Phase III Clinical Trial to Be Conducted This Year
Celltrion's antibody therapy "Regkinona" has been approved by the government as the first COVID-19 treatment developed by a Korean pharmaceutical company, but its efficacy is called into question.
The Korean Federation of Medical Activist Groups for Health Rights said in a statement on Jan. 18 that the result of the recent Phase II clinical trial showed that Regkinona only has the effect of shortening the recovery time in mild and moderate cases. But even this has not been fully verified through academic papers yet.
"Regkinona is known as a Celltrion treatment, but it was actually jointly developed by the Korea Disease Control and Prevention Agency and the National Institute of Health," the federation pointed out. "In other words, even though taxpayers’ money has been put into developing the drug, there has been no transparent and clear information disclosure up to now regarding the results of the Phase II clinical trial."
The federation also asserted that Celtrion's claim that Regkinona reduced the probability of mild and moderate cases developing into serious cases by 54 percent was not backed by statistics.
It also called on the government to explain the grounds for giving a conditional nod to the drug. "If the government intended to conditionally approve the treatment based on the outcome of the Phase II clinical trial, it should have provided more detailed information about it,” the federation said. “If approval was given based on sloppy screening, it could give wrong signals to pharmaceutical companies that are waiting for approval on their COVID-19-related drugs."
Seo Jung-jin, honorary chairman of Celltrion, held a press conference to clarify the controversy over Regkinona in person on Feb. 18.
"The Korean Ministry of Food and Drug Safety approved Regkinona on the condition that the results of the phase 3 clinical trial be submitted by the end of 2021," Seo said. “We will recruit 1,200 patients for the Phase III clinical trial and demonstrate its efficacy.”