South Korea’s GC Pharma is expected to submit a plan to local health authorities to commence a clinical trial of its COVID-19 plasma therapy this week.
The investigational therapy is expected to enter a phase 2 clinical trial upon approval skipping phase 1 based on the widely recognized safety profile of a plasma med, according to industry sources on Sunday.
The company has manufactured C5131A for clinical supply at its plant in Cheongju, Chungbuk since July 18 by concentrating the liquid component plasma from the blood of convalescent patients.
GC Pharma is developing the drug as part of a state project with the National Institute of Health and the Ministry of Health and Welfare is expected to grant a fast-track review given the urgency of a situation, making it available during August.
The company also plans to secure more blood samples from donors to complete commercialization by the end of this year.
A total of 1,093 promised to donate their blood plasma as of July 24 and the company has so far collected blood from 683 donors.
Shares of its parent Green Cross rose 5.09 percent to close Monday at 237,500 won.
By Kim Byung-ho and Minu Kim
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