South Korea's biotech company Helixmith Co. said Wednesday it has developed and patented a new freeze-dried formulation for Engensis (VM202), a non-viral plasmid DNA product, in the United States.
According to the company's explanation, the freeze-dried formulation developed lately enhances the stability of Engensis. In addition, it makes it possible to administer the active ingredients in an accurate and consistent manner when reconstituted as a solution after freeze-drying.
The formulation patent was registered in the United States for the first time. Evaluations are underway in Korea, Japan, Europe, and China.
With this US patent registration, Engensis' patent exclusiveness is to be extended until 2039. In addition, a major obstacle to the technology transfer and marketing approval of Engensis has been removed.
One of the important conditions in the process of technology transfer and product approval is chemistry, manufacturing, and controls (CMC), and it was especially difficult to control the quality of existing formulations.
"We have been able to extend Engensis' patent monopoly and at the same time build a system that allows commercial mass production. We have overcome one of the barriers in the future technology transfer and market approval process," said Sunyoung Kim, CEO of Helixmith.
Write to Jae-Young Han at
jyhan@hankyung.com
