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South Korea MFDS approves phase II/ III key trials of the anti-COVID-19 monoclonal antibody CT-P59.

 Last Update: 2020-10-02
 Source: Internet
 Author: User

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Celltrion Group announced today that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company's Application for Research New Drugs (IND) to allow the conduct of critical Phase II/III clinical trials against COVID-19 monoclonal antibody CT-P59 for patients with COVID-19.
this global trial will assess the safety and effectiveness of CT-P59 in patients with mild to moderate COVID-19.
is expected to have key results by the end of the year.
Celltrion has submitted INDs in six countries, including South Korea, the United States and Spain, and plans to recruit more than 1,000 patients from 12 countries.
the company hopes to apply for emergency use authorization (EUA) based on the results of key trials.
Celltrion has started manufacturing CT-P59 and plans to increase manufacturing capabilities to meet the current global demand for drugs against COVID-19 monoclonal antibodies.
, Senior Executive Vice President of Celltrion, said, "Given the significant threat to life from COVID-19, there is an urgent need to find treatments that can help us respond to the pandemic.
the launch of the global Phase II/III critical clinical trial of CT-P59 is an important step forward."
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