CelltrionHealthcare

TGA grants provisional approval for Celltrion’s regdanvimab (regkirona)

·        The monoclonal antibody treatment is provisionally approved for the intravenous treatment of mild-to-moderate COVID-19 patients in Australia[1]

December 7, 2021, INCHEON, KOREA –Celltrion Healthcare Australia Pty Ltd announced that the Therapeutic Goods Administration (TGA) granted provisional approval for the use of regdanvimab (regkirona) in adult patients with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

Monoclonal antibodies are proteins designed to attach to a specific target, in this case the spike protein of SARS-CoV-2, which works to block the path the virus uses to enter human cells. The TGA's decision is based on the efficacy and safety data in the global phase III clinical trial involving more than 1,315 people in 13 countries including the U.S., Spain, and Romania. Data showed regdanvimab (regkirona) reduced the risk of COVID-19 hospitalisation by 72% for patients at high-risk of progressing to severe COVID-19 and shorted the time for improving clinical symptoms by more than 4.7 days.

“Today’s provisional approval in Australia marks an important milestone in the fight against COVID-19 as monoclonal antibodies have proven to be an important therapeutic option in the ongoing battle against COVID-19,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We are now a step closer to providing a safe and effective monoclonal antibody treatment for patients at high-risk of progressing to severe COVID-19 in Australia.”

To date, regdanvimab has received market authorisation by the European Medicines Agency (EMA). It has also been granted regulatory approval in the Republic of Korea and emergency use authorisations in Indonesia, Brazil and conditional approval in Peru.

-       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 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 neutralises the wild type and mutant variants of concern. 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 phase II/III clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile inpatients with mild-to-moderate symptoms of COVID-19.[2] The EC granted marketing authorisation for Celltrion’s regdanvimab following positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in November 2021.

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