RECBIO-B(02179): The new drug application for the adjuvanted recombinant herpes zoster vaccine REC610 has been accepted by the National Medical Products Administration.

RECBIO-B (02179) announcement, the company's new adjuvant recombinant herpes zoster vaccine REC610 (REC610) new drug marketing application has recently been officially accepted by the National Medical Products Administration Drug Evaluation Center, acceptance number: CXSS2500145. Herpes zoster is a common disease caused by a latent infection of the virus. Patients may develop post-herpetic neuralgia after herpes zoster, which severely damages the health of patients and affects their quality of life. Statistics show that about 6 million people in China are infected with herpes zoster each year, and the incidence of the disease has been gradually getting younger in recent years. According to research data on herpes zoster vaccines already on the market globally, compared to attenuated live vaccines, the new adjuvant recombinant herpes zoster vaccine can provide stronger cell-mediated immunity, higher protective efficacy, and longer protection time. REC610 carries the company's self-developed novel adjuvant BFA01, which can promote the body to produce high levels of VZV glycoprotein E (gE) specific CD4+ T cells and antibodies. Currently, globally, the only new adjuvant recombinant herpes zoster vaccine on the market is GlaxoSmithKline's Shingrix. REC610 obtained the drug clinical trial approval notification letter issued by the National Medical Products Administration in October 2023 (Notification Number: 2023LP02151) and completed the enrollment of all subjects in Phase III clinical trials in December 2024. Currently, it is following the clinical trial protocol for subsequent visits and observations. This clinical study adopts a random, double-blind, placebo-controlled design, aiming to evaluate the protective efficacy, safety, and immunogenicity of the REC610 vaccine in healthy subjects aged 40 and above. Previously, REC610 conducted exploratory clinical studies in the Philippines and China using Shingrix as a positive control, and both studies yielded expected results. Data show that in healthy subjects aged 40 and above, two doses of REC610 are generally safe, and no serious adverse events (SAEs), adverse events of special interest (AESIs), or adverse events occurring after vaccination (TEAEs) related to the study vaccine were observed. REC610 can induce a strong gE-specific immune response, with levels comparable to the Shingrix group.