Celltrion seeks to distribute COVID-19 treatment from mid-Jan

South Korea's Celltrion Inc. has completed second-phase clinical trials of its COVID-19 treatment and is seeking conditional approval of its distribution at home, said both its senior executive and the country’s ruling party leader on Dec. 29.

Once approved, the new antibody COVID-19 virus killer will likely be distributed in South Korea from mid-January as the only treatment for the disease available outside of the US.

In coming weeks, Celltrion will also apply for emergency use authorization of the anti-COVID-19 monoclonal antibody CT-P59 from the US and Europe, said Celltrion Vice Chairman Kee Woo-sung.

“We have completed phase 2 clinical trials (of CT-P59) on 327 patients in both South Korea and Europe,” Kee told the 2020 Korea Bio Investment Conference hosted by The Korea Economic Daily on Monday.

“From next February, South Korea will become the second country in the world securing both COVID-19 vaccines and treatment,” Kee said in a keynote speech for the conference. “Then, our life will return to normal in the second half of next year."

Echoing Kee’s remarks, ruling Democratic Party leader Lee Nak-yon said in a meeting of the party’s supreme council on Monday that Celltrion was submitting an application for the treatment on Dec. 29 with the Ministry of Food and Drug Safety, and a decision on the application will be made next month.

Conditional approval is granted to a treatment of a disease for which no other therapy exists, on conditions that third-phase clinical trials will be conducted afterward.

Last month, two US companies – Regeneron and Eli Lilly – received emergency use authorization for their COVID-19 drugs. But they have not been shipped abroad due to the shortage of production capacity.

Celltrion has already begun manufacturing CT-P59 for use by about 100,000 patients, about double the number of confirmed cases in South Korea as of Monday, once the company gets government approval.

“We completed the new treatment development within just 10 months, by working 24-hour shifts. Generally, drug development takes more than 10 years," Kee said. 

EFFICACY, OVERSEAS MARKETS

When asked about its efficacy in comparison to the two other treatments developed by Regeneron and Eli Lilly, Kee said Celltrion will make public details within the next few days, adding: “Almost no side effects have been reported.”

Its CT-P56 kills the COVID-19 virus within three to five days of infection to prevent damage to internal organs. Like the antibody drugs from both Regeneron and Eli Lilly, CT-P56 is designed for mild to moderate patients of the novel coronavirus.
 
Citing the global supply shortage of COVID-19 drugs, Celltrion is expecting its COVID-19 treatment to penetrate into Europe and other foreign regions.

“If the two US companies, with insufficient production capacity, placed CMO orders, their mass production will likely take place one or two years later. In terms of supply capabilities, we are ahead of the two companies, which do not have their own production facilities," Kee said.

Celltrion will convert one of its plants in Songdo, Incheon into a COVID-19 drug production line.

Last month, Seo Jung-jin, founder and chairman of the biosimilar maker, said in a local radio program that Celltrion’s production capacity is about 7% of global drug output and could manufacture CT-P59 for up to two million people.

The company is planning to build its fourth plant in the city of Incheon, west of Seoul, as well as one abroad. By 2030, it is expected to have an annual production capacity of 600,00 liters, challenging Samsung Biologics’ targeted 620,000 liters.

Samsung Biologics, the world’s No.1 contract manufacturing organization, plans to build its fourth plant in Songdo, as well.

Celltrion's Kee said the COVID-19 treatment will be distributed at close to production cost in South Korea only. If so, the drug will be sold below the $390-per-bottle price of Gilead Sciences’ antiviral drug Remdesivir, he added. Remdesivir has been used for emergency use to treat patients hospitalized with COVID-19 and became the first drug approved for COVID-19 treatment in the US.

Also during the conference, two Kosdaq-listed companies unveiled clinical trial plans for their COVID-19 treatments under development.

Eutilex Co.’s CEO Choi Soo-young said his company will launch clinical trials of its COVID-19 drug next October. AbClon Inc., co-developing the antibody COVID-19 treatment with Yuhan Corp., will apply for phase 1 clinical trials of the treatment early next year, aiming to distribute the drug next year.

Write to Woo-Sub Kim and Woo-Sang Lee at duter@hankyung.com
Yeonhee Kim edited this article.