Jiangsu Recbio Technology Co., Ltd. announced that the novel adjuvanted recombinant shingles vaccine REC610 independently developed by the Company has recently achieved positive results in the interim analysis of first-in-human ("FIH") clinical trial in the Philippines. Previously, the Company conducted a GSK Shingrix active-controlled FIH clinical trial of REC610 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.

REC610induced 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. The humoral and cellular immune responses were comparable between REC610 and Shingrix group, and the immune response level in REC610 group was numerically higher than that in Shingrix group. Safety: REC610 had good safety profile with the two-dose vaccination regimen.

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 is approximately 700 million. Only GlaxoSmithKline's Shingrix, the new adjuvant recombinant vaccine, is on the market in China, and there is a strong demand for import substitution.

REC610 received a drug clinical trial approval notice (notice number: 2023LP02151) issued by the National Medical Products Administration in October 2023, and 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 Company will adopt a randomized, double-blind, parallel controlled phase I clinical trial in 180 healthy adult subjects aged 40 and above in Mainland China in near term to evaluate the safety, tolerability and immunogenicity of REC610.