[Asia Economy Reporter Lee Chun-hee] The European supply of Celltrion's COVID-19 antibody treatment 'Rekkirona' (generic name 'Regdanvimab'), sold by Celltrion Healthcare, has officially begun.
Celltrion Healthcare announced on the 30th that as of the 29th, it has signed supply contracts for Rekkirona with nine countries in Europe. Accordingly, the initial shipment of 150,000 vials (enough for 50,000 people) is scheduled to be shipped within this year, and considering the increase in COVID-19 cases and depletion of the initial supply in those countries, additional orders are expected to follow within the year.
In addition, Celltrion Healthcare is continuing export negotiations for Rekkirona with 47 other countries. The company expects that the initial supply could be delivered as early as this year. These countries belong to Europe, Asia, Latin America, the Middle East, and Oceania, and inquiries about Rekkirona supply continue beyond these regions as well.
On the 11th (local time), Rekkirona received a 'recommendation for approval' decision from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), and the very next day, on the 12th, it obtained formal marketing authorization from the European Commission (EC). Considering that formal marketing authorization is usually granted one to two months after the CHMP's recommendation, this was an unusually rapid decision. At that time, Celltrion explained, "This decision is interpreted as a swift response to the rapid surge in COVID-19 cases in Europe and to expand patient access to treatment."
COVID-19 is rapidly resurging in Europe. According to the weekly epidemiological report released by the World Health Organization (WHO) on the 24th, the number of new COVID-19 cases reported in Europe from the 15th to the 21st increased by about 11% compared to the previous week, reaching approximately 2.43 million. This accounts for about 67% of the world's new cases. Especially with winter approaching and temperatures dropping, indoor activities are expected to increase significantly, raising concerns about the spread of COVID-19 worldwide.
Celltrion Healthcare notes that as Rekkirona is actually being prescribed domestically and prescription data is accumulating, along with the recent government recommendation to expand its use, these factors are positively contributing to securing competitiveness in the global market. According to the Central Disease Control Headquarters on the same day, as of the 25th, Rekkirona has been administered to 25,209 patients at 134 hospitals.
Furthermore, from the 25th, the Central Disease Control Headquarters expanded the administration of Rekkirona beyond the previously designated infectious disease hospitals to include residential treatment centers and nursing/general hospitals. It is administered to adult COVID-19 patients within seven days of symptom onset who do not require oxygen therapy but are either over 50 years old or have underlying conditions, or have pneumonia findings on CXR or CT.
A Celltrion Healthcare official stated, "Amid growing concerns about the resurgence of COVID-19 worldwide, including Europe, after the 'With Corona' policy, Rekkirona has attracted significant attention by receiving formal marketing authorization just one day after the CHMP's recommendation. Since a single dose can be expected to have therapeutic effects, we plan to actively utilize Rekkirona's strengths in marketing to alleviate medical burdens and expand global supply."
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