Hanmi Pharm to Contract Manufacture Genexine's COVID-19 Vaccine

First Contract for Production Process Development and Contract Manufacturing... 24.5 Billion KRW Scale

[Asia Economy Reporter Kim Ji-hee] Hanmi Pharmaceutical will undertake the contract manufacturing of Genexine's COVID-19 vaccine 'GX-19N.'

On the 18th, Hanmi Pharmaceutical announced that it signed a first contract worth 24.5 billion KRW with Genexine for the development of the GX-19N production process and contract manufacturing, establishing a partnership for the global commercialization of GX-19N. Under this contract, Hanmi Pharmaceutical will carry out ▲development of commercialization production processes and analytical methods for GX-19N ▲pilot production of the commercial drug ▲preparation of documents required for approval (CTD) at its Pyeongtaek Bio Plant 2nd factory.

The two companies plan to additionally sign a supply contract for the commercial quantities of GX-19N, which is expected to receive emergency use authorization and be marketed soon.

Genexine recently agreed to supply 10 million doses of GX-19N to Indonesian pharmaceutical company Kalbe Farma. Last month, Genexine and Kalbe Farma also submitted an Investigational New Drug (IND) application to the Indonesian Food and Drug Authority for clinical phases 2 and 3 trials.

Seong Young-cheol, CEO of Genexine, stated, “We have established a foundation to stably mass-produce DNA vaccines together with Hanmi Pharmaceutical, which has global-level production facilities and expertise.”

Kwon Se-chang, President of Hanmi Pharmaceutical, said, “This collaboration between Genexine and Hanmi Pharmaceutical will be an important milestone for Korea’s self-reliance in gene vaccine technology,” adding, “Through rapid clinical development and production based on cooperation with Genexine, we will do our best to ensure that Korean pharmaceutical and bio companies play a central role in ending the COVID-19 pandemic.”