RECBIO-B (02179) announced that the Phase III clinical trial of its independently developed new adjuvant recombinant shingles vaccine REC610 has been completed, registration number: CTR20243742, and the company has recently obtained the clinical trial summary report for this study.
It is reported that REC610 is a new adjuvant recombinant shingles vaccine independently developed by the company, using varicella-zoster virus (VZV) glycoprotein E (gE) protein as the antigen, and equipped with the company's independently developed novel adjuvant BFA01. BFA01 can promote the production of high levels of gE-specific CD4+ T cells and antibodies.
REC610 is suitable for adults aged 40 and above to prevent shingles. If REC610 is ultimately approved for marketing, it will provide more options for the domestic vaccinated population and help meet the clinical needs in China's shingles prevention field.
According to the summary report and information available as of the date of this announcement, this study has been smoothly implemented and completed according to the research protocol, and REC610 has shown good overall safety and immunogenicity in this study.
Following the completion of the summary report, the company will actively communicate with the National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE) of the People's Republic of China, and make every effort to advance the product's application and review process.
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