Celltrion Healthcare signs Regkirona deals with 9 European countries

Industry

Published: 30 Nov. 2021, 16:31

Celltrion Healthcare signs Regkirona deals with 9 European countries

Celltrion's Regkirona Covid-19 treatment [YONHAP]

Celltrion Healthcare has signed agreements with nine European countries for the distribution of Regkirona, Korea's first Covid-19 treatment.

Celltrion Healthcare handles the overseas distribution of biopharmaceuticals developed by Celltrion.

The deals involve 150,000 vials, which can treat 50,000 patients. The distribution could start this year, the company said Tuesday.

Celltion won marketing approval for Regkirona from the European Commission on Nov. 12, only a day after the therapy received an approval recommendation from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency. Celltrion said it is very rare for the European Commission to grant permission so quickly as it normally takes about one to two months to approve a new drug after the CHMP's recommendation.

"We are currently in talks with another 47 countries," Celltrion Healthcare said in Tuesday's statement. "As the demand for Regkirona is on the rise recently, we anticipate we could win more orders soon."

Around 2.43 million new infections were reported Nov. 15 to 21, up 11 percent compared to the previous week, according to Celltrion Healthcare, citing a report from World Health Organization.

Regkirona received formal marketing authorization from Korea's Ministry of Food and Drug Safety in September. A total of 25,209 patients at 134 hospitals in Korea received the treatment as of Nov. 25.

Staring Nov. 25, Regkirona is being used in regional treatment centers and nursing homes, as well as at government-designated hospitals specializing in infectious diseases. The Korean government expanded the use of Regkirona in an effort to prevent patients with light and moderate symptoms from becoming more seriously ill.

Based on Phase 3 trial results, Regkirona slowed the progression rate of the disease by 70 percent, and by 72 percent for high-risk patients over 50 or those with underlying conditions. Regkirona is administered intravenously for a 60-minute period.

BY SARAH CHEA [chea.sarah@joongang.co.kr]