Jiangsu Recbio Technology Co., Ltd. announced that, the Group has recently received the clinical trial approval for its novel adjuvanted recombinant shingles vaccine, REC610, from the Food and Drug Administration of the Philippines. The study is a randomized, observer-blinded, GSK Shingrix(R) active-controlled phase I clinical trial to evaluate the safety and immunogenicity of REC610 in healthy adult subjects aged 40 and above. Shingles is an acute infectious skin disease caused by reactivation of latent varicella zoster virus (VZV) in the body.

There is no specific medicine for shingles, and vaccine is an effective means of preventing shingles. According to research data on shingles vaccines that have been marketed around the world, the novel adjuvanted vaccine can provide stronger cellular immunity and protective efficacy as compared to live attenuated vaccines. 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.

Preclinical studies have shown that REC610 has favorable immunogenicity and can induce high levels of gE-specific CD4+T cell responses and IgG antibody, and its immune response is non-inferior to the controlled vaccine Shingrix(R). The clinical trial approval of REC610 is another testament of the Company's leading strength in the field of novel adjuvanted vaccines. At present, the aging population is increasing and the incidence of shingles is increasing, and it is believed that REC610 will provide a more effective vaccine option for vaccination.