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Vaccine business

Genexine exports COVID vaccine candidate to Indonesia

Apr 28, 2021 (Gmt+09:00)

Genexine's researcher is culturing cells in a lab 
Genexine's researcher is culturing cells in a lab 

Genexine Inc., one of the five South Korean pharmaceutical companies whose COVID-19 vaccine candidates have entered clinical trials, will export its product to Indonesia within this year according to the company's delivery plan.

The company said on Apr. 27 that it agreed to supply at least 10 million doses of its vaccine candidate GX-19N in a pre-order to the Indonesian pharma company Kalbe Farma.

Genexine will be conducting phase II and phase III clinical trials for GX-19N globally, giving shots to 30,000 subjects. The company has submitted the investigational new drug (IND) filing to the Indonesian health authorities last month to give shots to 1,000 subjects in the country.

“Once we receive approval for the clinical trials, we will increase the number of subjects in the country to several thousand. We will also conduct our third phase trial in Africa and South America,” said a company representative.

In Korea, the company has completed giving shots to 150 subjects this month as part of its phase IIa clinical trial.

Genexine said that it will target delivering the pre-ordered volume to Indonesia by the end of 2021.

The company is currently in discussion with contract manufacturing organizations (CMO) in Korea for the mass production of GX-19N. Under the agreement with Kalbe Farma, the first batch of the GX-19N volume produced will be supplied to Indonesia.

GX-19N is a DNA vaccine, a type that transfects a specific antigen-coding DNA sequence onto the cells of an immunized species. There is currently no DNA vaccine in the world yet that has been approved for actual use by COVID patients.

Pfizer and Moderna use mRNA vaccine, a type that uses a copy of a natural chemical called messenger RNA (mRNA) to produce an immune response, while AstraZeneca uses viral vector vaccine, which uses a modified version of a different virus -- the vector -- to deliver a piece of genetic code to our cells.

VACCINE DEVELOPMENT PROGRESS OF KOREAN COMPANIES

Among the five Korean companies whose vaccine candidates have entered clinical trials, two are using the DNA method, one is using the virus vector method, while the other two are using recombinant protein method, which injects fragments of viral proteins into the human body as antigens.

GeneOne Life Science Inc., another company that uses the DNA method, is currently conducting its phase I trial with plans to enter phase III in the second half of this year.

Cellid Co., which uses the virus vector method like AstraZeneca, is going through phase II trial with plans to apply for conditional approval to the Korean health authorities by August this year.

SK Bioscience Co. and EuBiologics Co. use the recombinant protein method. SK Bioscience is testing two different candidates, going through phase I and II trials, whereas EuBiologics has given shots to 50 subjects as part of its phase 1 trial.

The mRNA method is still in its nascent stage in Korea. Eyegene Inc. will kick off a domestic phase I trial in June with commercialization plans in 2022. Other companies like mCureX Therapeutics, a subsidiary of OliX Pharmaceuticals, and Samyang Holdings are jointly developing mRNA-related technologies.

“If COVID-19 keeps mutating and breaks out every year like common flu, there will be a constant demand for its vaccines as it is the case for flu,” said an mCureX spokesman.

Write to Ju-hyun Lee at deep@hankyung.com

Daniel Cho edited this article.

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