China's Shingles Vaccine Candidate Posts Positive Clinical Trial Results

Jiangsu Recbio Technology Co., Ltd. today announced that the novel adjuvanted recombinant shingles vaccine candidate REC610 recently achieved positive results in the interim analysis of the first-in-human clinical trial in the Philippines.

Published on December 29, 2023, the Interim Analysis results showed that REC610 demonstrated an overall favorable safety and tolerability profile in healthy participants aged 40 and above after two vaccination doses.

REC610 induced strong gE-specific humoral and cellular immune responses, which were evident after the first vaccination and peaked 30 days after the second vaccination.

The humoral and cellular immune responses were comparable between REC610 and the Shingrix® vaccine comparison group, and the immune response level in the REC610 group was numerically higher than that in the Shingrix group.

REC610 is intended to prevent shingles in adults aged 40 and above. It 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 antibodies.

REC610 received a drug clinical trial approval notice issued by the National Medical Products Administration in October 2023. It is approved as a preventive 3.3 biological product in its Phase I and III clinical trials in China.

The Company will soon adopt a randomized, double-blind, parallel controlled phase I clinical trial in 180 healthy adult subjects aged 40 and above in Mainland China to evaluate the safety, tolerability, and immunogenicity of REC610.

According to statistics, China's population aged 40 and above is approximately 700 million, and about 6 million new shingles cases occur each year in China.

Furthermore, the incidence of shingles has gradually become younger in recent years. 

Only Shingrix is on the market in China, and there is a strong demand for import substitution, according to Jiangsu Recbio Technology's press release.

Beginning in January 2024, Chongqing Zhifei Biological Products will have exclusive rights to import and distribute Shingrix in China.