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noimage Celltrion Healthcare receives positive CHMP opinion for Remsima® SC for direct use of subcutaneous therapy without IV loading 2021-03-31

Celltrion Healthcare receives positive CHMP opinion for subcutaneous formulation of infliximab, Remsima® SC, for direct use of subcutaneous therapy without IV loading in adults with rheumatoid arthritis The Committee for Medicinal Products for Human Use (CHMP) recommends that Remsima® SC can be initiated without IV loading in patients with rheumatoid arthritis (RA) The recommended new posology is to start Remsima® SC 120mg weekly up to week 4 and inject every 2 weeks thereafter; For patients currently on infliximab IV, Remsima® SC can be administered after 8 weeks from last dose without additional IV loading The availability of the subcutaneous induction therapy could potentially shorten drug administration time, reduce healthcare practitioner time, and offer additional flexibility for patients March 31, 2021 05:04 AM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Remsima® SC for direct use of subcutaneous therapy without IV loading in patients with rheumatoid arthritis (RA).1 As a result of the CHMP opinion, if agreed by European Commission (EC), Remsima® SC 120 mg can be used without IV infusion both for new and existing RA patients. The recommended posology for newly diagnosed or newly infliximab-initiated patients, suggests that Remsima® SC should be initiated as a subcutaneous injection at week 0 and additional injections will be given at week 1, 2, 3 and 4 after the first injection. Then, maintenance therapy will be followed every 2 weeks thereafter. For existing patients, Remsima® SC is administered without additional IV loading 8 weeks after last administration of the infliximab IV. “IV administration of infliximab requires frequent hospital visits which can pose a challenge to some patients especially given the current COVID-19 pandemic,” said Professor Roberto Caporali, Professor of Rheumatology at the University of Milan and Head of Rheumatology Unit of Gaetano Pini Hospital, Milan Italy. “The direct subcutaneous induction of the SC formulation of infliximab could potentially shorten drug administration time via self-administration at home, reduce healthcare practitioner time and burden on healthcare system, as well as offering additional flexibility and convenience for patients.” Previous pharmacoeconomic model which estimates delivering subcutaneous infliximab with IV induction regimen yields savings of 21 million GBP compared to IV infliximab when treating British RA patients in one-year time frame. Remsima® SC without IV induction can generate additional saving of 14 million GBP. All models project potential savings from IV administration costs thus societal gain may be greater than the estimates.2 “Today’s positive CHMP opinion marks a step forward in our goal to provide flexible treatment schedules to patients with rheumatoid arthritis especially under COVID-19 situation,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. "If the recommendation of EMA is agreed by EC, Remsima® SC could be used without IV infusion for newly initiated patients as well as patients currently on infliximab treatment.” - ENDS - Notes to Editors: About Remsima® (CT-P13) intravenous (IV) formulation1Remsima® IV is usually given as 3 mg per kg/body weight in rheumatoid arthritis (RA) and as 5 mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. About Remsima® CT-P13 subcutaneous (SC) formulation3,4A 120 mg fixed dose of Remsima® SC has been granted marketing authorisation in the EU, in adults regardless of body weight, in all previously approved indications for the IV formulation. Remsima® SC has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration. About CT-P13 (biosimilar infliximab)CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 96 countries (as of March 2021) including the US, Canada, Japan and throughout Europe. About Celltrion HealthcareCelltrion 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 References 1 Opinion of the committee for medicinal products for human use on a type II variation to the terms of the marketing authorisation | European Medicines Agency (europa.eu). [Last accessed 29 March 2021] 2 M. Perry et al. Budget Impact Analysis of Introducing subcutaneous infliximab CT-P13 SC from the UK payer perspective. Abstract presented at EULAR 2020 3 Yoo DH, Jaworski J, Matyska-Piekarska E et al. A Novel Formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: One-year results from part one of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (FRI0128). Presented at EULAR 2019. 4 Westhovens R, Wiland P, Zawadzki M et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 30-week results from part two of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (SAT0170). Presented at EULAR 2019.

noimage EMA issues advice on the use of Celltrion’s anti-COVID-19 monoclonal antibody treatment regdanvimab (CT-P59) for COVID-19 patients in the European Uni 2021-03-26

EMA issues advice on the use of Celltrion’s anti-COVID-19 monoclonal antibody treatment regdanvimab (CT-P59) for COVID-19 patients in the European Union Positive scientific opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) supports national authorities within European (EU) member states on the use of regdanvimab (CT-P59) for the treatment of COVID-19, prior to formal marketing authorisation being granted Rolling review of regdanvimab (CT-P59) has been initiated by the EMA in parallel, to accelerate time to potential marketing authorisation Regdanvimab (CT-P59) demonstrated neutralising capability against key emerging mutations, including the UK variant in addition to six variant genome mutations of SARS-CoV-2 Initial sales agreements for regdanvimab (CT-P59) have been made for Nordic countries March 26, 2021 11:20 PM Greenwich Mean Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for the company’s anti-COVID-19 monoclonal antibody treatment candidate, regdanvimab (CT-P59). The CHMP recommends that regdanvimab 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.1 Under Article 5 (3) of Regulation 726/2004, the CHMP’s scientific opinion provides a harmonised EU- level opinion on the efficacy, quality and safety of antibodies. The scientific opinion can be considered by EU member states when making decisions on the possible use of monoclonal antibody therapies at a national level prior to a marketing authorisation. The EMA has also initiated a rolling review of regdanvimab based on data from animal studies (non- clinical data) and clinical trials, in addition to data on the quality of the medicine. The EMA uses its rolling review process to accelerate the assessment of a promising medicine during a public health emergency and once finalised it will provide the basis of an EU marketing authorisation for the monoclonal antibody treatment. “Today’s CHMP positive scientific opinion by the EMA takes us a significant step closer to providing a safe and effective monoclonal antibody treatment against COVID-19 worldwide. Based on clinical data and CHMP’s positive scientific opinion, regdanvimab has been adopted and contracts for initial supplies have been made with distributors towards Nordic countries including Denmark, Norway, Sweden and Finland,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We believe the CHMP’s positive opinion will accelerate reviews and authorisations by national authorities who may take evidence-based decisions on the use of our therapy. We will also continue to work in close collaboration with the EMA to complete the rolling review and marketing authorisation process.” Regarding mutations, the Korea Disease Control and Prevention Agency (KDCA) has independently confirmed that CT-P59 successfully neutralised the SARS-CoV-2 variants first identified in the UK (B.1.1.7) in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). They also added that cocktail therapy of CT-P59 with another monoclonal antibody candidate demonstrated neutralising capability against the UK (B.1.1.7) and South African (B.1.351) variants. Global Principal Investigator Professor Adrian Streinu-Cercel, MD, PhD, Professor of Infectious Diseases at the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, commented, “CT-P59 has demonstrated its ability to shorten time to clinical recovery and reduce rate of progression to severe COVID-19. From the clinical trial, one of my patients with COVID-19 aged 85 and with an underlying condition, has recovered from the virus within 48 hours of being treated with CT-P59. The antibody treatment candidate would be most useful within 3-5 days of testing positive for the virus. This will greatly aid efforts to address the current burden on healthcare systems and resources.” - 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 CT-P59 (regdanvimab) 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 neutralize the wild type and mutant viruses of concern including the UK variant (B.1.17). 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 clinical trial of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.2 Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2. 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 1 EMA issues advice on use of regdanvimab for treating COVID-19 | European Medicines Agency (europa.eu). Last accessed 26 March 2021. 2 Celltrion Data on file