Celltrion’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59) becomes the first authorized COVID-19 treatment approved by the Korean Ministry of Food and Pharmaceutical Safety (MFDS)


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  • Approval Marks First Time Monoclonal Antibody Therapy For COVID-19 Receives Full Approval To Treat Patients With COVID-19
  • Approval includes an increase in the number of patients who can be treated with regdanvimab (CT-P59) for COVID-19 and a reduced time period for administration of treatment
  • Celltrion continues discussions with global regulators to make regdanvimab (CT-P59) available to patients with COVID-19

INCHEON, South Korea – Celltrion Group announced that the Korean Ministry of Food and Pharmaceutical Safety (MFDS) has approved regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19 for prolonged use in patients aged 50 and over, or with at least one underlying medical condition (obesity, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, and patients with immunosuppressants) with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19. This is the first time that a monoclonal antibody treatment for COVID-19 has received full approval to treat patients with COVID-19 from the Korean MFDS.

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In February, the Korean MFDS granted conditional marketing authorization (CMA) for the emergency use of regdanvimab (CT-P59) and authorized the use of CT-P59 in adult patients aged 60 years. and more, or with at least one underlying medical condition. (cardiovascular, chronic respiratory disease, diabetes, high blood pressure) with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19.

The duration of administration of the recommended dose of regdanvimab (CT-P59), a single intravenous (IV) infusion of 40 mg / kg, has been reduced from 90 minutes to 60 minutes.

Celltrion has successfully enrolled more than 1,315 people in its global Phase III clinical trial, which evaluated the efficacy and safety of regdanvimab (CT-P59) in 13 countries, including the United States, Spain and Romania. Data showed that regdanvimab (CT-P59) significantly reduced the risk of hospitalization or death from COVID-19 by 72% for patients at high risk of progressing to severe COVID-19 and by 70% for all patients. Additionally, preclinical data for regdanvimab (CT-P59) demonstrated strong neutralizing activity against the Delta variant (B.1.617.2, first identified in India) with results showing a 100% survival rate. with eradication of the virus in all animals treated with therapeutic agents. dose of CT-P59.

“Recent clinical data has helped improve the understanding of healthcare professionals and public health authorities of the potential role of regdanvimab in the treatment of patients with mild to moderate symptoms of COVID-19,” said Dr HoUng Kim , Ph.D., head of the medical and marketing division of Celltrion Healthcare. “Regdanvimab is the first of its kind for the treatment of COVID-19, therefore the efficacy and safety profile must be thoroughly evaluated. Along with the continued and positive feedback from expert scientists and clinicians, we are encouraged by the regulatory agency’s decision to confirm that this treatment is safe and effective. The Celltrion group remains in diligent communication with other regulatory authorities around the world.

As of September 2021, more than 14,857 people had been treated with regdanvimab (CT-P59) in 107 hospitals in the Republic of Korea.

ENDS –

Notes to Editors:

About Celltrion Santé

Celltrion Healthcare is committed to providing innovative and affordable medicines to promote patient access to advanced therapies. Its products are manufactured in state-of-the-art mammalian cell culture facilities designed and built to comply with US FDA cGMP guidelines and EU GMP guidelines. Celltrion Healthcare strives to deliver high quality cost effective solutions through an extensive global network that spans over 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com.

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About regdanvimab (CT-P59)

CT-P59 has been identified as a potential treatment for COVID-19 through screening for antibody candidates and selecting those that have shown the greatest potency to neutralize the SARS-CoV-2 virus. In vitro and in vivo preclinical studies have shown that CT-P59 binds strongly to SARS-CoV-2 RBD and significantly neutralizes wild-type and mutant variants of concern, including the Alpha variant (B.1.1.7, first identified UK). In in vivo models, CT-P59 effectively reduced SARS-CoV-2 viral load and inflammation in the lungs. The results of the phase I and II global clinical trials of CT-P59 have demonstrated a promising profile of safety, tolerability, antiviral effect and efficacy in patients with mild to moderate symptoms of COVID-19.1 Celltrion also recently started the development of a neutralizing antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.

FORWARD-LOOKING STATEMENT

Certain information contained in this press release contains statements relating to our future business and financial performance and to future events or developments involving Celltrion / Celltrion Healthcare which may constitute forward-looking statements under relevant securities laws.

These statements can be identified by words such as “prepare”, “hope”, “to come”, “is considering”, “aims”, “to launch”, “is preparing”, “once won” , “Could”, “for the purpose of”, “may”, “once identified”, “will”, “work towards”, “is due”, “become available”, “has the potential to”, the negative of these words or any other variant or comparable terminology.

In addition, our representatives may make oral forward-looking statements. These statements are based on current expectations and certain assumptions of the management of Celltrion / Celltrion Healthcare, many of which are beyond its control.

Forward-looking statements are provided to enable potential investors to understand management’s beliefs and opinions regarding the future so that they can use those beliefs and opinions as a factor in valuing an investment. These statements are not guarantees of future performance and should not be relied on unduly.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results for future periods to differ materially from any projection of future performance or results expressed or implied by such statements. prospective.

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Although the forward-looking statements contained in this presentation are based on what the management of Celltrion / Celltrion Healthcare considers to be reasonable assumptions, there can be no assurance that the forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those provided for in these declarations. Celltrion / Celltrion Healthcare assumes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions change, except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

The references


1 Celltrion Data on File

See the source version on businesswire.com: https://www.businesswire.com/news/home/20210918005026/en/

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