GenScript ProBio Congratulates EyeGene for Clinical Trial Approval for mRNA COVID-19 Vaccine in South Korea
PR91934
NANJING, China, Sept. 27, 2021 /PRNewswire=KYODO JBN/ --
EyeGene's mRNA vaccine against COVID-19, namely "EG-COVID", has recently been
approved for clinical trials by South Korea's Ministry of Food and Drug Safety
(MFDS). GenScript ProBio hereby extended its warm congratulations to the
partner.
EG-COVID will undergo a Phase I/IIa clinical trial to test the safety,
tolerability and immunogenicity of the vaccine. GenScript ProBio, as a partner
of EyeGene, will provide the project with plasmids for mRNA vaccine production.
The vaccine uses a cationic liposome-based vaccine delivery system and is
produced in a freeze-drying formula. It is refrigerated at 2-8 degrees Celsius
for preservation, and is thus competitive for export to foreign markets with
insufficient low-temperature refrigeration facilities.
An EyeGene official said: "Now that the pandemic is still raging around the
world, we are very excited to get EG-COVID approved for clinical trial. Our
scientists have used a cationic liposome-based delivery system for the vaccine,
and we are very confident in its safety and effectiveness. GenScript ProBio is
the largest plasmid CDMO supplier in China and the China's sole GMP production
platform that provides in vitro transcription (IVT) template linearized
plasmids for mRNA vaccines. I believe this highly specialized platform can help
us accelerate the product launch and defeat the pandemic sooner."
"We congratulate EG-COVID for the clinical trial approval from MFDS," said Dr.
Brian Min, CEO of GenScript ProBio. "As the pandemic continued to roam the
planet, we have built cooperation with almost all mRNA vaccine companies in
China. And we have supported two clients of mRNA vaccine programs get IND
approved from the MFDS (South Korea) and PMDA (Japan) We will continue to
provide support for the fight against the global pandemic, give continuous
attention to the progress of the clinical trials of the EG-COVID project, and
hope we can defeat COVID-19 in the near future."
About EyeGene
EyeGene took its first step in the development of innovative biopharmaceutical
drugs when it was first established in June 2000. Since then, EyeGene's R&D
Scientists have continued to research and develop innovative drugs for the
treatment and prevention of age-related diseases.
More Info: http://eyegene.co.kr/kor/
About GenScript ProBio
GenScript ProBio is the biologics CDMO segment of GenScript, proactively
providing end-to-end service from drug discovery to commercialization with
proactive strategies, professional solutions and efficient processes in
antibody drug and gene and cell therapy to accelerate drug development for
customers.
GenScript ProBio's innovative solutions for antibody drug development include
antibody drug discovery, antibody engineering and antibody characterization. In
terms of biologics development service, GenScript ProBio has built a
regulatory-compliant platform, from stable cell line development, host cell
license, process development, analytical development to clinical manufacturing
services, providing fed-batch and perfusion process to accelerate IND process
and high quality material for clinical trials. GenScript ProBio has
successfully delivered multiple CMC and GMP manufacturing projects.
GenScript ProBio's total gene and cell therapy solution covers CMC of plasmid
and virus for IND filing as well as clinical manufacturing and commercial
manufacturing. Our quality management systems ensure phase appropriate
compliance, data integrity and traceability.
https://www.genscriptprobio.com
SOURCE: GenScript ProBio
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