News
2021.05.18
A KRW 24.5 billion agreement signed for pilot production of GX-19N (DNA vaccine)
A supply contract is set to be concluded for commercial production
Hanmi Pharmaceutical will be manufacturing GX-19N, a DNA vaccine for COVID-19 developed by Genexine.
According to industry officials, the two companies concluded a KRW 24.5 billion agreement on developing the production process and commencing the contract production of GX-19N. They also formed a partnership for commercialization of GX-19N for the global market.
According to the agreement, Hanmi Pharmaceutical is to develop the production process and analytical method for GX-19N and commence pilot production of the commercialized drug at its Pyeongtaek Bio Plant II, in addition to preparing the necessary documents for approval (CTD).
The two partners will enter into a supply agreement for GX-19N, which is set to be marketed and sold as soon as an emergency use authorization is obtained.
GX-19N developed by Genexine is a DNA vaccine that exhibits antiviral effects by activating antibody responses including T-cell responses and neutralizing antibody responses against SARS-CoV-2. The developer has agreed to supply 10 million doses of GX-19N to Kalbe Farma, a pharmaceutical company based in Indonesia.
Genexine and Kalbe Farma have submitted the investigational new drug (IND) application to the National Agency of Drug and Food Control (BPOM) of Indonesia to proceed with Phase II and Phase III of the clinical trial.
Sung Young-chul, CEO of Genexine, said, “We’ve laid the groundwork to mass produce our DNA vaccine with Hanmi Pharmaceutical, which boasts world-class production facilities and knowhow. We plan to maintain a robust cooperation system to ensure the success of the commercialization and production of our DNA vaccine.”
Kwon Se-chang, Co-CEO of Hanmi Pharmaceutical, said, “The collaboration between Hanmi Pharmaceutical and Genexine will become a milestone marking Korea’s self-sufficiency in developing and producing gene-based vaccines. By ensuring swift clinical development and production in collaboration with Genexine, we will make sure that Korean pharmaceutical and bio companies play pivotal roles in ending the COVID-19 pandemic.”
Source: Financial News