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.
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 us.
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.
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.