Celltrion’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59) becomes the first authorized COVID-19 treatment approved from the Korean Ministry of Food and Drug Safety (MFDS)

• The approval marks the first time a monoclonal antibody treatment for COVID-19 received full approval to treat patients with COVID-19
• The approval includes an expansion of patients that can be treated with regdanvimab (CT-P59) for COVID-19 and a reduced time period for the treatment administration
• Celltrion continues discussions with global regulators to make regdanvimab (CT-P59) available to patients with COVID-19

Celltrion Group announced that the Korean Ministry of Food and Drug Safety (MFDS) approved regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19 for the extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition (the obese, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, and patients with immunosuppressive agents) with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19. This marks the first time a monoclonal antibody treatment for COVID-19 has received a full approval to treat patients with COVID-19 from the Korean MFDS.

In February, the Korean MFDS granted a Conditional Marketing Authorisation (CMA) for the emergency use of regdanvimab (CT-P59) and allowed the 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 administration time for the recommended dosage of regdanvimab (CT-P59), a single intravenous (IV) infusion of 40 mg/kg, has been reduced from 90 minutes to 60 minutes.

Celltrion has successfully enrolled more than 1,315 people in its global Phase III clinical trial, which evaluated the efficacy and safety of regdanvimab (CT-P59) in 13 countries including the U.S., Spain, and Romania. Data showed regdanvimab (CT-P59) significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high- risk of progressing to severe COVID-19 and 70% for all patients. In addition, pre- clinical data for regdanvimab (CT-P59) demonstrated strong neutralising activity against the Delta variant (B.1.617.2, first identified in India) with results showing 100% survival rate with virus eradication from all animals treated with therapeutic dosage of CT-P59.

“Recent clinical data have helped improve healthcare professionals’ and public health authorities’ understanding of the potential role of regdanvimab in the treatment of patients with mild-to-moderate symptoms of COVID-19,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Regdanvimab is the first of its kind for the treatment of COVID-19, so the efficacy and safety profile should be assessed thoroughly. Along with a continuous and positive feedback from expert scientists and clinicians, we are encouraged by the decision of regulatory agency to confirm this treatment is safe and effective. Celltrion group remains in diligent communication with other regulatory authorities worldwide.”

As of September 2021, more than 14,857 people have been treated with regdanvimab (CT-P59) in 107 hospitals in the Republic of Korea.

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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.

About regdanvimab (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. In vitro and in vivo pre- clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralise the wild type and mutant variants of concern including the Alpha variant (B.1.1.7, first identified in the UK). In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I and II clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild- to- moderate symptoms of COVID-19.¹ Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.

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References

¹ Celltrion Data on file

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