RECBIO-B (02179) announced that the new drug application for its novel adjuvant recombinant shingles vaccine REC610 has been formally accepted by the Center for Drug Evaluation of the National Medical Products Administration, with the acceptance number CXSS2500145. Shingles is a common disease caused by the reactivation of a latent virus, and patients may develop postherpetic neuralgia, a severe nerve pain that significantly impairs health and quality of life. Statistics indicate that approximately 6 million people in China suffer from shingles annually, with a trend of the disease increasingly affecting younger populations in recent years. According to research data on globally marketed shingles vaccines, compared to live attenuated vaccines, novel adjuvant recombinant shingles vaccines can provide stronger cellular immunity, higher protective efficacy, and longer duration of protection. REC610 is equipped with the BFA01 novel adjuvant independently developed by the company, which can stimulate the body to produce high levels of VZV glycoprotein E (gE) specific CD4+ T cells and antibodies. Currently, globally, the only novel adjuvant recombinant shingles vaccine on the market is GSK's Shingrix®. REC610 received a clinical trial approval notice from the NMPA in October 2023 (Notice No.: 2023LP02151) and completed the enrollment of all participants for its Phase III clinical trial in December 2024, with follow-up visits currently ongoing as per the clinical protocol. This clinical study employs a randomized, double-blind, placebo-controlled design aimed at evaluating the protective efficacy, safety, and immunogenicity of the REC610 vaccine in healthy subjects aged 40 and above. Previously, REC610 conducted exploratory clinical studies in both the Philippines and China using Shingrix® as a positive control, both of which achieved the expected results. Data shows that in healthy subjects aged 40 and above, the administration of two doses of REC610 demonstrated a favorable overall safety profile, with no serious adverse events (SAE), adverse events of special interest (AESI), or treatment-emergent adverse events (TEAE) related to the study vaccine observed. REC610 induced a strong gE-specific immune response, with levels comparable to those observed in the Shingrix® group.
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