Recbio's Novel Adjuvanted Shingles Vaccine Receives Clinical Trial Approval in China and Progresses Overseas

27 July 2023 | Thursday | News

Jiangsu Recbio Technology Co., Ltd. (the"Board") is pleased to announce that the Group has recently received the notice of acceptance (acceptance number: CXSL2300518) issued by National Medical Products Administration ("NMPA"), pursuant to which the clinical trial application for its self-developed novel adjuvanted recombinant shingles vaccine REC610 has been accepted. Within 60 days from the date of acceptance, the Company may carry out clinical trials in accordance with the submitted plan if no negative or doubtful comments are received from the Center for Drug Evaluation of NMPA.
Image Source : Public Domain

Image Source : Public Domain

The Company proposes to adopt a randomized, double-blind, Shingrix® parallel controlled phase I clinical trial in 180 healthy adult subjects aged 40 and above in Mainland China to evaluate the safety, tolerability of REC610 and have a preliminary assessment of its immunogenicity.

Shingles is a common viral infectious disease that seriously affects the quality of life of patients, especially elderly patients. It is estimated that more than 1.5 million new cases of shingles occur each year in people aged 50 and over in China. In recent years, with the accelerated pace of life, the incidence of shingles has gradually become younger. REC610 is equipped with a novel adjuvant BFA01 independently developed by the Company, which can promote the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibody. REC610 is intended to prevent shingles in adults aged 40 and above. Preclinical studies have shown that REC610 has favorable immunogenicity and can induce high levels of gE antigen-specific CD4+T cell responses and IgG antibody, and its immune response is non-inferior to the controlled vaccine Shingrix®.

Previously, the Company commenced the first-in-human GSK Shingrix® active controlled clinical trial of REC610 in the Philippines in February 2023. Currently, the clinical trial is being executed smoothly. All subjects have completed 30 days of follow-up studies after two doses of the vaccination, with favorable safety and tolerability profile.

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