Celltrion submits application for Conditional Marketing Authorisation of its COVID-19 treatment candidate CT-P59 to the Korean MFDS

▲ Celltrion's antiviral treatment for COVID-19, CT-P59 - Celltrion submitted today an application for Conditional Marketing Authorisation of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate to the Korean Ministry of Food and Drug Safety (MFDS) - Celltrion plans to submit Emergency Use Authorisation (EUA) to the U.S. FDA and Conditional Marketing Authorisation (CMA) to the European Medicines Agency (EMA) for CT-P59 in the coming months - Celltrion successfully completed its global clinical trial of CT-P59, meeting objectives of clinical endpoints; top-line data to be announced in the first half of 2021 [29 Dec 2020] INCHEON, South Korea-- Celltrion Group has submitted today a formal Application for Conditional Marketing Authorisation (CMA) to the Korean Ministry of Food and Drug Safety (MFDS). This submission is based on the data from global Phase II/III clinical trial of CT-P59, meeting objectives of clinical endpoints. Celltrion has previously enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three groups (placebo, low concentration, high concentration) to evaluate the efficacy and safety of CT-P59 in combination with standard of care in patients with SARS-CoV-2 infection. The top-line data of the global Phase II/III clinical trial of CT-P59 are to be presented in the first half of 2021. “Today’s filing for Conditional Marketing Authorisation in Korea is a significant milestone in the fight against COVID-19,” said HoUng Kim, Head of Medical and Marketing Division at Celltrion Healthcare. “We remain committed to closely working with the regulatory agencies worldwide including the U.S. FDA and the European Medicines Agency (EMA) to ensure that patients around the world have access to safe and effective treatment against COVID-19 as early as possible.” Celltrion plans to initiate a global Phase III clinical trial, a pivotal part of the study in more than 10 countries to obtain more comprehensive safety and efficacy results of CT-P59. The company plans to submit Emergency Use Authorisation (EUA) to the U.S. FDA and Conditional Marketing Authorisation (CMA) to the European Medicines Agency (EMA) for CT-P59 in the coming months. Celltrion submits application for Conditional Marketing Authorisation of its COVID-19 treatment candidate CT-P59 to the Korean MFDS Celltrion Healthcare receives EU CHMP positive opinion for biosimilar adalimumab, CT-P17 List

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