CelltrionHealthcare

Brazilian Health Regulatory Agency (ANVISA) grants emergency use authorisation (EUA) for Celltrion’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59) in Brazil

• Regdanvimab (CT-P59) receives emergency use authorisation from the Brazilian Health Regulatory Agency (ANVISA, Agencia Nacional de Vigilancia Sanitaria) 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

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.[1]

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.[2]

“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)[3], Gamma (P.1, first identified in Brazil) [4] 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.[5] Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.

[1] 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]

[2] Worldometer. Available at: https://www.worldometers.info/coronavirus/country/brazil/ [Last accessed August 2021]

[3] 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]

[4] 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

[5] Celltrion Data on file