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Legdambimab (CT-P59), a monoclonal antibody therapy against celltrion COVID-19, is the first approved COVID-19 treatment approved by the Korean Ministry of Food and Drug Safety (MFDS).

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  • This is the first time that COVID-19 monoclonal antibody therapy has been fully approved to treat patients with COVID-19.
  • Approval includes increasing the number of patients who can be treated with COVID-19 legdumbimab (CT-P59) and shortening the duration of treatment.
  • Celltrion continues discussions with global regulators to make legdumbimab (CT-P59) available to patients with COVID-19

Incheon, South Korea — Celltrion Group has approved the Korean Ministry of Food and Drug Safety (MFDS) for long-term use of COVID-19 monoclonal antibody treatment, legdumbimab (CT-P59), for elderly patients over 50 years of age. Was announced. At least one underlying disorder with mild symptoms of COVID-19 (patients with obesity, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, and immunosuppressants), and moderate symptoms of COVID Adult patients with -19. This is the first time that COVID-19 monoclonal antibody therapy has been fully approved by the Korean MFDS to treat patients with COVID-19.

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In February, South Korea’s MFDS granted Conditional Marketing Approval (CMA) for emergency use of legdumbimab (CT-P59) to use CT-P59 in adult patients aged 60 years or older or with at least one underlying disorder. I allowed it. (Cardiovascular, Chronic Respiratory Disease, Diabetes, Hypertension) Adult patients with mild symptoms of COVID-19 and moderate symptoms of COVID-19.

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

Celltrion has successfully enrolled more than 1,315 people in a global phase III clinical trial evaluating the efficacy and safety of legdumbimab (CT-P59) in 13 countries, including the United States, Spain and Romania. Data show that legdumbimab (CT-P59) significantly reduced the risk of COVID-19-related hospitalization or death by 72% in patients at high risk of progressing to severe COVID-19 and 70% in all patients. I showed that. In addition, preclinical data for legdumbimab (CT-P59) showed potent neutralizing activity against the delta variant (B.1.617.2, first identified in India) and all treated with therapeutic agents. The dose of CT-P59 showed 100% survival by eradicating the virus from animals.

“Recent clinical data has helped improve the understanding of healthcare professionals and public health authorities about the potential role of legdumbimab in the treatment of patients with mild to moderate symptoms of COVID-19.” Dr. HoUngKim said. , Head of Healthcare and Marketing at Sertorion Healthcare. “Because legdumbimab is the first treatment for COVID-19, its efficacy and safety profile needs to be thoroughly evaluated. Continuous and positive from professional scientists and clinicians. In addition to feedback, it is encouraged by regulatory decisions to ensure that this treatment is safe and effective. The Sertorion Group continues to communicate enthusiastically with other regulators around the world. increase.”

As of September 2021, more than 14,857 people were treated with legdumbimab (CT-P59) at 107 hospitals in South Korea.

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Notes to editors:

About Celltrion Healthcare

Celltrion Healthcare is committed to providing innovative and affordable medicines to facilitate access to advanced treatments for patients. The product is manufactured in a state-of-the-art mammalian cell culture facility and is designed and manufactured to comply with US FDAcGMP and EU GMP guidelines. Celltrion Healthcare strives to provide high quality and cost effective solutions through its extensive global network across more than 110 countries. See below for more information. 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 of antibody candidates and selection of the most potent in neutralizing the SARS-CoV-2 virus. In vitro When In vivo In preclinical studies, CT-P59 binds strongly to SARS-CoV-2 RBD and is of concern for wild-type and mutant mutants, including alpha mutants (B.1.1.7, first identified in the UK). It has been shown to be significantly neutralized.of In vivo In the model, CT-P59 effectively reduced SARS-CoV-2 viral load and lung inflammation. Results from global Phase I and Phase II clinical trials of CT-P59 show promising safety, tolerability, antiviral efficacy, and efficacy in patients with mild to moderate symptoms of COVID-19. Shown the profile.1 Celltrion has also recently begun developing a neutralizing antibody cocktail with CT-P59 against a newly emerging variant of SARS-CoV-2.

Future-oriented statement

The specific information contained in this press release may constitute a forward-looking statement under the relevant securities law, and our future business and financial performance related to celltrion / celltrion healthcare. And contains statements related to future events or developments.

These statements are “prepared”, “desired”, “future”, “planned”, “aimed”, “launched”, “prepared”, “obtained once”, “made” Can be identified by words such as “. , “With purpose”, “May”, “Once identified”, “Will”, “Effort”, “Deadline”, “Available”, “May”, Variations or equivalent terms such as the negation of these words.

In addition, our representatives may verbally make forward-looking statements. Such statements are based on the current expectations and specific assumptions of Celltrion / Celltrion Healthcare management, many of which are beyond their control.

Forward-looking statements provide potential investors with an opportunity to understand management’s beliefs and opinions about the future and allow them to be used as a factor in assessing investments. increase. These statements do not guarantee future performance and should not be overly trusted.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, and actual performance and financial results for future periods are expressed or implied by such forward-looking statements. It may differ significantly from future performance or results forecasts.

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The forward-looking statements contained in this presentation are based on what Celltrion / Celltrion Healthcare management believes are reasonable assumptions, but actual results and future events are such. What is expected in the statement. Celltrion / Celltrion Healthcare undertakes no obligation to update any forward-looking statement if circumstances or management estimates or opinions change, except as required by applicable securities law. Readers should be careful not to place undue reliance on forward-looking statements.

References


1 Sertorion data on file

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

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Legdambimab (CT-P59), a monoclonal antibody therapy against celltrion COVID-19, is the first approved COVID-19 treatment approved by the Korean Ministry of Food and Drug Safety (MFDS).

https://financialpost.com/pmn/press-releases-pmn/business-wire-news-releases-pmn/celltrions-monoclonal-antibody-treatment-for-covid-19-regdanvimab-ct-p59-becomes-the-first-authorized-covid-19-treatment-approved-from-the-korean-ministry-of-food-and-drug-safety-mfds Legdambimab (CT-P59), a monoclonal antibody therapy against celltrion COVID-19, is the first approved COVID-19 treatment approved by the Korean Ministry of Food and Drug Safety (MFDS).

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