Tuesday, 28 June 2022

Korean firm EuBiologics receives approval for Ph III trial of COVID-19 vaccine

04 February 2022 | News

The first Phase III clinical trial IND approval with Eubiologics’ own vaccine development technology

image credit- businesswire

image credit- businesswire

EuBiologics, a South Korean biotech company, has announced that EuCorVac-19, a COVID-19 vaccine candidate obtained approval to conduct Phase III comparison clinical trials (Phase III IND Approval) from the Ministry of Food and Drug Safety in South Korea.

Eubiologics is able to commence Phase III comparison trial for 4,000 healthy participants including the Philippines, Bangladesh and other countries based on the standard comparison clinical trial guideline by the Ministry of Food and Drug Safety in Korea. Eubiologics will work closely with the global CROs for recruiting the participants to expedite the entire process in low vaccination rate countries.

Eubiologics is developing EuCorVac-19, its vaccine platform, which consists of owned antigen, EulMT in-licensed from Korea Institute of Science and Technology and SNAP technology of POP Biotechnologies that EuBiologics has invested. 

The company has 2 main animal-based bioreactors (1,000L) to produce recombinant protein antigens at Chuncheon Plant 1 and EcML which is adjuvant at Chuncheon Plant 2. The total capacity of COVID-19 vaccine is from 100M to 200M doses per year.

It has already received funds for Phase I/II (9.4billion KRW) in March 2021 from the new drug development committee of the Ministry of Health and Welfare in Korea and recently submitted the application for phase III trial to get additional financial assistance.

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