Luzhu Biotech Announces Publication of Positive Phase III Data for Shingles Vaccine LZ901 in Nature Communications

Bulletin Express
08/09

Beijing Luzhu Biotechnology Co., Ltd. (Luzhu Biotech) released an update on its core asset, recombinant herpes zoster vaccine candidate LZ901, after Phase III trial results were published in the journal Nature Communications on 7 August 2026.

Key Trial Parameters • Design: Multi-centre, randomised, double-blind, placebo-controlled Phase III study conducted in China. • Population: 26,039 adults aged 40 years and above; 25,577 participants received two doses of LZ901 or placebo administered 30 days apart.

Efficacy Highlights (12-Month Follow-up) • Overall vaccine efficacy: 91.6% (95% CI: 86.3%–95.3%). • Efficacy against laboratory-confirmed herpes zoster: 92.1% (95% CI: 86.7%–95.7%). • Protection against complications: – Post-herpetic neuralgia: 95.9% (95% CI: 63.9%–99.9%). – Severe acute pain associated with herpes zoster: 92.6% (95% CI: 87.2%–96.1%).

Safety and Tolerability • Any adverse reaction within 30 days: 16.4% (2,137/13,011) in the LZ901 group vs 9.0% (1,167/13,008) in placebo (p<0.001). • Solicited reactions (within seven days): – Injection-site: 11.6% in the vaccine group vs 3.7% in placebo (p<0.001). – Systemic: 5.2% vs 4.3% respectively (p<0.001). • Grade 3 reactions: 0.4% in the vaccine group vs 0.3% in placebo (p=0.672), indicating no significant difference in severe events.

Regulatory Status A biologics licence application (BLA) for LZ901 was submitted to China’s National Medical Products Administration in January 2025 and accepted in February 2025; review remains in progress.

Implications The publication of robust Phase III data in a high-impact journal underscores LZ901’s potential to address the unmet need for effective shingles prevention in adults aged 40 years and older. The favourable safety profile and high efficacy, particularly against post-herpetic neuralgia and severe pain, position the candidate competitively as it advances through regulatory review.

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