturing capacity position it well to scale production once regulatory approvals are secured.-Fineline Info & Tech