Clinical Trial Approval For The Company’s Novel Adjuvanted Recombinant Shingles Vaccine REC610 In The Philippines
Jiangsu Recbio Technology Co., Ltd. (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that, the Group has recently received the clinical trial approval for its novel adjuvanted recombinant shingles vaccine, REC610, from the Food and Drug Administration of the Philippines.
The study is a randomized, observer-blinded, GSK Shingrix® active-controlled phase I clinical trial to evaluate the safety and immunogenicity of REC610 in healthy adult subjects aged 40 and above.
Shingles is an acute infectious skin disease caused by reactivation of latent varicella zoster virus (VZV) in the body. There is no specific medicine for shingles, and vaccine is an effective means of preventing shingles. According to research data on shingles vaccines that have been marketed around the world, the novel adjuvanted vaccine can provide stronger cellular immunity and protective efficacy as compared to live attenuated vaccines. 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. Preclinical studies have shown that REC610 has favorable immunogenicity and can induce high levels of gE-specific CD4+T cell responses and IgG antibody, and its immune response is non-inferior to the controlled
vaccine Shingrix®.
The clinical trial approval of REC610 is another testament of the Company’s leading strength in the field of novel adjuvanted vaccines. At present, the aging population is increasing and the incidence of shingles is increasing, and it is believed that REC610 will provide a more effective vaccine option for vaccination.
About Recbio
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/en/.