Celltrion said that it has completed administering Regkirona (ingredient: Regdanvimab), its Covid-19 treatment, to 1,300 patients participating in its phase 3 global clinical trial.
The company has been conducting phase 3 clinical trials in 13 countries, including Korea, the U.S., Spain, and Romania, since January. Celltrion initially planned to conduct its phase 3 global clinical trials with 1,172 people. However, to secure safety and efficacy results from more patients, the company expanded the final recruitment number to 1,300.
“To date, there have been no specific safety issues among patients who have received the medication. No have there been any discontinuation of the study due to adverse reactions after medication,” the company said. “We will emphasize the safety of Regkirona in the export discussions. We plan to analyze data for phase 3 clinical trials by the end of June and submit them to regulatory agencies both here and abroad.”
The company expects the process will accelerate the review rate for the permit application, it added.
In February, Celltrion obtained conditional approval for the treatment from the Ministry of Food and Drug Safety to treat high-risk, mild, and moderately ill patients aged 60 or older.
“However, if the company proves the safety and efficacy of Regkirona thorough this large-scale global phase 3 trial, we expect that the target group will be expanded,” the company said.
The company stressed that it completed the production of Regkirona for 100,000 people last year and can produce the treatment for 1.5 to 3 million people per year depending on demand.
“The Covid-19 virus is still prevalent in many countries, and with the great effort of the clinical team at headquarters and local staff, we were able to recruit a sufficient number of patients in a short time,” a company official said. “We expect the export negotiations to gain further momentum and will focus our capabilities to derive excellent results through phase 3 clinical data analysis in the first half of this year.”