• CT-P63 demonstrated a well- established safety profile in the global Phase I trial
• CT-P63 maintained strong neutralising ability against the Omicron variant (B.1.1.529) based on structural analysis by X-ray crystallography and neutralisation data from pseudo- virus testing
• Celltrion plans to provide dual treatment options for COVID-19; Regkirona™ for hospitalised patients and a nebulised cocktail therapy (CT-P63 in combination with Regkirona™) for at- home settings

Celltrion Group announced today results for its cocktail therapy candidates including neutralisation data against the Omicron variant (B.1.1.529).

The Phase I clinical trial is a randomised, double- blind and placebo- controlled trial designed to evaluate the safety, tolerability and pharmacokinetics of CT-P63 in 24 healthy subjects in Poland.¹ The study met its primary objectives with data showing CT-P63 to be safe and well tolerated, with no significant drug- related adverse events (AEs).

In an experiment conducted in partnership with the National Institutes of Health (NIH), CT-P63 showed strong neutralising activity against the Omicron variant based on structural analysis by X- ray crystallography and neutralisation data from pseudo- virus testing. Celltrion anticipates results of the SARS-CoV-2 Omicron variant assays and animal model studies by the end of the first quarter this year.

In order to elicit potent neutralising antibody response against the new emerging variants, Celltrion previously identified a total of 38 potent neutralising antibodies against SARS-CoV-2 in which antibody candidate No. 32 (CT-P63) produced high neutralisation titres against new emerging strains. CT-P63 has previously been demonstrated to have neutralising activity against the most common variants, including the Alpha, Beta, Gamma and Delta variants.

“The positive results demonstrate the potential of our cocktail therapy to retain neutralising ability against the Omicron variant” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We are confident that our antibody platform including Regkirona and CT-P63 will provide significant benefit for patients with COVID-19. Regkirona is given to a patient intravenously, so the drug could effectively treat patients hospitalised with COVID-19 at an early stage, while the nebulised cocktail therapy could address patients’ unmet needs for at- home treatment. We plan to discuss large- scale clinical trial for our nebulised cocktail therapy (CT-P63 in combination with Regkirona™) with regulatory agencies worldwide in the near future.”