REC610-Novel Adjuvanted Recombinant Shingles Vaccine

REC610 received a drug clinical trial approval notice (notice number: 2023LP02151) issued by the NMPA in October 2023, which is approved for use as a preventive 3.3 biological product in its phase I and phase III clinical trials being carried out in China. The novel adjuvanted recombinant shingles vaccine REC610 independently developed by the Company has officially initiated phase III clinical trial in China recently and achieved the first subject enrollment.This study is a randomized, double-blind, placebo-controlled phase III clinical trial in 24,640 healthy subjects aged 40 and above in China to evaluate the efficacy, safety and immunogenicity of REC610.

REC610 achieved positive results in the interim analysis of phase I clinical trial in the Philippines. The Interim Analysis (IA) results showed that REC610 demonstrated overall favorable safety and tolerability profile in healthy participants aged 40 and above after two doses of the vaccination. REC610 induced strong gE-specific humoral and cellular immune responses, which were evident after the first vaccination and reached the peak at 30 days after the second vaccination.

Shingles is a common viral infectious disease. According to statistics, about 6 million new cases of shingles occur each year in China, and the incidence of shingles has gradually become younger in recent years^[1]. According to global research data on shingles vaccines that have been marketed, as compared to attenuated live vaccines, novel adjuvanted recombinant shingles vaccines can provide stronger cellular immune and protective efficacy. 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. According to statistics, China’s population aged 40 and above is approximately 700 million. Only GSK Shingrix®, the novel adjuvant recombinant vaccine, is on the market in China, and there is a strong demand for import substitution.

Source：
[1] Zhang Z et al. The incidence of herpes zoster in China: A meta-analysis and evidence quality assessment. Hum Vaccin Immunother. 2023;19(2):2228169