• The Korean Ministry of Food and Drug Safety (MFDS) has approved Celltrion�s Investigational New Drug (IND) application to initiate the post-exposure prophylaxis clinical trial of CT-P59
• The Phase III trial is set to enrol approximately 1,000 subjects to evaluate protective efficacy in contacts of SARS-CoV-2 infected patients
• Celltrion will continue to generate data from ongoing clinical trials of CT-P59 in various clinical settings

INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group today announced the launch of its Phase III clinical trial investigating CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate as a preventative measure. The initiation of the post-exposure prophylaxis clinical trial follows the approval of the Investigational New Drug (IND) application by the Korean Ministry of Food and Drug Safety (MFDS) on October 8^th, 2020.

Celltrion anticipates the enrolment of approximately 1,000 patients to evaluate population-based prophylaxis in contacts of SARS-CoV-2 infected patients. The post-exposure prophylaxis clinical trial will evaluate the preventive effect and safety of CT-P59 and whether CT-P59 can elicit a neutralising antibody response to prevent the virus from infecting human cells.

�We hope anti-COVID-19 monoclonal antibodies such as CT-P59 can provide high-risk individuals with effective protection against COVID-19 and help prevent further spread in the community,� said Dr Sang Joon Lee, Senior Executive Vice President of Celltrion. �We look forward to continued data generation as this trial proceeds and we remain committed to combatting the spread of the virus around the world.�

Celltrion has previously shown promising safety results in the Phase I clinical trial in healthy volunteers. The MFDS has now approved Celltrion�s IND application to initiate a Phase II/III pivotal trial of this potential treatment in mild-to-moderate patients.

- 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 COVID-19^1,2

Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.

The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19.

Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1

About CT-P59

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 including the mutated G-variant strain (D614G variant). 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.³

References

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

² Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: October 2020

³ Celltrion. Data on file

Contacts

Preetika Ramjoorawon

[email protected]?

+44 (0) 20 3817 6766

Zuzanna Grzeskiewicz

[email protected]?

+44 (0) 7506 339043