Recco Bio-B (02179): The new drug marketing application for the new adjuvant recombinant herpes zoster vaccine REC610 was accepted by the State Drug Administration

Zhitong Finance App News, Recco Bio-B (02179) issued an announcement. The new drug marketing application for the company's new adjuvant recombinant herpes zoster vaccine REC610 (REC610) has recently been officially accepted by the Drug Evaluation Center of the China Drug Administration. Acceptance number: CXSS2500145.

Shingles is a common disease caused by a latent infection of the virus. Patients may be complicated by post-shingles neuralgia. This severe nerve pain seriously impairs the patient's health and affects the patient's quality of life. According to statistics, about 6 million people in China suffer from shingles every year, and in recent years there has been a gradual trend in the incidence of shingles. According to research data on the shingles vaccine already on the market worldwide, compared with live attenuated vaccines, the new adjuvant recombinant shingles vaccine can provide stronger cellular immunity, higher protective efficacy, and longer protection time. REC610 is equipped with a novel BFA01 adjuvant independently developed by the company, which can promote the body to produce high levels of VZV glycoprotein E (gE) specific CD4+ T cells and antibodies. Currently, only GlaxoSmithKline Shingrix® is the only new adjuvant recombinant shingrix® for sale worldwide.

REC610 obtained the drug clinical trial approval notice (Notice Number: 2023LP02151) issued by the China Drug Administration in October 2023, and completed the enrollment of all phase III clinical subjects in December 2024. Follow-up visits and observations are currently being carried out in accordance with the clinical plan. The clinical study used a randomized, double-blind, placebo-controlled design 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 using SHINGRIX® as a positive control in the Philippines and China, respectively, and both achieved the expected results. The data showed that among healthy subjects aged 40 and above, the two doses of REC610 were generally safe, and no serious adverse events (SAE), special adverse events (AESI), or adverse events (TEAE) related to research vaccination were observed. Rec610 induces a strong GE-specific immune response at levels comparable to those in the Shingrix® group.