Clinical Trial Approval For mRNA Covid-19 Vaccine For Omicron Variant In The Philippines
The board of directors of the Company (the “Board”) is pleased to announce that, the Group has recently received the clinical trial approval (the“Clinical Trial Approval”) for its R520A, a mRNA COVID-19 vaccine (“R520A”), from the Food and Drug Administration of the Philippines.
R520A is an mRNA COVID-19 vaccine specifically targeting the Omicron variant developed by Wuhan Recogen Biotechnology Co., Ltd. (武漢欧洲杯买球吉生物技術有限公司), a subsidiary of the Company. R520A adopts a self-developed lyophilization technology that can effectively sustain the physiochemical properties and bioactivity of mRNA-LNP and achieve long-term storage at 2℃–8℃. In the pre-clinical studies, the level of neutralizing antibody titers against Omicron variant increased to a high level of 4,758 and it can also induce neutralization response against Delta variant, indicating its promising immunogenicity profile. The relevant research results have been posted on the preprint server, bioRxiv.
About Recbio
Founded in 2012, Recbio is an innovative vaccine company. With the vision of "Become the Leader of Innovative Vaccine in the Future," Recbio takes "Protect Human Health with Best-in-Class Vaccines" as its mission. It has established three major cutting-edge technology platforms including novel adjuvants platform, protein engineering platform, immunological evaluation platform and mRNA vaccine platform . Recbio has a high-value vaccine portfolio consisted of HPV vaccine candidates, COVID-19 vaccine candidates, shingles vaccine candidates, influenza vaccine candidates, adults TB vaccine candidates etc. The core management team has more than 20 years of experience in the development and commercialization of innovative vaccines. For more information, please visit http://6ner.svdxn96.com/.
About Recogen
Recogen is a holding subsidiary of Recbio which was founded in 2021. Recogen is a biotechnology company that combines the state of the art mRNA vaccine platform technology with new adjuvant technology. Headquartered in Wuhan, Recogen is a joint venture between Jiangsu Recbio Technology Co., Ltd and Shenzhen Rhegen Biotechnology Co. Ltd. Adhering to the strategy of "immunology embraces the central principle", Recogen has independently developed the platform technology required for the design, synthesis and evaluation of mRNA vaccines and applies the platform to the development of various infectious diseases vaccines.
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