LZ901 Recombinant Herpes Zoster Vaccine Demonstrates 91.6% Efficacy in Phase III Trial Published in Nature Communications
核心洞察
LZ901, a recombinant gE-Fc fusion protein subunit vaccine, achieved 91.6% overall efficacy against herpes zoster (搜索) in a Phase III trial of 26,018 adults aged ≥40 years.
Vaccine efficacy was 93.9% in participants aged 40–69 but declined to 66.9% in those aged ≥70, with 95.5% efficacy against post-herpetic neuralgia (搜索).
LZ901 uses an aluminum hydroxide adjuvant, differentiating it from GSK's Shingrix, and demonstrated a favorable safety profile with low grade 3 reactions.
A pivotal Phase III trial evaluating LZ901, a recombinant herpes zoster (搜索) vaccine candidate developed by Beijing Luzhu Biotechnology Co., Ltd., has demonstrated 91.6% overall efficacy against herpes zoster in adults aged 40 years and older, according to results published in Nature Communications. The randomized, placebo-controlled, double-blind study enrolled 26,018 participants across China, providing the evidentiary foundation for a biologics license application (BLA) currently under review by China's National Medical Products Administration (NMPA).
The publication marks a significant milestone for what could become the first domestically developed recombinant zoster vaccine approved in China, a market presently served only by GSK's Shingrix (zoster vaccine recombinant, adjuvanted).
Trial Design and Efficacy Results
The multi-center Phase III trial (ChiCTR2300076253) randomized 26,018 participants to receive either two intramuscular doses of LZ901 (n = 13,010) or placebo (n = 13,008), administered 30 days apart. The primary objective was assessment of herpes zoster (搜索) risk within 12 months following vaccination.
During the follow-up period, 15 LZ901 recipients and 178 placebo recipients were confirmed positive for herpes zoster (搜索). Overall vaccine efficacy was 91.6% (95% CI: 86.3–95.3; p < 0.001). Efficacy against laboratory-confirmed cases reached 92.1% (95% CI: 86.7–95.7%).
A notable age-related gradient emerged in the efficacy data. Among participants aged 40–69 years, vaccine efficacy was 93.9% (95% CI: 89.1–97.0; p < 0.001), while efficacy in those aged ≥70 years was 66.9% (95% CI: 14.6–89.2; p = 0.016), with a wide confidence interval reflecting greater uncertainty in the older subgroup.
Protection Against Complications
LZ901 demonstrated robust protection against herpes zoster (搜索)-related complications. Post-herpetic neuralgia (搜索) (PHN) occurred in 1 of 15 herpes zoster cases in the LZ901 group compared with 24 of 187 cases in the placebo group, corresponding to a vaccine efficacy of 95.5% against PHN (95% CI: 63.9–99.93; p < 0.001). Protection against herpes zoster-associated severe acute pain was 92.6% (95% CI: 87.2–96.1%).
Vaccine Design and Differentiation
LZ901 is a recombinant herpes zoster (搜索) vaccine built around a tetrameric VZV glycoprotein E (搜索) (gE)-Fc fusion protein engineered to enhance antigen presentation. Unlike GSK's Shingrix, which combines recombinant gE with the AS01B adjuvant system containing MPL and QS-21, LZ901 employs its engineered Fc-containing antigen structure alongside an aluminum hydroxide adjuvant.
Luzhu has also completed a head-to-head study of LZ901 against Shingrix in adults aged 50 and older, reporting superior cellular immunogenicity and a more favorable safety profile for LZ901, though the study did not provide a head-to-head comparison of clinical efficacy.
Safety Profile
Within 30 days of vaccination, 16.4% of LZ901 recipients reported at least one adverse reaction compared with 9.0% in the placebo group (p < 0.001). Injection-site reactions occurred in 11.6% of vaccinees versus 3.7% of placebo recipients. Grade 3 reactions were comparably low in both groups (0.4% vs. 0.3%; p = 0.672). No serious adverse events or safety concerns associated with LZ901 were noted, suggesting the reactogenicity profile, while higher than placebo, did not produce serious adverse events at a meaningful rate.
Regulatory Status and Market Implications
Beijing Luzhu Biotechnology submitted its BLA to the NMPA in January 2025, with the application accepted in February 2025 and remaining under review. The company also holds US FDA investigational new drug approval for LZ901, and a Phase IIIb trial is ongoing. According to an April 2026 filing, the company reallocated approximately HKD 27.6 million of IPO proceeds toward LZ901 clinical trial expenses.
LZ901's Phase III program enrolled adults from age 40, potentially supporting a broader age indication compared with Shingrix, which is generally indicated for immunocompetent adults aged 50 and older. If the NMPA grants a label reflecting the study population, LZ901 could offer differentiation through expanded age eligibility.