Specific outlines of the commercialization of COVID-19 antibody treatment (CT-P59), which is under development by Celltrion have been revealed.
"We will produce about 10 batches of commercial production from September," said Seo Jung-jin, chairman of the Celltrion," at an online press conference on July 20 due to COVID-19. "The end of production overlaps with the end of Phase II clinical trials, and once the Phase 2 clinical trials are completed and emergency use approval is obtained, it can be immediately applied to patients."
Chairman Seo said, "An antibody treatment will have low side effects as mechanism has been identified. We expect the efficacy to be as good as it was seen in animal tests."
He stressed, "Since the COVID-19 treatment is a public material, we will try to provide it as cheaply as possible by lowering development costs and manufacturing costs. We will not create a business model that seeks profit from the COVID-19 treatment."
Noting that Celltrion plans to target 50 patients for clinical first phase, 200 to 300 patients for global second phase, and 2,000 to 3,000 patients for third phase, Chairman Seo said, "In order to shorten the clinical period, we need to recruit patients quickly. If there is no big gap in side effects and efficacy in the clinical process, we can consider emergency approval for use, but it is not something that a company can decide."
Regarding production volume, he explained, "When Celltrion is operating its Songdo production facility as much as possible, we can produce 6 million doses a year of treatments of corona antibody. We are also consulting with CMO companies because we have to produce corona treatments while maintaining the production of existing products."
On July 17, Celltrion announced that it will begin human clinical trials of COVID-19 antibody treatments (IND), which is being developed as a national project with the Korea Center for Disease Control and Prevention, after receiving approval from the Ministry of Food and Drug Safety.
The first phase of the clinical trial will be conducted on 32 healthy subjects at Chungnam National University Hospital, and the first administration will be started to the subjects immediately after approval and the test will be completed around this fall.
"Korea has the sovereignty of COVID-19 vaccines and treatments as well as the U.S. and Europe," Chairman Seo said. "We have self-developed skills in the entire product lineup, including antibody treatments, blood plasma drugs, cytokines and vaccines. It means that the level of Korea's biotechnology industry has increased," he added.
