The Korea Herald


Celltrion’s COVID-19 antibody gets temporary Swiss approval

By Kan Hyeong-woo

Published : Jan. 14, 2022 - 14:44

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Celltrion’s Corporate Identity (Celltrion) Celltrion’s Corporate Identity (Celltrion)
Celltrion’s COVID-19 antibody treatment Regkirona has received temporary approval in Switzerland, the Korean biopharmaceutical company said Friday.

Celltrion submitted the results from its global third-phase clinical trial and all clinical data on virus variants including the delta variant, according to the company.

Swissmedic, which is responsible for the authorization and supervision of therapeutic products in Switzerland, gave the temporary nod Wednesday. The approval is for use Regkirona for COVID-19 in adults who do not require oxygen therapy, but are likely to be hospitalized due to a high risk of developing severe symptoms.

Swissmedic said Celltrion, the applicant, did not submit any information on the treatment’s efficacy against the omicron variant of the coronavirus.

According the Swiss Federal Office of Public Health, the European country is experiencing a fifth wave of the COVID-19 pandemic with the number of daily new cases posting record highs as of late. There were 32,773 new cases reported from Monday alone. About three weeks ago, the number of daily new cases recorded 6,463 on Christmas Day.

“Based on the safety and efficacy proven through Regkirona’s global clinical data, it has been recognized by the Swiss health authorities as an official COVID-19 treatment,” a Celltrion official said.

“We will do our best so Regkirona can contribute to help ease the burden on medical workers in the field due to the current surge in the number of confirmed patients in Switzerland.”

With the latest temporary approval of Celltrion’s COVID-19 antibody treatment, the Korean biopharmaceutical firm’s product is now being used in a number of countries across the world including Australia, Brazil, Indonesia and Peru. Regkirona also obtained the approval as an official product license from regulatory authorities in South Korea and Europe last year.

Celltrion said its COVID-19 antibody treatment has validated its safeness and effectiveness through the global third-phase clinical trials conducted on 1,315 patients in 13 countries including South Korea, the US, Spain and Romania.

The company explained that among patients at high risk, those who received Regkirona saw the probability of developing severe symptoms decrease by 72 percent, compared to those who did not get the antibody treatment. The time it took for the symptoms to improve was also shortened by 4.7 days in the patients who were administered with Regkirona.

As of Jan. 6, about 38,000 patients at 236 hospitals across South Korea were administered with Regkirona, according to Celltrion.