The Celltrion Group filed a formal application for conditional manufacturing and marketing approval (CMA) with the Ministry of Food and Drug Safety (MFDS) of Korea. This application is based on the results of a global Phase 2/3 clinical trial of CT-P59 that achieved the objectives of the clinical endpoint.

Sertorion enrolled 327 patients with mild to moderate COVID-19 symptoms and assigned them to 3 groups (placebo, low and high), and CT in SARS-CoV-2 infected patients with standard treatment. -We evaluated the efficacy and safety of P59. Top-line data for the CT-P59 global Phase 2/3 clinical trial will be available in the first half of 2021.

Ho Ung Kim, Head of Medical & Marketing at Sertorion Healthcare, said: " Today's conditional manufacturing and marketing approval application in South Korea is an important milestone in the fight against COVID-19. We continue to include the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) worldwide. We are working closely with national regulators to ensure that patients around the world have access to safe and effective COVID-19 treatments as soon as possible. "

Celltrion plans to begin global Phase 3 clinical trials, a very important part of this study, in more than 10 countries to obtain more comprehensive safety and efficacy data for CT-P59. We plan to apply for an Emergency Use Authorization (EUA) for CT-P59 to the US FDA and a Conditional Manufacturing and Marketing Authorization (CMA) to the European Medicines Agency (EMA) in the coming months.

About Sertorion Healthcare

Sertorion Healthcare is committed to providing innovative and inexpensive medicines and facilitating patients' access to advanced therapeutics. Our products are manufactured in state-of-the-art mammalian cell culture facilities designed and constructed to comply with the US FDA's cGMP and EU GMP guidelines. Sertorion Healthcare is committed to providing high quality and cost effective solutions through its extensive global network of more than 110 countries. For more information , please visit https://www.celltrionhealthcare.com/en-us .

About COVID-19 1 , 2

Coronavirus (CoV) is a group of viruses that cause the common cold to severe illness. The new coronavirus SARS-CoV-2 is the cause of COVID-19 infection. Discovered in 2019, this new strain is behind the ongoing global epidemic.

The most common signs of COVID-19 are fever, dry cough, and tiredness, but you may also experience other symptoms such as shortness of breath and difficulty breathing. Most patients infected with this virus present with mild to moderate symptoms, but older people and patients with underlying disorders such as cardiovascular disease and diabetes are more likely to develop more severe COVID-19. ..

Get the latest information on this global epidemic from the World Health Organization ( https://www.who.int/health-topics/coronavirus#tab=tab_1 ).

About CT-P59 (Regdanvimab)

Through screening of antibody candidates, CT-P59 was selected to have the highest neutralizing ability against SARS-CoV-2 virus including G mutant strain (D614G mutant strain), and was selected as a therapeutic drug candidate for COVID-19. It was discovered as. The therapeutic agent candidate in preclinical data, while reducing the viral load of SARS-CoV-2 to 1/100, was reduced lung inflammation 3 . CT-P59 global first phase results of a clinical trial of safety in patients with mild COVID-19 symptoms, tolerability, antiviral activity, showed promising profile of efficacy 3 .

Forward-looking statement

Certain information contained in this press release describes our future business and financial results, future events and new developments related to Celltrion / Celltrion Healthcare, and is a forward-looking statement as stipulated by the relevant Securities and Exchange Law. Includes what can be said about.

These descriptions are "prepared", "expected", "come", "planned", "aimed", "planned to be released", "preparing", "as soon as obtained", "possible" , "For the purpose of", "Maybe", "As soon as it is discovered", "Would", "Strive for", "Plan to", "Available", " It may be identifiable by words such as "possible", these negative forms or other variants or similar phrases.

Our representatives may also verbally announce future prospects. These statements and announcements are based on current expectations and certain assumptions made by Celltrion / Celltrion Healthcare management, many of which are beyond our control.

Forward-looking statements are provided to potential investors to understand the future thoughts and opinions of our management and to use those thoughts and opinions as an element in assessing investments. It is something to do. These statements do not guarantee future performance and should not be overly trusted.

Such forward-looking statements inevitably involve known and unknown risks and uncertainties, and these risks and uncertainties refer to such forward-looking statements regarding actual performance and financial results for the future period. It may cause any explicit or implied forecast or significant differences from future performance or results.

The forward-looking statements contained in this press release are based on what Celltrion / Celltrion Healthcare management considers to be reasonable assumptions, but actual results and future events may relate to such forward-looking statements. There is no guarantee that the forward-looking statements are accurate, as the statements may differ materially from what is expected. Celltrion / Celltrion Healthcare undertakes no obligation to update forward-looking statements in the event of changes in circumstances or management's expectations or opinions, except as required by applicable securities trading law. Readers should be careful not to overly trust the forward-looking statements.

References

1 Coronavirus. World Health Organization . Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: December 2020 ("Coronavirus", World Health Organization)

2 Coronaviruses. National Institute of Allergy and Infectious Diseases . Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: December 2020 ("Coronavirus", National Institute of Allergy and Infectious Diseases) )

3 Celltrion in-house materials

The official version of this press release is the original language version. The translated language version is provided for the convenience of the reader and has no legal effect. When using the translated language version as a material, please compare it with the original language version, which is the only version that has legal effect.

Contacts
Sophia Eminson
seminson@hanovercomms.com
+44 (0) 7751 11625

Donna Curran
dcurran@hanovercomms.com
+44 (0) 7984550312

 

Source: businesswire.com

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