Jung-Jin Seo, COVID-19 tx will be applied within this year

Jung-Jin Seo, Chairman at Celltrion, keynote lecture on the first day of GBC 2020 on the 7th...Updated the status of COVID-19 antibody development

Phase II and III at the same time at the end of September, targeting to complete phase III clinical trials in March next year

Jung-Jin Seo, Chairman at Celltrion is giving a keynote lecture on the first day of GBC

Jung-Jin Seo, Chairman at Celltrion announced that he will apply for approval for emergency use of COVID-19 antibody treatment within this year.

 

The strategy is to finish early phase I clinical trial of the COVID-19 antibody treatment, which started at the end of July, and start an integrated phase II and III clinical trial at the end of this month to complete the effectiveness and safety verification.

 

It will also start commercial batch production this month to enable mass production as soon as it obtains emergency use approval.

 

He gave a keynote lecture on the theme of 'Post COVID-19 Era, Crisis is an Opportunity' at the 2020 Global Bio Conference (GBC) online event hosted by the MFDS, and introduced the current status of COVID-19 antibody development.

 

According to the announcement on the day, the Phase I clinical trial of the antibody 'CT-P59' for the treatment of COVID-19 developed by Celltrion has recently been administered to healthy subjects.

 

It is a policy to end phase I clinical trial in Korea early, and to discuss with regulatory agencies to simultaneously proceed with phase II and III clinical trials from the end of this month.

 

Celltrion believes that it will be able to apply for an emergency use approval at the end of the year if its efficacy and safety are verified in the Phase II clinical phase.

 

If phase III clinical trial is completed in May next year as planned, the world's first COVID-19 antibody treatment will be developed.

 

He said, "We hope to start an integrated phase II and III clinical study this month through cooperation with regulatory agencies.

 

We plan to start large-scale production from this month in order to respond to global demand, centering on domestic COVID-19 patients.

 

It is also progressing without a hitch.” He predicted that it would be difficult for the neutralizing antibody formation rate to exceed 50% with only the gene-recombined and protein-recombined vaccines that are currently being developed.

 

Since it is difficult for the vaccine under development to have a complete preventive effect, the company is in a position to put all efforts into accelerating the time of development of the treatment.

 

He said, "At this stage, the best way to lower the mortality rate of COVID-19 patients is early diagnosis and early treatment," he said.

 

"Korea is developing antibody treatments and blood system drugs as a world leader.

 

The production capacity is unrivaled enough to account for 15%,” he emphasized.

 

It is evaluated that it has high competitiveness as a production base even if the leading position in the development of COVID-19 treatment or vaccine is lost to advanced countries such as the United States.

 

He also said, "Korea is developing the world's leading antibody treatments and blood system treatments.

 

If the protein-recombined COVID-19 vaccine being developed overseas succeeds in commercialization, we will suggest securing the quantity of vaccines for domestic use as the top priority in the consignment production contract process.

 

He said, "Celltrion will play at the forefront to turn the national crisis caused by COVID-19 into an opportunity."