South
Korea's Celltrion to begin commercial production of
COVID-19 antibody drug
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[September 08, 2020]
By Sangmi Cha
SEOUL (Reuters) - South Korea's Celltrion
Inc will begin commercial production of its experimental treatment for
COVID-19 this month, it said on Tuesday, as it pushes ahead with
clinical trials of the antibody drug.
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The company said it planned to make a request soon to regulators for
emergency use authorisation of the drug, but that it would start
mass production - likely to amount to around 1 million doses -
before receiving that approval.
The treatment became the country's first COVID-19 antibody drug to
be tested on humans after receiving regulatory approval in July for
clinical trials.
"We have confirmed the safety of the antiviral antibody drug in the
process of the local Phase I clinical trial," Kwon Ki-sung, head of
Celltrion's R&D unit, told Reuters.
Celltrion completed a Phase I trial on 32 volunteers in the country
and is enrolling an additional nine participants for another Phase I
study before moving on to later stage trials, for which regulatory
reviews are already underway.
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The company is separately conducting overseas human trials of its treatment in
the United Kingdom, which will be followed by global second and third stage
trials in patients with mild and moderate symptoms.
Shares of Celltrion surged as much as 5.6% on Tuesday, while the broader KOSPI
gained 0.7%.
Other companies developing potential COVID-19 treatments include Eli Lilly and
Co, Regeneron Pharmaceuticals Inc and AbbVie.
(Reporting by Sangmi Cha, Additional reporting by Joori Roh; Editing by Miyoung
Kim and Mark Potter)
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