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| A researcher at a Celltrion lab conducts an experiment to develop COVID-19 medication. / Courtesy of Celltrion |
By Kim Hyun-bin
All eyes are on whether Cellltrion will become the first company in Korea to develop a medicine for COVID-19, after it recently began Phase 2 clinical trials of its antibody treatment CT-P59.
Celltrion is analyzing data on the efficiency and safety of CT-P59 before applying for approval from the Ministry of Food and Drug Safety approval to commercialize the drug if the Phase 2 trials are successful.
The antibody under development is similar to Regeneron produced by U.S. pharmaceutical company Eli Lilly, which received emergency use approval from the U.S. Food and Drug Administration.
The treatment is manufactured by multiplying antibodies taken from patients who have recovered from the disease that demonstrate an ability to neutralize the coronavirus. These "new" antibodies can also stimulate a patient's own immune system to copy them and thus more effectively combat the disease.
In order for a person to develop COVID-19, a spike protein on a viral cell needs to connect to a healthy cell's angiotensin-converting enzyme (ACE2) "spike" thus disabling it and turning it into a virus replicator.
However, the anti-body prevents this process from occurring.
Five companies worldwide are developing COVID-19 antibody treatments ― Eli Lilly, Regeneron, Celltrion, GSK and Astrazeneca ― but currently, only Eli Lilly's Regeneron has received FDA approval for emergency use.
Celltrion plans to conduct its Phase 3 CT-P59 clinical trials in 10 countries.
The company started production of the treatment at its Songdo facility in Incheon, and has already manufactured doses for 100,000 patients ― once mass production begins, it will be able to produce enough to treat 2 million annually.
Industry watchers believe, there is a high possibility the drug safety ministry will give a conditional approval of the drug next month.
"Since Celltrion is in the final stages and well prepared to mass produce its COVID treatment, the government is expected to give swift approval of the drug in the near future," a bio industry official said.
