TAIZHOU, China, July 27, 2023 /PRNewswire/ — Jiangsu Recbio Technology Co., Ltd. (the”Board”) is pleased to announce that the Group has recently received the notice of acceptance (acceptance number: CXSL2300518) issued by National Medical Products Administration (“NMPA”), pursuant to which the clinical trial application for its self-developed novel adjuvanted recombinant shingles vaccine REC610 has been accepted. Within 60 days from the date of acceptance, the Company may carry out clinical trials in accordance with the submitted plan if no negative or doubtful comments are received from the Center for Drug Evaluation of NMPA.
The Company proposes to adopt a randomized, double-blind, Shingrix® parallel controlled phase I clinical trial in 180 healthy adult subjects aged 40 and above in Mainland China to evaluate the safety, tolerability of REC610 and have a preliminary assessment of its immunogenicity.
Shingles is a common viral infectious disease that seriously affects the quality of life of patients, especially elderly patients. It is estimated that more than 1.5 million new cases of shingles occur each year in people aged 50 and over in China. In recent years, with the accelerated pace of life, the incidence of shingles has gradually become younger. 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. Preclinical studies have shown that REC610 has favorable immunogenicity and can induce high levels of gE antigen-specific CD4+T cell responses and IgG antibody, and its immune response is non-inferior to the controlled vaccine Shingrix®.
Previously, the Company commenced the first-in-human GSK Shingrix® active controlled clinical trial of REC610 in the Philippines in February 2023. Currently, the clinical trial is being executed smoothly. All subjects have completed 30 days of follow-up studies after two doses of the vaccination, with favorable safety and tolerability profile.
Founded in 2012, Jiangsu Recbio Technology Co., Ltd. (hereinafter referred to as Recbio or the Company; stock code: 02179.HK) is an innovative vaccine company driven by self-developed technologies. We are dedicated to the R&D, production and commercialization of innovative vaccines, leveraging our core technology platforms (novel adjuvant, protein engineering, immunological evaluation). Staying true to the mission of “Protect human health with best-in-class vaccines”, the Company has established high-value pipelines consisting of several blockbuster vaccines with proprietary rights to satisfy the huge unmet demands in the markets of high-burden diseases.
Through years of devotion to the vaccine industry, Recbio has developed three advanced innovative technology platforms, namely novel adjuvant, protein engineering and immunological evaluation platforms, and become one of the few companies in the world capable of developing novel adjuvant systems. We develop promising vaccine candidates constantly, taking advantage of the synergy between the novel adjuvant platform, optimized antigen designs, and immunological evaluation technologies. Recbio never ceases to optimize its technology platforms, and strives to achieve breakthroughs in mRNA vaccines using a joint venture model.
With robust R&D capacity, the Company has developed high-value innovative vaccine portfolios consisting of ten-odd differentiated vaccines, covering cervical cancer, shingles, COVID-19, TB and other high-burden diseases. Our core product REC603, a recombinant 9-valent HPV vaccine in Phase III clinical trial, shows great promise of becoming the first marketed domestic 9-valent HPV vaccine. Apart from that, ReCOV, a recombinant COVID-19 vaccine with its commercialization in the offing, has been recognized as one of the most competitive next-generation COVID-19 vaccines in the world. Recbio has a clear commercialization strategy aiming to penetrate the diversified global vaccine market.
Honed and refined for ten years, Recbio is going to reap the rewards as several products are approaching commercialization.
For more information, please visit https://www.recbio.cn/.
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Jiangsu Recbio Technology Co., Ltd.