Beijing Luzhu Biotechnology Co., Ltd. (HKEX: 02480) announced on that Phase III clinical trial results for its recombinant herpes zoster vaccine candidate LZ901 have been published in Nature Communications, providing peer-reviewed support for a biologics license application currently under review by China's National Medical Products Administration (NMPA). The publication supplies the evidentiary foundation for what would be the first domestically developed recombinant zoster vaccine approved in China, entering a market currently served only by GSK's Shingrix (zoster vaccine recombinant, adjuvanted).
The Phase III study was a multi-center, randomized, double-blind, placebo-controlled trial enrolling 26,039 adults aged 40 years and older across China, of whom 25,577 received two doses of LZ901 or placebo administered 30 days apart. Within one year post-vaccination, overall vaccine efficacy was 91.6% (95% CI: 86.3%–95.3%). Efficacy against laboratory-confirmed cases was 92.1% (95% CI: 86.7%–95.7%), while protection against post-herpetic neuralgia (PHN) reached 95.9% (95% CI: 63.9%–99.9%), and against herpes zoster-associated severe acute pain was 92.6% (95% CI: 87.2%–96.1%). Notably, efficacy was 93.9% among participants aged 40–69 but fell to 66.9% among those aged 70 and older, although the confidence interval for the older subgroup was wide.
LZ901 is a recombinant herpes zoster vaccine built around a tetrameric VZV glycoprotein E (gE)-Fc fusion protein designed to enhance antigen presentation. Unlike GSK's Shingrix, which combines recombinant gE with the AS01B adjuvant system containing MPL and QS-21, LZ901 uses its engineered Fc-containing antigen structure alongside an aluminum hydroxide adjuvant.
On safety, 16.4% of LZ901 recipients reported at least one adverse reaction within 30 days versus 9.0% in the placebo group (p<0.001). Injection-site reactions occurred in 11.6% of vaccinees compared with 3.7% of placebo recipients. Grade 3 reactions did not differ significantly between groups (0.4% vs. 0.3%; p=0.672), suggesting the reactogenicity profile, while higher than placebo, did not produce serious adverse events at a meaningful rate.