CelltrionHealthcare

• Celltrion Healthcare Canada remains committed to working closely with Health Canada to make its monoclonal antibody treatment for COVID-19 available in Canada

TORONTO, Aug. 2, 2021 /CNW/ - Celltrion Healthcare Canada Limited announced today that the New Drug Submission (NDS) file for regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19, submitted to Health Canada as rolling submission on May 28, 2021 has completed the screening phase. Regdanvimab (CT-P59) has been screened and found acceptable for review as a New Drug Submission with flexibilities for designated COVID-19 drugs (NDS-CV).

The rolling submission process was recommended and accepted under the Minister of Health's Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD IO) and transitioned to a New Drug Submission for COVID-19, which permits companies to submit safety and efficacy data and information as they become available.¹ Often referred to as a rolling review, this allows Health Canada to start its review right away, as information continues to come in, to accelerate the overall review process.

The Food and Drug Regulations have been amended to allow for modified requirements that facilitate the regulatory process for new COVID-19 drugs to receive a notice of compliance (NOC) through a new drug submission (NDS). The amendments maintain some of the mechanisms introduced through the ISAD IO, thus continuing to provide Canadians with quick access to safe and effective COVID-19 drugs.²

"We are pleased the New Drug Submission has been screened and accepted for review by Health Canada and anticipate this accelerated review process will enable people in Canada to have access to safe and effective treatment against COVID-19 as early as possible," said Jovan Antunovic, Commercial Director at Celltrion Healthcare Canada. "The initiation of a rolling submission for regdanvimab (CT-P59) in Canada is a significant milestone and we remain committed to closely working with the Canadian regulatory authorities."

Celltrion's global Phase III data showed regdanvimab (CT-P59) significantly reduced the risk of COVID-19 related hospitalization, oxygen therapy or death by 72% for patients at high- risk of progressing to severe COVID-19 and 70% for all patients compared to placebo. In addition, patients who were treated with regdanvimab (CT-P59) reported a significantly shortened time to clinical recovery by at least 4.7 days for patients at high- risk of progressing to severe COVID-19 and by 4.9 days compared to placebo for all patients.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has made its recommendation for regdanvimab (CT-P59) that CT-P59 can be considered a treatment option for patients at high risk of progressing to severe COVID-19, based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm.³

Notes to Editors:

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 neutralizing the SARS-CoV-2 virus. Pre-clinical studies showed that CT-P59 strongly binds to the receptor binding domain (RBD) of SARS-CoV-2 and significantly neutralizes the wild type virus. In vitro and In vivo studies demonstrated potency of CT-P59 against multiple variants of concern including the Alpha (B.1.1.7, first identified in the UK), Beta (B.1.351, first identified in South Africa), Gamma (P.1, first identified in Brazil) and Delta (B.1.617.2, first identified in India) variants. Results from the global Phase I through III 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. Celltrion also has recently commenced the development of a neutralizing antibody cocktail with CT-P59 which is expected to neutralize a wider range of new emerging variants of SARS-CoV-2.

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 U.S. 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.ca/en-ca

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