CelltrionHealthcare

Switching to subcutaneous infliximab leads to higher trough level and low risk of relapse in patients with inflammatory bowel disease

Switching to Subcutaneous Infliximab Leads to Higher Trough Level and Low Risk of Relapse in Patients with Inflammatory Bowel Disease - New data from the REMSWITCH study shows switching from intravenous (IV) to subcutaneous (SC) infliximab leads to higher infliximab trough levels and a low risk of relapse in patients with inflammatory bowel disease (IBD)1 - Data from the RTDM study show infliximab drug levels are stable across a 14-day treatment cycle for Crohn’s disease (CD) patients in remission, under maintenance therapy with Remsima® SC, enabling therapeutic drug monitoring to be performed at any time between the two SC injections2 February 18, 2022 06:30 AM Eastern Standard Time INCHEON, South Korea--(BUSINESS WIRE)--Today, Celltrion Healthcare announced two new data sets on the SC formulation of infliximab, Remsima® (CT-P13) in IBD, at the European Crohn’s and Colitis Organisation (ECCO) virtual congress 2022. The REMSWITCH Study REMSWITCH, investigated the clinical and pharmacological impact of switching from IV to SC formulation of infliximab in patients with IBD, to evaluate the feasibility of switching and to determine the equivalence between IV and SC doses.1 In the study, 130 patients (73.1% CD patients, 26.9% ulcerative colitis [UC] patients) in clinical remission, each on an IV dose regimen of 5mg/kg/8weeks, 10mg/kg/8weeks, 10mg/kg/6weeks and 10mg/kg/4weeks, were switched to SC infliximab 120mg/2weeks, regardless of IV doses.1 Results showed switching patients from IV to SC infliximab is feasible, well-accepted and leads to a low risk of relapse in patients with IBD: Infliximab trough levels were significantly higher after switching from IV to SC (9.8 ± 6.4 µg/ml vs 14.4 ± 5.7 µg/ml; p Trough levels increased in patients receiving 5mg/kg/8weeks (6.3 ± 3.4 µg/ml vs 14.7 ± 5.7 µg/ml; p Trough levels remained stable in those treated with 10mg/kg/6weeks (11.1 ±7.6 µg/ml vs 13.1 ±5.1 µg/ml; p=0.31) or 10mg/kg/4weeks (17.8 ±4.2 µg/ml vs 15.8 ±4.6 µg/ml; p=0.12) Infliximab trough levels remained stable (variation V1-V0 (Visit 0 = V0) Clinical relapse after switching which leads to therapeutic escalation was observed in 11.1% and dose increase (240mg/2weeks) induced clinical remission in 93.3% of relapsed patients. The risk of relapse was higher in patients with stable or decreasing trough levels after the switch, compared to those with increased trough levels (31.8% vs 7.1%; p=0.024) Patient’s acceptability was better with SC injections compared to IV infusions (10-point acceptability numerical scale = 8.7 ±1.6 µg/ml vs 6.8 ±0.9 µg/ml; p Professor Anthony Buisson, MD, PhD, IBD Unit, CHU Clermont-Ferrand, France and Principal Investigator of the trial said, “The study results show that switching from intravenous to subcutaneous infliximab (120mg/2weeks) is feasible and well-accepted leading to a low risk of relapse in patients with IBD including those with escalated intravenous doses. In addition, dose increase (240mg/2weeks) induced clinical remission in 93.3% of relapsing patients.” The RDTM Study The second study investigated the intra-individual variations of infliximab drug levels at multiple time points during two consecutive cycles of maintenance therapy with Remsima® SC. Study results show that infliximab drug levels are stable across a 14-day treatment cycle. For CD patients in remission under maintenance therapy with Remsima® SC, therapeutic drug monitoring of infliximab can therefore be performed at any time between the two SC injections.2 “This is the first real-world study analysing serum levels of infliximab at different time-points between two SC injections of infliximab and during two cycles at steady state during maintenance regimen in remitted CD patient,” said Professor Xavier Roblin, Department of Gastroenterology, University Hospital of Saint-Etienne, Saint-Etienne, France. “Our results clearly demonstrated stable levels of infliximab all over this period.” - ENDS - Notes to Editors: About inflammatory bowel disease Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.3 They affect an estimated 5 million people globally.4 IBDs account for substantial costs to the healthcare system and society - the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.5 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 Rheumatoid Arthritis (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 Food and Drug Administration (FDA) approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 96 countries (as of February 2022) including the US, Canada, Japan and throughout Europe. About Remsima® intravenous (IV) formulation6 Remsima® 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 including IBD. 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® subcutaneous (SC) formulation A 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 in adult for the IV formulation. Remsima® SC has three available devices; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard.6 The SC formulation has the potential to enhance treatment options for the use of infliximab by providing high consistency in drug exposure and a convenient method of administration.7,8 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 Current Good Manufacturing Practice (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 References _______________________ 1 Buisson A et al., Evolution of clinical and pharmacological parameters after switching from intra-venous to subcutaneous infliximab in patients with inflammatory bowel disease: the REMSWITCH study. Journal of Crohn’s and Colitis. 2022:16(S1):i393-i394. 2 Xavier Roblin, et al. Stability of subcutaneous serum IFX (CTP13) levels between two injections and over two successive cycles in patients with Crohn’s disease. Journal of Crohn’s and Colitis. 2022:16(S1):i436-i437. 3 Molodecky, N. A., et al. (2012) Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology, 142(1), 46-54. Retrieved from: www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed January 2022]. 4 The European Federation of Crohn’s & Ulcerative Colitis Associations. What is IBD? Science. Retrieved from www.efcca.org/en/science [Last accessed January 2022]. 5 Burisch, J., et al. (2013). The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis, 7(4), 322-337.Retrieved from: https://www.sciencedirect.com/science/article/pii/S1873994613000305?via%3Dihub [Last accessed January 2022]. 6 European Medicines Agency Summary of Product Characteristics (SmPC). Infliximab. Available at https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf [Last accessed January 2022]. 7 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. 8 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.

2022-03-02

Celltrion Submits IND Application to Initiate a Global Phase III Clinical Trial Evaluating an Inhaled COVID-19 Antibody Cocktail Therapy

Celltrion Submits Investigational New Drug (IND) Application to Initiate a Global Phase III Clinical Trial Evaluating an Inhaled COVID-19 Antibody Cocktail Therapy Celltrion submitted an IND application for a global Phase III clinical trial of inhaled antibody cocktail therapy with CT-P59 and CT-P63; the company expects to enrol 2,200 patients with mild-to-moderate symptoms of COVID-19 The inhaled COVID-19 antibody cocktail therapy and CT-P63 maintained strong neutralising ability against the Omicron variant (B.1.1.529) The inhaled COVID-19 antibody cocktail directly traps virus in airway mucus and rapidly eliminates the virus from the lungs using the muco-trapping antibody platform February 07, 2022 09:55 AM Japan Standard Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group announced today it has submitted an Investigational New Drug (IND) application to conduct a global Phase III clinical trial evaluating the efficacy and safety of an inhaled COVID-19 antibody cocktail therapy for patients with mild-to-moderate symptoms of COVID-19; the trial is expected to enrol 2,200 patients globally. The inhaled COVID-19 antibody cocktail is a combination of monoclonal antibodies with regdanvimab (CT-P59) and CT-P63 and has been developed to target newly emerging mutations of SARS-CoV-2, including the Omicron variant (B.1.1.529). The global Phase III clinical trial proposed in the IND is designed to evaluate the safety and efficacy profile of the inhaled COVID-19 antibody cocktail. The muco-trapping antibody platform used for the inhaled COVID-19 antibody cocktail directly traps the virus in airway mucus, preventing the local spread of the infection, and quickly eliminates the virus from the lungs through the body's natural ability to clear mucus. “We have accelerated development of our inhaled COVID-19 antibody cocktail therapy, leveraging our antibody platform to address the ongoing challenges of the pandemic” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Inhaled delivery substantially reduces the dose required to achieve a therapeutic effect compared to intravenous injections, thereby reducing the cost of treatment. An inhalable treatment can be self-administered in at-home settings, and at a scale not achievable using the conventional inpatient intravenous infusion treatments. We are working diligently to increase access to effective and safe monoclonal antibodies that are convenient and cost-effective. We look forward to sharing additional updates on the progress of patient enrolment and global clinical trials in the coming months.” Celltrion & Inhalon: inhaled formulation of CT-P59 In August 2020, Celltrion and Inhalon Biopharma signed a Confidential Disclosure and Material Transfer Agreement for the research and development of an inhaled administration formulation of regdanvimab. The companies received approval from the Therapeutic Goods Administration (TGA) of Australia to conduct a Phase I trial in 24 healthy volunteers. The study showed the inhaled formulation of regdanvimab (CT-P59) achieved an endpoint of safety and tolerability, and no serious adverse events (SAEs) related to treatment were reported. Celltrion’s monoclonal antibody: CT-P63 Celltrion enrolled 24 healthy volunteers in a global Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of CT-P63. The study showed CT-P63 to be safe and well tolerated, with no significant drug-related adverse events (AEs). CT-P63 showed strong neutralising activity against the Omicron variant based on structural analysis by X-ray crystallography and neutralisation data from pseudo-virus testing. - 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 in patients with mild-to-moderate symptoms of COVID-19.1 The EC granted marketing authorisation for regdanvimab following positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in November 2021. About CT-P63 CT-P63 is a monoclonal antibody targeting SARS-CoV-2 spike receptor binding domain (RBD) as a treatment for COVID-19 infection. CT-P63 is currently being developed as a potential treatment for SARS-CoV-2 infection. About inhaled formulation The inhaled formulation of the monoclonal antibody not only targets SARS-CoV-2 spike receptor binding domain (RBD) and elicits a neutralising antibody response, but it also has ‘trapping’ mechanism of action and thereby neutralises and traps in mucus with exceptional potency. The muco-trapping antibody platform directly traps the virus in airway mucus, preventing the local spread of the infection, and quickly eliminating the virus from the lungs through the body's natural ability to clear mucus. Inhaled formulation can be readily self-administered by patients through nebuliser, extend critical drug supplies to more patients by reducing the dosage needed, and does not place excessive demands on healthcare staff and infusion clinic space that intravenous (IV) drugs do. 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

2022-02-07

Celltrion announces positive results for its cocktail therapy candidates including neutralisation data against Omicron variant

Celltrion announces positive results for its cocktail therapy candidates including neutralisation data against Omicron variant CT-P63 demonstrated a well- established safety profile in the global Phase I trial CT-P63 maintained strong neutralising ability against the Omicron variant (B.1.1.529) based on structural analysis by X-ray crystallography and neutralisation data from pseudo- virus testing Celltrion plans to provide dual treatment options for COVID-19; Regkirona™ for hospitalised patients and a nebulised cocktail therapy (CT-P63 in combination with Regkirona™) for at- home settings INCHEON, South Korea--(BUSINESS WIRE)-- Celltrion Group announced today results for its cocktail therapy candidates including neutralisation data against the Omicron variant. The Phase I clinical trial is a randomised, double- blind and placebo- controlled trial designed to evaluate the safety, tolerability and pharmacokinetics of CT-P63 in 24 healthy subjects in Poland.1 The study met its primary objectives with data showing CT-P63 to be safe and well tolerated, with no significant drug- related adverse events (AEs). In an experiment conducted in partnership with the National Institutes of Health (NIH), CT-P63 showed strong neutralising activity against the Omicron variant (B.1.1.529) based on structural analysis by X- ray crystallography and neutralisation data from pseudo- virus testing. Celltrion anticipates results of the SARS-CoV-2 Omicron variant assays and animal model studies by the end of the first quarter this year. In order to elicit potent neutralising antibody response against the new emerging variants, Celltrion previously identified a total of 38 potent neutralising antibodies against SARS-CoV-2 in which antibody candidate No. 32 (CT-P63) produced high neutralisation titres against new emerging strains. CT-P63 has previously been demonstrated to have neutralising activity against the most common variants, including the Alpha, Beta, Gamma and Delta variants. “The positive results demonstrate the potential of our cocktail therapy to retain neutralising ability against the Omicron variant” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We are confident that our antibody platform including Regkirona and CT-P63 will provide significant benefit for patients with COVID-19. Regkirona is given to a patient intravenously, so the drug could effectively treat patients hospitalised with COVID-19 at an early stage, while the nebulised cocktail therapy could address patients’ unmet needs for at- home treatment. We plan to discuss large- scale clinical trial for our nebulised cocktail therapy (CT-P63 in combination with Regkirona™) with regulatory agencies worldwide in the near future.” - 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 in patients 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. About CT-P63 CT-P63 is a monoclonal antibody targeting SARS-CoV-2 spike receptor binding domain (RBD) as a treatment for COVID-19 infection. CT-P63 is currently being developed as a potential treatment for SARS-CoV-2 infection. About nebulised formulation The nebulised formulation of the monoclonal antibody not only targets SARS-CoV-2 spike receptor binding domain (RBD) and elicit neutralising antibody response but it also has ‘trapping’ mechanism of action and thereby neutralises and traps in mucus with exceptional potency. The muco-trapping antibody platform directly traps the virus in airway mucus, preventing the local spread of the infection, and quickly eliminating the virus from the lungs through the body's natural ability to clear mucus. Nebulized formulation can be readily self-administered by patients, extend critical drug supplies to more patients by reducing the dosage needed, and does not place excessive demands on healthcare staff and infusion clinic space that intravenous (IV) drugs do. 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 ClinicalTrials.gov. To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects. Available at: https://clinicaltrials.gov/ct2/show/NCT05017168#wrapper [Last Accessed January 2022] 2 Celltrion Data on file

2022-01-03

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

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 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 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 [1] TGA Provisional Approval of Celltrion Healthcare Australia Pty Ltd COVID-19 treatment, regdanvimab (REGKIRONA) Available at https://www.tga.gov.au/node/941716 [Last accessed December 2021] [2] Celltrion Data on file

2021-12-07

Celltrion accelerates development of nebulised cocktail therapy (CT-P63 in combination with CT-P59) using its antibody platform to tackle new COVID-19

Celltrion accelerates development of nebulised cocktail therapy (CT-P63 in combination with CT-P59) using its antibody platform to tackle new COVID-19 variants Celltrion previously completed phase I clinical trials with a nebulised formulation of Regkirona (regdanvimab, CT-P59), a monoclonal antibody treatment for COVID-19 Celltrion anticipates CT-P63 to maintain strong neutralising ability against Omicron based on structural analysis by X-ray crystallography and neutralisation data from pseudo-virus testing A separate global phase I clinical trial is set to be completed for CT-P63 by the end of the year November 29, 2021 08:08 AM Eastern Standard Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group announced today that the company has accelerated development of a nebulised formulation of its neutralising antibody cocktail treatment, to respond to emerging mutants from SARS-CoV-2. Targeting newly emerging mutations of SARS-CoV-2 and using its already constructed antibody platform, Celltrion has developed a neutralising antibody cocktail consisting of CT-P63 together with its monoclonal antibody treatment Regkirona (regdanvimab, CT-P59), which was recently approved by the European Commission (EC) for the treatment of COVID-19. Celltrion enrolled 24 healthy volunteers in its global phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of CT-P63 and the company anticipates results by the end of the year. CT-P63 is a monoclonal antibody targeting SARS-CoV-2 spike receptor binding domain (RBD) as a treatment for COVID-19 infection. Celltrion plans to evaluate neutralisation of new emerging variants tailored to specific regions and assess potential escape mutants by using in vitro pseudo-virus assay. After verifying safety results in phase I clinical trial, Celltrion plans to confirm the extensive neutralising capacity of the cocktail therapy with Regkirona and CT-P63 on new variants as a follow up trial, with a nebulised formulation of Regkirona. “The mutations in Omicron, also known as B.1.1.529, could help the virus evade the body’s immune response and make it more transmissible” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Omicron has many mutations in the same regions of the spike protein, however we anticipate CT-P63 to maintain strong neutralising ability against Omicron based on structural analysis by X-ray crystallography and neutralisation data from pseudo-virus testing. By leveraging our antibody platform including Regkirona (CT-P59) and CT-P63, as well as patented formulation, the development of a nebulised cocktail therapy will be accelerated.” Regkirona has previously demonstrated in vivo efficacy against the most common variants, including the Alpha, Beta, Gamma and Delta variants. - 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 in patients with mild-to-moderate symptoms of COVID-19.1 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. About nebulised formulation The nebulised formulation of the monoclonal antibody not only targets SARS-CoV-2 spike receptor binding domain (RBD) and elicit neutralising antibody response but it also has ‘trapping’ mechanism of action and thereby neutralises and traps in mucus with exceptional potency. The muco-trapping antibody platform directly traps the virus in airway mucus, preventing the local spread of the infection, and quickly eliminating the virus from the lungs through the body's natural ability to clear mucus. Nebulised formulation can be readily self-administered by patients, extend critical drug supplies to more patients by reducing the dosage needed, and does not place excessive demands on healthcare staff and infusion clinic space that intravenous (IV) drugs do. 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

2021-11-29

Celltrion’s Monoclonal Antibody Treatment regdanvimab, Approved by the European Commission for the Treatment of COVID-19

Celltrion’s Monoclonal Antibody Treatment regdanvimab, Approved by the European Commission for the Treatment of COVID-19 The European Commission (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) last week (11/11/2021) Celltrion continues to discuss supply agreements with regulatory agencies and contractors in more than 30 countries in Europe, Asia and LATAM to accelerate global access to regdanvimab The use of regdanvimab across the Republic of Korea is rapidly increasing to address the ongoing outbreaks November 14, 2021 08:04 PM Eastern Standard Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group announced today that the European Commission (EC) has approved Regkirona (regdanvimab, CT-P59), one of the first monoclonal antibody treatments granted marketing authorisation from the European Medicines Agency (EMA). The EC granted marketing authorisation for adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The decision from the EC follows a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on November 11th, 2021.1 “Today’s achievement, coupled with CHMP positive opinion for regdanvimab, underscores our ongoing commitment to addressing the world’s greatest health challenges,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Typically, the recommendations from the CHMP are passed on to the EC for rapid legally binding decisions within a month or two, however, given the unprecedented times, we have received the EC approval within a day. As part of our global efforts to accelerate access, we have been communicating with the governments and contractors in 30 countries in Europe, Asia and LATAM. We will continue working with all key stakeholders to ensure COVID-19 patients around the world have access to safe and effective treatments.” 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 EC approval is based on the global Phase III clinical trial involving more than 1,315 people to evaluate the efficacy and safety of regdanvimab in 13 countries including the U.S., Spain, and Romania. Data showed regdanvimab significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high-risk of progressing to severe COVID-19. Emergency use authorisations are currently in place in Indonesia and Brazil, and the monoclonal antibody treatment is fully approved in the Republic of Korea. In the U.S., regdanvimab has not yet been approved by the Food and Drug Administration (FDA), but the company is in discussion with the FDA to submit applications for an Emergency Use Authorisation (EUA). As of November 12th, 2021, more than 22,587 people have been treated with regdanvimab in 129 hospitals in the Republic of Korea. 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 neutralise 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 in patients with mild-to-moderate 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 European Medicines Agency. COVID-19: EMA recommends authorisation of two monoclonal antibody medicines. Available at https://www.ema.europa.eu/en/news/covid-19-ema-recommends-authorisation-two-monoclonal-antibody-medicines [Last accessed November 2021]. 2 Celltrion Data on file

2021-11-15

Celltrion Receives CHMP Positive Opinion for regdanvimab (CT-P59) as One of the First Monoclonal Antibodies for COVID-19 by the CHMP

Celltrion Receives CHMP Positive Opinion for regdanvimab (CT-P59) as One of the First Monoclonal Antibodies Recommended as a Treatment for COVID-19 by the CHMP  The CHMP positive opinion marks the first time a monoclonal antibody treatment for COVID-19 has received a recommendation for marketing authorisation from the EMA The recommendation is based on data from the global Phase III clinical trial investigating regdanvimab as a treatment for multiple variants of COVID-19, including the Delta variant Regdanvimab is the first authorised COVID-19 treatment approved from the Korean Ministry of Food and Drug Safety (MFDS); More than 21,366 people treated with regdanvimab in 127 hospitals in the Republic of Korea INCHEON, Korea--(BUSINESS WIRE)-- Celltrion Group announced today that the European Medicine’s Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive scientific opinion recommending marketing authorisation for regdanvimab (CT-P59), a monoclonal antibody treatment for adults with COVID-19 that do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The CHMP positive opinion is a scientific recommendation to the European Commission (EC), which authorises marketing approval in the European Union. “We have accumulated the safety and efficacy data of regdanvimab in the treatment of patients infected with COVID-19 and its associated variant strains, including the more virulent Delta variant,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “At Celltrion, we are proud to play our part in tackling the unprecedented global threat of COVID-19 and believe regdanvimab offers an important addition to the treatment arsenal. Using our stable supply system and commercial network, we will expedite required process and continue to work with stakeholders globally to ensure eligible patients can benefit from this treatment as quickly as possible. Currently, we are in discussions with regulatory agencies and companies from approximately 30 countries around the world, to supply our monoclonal antibody treatment for COVID-19 and those will be our top priorities in the coming months.” The positive CHMP opinion was supported by data from the global Phase III clinical trial in which Celltrion enrolled more than 1,315 people to evaluate the efficacy and safety of regdanvimab in 13 countries including the U.S., Spain, and Romania. Data showed regdanvimab significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high-risk of progressing to severe COVID-19. “The primary benefits of monoclonal antibodies are their high specificity and safety – they are highly specific for a single target, so these monoclonal antibodies rarely cause undesirable side effects,” said Oana Sandulescu, MD, PhD, Associate Professor of Infectious Diseases at the Carol Davila University of Medicine and Pharmacy in Romania. “An infusion of an hour of monoclonal antibodies like regdanvimab can ease COVID-19 symptoms and reduce complications in recently diagnosed, non-hospitalised people at high risk, and thus plays an important role in preventing further spread of the virus.” Rolling review of regdanvimab had been initiated by the EMA on February this year and the announcement of the CHMP positive opinion for regdanvimab follows the submission of a marketing authorisation application (MAA) to the EMA seeking approval of regdanvimab in October 2021. As of November 2021, more than 21,366 people have been treated with regdanvimab in 127 hospitals in the Republic of Korea. 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 neutralise 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 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. 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

2021-11-12

Celltrion submits Marketing Authorisation Application to the European Medicines Agency for regdanvimab (CT-P59)

Celltrion submits Marketing Authorisation Application to the European Medicines Agency for regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19 ·         The European Medicines Agency (EMA) accepted application for marketing authorisation for regdanvimab (CT-P59) as sufficient evidence is available ·         Submission supported by previously announced data from the global Phase III clinical trial; EMA to assess the benefits and risks of regdanvimab (CT-P59) under a reduced timeline ·         Celltrion anticipates accelerating time to potential marketing authorisation following the positive scientific opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the EMA of regdanvimab (CT-P59)   October 05 2021, INCHEON, KOREA – Celltrion Group today announced it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19. The indication applies for the treatment of confirmed COVID-19 in adults (≥18) who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID-19. In March, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for regdanvimab (CT-P59) as it can be considered a treatment option for patients at high risk of progressing to severe COVID-19 and based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm.[1] In addition, in June, the European Commission (EC) announced Celltrion’s regdanvimab to be part of the COVID-19 therapeutics portfolio for authorisation for the treatment of COVID-19 patients as part of its strategy for COVID-19 therapeutics. “We are once again encouraged with the regulatory milestone that brings us close to providing an effective treatment of COVID-19,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “As we continue to face serious health challenges from COVID-19, we will closely liaise with the regulatory agency to fast track the decision granting the marketing authorisation of regdanvimab in all EU and EEA member States.” 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. As of October 2021, more than 16,862 people have been treated with regdanvimab (CT-P59) in 114 hospitals in the Republic of Korea.    -        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.   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.[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 5 October 2021. [2] Celltrion Data on file

2021-10-05

Celltrion’s regdanvimab (CT-P59) becomes the first authorized COVID-19 treatment approved from the Korean MFDS

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 INCHEON, South Korea--(BUSINESS WIRE)--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. - 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. 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. 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

2021-09-18

Brazilian Health Regulatory Agency (ANVISA) grants emergency use authorisation (EUA) for Celltrion’s regdanvimab (CT-P59)

Brazilian Health Regulatory Agency (ANVISA) grants emergency use authorisation (EUA) for Celltrion’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59) in Brazil Regdanvimab (CT-P59) receives emergency use authorisation from the Brazilian Health Regulatory Agency (ANVISA, Agencia Nacional de Vigilancia Sanitaria) for the treatment of adults with mild-to-moderate COVID-19 who do not require supplemental oxygen and who are at high risk of progression to severe COVID August 12 2021, INCHEON, KOREA – Celltrion Healthcare today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted an emergency use authorisation (EUA) for the company’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59) for the treatment of adults with mild-to-moderate COVID-19 who do not require supplemental oxygen and who are at high risk of progression to severe COVID.[1] Brazil had the highest number of confirmed cases from COVID-19 in Latin America with an average of 35,000 cases per day. Since the beginning of the pandemic, at least 1 in 10 residents have been infected, a total of 20,249,176 reported cases.[2] “Today’s announcement of emergency use authorisation for regdanvimab takes us a significant step closer to providing a safe and effective monoclonal antibody treatment against COVID-19 to patients in Brazil,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Regdanvimab demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in its global clinical trial. The use of monoclonal antibodies is an important tool in the fight against COVID-19. We are actively exploring additional authorisation in other countries and regions to help COVID-19 patients around the world.” Celltrion’s global Phase III 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, 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. In addition, in vitro and in vivo studies demonstrated potency of regdanvimab (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)[3], Gamma (P.1, first identified in Brazil) [4] and Delta (B.1.617.2, first identified in India) variants. The monoclonal antibody regdanvimab (CT-P59) also demonstrated strong neutralising capability against the Lambda variant (C.37, first identified in Peru) in a cell-based pseudo- virus assay study performed by the National Institutes of Health (NIH), U.S. -        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.  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.[5] Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2. [1] Anvisa autoriza uso emergencial de novo medicamento para Covid-19. Available at: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2021/anvisa-autoriza-uso-emergencial-de-novo-medicamento-para-covid-19 [Last accessed August 2021] [2] Worldometer. Available at: https://www.worldometers.info/coronavirus/country/brazil/ [Last accessed August 2021] [3] Ryu DK., et al. Therapeutic effect of CT-P59 against SARS-CoV-2 South African variant. Biochemical and Biophysical Research Communications, Volume 566, 2021, Pages 135-140, https://doi.org/10.1016/j.bbrc.2021.06.016. [Last accessed August 2021] [4] Ryu DK., et al. Therapeutic efficacy of CT-P59 against P.1 variant of SARS-CoV-2. bioRxiv 2021.07.08.451696; doi: https://doi.org/10.1101/2021.07.08.451696 [5] Celltrion Data on file

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