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Celltrion's CP-P59 COVID-19 treatment (Celltrion) |
South Korean pharmaceutical giant Celltrion said Tuesday that the company has submitted marketing approval applications for the company’s COVID-19 treatment to health authorities in several countries in the Middle East. The countries include Saudi Arabia, United Arab Emirates, Jordan, Iraq and Morocco.
Celltrion’s announcement on Tuesday followed a day after the company said it landed its first overseas supply deal to export 100,000 vials of Regkirona to Pakistan.
Celltrion expects supply of the company’s COVID-19 treatment to Europe would also speed up as the European Commission is seeking to expedite the assessment process of promising COVID-19 treatments.
The commission currently plans to build a portfolio of 10 potential COVID-19 treatments, five of them by June. It also plans to authorize at least three new treatments by October and possibly two more by the end of this year.
The European Medicines Agency is also conducting a review of Celltrion’s antibody treatment.
The EMA said it is conducting the more comprehensive rolling review on Celltrion’s treatment before giving a marketing authorization, while sharing an expert opinion that health authorities should take evidence-based decisions on early use of Celltrion’s treatment.
Regkirona, or CT-P59, has received conditional approval from the South Korean drug safety agency in February. The company has been accelerating preparations for its sales overseas.
“Due to the limited amount of antibody treatments available at the moment, Celltrion would prioritize supply of the COVID-19 treatment to the countries that have health infrastructures capable of early diagnosis of COVID-and handling patients with severe symptoms,“ a Celltrion official said.
By Shim Woo-hyun (
ws@heraldcorp.com)