Covid-19 treatment production starts ahead of approvals
The treatments will not be immediately available for public use. They are being manufactured in anticipation of regulatory approval and the sudden uptick in demand that will result.
The Korean government is working with two partners under a national initiative to develop a treatment for Covid-19.
GC Pharma is developing the GC5131A plasma treatment candidate, which is made from immune proteins extracted from blood plasma donated by people who have recovered from an infection. Celltrion is the other partner. It is working on the CT-P59 antibody treatment candidate.
According to KCDC Deputy Director Kwon Jun-wook, mass production of the GC Pharma plasma treatment started today and will be completed by mid-October. According to the company, part of the output will be used for trials, but most of it will be saved for public use in the future. GC Pharma mass-produced its first batch of the treatment in August, but that volume was reserved for clinical trials.
“The plasma treatment was approved for Phase 2 clinical tests on Aug. 20, and it is currently being tested at six medial institutions to verify safety and efficacy,” Kwon said during a daily press briefing on Tuesday.
Mass production of Celltrion treatment will start this month, Kwon said.
“Phase 1 clinical tests for the antibody treatment was completed, and the results are being analyzed. Another Phase 1 trial for light-symptom coronavirus patients was approved on Aug. 25, and we’re currently taking applicants from patients who want to participate,” said Kwon.
“The Ministry of Food and Drug Safety is reviewing approval for Phase 2 and 3 trials. The plan is to start mass production for commercialization in September.”
Celltrion founder and chairman, Seo Jung-jin, said Monday that the company will submit a request for emergency use at the end of the year if Phase 2 clinical trials confirm the treatment candidate’s efficacy.
“I hope Phase 2 and 3 trials can start by the end of September,” he said during an opening speech of the Global Bio Conference hosted by the Ministry of Food and Drug Safety on Monday.
“We’re expecting Phase 3 trials to be completed by May, at latest. Under this scenario, mass production will start this month so that supply can meet domestic demand.”
Remdesivir, which is from Gilead Sciences and is the only Covid-19 treatment approved for emergency use in Korea, has been supplied to 274 candidates in Korea as of Tuesday.
BY SONG KYOUNG-SON [email@example.com]