Genexine Subsidiary VGXI Successfully Completes U.S. FDA Inspection

Genexine announced on the 16th that its subsidiary VGXI, a leading contract development and manufacturing organization (CDMO) in the field of nucleic acid biopharmaceuticals such as gene therapies, DNA vaccines, and RNA medicines, has successfully completed a regulatory inspection of its GMP production facility by the U.S. Food and Drug Administration (FDA), enabling its client to receive Biologics License Application (BLA) approval.

The company stated, "This recent BLA approval by the U.S. FDA acknowledges VGXI's quality and production capabilities in plasmid DNA manufacturing, which is used in the development and commercialization of cell and gene therapies, based on over 20 years of accumulated experience and expertise." The company added, "This achievement once again demonstrates VGXI's long-standing commitment to regulatory compliance, quality improvement, and supporting the success of clients in launching innovative therapies."

Park Youngkeun, CEO of Genexine, emphasized, "The successful completion of the FDA inspection, which evaluates the ability to meet strict requirements for the safety and efficacy of CDMO operations, demonstrates VGXI's competitiveness." He continued, "Clients entrust their promising programs to VGXI based on this trust. We will continue to strengthen VGXI's capabilities to help shorten client development timelines, reduce regulatory risks, and accelerate the delivery of life-changing medicines to patients."