Celltrion’s COVID-19 treatment candidate receives Korean MFDS Conditional Marketing Authorisation
Celltrion’s COVID-19 Treatment Candidate Receives Korean MFDS Conditional Marketing Authorisation
- Regdanvimab (CT-P59) receives conditional marketing authorisation from the Korean Ministry of Food and Drug Safety (MFDS); first anti-COVID-19 monoclonal antibody treatment to be approved in Korea
- CT-P59 is authorised for the treatment of adult patients aged 60 and over, or with at least one underlying medical condition, with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19
- Celltrion is under discussion with the European Medicines Agency (EMA) for Conditional Marketing Authorisation (CMA) and with the U.S. FDA for Emergency Use Authorisation (EUA)
- The global Phase III clinical trial is on track and the trial is expected to enrol 1,172 patients with mild-to-moderate symptoms of COVID-19
INCHEON, Korea--(BUSINESS WIRE)--Celltrion Group today announced that the Korean Ministry of Food and Drug Safety (MFDS) granted a Conditional Marketing Authorisation (CMA) for the emergency use of Regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment candidate. The CMA allows for emergency use of CT-P59 in adult patients aged 60 years and over, 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 CMA is based on Part 1 of the Phase II/III trial which showed;
- Patients treated with CT-P59 reporting a significantly reduced risk of COVID-19 related hospitalization and oxygenation up to Day 28
- Progression rates to severe COVID-19 were reduced by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over
- A significantly shortened time to clinical recovery in CT-P59 treated patients (40 mg/kg) ranging from 3.4 to 6.4 days quicker compared with placebo.
“With the pandemic still raging in Korea, we believe today’s Conditional Marketing Authorisation of Regdanvimab marks an important milestone in the fight against COVID-19” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Patients with COVID-19 in Korea now have access to a therapy according to the authorised indications early in the course of their infection. We remain committed to closely working with the regulatory agencies worldwide including the U.S. FDA and the European Medicines Agency (EMA) to ensure that patients around the world have access to safe and effective treatment against COVID-19 as in the case of Korea.”
A global Phase III clinical trial is currently recruiting and expected to enrol 1,172 patients with mild-to-moderate symptoms of COVID-19 in more than 10 global sites to evaluate efficacy and safety results of CT-P59. Celltrion is set to demonstrate clinical efficacy against COVID-19 in both UK and South African variants and the results to be expected in the coming days.
- ENDS -
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/en-us.
About CT-P59 (Regdanvimab)
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. The mutated G-variant strain (D614G variant) was later identified and confirmed to be inactivated by CT-P59. In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation. Results from the global Phase I clinical trial of CT-P59 demonstrated promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.1
FORWARD LOOKING STATEMENT
Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.
These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control.
Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.
Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.
Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
1 Celltrion Data on file