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noimage Celltrion Healthcare receives European Commission (EC) approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, Y 2021-02-15

Yuflyma™ (CT-P17) is the first adalimumab biosimilar with a high concentration, low-volume and citrate-free formulation; 60% of adalimumab market captured by high concentration formulation in Europe according to IQVIA Yuflyma™ is approved in all intended indications for the treatment of multiple chronic inflammatory diseases Yuflyma™ has 29G needle size, latex-free device, and a shelf-life up to 24 months (2-8℃); at room temperature Yuflyma™ is stable up to 30 days February 15, 2021 07:29 AM Eastern Standard Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today announced that on February 11th, the European Commission (EC) has granted marketing authorisation for Yuflyma™ (CT-P17), an adalimumab biosimilar, across all thirteen intended indications for the treatment of multiple chronic inflammatory diseases. The EC approval of Yuflyma™ follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in December 2020. The marketing authorisation is based on analytical, preclinical and clinical studies, demonstrating that Yuflyma™ is comparable to adalimumab, the reference product, in terms of safety, efficacy, PK/PD and immunogenicity up to 24 weeks1 and 1 year2 following treatment. Based on the results of the pivotal study, a high concentration formulation of Yuflyma™ has been approved for use in the European Union (EU), in patients with thirteen chronic inflammatory diseases; rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), axial spondyloarthritis without radiographic evidence of AS (nr-axSpA), psoriatic arthritis (PsA), psoriasis (PsO), paediatric plaque psoriasis (pPsO), hidradenitis suppurativa (HS), Crohn’s disease (CD), paediatric Crohn’s disease (pCD), ulcerative colitis (UC), uveitis (UV) and paediatric uveitis (pUV). “In Europe, according to IQVIA data, 60% of the whole adalimumab market has been taken by high concentration formulation and over 90% of the original adalimumab market has already been replaced with a high concentration version. With high concentration, low-volume, and consequently less pain, adalimumab can improve treatment adherence at the very least. Therefore, we focused on development of a high concentration biosimilar to provide a significant alternative to the adalimumab treatment category,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “In terms of the administration device, we have looked to ensure improved convenience for patients as well as providers with the inclusion of needle size (29G), latex-free to reduce allergy risk, and a long storage period or shelf life at room temperature for 30 days.” Professor Rieke Alten, Head of the Department of Internal Medicine, Rheumatology, Clinical Immunology and Osteology at Schlosspark-Klinik, Teaching Hospital of Charité, Berlin, Germany said, “Over the past two decades, anti-tumour necrosis factor (TNF) biologics have revolutionised the management of chronic immune-mediated inflammatory diseases, but some of the features needed improvement for patients to reach their therapeutic goals. As a physician, we welcome these value-added features such as high concentration and low-volume formulations to reduce injection discomfort.” The centralised marketing authorisation granted by the EC is valid in all EU Member States as well as in the European Economic Area countries Iceland, Liechtenstein and Norway. This announcement will enable affordable access to a high concentration adalimumab biosimilar, broadening treatment alternatives for patients suffering with chronic inflammatory disease including rheumatoid arthritis, psoriasis, Crohn’s disease and ulcerative colitis. Celltrion will take the EC Decision Reliance Procedure (ECDRP) to minimise lead time to launch the product in the UK and remains committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. - ENDS - Notes to Editors: About CT-P17 (biosimilar adalimumab) CT-P17 is the first proposed high concentration, low- volume and citrate-free adalimumab biosimilar. CT-P17 is indicated for the treatment of patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), axial spondyloarthritis without radiographic evidence of AS (nr-axSpA), psoriatic arthritis (PsA), psoriasis (Ps), paediatric plaque psoriasis (pPs), hidradenitis suppurativa (HS), Crohn’s disease (CD), paediatric Crohn’s disease (pCD), ulcerative colitis (UC), uveitis (UV) and paediatric uveitis (pUV). CT-P17 is a recombinant human monoclonal antibody that contains the active ingredient adalimumab. Adalimumab is a fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. CT-P17 provides pain-reducing features as it comes with citrate-free formulation, meaning it causes less pain upon injection. 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 References 1 J. Kay., et al. (2020). A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar (CT-P17) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis. Poster Presented at ACR Convergence 2020 2 Data on file

noimage Celltrion Develops Tailored Neutralising Antibody Cocktail Treatment with CT-P59 to Tackle COVID-19 Variant Spread Using Its Antibody Development Plat 2021-02-11

Celltrion is on track developing a neutralising antibody cocktail with Regdanvimab (CT-P59) tailored to fight against the emerging new variants CT-P59 demonstrated neutralising capability against key emerging mutations, including the UK variant in addition to six variant genome mutations of SARS-CoV-2 Celltrion has constructed a COVID-19 antibody portfolio and clinical development platform to help combat the spread of the virus mutations February 11, 2021 12:18 AM Eastern Standard Time INCHEON, Korea--(BUSINESS WIRE)--Celltrion Group today announced that CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, has confirmed neutralising potency against emerging virus mutations and that the company has initiated development of a neutralising antibody cocktail treatment with CT-P59. The Korea Disease Control and Prevention Agency (KDCA) has assessed and independently confirmed that CT-P59 successfully neutralises 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. As of 19 January 2021, according to media and official sources, approximately 2,000 cases of the variant VOC 202012/01 (Variant of Concern, year 2020, month 12, variant 01, previously designated VUI, Variant under Investigation) had been identified in 60 countries. In the EU/EEA, about 1,300 cases have been identified in 23 countries. Outside the EU/EEA, approximately 700 cases have been identified in 37 countries.1 In order to elicit potent neutralising antibodies against the new emerging variants and to minimise lead time for introducing cocktail treatments with CT-P59, Celltrion previously captured a total of 38 potent neutralising antibodies against SARS-CoV-2 in which antibody candidate No. 32 produced neutralising titres against new emerging strains in the UK and South Africa. Using an already constructed antibody portfolio and encouraged by confirmed potency on various mutants, Celltrion has commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2. To date, CT-P59 has been shown to significantly reduce the risk of COVID-19 related hospitalisation and oxygenation up to Day 28, reduce rate of progression to severe COVID-19 by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over, and significantly shorten the time to clinical recovery ranging from 3.4 to 6.4 days quicker compared to placebo. A global Phase III clinical trial is currently recruiting and is expected to enroll 1,172 patients with mild-to-moderate symptoms of COVID-19 at more than 10 global sites to evaluate the efficacy and safety of CT-P59. Global Principal Investigator Professor Adrian Streinu-Cercel, MD, PhD, Professor of Infectious Diseases at the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, said, “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.” 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. The mutated G-variant strain (D614G variant) was later identified and confirmed to be inactivated by CT-P59. In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation. Results from the global Phase I clinical trial of CT-P59 demonstrated promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.2 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 Risk related to the spread of new SARS-CoV-2 variants of concern in the EU/EEA – first update 21 January 2021, European Center for Disease Prevention and Control. [Last accessed February 2021] 2 Celltrion Data on file

noimage Celltrion’s COVID-19 treatment candidate receives Korean MFDS Conditional Marketing Authorisation 2021-02-05

Celltrion’s COVID-19 Treatment Candidate Receives Korean MFDS Conditional Marketing Authorisation Regdanvimab (CT-P59) receives conditional marketing authorisation from the Korean Ministry of Food and Drug Safety (MFDS); first anti-COVID-19 monoclonal antibody treatment to be approved in Korea CT-P59 is authorised for the treatment of adult patients aged 60 and over, or with at least one underlying medical condition, with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19 Celltrion is under discussion with the European Medicines Agency (EMA) for Conditional Marketing Authorisation (CMA) and with the U.S. FDA for Emergency Use Authorisation (EUA) The global Phase III clinical trial is on track and the trial is expected to enrol 1,172 patients with mild-to-moderate symptoms of COVID-19 February 05, 2021 08:26 AM Eastern Standard Time INCHEON, Korea--(BUSINESS WIRE)--Celltrion Group today announced that the Korean Ministry of Food and Drug Safety (MFDS) granted a Conditional Marketing Authorisation (CMA) for the emergency use of Regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment candidate. The CMA allows for emergency 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 CMA is based on Part 1 of the Phase II/III trial which showed; Patients treated with CT-P59 reporting a significantly reduced risk of COVID-19 related hospitalization and oxygenation up to Day 28 Progression rates to severe COVID-19 were reduced by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over A significantly shortened time to clinical recovery in CT-P59 treated patients (40 mg/kg) ranging from 3.4 to 6.4 days quicker compared with placebo. “With the pandemic still raging in Korea, we believe today’s Conditional Marketing Authorisation of Regdanvimab marks an important milestone in the fight against COVID-19” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Patients with COVID-19 in Korea now have access to a therapy according to the authorised indications early in the course of their infection. We remain committed to closely working with the regulatory agencies worldwide including the U.S. FDA and the European Medicines Agency (EMA) to ensure that patients around the world have access to safe and effective treatment against COVID-19 as in the case of Korea.” A global Phase III clinical trial is currently recruiting and expected to enrol 1,172 patients with mild-to-moderate symptoms of COVID-19 in more than 10 global sites to evaluate efficacy and safety results of CT-P59. Celltrion is set to demonstrate clinical efficacy against COVID-19 in both UK and South African variants and the results to be expected in the coming days. - ENDS - Notes to Editors: 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. 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. The mutated G-variant strain (D614G variant) was later identified and confirmed to be inactivated by CT-P59. In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation. Results from the global Phase I clinical trial of CT-P59 demonstrated promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.1 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 Celltrion Data on file