Brazilian Health Regulatory Agency (ANVISA) grants emergency use authorisation (EUA) for Celltrion’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59) in Brazil
August 12 2021, INCHEON, KOREA – Celltrion Healthcare today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted an emergency use authorisation (EUA) for the company’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59) for the treatment of adults with mild-to-moderate COVID-19 who do not require supplemental oxygen and who are at high risk of progression to severe COVID.
Brazil had the highest number of confirmed cases from COVID-19 in Latin America with an average of 35,000 cases per day. Since the beginning of the pandemic, at least 1 in 10 residents have been infected, a total of 20,249,176 reported cases.
“Today’s announcement of emergency use authorisation for regdanvimab takes us a significant step closer to providing a safe and effective monoclonal antibody treatment against COVID-19 to patients in Brazil,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Regdanvimab demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in its global clinical trial. The use of monoclonal antibodies is an important tool in the fight against COVID-19. We are actively exploring additional authorisation in other countries and regions to help COVID-19 patients around the world.”
Celltrion’s global Phase III data showed regdanvimab (CT-P59) significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high- risk of progressing to severe COVID-19 and 70% for all patients. In addition, patients who were treated with regdanvimab (CT-P59) reported a significantly shortened time to clinical recovery by at least 4.7 days for patients at high- risk of progressing to severe COVID-19 and by 4.9 days compared to placebo for all patients.
In addition, in vitro and in vivo studies demonstrated potency of regdanvimab (CT-P59) against multiple variants of concern including the Alpha (B.1.1.7, first identified in the UK), Beta (B.1.351, first identified in South Africa), Gamma (P.1, first identified in Brazil)  and Delta (B.1.617.2, first identified in India) variants. The monoclonal antibody regdanvimab (CT-P59) also demonstrated strong neutralising capability against the Lambda variant (C.37, first identified in Peru) in a cell-based pseudo- virus assay study performed by the National Institutes of Health (NIH), U.S.
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Notes to Editors:
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com.
About regdanvimab (CT-P59)
CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus. In vitro and in vivo pre- clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralise the wild type and mutant variants of concern including the Alpha variant (B.1.1.7, first identified in the UK). In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I and II clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild- to- moderate symptoms of COVID-19. Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.
 Anvisa autoriza uso emergencial de novo medicamento para Covid-19. Available at: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2021/anvisa-autoriza-uso-emergencial-de-novo-medicamento-para-covid-19 [Last accessed August 2021]
 Worldometer. Available at: https://www.worldometers.info/coronavirus/country/brazil/ [Last accessed August 2021]
 Ryu DK., et al. Therapeutic effect of CT-P59 against SARS-CoV-2 South African variant. Biochemical and Biophysical Research Communications, Volume 566, 2021, Pages 135-140, https://doi.org/10.1016/j.bbrc.2021.06.016. [Last accessed August 2021]
 Ryu DK., et al. Therapeutic efficacy of CT-P59 against P.1 variant of SARS-CoV-2. bioRxiv 2021.07.08.451696; doi: https://doi.org/10.1101/2021.07.08.451696
 Celltrion Data on file