Celltrion receives MHRA approval to initiate Phase I trial of potential COVID-19 antiviral antibody treatment, CT-P59, in the UK

• The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved Celltrion’s clinical trial authorization (CTA) application to initiate a Phase I trial of CT-P59, a potential COVID-19 antiviral antibody treatment
• Celltrion’s Phase I trial will enrol patients with mild symptoms of SARS-CoV-2 infection to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59; a Phase I clinical trial in healthy volunteers is ongoing in South Korea
• Celltrion anticipates results from Phase II/III trials by the end of the year with commercial production set to commence this September

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion Group announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the company’s Clinical Trial Authorisation (CTA) application for a Phase I clinical trial with CT-P59, a COVID-19 antiviral antibody treatment candidate, in patients with mild symptoms of SARS-CoV-2 infection. The clinical trial is set to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59.

Celltrion plans to conduct further global Phase II/III trials in patients with mild and moderate COVID-19 and anticipates results from these pivotal studies by the end of the year. Furthermore, a clinical trial investigating the use of CT-P59 as a preventative measure, by enrolling people in close contact with COVID-19 patients globally, is also planned and the topline data for this trial are anticipated in Q1 of 2021.

Celltrion will start the full-scale commercial production of CT-P59 in September this year and is securing sufficient manufacturing capacity to produce enough of the potential COVID-19 treatment for up to 5 million patients a year.

“This is a timely approval from the UK regulatory authority for the Phase I clinical trial with CT-P59 as the global pandemic continues to grow and there remains a significant need for a safe and effective treatment for COVID-19,” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. “We are rapidly advancing our COVID-19 programme with CT-P59, including a Phase I clinical trial in healthy volunteers in Korea. Furthermore, we are making efforts to ensure that if the clinical trial programme is successful we are able to scale up manufacturing appropriately.”

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.¹

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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-19^2,3

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

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.

References  

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¹ Celltrion. Data on file

² Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: July 2020

³ Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: July 2020

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