CelltrionHealthcare

Celltrion Initiates Post-exposure Prophylaxis Clinical Trial of an Anti-COVID-19 Monoclonal Antibody Treatment Candidate, CT-P59

Celltrion Initiates Post-exposure Prophylaxis Clinical Trial of an Anti-COVID-19 Monoclonal Antibody Treatment Candidate, CT-P59 The Korean Ministry of Food and Drug Safety (MFDS) has approved Celltrion’s Investigational New Drug (IND) application to initiate the post-exposure prophylaxis clinical trial of CT-P59 The Phase III trial is set to enrol approximately 1,000 subjects to evaluate protective efficacy in contacts of SARS-CoV-2 infected patients Celltrion will continue to generate data from ongoing clinical trials of CT-P59 in various clinical settings October 12, 2020 10:30 AM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group today announced the launch of its Phase III clinical trial investigating CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate as a preventative measure. The initiation of the post-exposure prophylaxis clinical trial follows the approval of the Investigational New Drug (IND) application by the Korean Ministry of Food and Drug Safety (MFDS) on October 8th, 2020. Celltrion anticipates the enrolment of approximately 1,000 patients to evaluate population-based prophylaxis in contacts of SARS-CoV-2 infected patients. The post-exposure prophylaxis clinical trial will evaluate the preventive effect and safety of CT-P59 and whether CT-P59 can elicit a neutralising antibody response to prevent the virus from infecting human cells. “We hope anti-COVID-19 monoclonal antibodies such as CT-P59 can provide high-risk individuals with effective protection against COVID-19 and help prevent further spread in the community,” said Dr Sang Joon Lee, Senior Executive Vice President of Celltrion. “We look forward to continued data generation as this trial proceeds and we remain committed to combatting the spread of the virus around the world.” Celltrion has previously shown promising safety results in the Phase I clinical trial in healthy volunteers. The MFDS has now approved Celltrion’s IND application to initiate a Phase II/III pivotal trial of this potential treatment in mild-to-moderate patients. - 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 COVID-191,2 Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak. The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19. Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1 About 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 including the mutated G-variant strain (D614G variant). 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.3 References 1 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: October 2020 2 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: October 2020 3 Celltrion. Data on file

2020-10-12

New data presented at UEG Week Virtual 2020 show positive association between Remsima® SC pre-dose level with efficacy outcomes

New data presented at UEG Week Virtual 2020 show positive association between Remsima® SC pre-dose level with efficacy outcomes Data show positive association between subcutaneous infliximab (Remsima® SC / CT-P13 SC) exposure with efficacy and fecal calprotectin (FC) outcomes in patients with active Crohn’s disease (CD) and ulcerative colitis (UC)1 These findings suggest that higher SC infliximab pre-dose levels may be associated with better clinical outcomes compared to intravenous (IV) infliximab1 October 10, 2020 06:00 PM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today announced two new data sets relating to the use of the subcutaneous formulation of infliximab, Remsima® SC (CT-P13 SC), in inflammatory bowel disease (IBD) at a poster presentation at UEG Week Virtual 2020. The first study investigated the association between the pre-dose serum of infliximab concentrations, with clinical efficacy and fecal calprotectin (FC) response.1 The results show a positive association between CT-P13 SC exposure with both efficacy and FC outcomes in patients with Crohn’s disease (CD) and ulcerative colitis (UC).1 Among 54 patients in the SC arm who have completed the CT-P13 SC maintenance treatment up to Week 54, 42 (77.8%) patients achieved clinical remission at Week 54. 1 Upon subgrouping patients according to quartiles of drug level exposure, the analysis shows that as a proportion, patients with the highest infliximab exposure (>26.7 μg/mL) achieved highest efficacy outcomes.1 The second study presented investigated the accuracy of the use of FC in monitoring mucosal change in a controlled trial of CT-P13 SC and IV for patients with moderate to severe UC.2 The results of this trial demonstrate that FC levels are associated with changes in status of mucosal inflammation, and specifically with improved endoscopic activity in UC patients who are treated with CT-P13 SC.2 A total of 68 UC patients were included in the multicentre, randomised controlled pivotal trial with 33 patients in the SC arm and 35 in the IV arm.2 At baseline, the median FC level in the entire cohort was 880 µg/g (786 µg/g and 978 µg/g in the SC and IV arms, respectively). 59 of 68 (86.8%) patients achieved FC level > 250 µg/g overall. In the SC arm, this accounted for 29 of 33 patients (87.9%), and in the IV arm, 30 of 35 patients (85.7%). The proportion of patients with FC level > 250 µg/g decreased to 39.0% (23/59) overall at week 22; with 44.4% (12/27) in the SC arm, and 34.4% (11/32) in the IV arm.2 Professor Walter Reinisch, Director of Clinical IBD Study Group, Department of Gastroenterology and Hepatology, Medical University of Vienna said, “These promising results support the use of the subcutaneous formulation of Remsima® in inflammatory bowel disease as an alternative option for eligible patients with UC and CD. In addition, the use of FC for monitoring the mucosal response to infliximab SC presents a viable, non-invasive choice for monitoring treatment – providing patients and clinicians with greater flexibility to suit their needs.” --- 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)6,7,8 CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The U.S. Food and Drug Administration approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 94 countries (as of October 2020) including the US, Canada, Japan and throughout Europe. CT-P13 IV is usually given as 3mg per kg/body weight in RA and as 5mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. Celltrion has also developed a subcutaneous (SC) formulation of infliximab that has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration. CT-P13 SC received EU marketing authorisation for the treatment of people with RA and IBD in November 2019 and July 2020, respectively. In the United States, Remsima® SC will be reviewed through the new drug pathway by the US Food and Drug Administration (FDA) with the outcome expected by 2022. 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 endeavors 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 Ye, B.D., et al. (2020). Exposure-response relationship of subcutaneous infliximab (CT-P13 SC) in patients with active Crohn’s disease and ulcerative colitis: analysis from a multicentre, randomized controlled pivotal trial. Moderated Poster Presentation (P0482). Presented at UEG Week Virtual 2020. 2 Reinisch, W., et al. (2020). Evaluation of clinical relationship between fecal calprotectin and endoscopic findings in ulcerative colitis patients treated with infliximab (ct-p13) subcutaneous and intravenous therapy: results from a multicenter, randomized, controlled pivotal trial. E-Poster Presentation (P0593). Presented at UEG Week Virtual 2020. 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 October 2020]. 4 The European Federation of Crohn’s & Ulcerative Colitis Associations. (n.d). What is IBD? Science. Retrieved from www.efcca.org/en/science [Last accessed October 2020]. 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 October 2020]. 6Yoo DH, Jaworski J, Matyska-Piekarska E et al. (2019). 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. 7 Westhovens R, Wiland P, Zawadzki M et al. (2019). 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. 8 European Medicines Agency Summary of Product Characteristics (SmPC). CT-P13. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/002576/WC500150871.pdf [Last accessed October 2020].

2020-10-10

Celltrion receives Korean MFDS approval to initiate Phase II/III pivotal trial of an anti-COVID-19 monoclonal antibody treatment candidate, CT-P59

Celltrion receives Korean MFDS approval to initiate Phase II/III pivotal trial of an anti-COVID-19 monoclonal antibody treatment candidate, CT-P59 Following positive interim results of the Phase I clinical trial of CT-P591, the Korean Ministry of Food and Drug Safety (MFDS) has approved Celltrion’s Investigational New Drug (IND) application to initiate a Phase II/III pivotal trial of the potential treatment in mild-to-moderate patients The global Phase II/III trial is set to enrol 1,000 patients from up to 12 countries to investigate the safety and efficacy of CT-P59 Celltrion expects to apply for emergency use authorisation (EUA), conditional on the results September 17, 2020 09:33 AM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group announced today that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application for a Phase II/III pivotal clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. The global trial will evaluate the safety and efficacy of CT-P59 in patients with mild-to-moderate symptoms of SARS-CoV-2 infection. Celltrion is set to obtain the summary of the primary results for Phase II of the study by the end of the year. Celltrion has submitted the IND application for the clinical trial in 6 countries including Korea, the U.S and Spain, and plans to enrol more than 1,000 patients from up to 12 countries. The company expects to be able to apply for emergency use authorisation (EUA), conditional on the results of the pivotal trial. Celltrion has begun manufacturing the process validation batch of CT-P59 and plans to increase manufacturing capabilities to meet the current global and domestic demand for the anti-COVID-19 monoclonal antibody treatment candidate. “Given that COVID-19 represents a significant global threat to life, there is an urgent need to identify treatments that can help stabilise our response to the pandemic. The initiation of the global Phase II/III pivotal trial of CT-P59 is an important step forward, and together with the ongoing Phase I trial in patients with mild symptoms, Celltrion remains committed to investigating a potential anti-COVID-19 monoclonal antibody treatment,” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. As part of its efforts to address the pandemic, Celltrion has also initiated an ongoing in-human global Phase I clinical trial of CT-P59 in mild COVID-19 patients, and plans to investigate the use of CT-P59 as a preventative treatment for COVID-19 in those in close contact with COVID-19 patients as part of a prevention clinical trial. - 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 COVID-192,3 Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak. The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19. Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1 About CT-P59 CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralizing the SARS-CoV-2 virus including the mutated G-variant strain (D614G variant). 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.4 References 1 Celltrion announces positive interim results from Phase I trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate [Press Release] Retrieved from https://www.businesswire.com/news/home/20200911005199/en/Celltrion-Announces-Positive-Interim-Results-Phase-Trial 2 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: September 2020 3 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: September 2020 4 Celltrion. Data on file

2020-09-17

Celltrion Announces Positive Interim Results From Phase I Trial of CT-P59, an Anti-COVID-19 Monoclonal Antibody Treatment Candidate

Celltrion Announces Positive Interim Results From Phase I Trial of CT-P59, an Anti-COVID-19 Monoclonal Antibody Treatment Candidate CT-P59 demonstrated a reassuring safety profile in Celltrion’s Phase I trial The company anticipates enrolment of 500 patients from 12 countries for the global Phase II and III trials Celltrion has also launched commercial production of CT-P59 as part of the preparation process September 11, 2020 07:22 AM Eastern Daylight Time INCHEON, Korea--(BUSINESS WIRE)--Celltrion Group announced today interim results from the Phase I clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. The results showed a promising safety, tolerability and pharmacokinetics profile of CT-P59. The Phase I clinical trial is a randomised, double blind and placebo-controlled trial designed to evaluate the safety, tolerability and pharmacokinetics of CT-P59 in healthy subjects.1 The results demonstrated no significant drug-related adverse events (AEs), and importantly there were no adverse events from the maximum tolerated dose cohort. “Along with these promising safety results, we have launched commercial production of CT-P59 this month to ensure, if trials are successful, we can meet the urgent global demand for a safe and effective antiviral treatment against COVID-19,” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. “Should we receive positive results from our series of ongoing clinical trials, we intend to request emergency use authorisation for our drug.” Celltrion has initiated an in-human, global, Phase I clinical trial of CT-P59 in mild COVID-19 patients and plans to conduct further global Phase II and III trials in 500 patients from 12 countries including Korea. Celltrion anticipates the enrolment of a total of 3,000 patients including those involved in the prevention clinical trial, investigating the use of CT-P59 as a preventative treatment for COVID-19 in those in close contact with COVID-19 patients. The company anticipates the development of the anti-COVID-19 monoclonal antibody treatment candidate will be complete by the first half of 2021. - 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 COVID-192,3 Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak. The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19. Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1 About 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 including the mutated G-variant strain (D614G variant). 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.4 References 1 ClinicalTrials.gov. A Phase 1, randomized, double-blind, placebo-controlled, parallel group, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of CT-P59 in healthy subjects. Available at: https://clinicaltrials.gov/ct2/show/NCT04525079?term=celltrion&cond=covid+19&cntry=KR&draw=2&rank=1 Last accessed: September 2020 2 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: September 2020 3 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: September 2020 4 Celltrion. Data on file

2020-09-11

Celltrion receives Korean MFDS approval to initiate Phase I trial of COVID-19 antiviral antibody treatment candidate, CT-P59, in patients

Celltrion receives Korean MFDS approval to initiate Phase I trial of COVID-19 antiviral antibody treatment candidate, CT-P59, in patients The Korean Ministry of Food and Drug Safety (MFDS) approved Celltrion’s Investigational New Drug (IND) application to initiate a Phase I trial of CT-P59 in patients By the end of the year Celltrion anticipates global pivotal study results from Phase II/III trials in patients with mild symptoms of COVID-19, the Phase III trial in moderate-to-severe patients, and the prevention trial As part of the prevention clinical trial, Celltrion will enrol those who are in close contact with COVID-19 patients and those with no symptoms to investigate the potential short-term preventative effects of CT-P59 against SARS-CoV-2 infection AUGUST 26th 2020, INCHEON, KOREA – Celltrion Group announced today that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application for a Phase I clinical trial of CT-P59, a COVID-19 antiviral antibody treatment candidate. Celltrion has initiated enrolment of patients with mild symptoms of SARS-CoV-2 infection and the clinical trial is set to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59. Celltrion anticipates global pivotal study results from the Phase II and III trials in patients with mild symptoms, the Phase III trial in patients with moderate-to-severe COVID-19, and the prevention clinical trial, by the end of the year. Celltrion plans to enrol people that are in close contact with COVID-19 patients and those with no symptoms as part of a prevention clinical trial to evaluate whether CT-P59 can elicit a neutralising antibody response to prevent the virus from infecting human cells. “We have initiated an in-human global Phase I clinical trial of CT-P59 in mild COVID-19 patients and we plan to conduct further global Phase II and III trials in this patient group. In addition, Celltrion plans to combine Phase II and III trials in patients with moderate-to-severe COVID-19 with the prevention clinical trials.,” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. “We are extremely encouraged by the consistent progress we are making in preparation for our CT-P59 clinical trials in various settings, and we remain on track to reach our upcoming milestones.” In July, Celltrion initiated a Phase I trial of CT-P59 in the UK following the approval of the clinical trial authorisation (CTA) application from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Celltrion has also completed an infusion and initial safety assessment for the Phase I study in healthy volunteers in Korea and the study is set for completion by Q3 this year as originally planned.   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 COVID-19[1],[2] Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.   The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19.   Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_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] Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: August 2020 [2] Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: August 2020

2020-08-26

Celltrion receives MHRA approval to initiate Phase I trial of potential COVID-19 antiviral antibody treatment, CT-P59, in the UK

Celltrion receives MHRA approval to initiate Phase I trial of potential COVID-19 antiviral antibody treatment, CT-P59, in the UK The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved Celltrion’s clinical trial authorization (CTA) application to initiate a Phase I trial of CT-P59, a potential COVID-19 antiviral antibody treatment Celltrion’s Phase I trial will enrol patients with mild symptoms of SARS-CoV-2 infection to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59; a Phase I clinical trial in healthy volunteers is ongoing in South Korea Celltrion anticipates results from Phase II/III trials by the end of the year with commercial production set to commence this September July 30, 2020 07:27 AM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the company’s Clinical Trial Authorisation (CTA) application for a Phase I clinical trial with CT-P59, a COVID-19 antiviral antibody treatment candidate, in patients with mild symptoms of SARS-CoV-2 infection. The clinical trial is set to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59. Celltrion plans to conduct further global Phase II/III trials in patients with mild and moderate COVID-19 and anticipates results from these pivotal studies by the end of the year. Furthermore, a clinical trial investigating the use of CT-P59 as a preventative measure, by enrolling people in close contact with COVID-19 patients globally, is also planned and the topline data for this trial are anticipated in Q1 of 2021. Celltrion will start the full-scale commercial production of CT-P59 in September this year and is securing sufficient manufacturing capacity to produce enough of the potential COVID-19 treatment for up to 5 million patients a year. “This is a timely approval from the UK regulatory authority for the Phase I clinical trial with CT-P59 as the global pandemic continues to grow and there remains a significant need for a safe and effective treatment for COVID-19,” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. “We are rapidly advancing our COVID-19 programme with CT-P59, including a Phase I clinical trial in healthy volunteers in Korea. Furthermore, we are making efforts to ensure that if the clinical trial programme is successful we are able to scale up manufacturing appropriately.” 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 including the mutated G-variant strain (D614G variant). 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.1 - 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 COVID-192,3Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak. The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19. Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1 FORWARD LOOKING STATEMENTCertain 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.

2020-07-30

European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima® SC, for an additional five indic

European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima® SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis The European Union (EU) marketing authorisation for the subcutaneous (SC) formulation of Remsima® (CT-P13) now applies to all previously approved indications for the intravenous (IV) formulation in adult patients including: ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis (PsO) The EU marketing authorisation is based on pivotal data comparing the pharmacokinetics, efficacy and safety of the IV and SC formulations of Remsima® in people with active CD and UC Celltrion’s Remsima® SC is the first and only infliximab to have both IV and SC formulations; Remsima® SC reduces treatment time to approximately 2-5 minutes, with a comparable efficacy and safety profile to the IV formulation of Remsima® July 27, 2020 07:38 AM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today announced that the European Commission (EC) has granted marketing authorisation for Remsima® (infliximab, CT-P13) subcutaneous (SC) formulation for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.1 The approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June and is based on data from a pivotal study comparing the pharmacokinetics, efficacy and safety of the SC and intravenous (IV) formulations of Remsima® in people with active Crohn’s disease and ulcerative colitis, throughout a 1-year treatment period.2,3 Based on the results of the pivotal study, a 120 mg fixed dose of Remsima® SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and newly added indications. Professor Stefan Schreiber, Director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany said: “The subcutaneous formulation of Remsima® (Remsima® SC) has been shown to have very high efficacy, and favourable data, which are fully comparable to the efficacy and safety profile of the IV formulation. Today’s approval marks an important progress for the gastroenterology community as it means that treatment can now be administered in significantly less time, thereby providing patients more flexibility and control over how they receive their treatment.” “We are pleased to announce this important regulatory milestone earlier than we expected, with the European Commission prioritising review of this important new administration option. We will accelerate the launch process on a country-by-country basis in order to expand treatment options for patients with chronic inflammatory diseases such as inflammatory bowel disease and ankylosing spondylitis,” said Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “We will do our best to make Remsima® SC available as early as possible and hope this medication will contribute to minimising the risks involved with administering medical treatments during the COVID-19 pandemic.” Celltrion anticipates receiving approval of Remsima® SC in 97 countries, including 31 countries in Europe. -- ENDS -- Notes to Editors: About Remsima® (CT-P13) intravenous (IV) formulation1Remsima® IV is usually given as 3 mg per kg/body weight in rheumatoid arthritis (RA) and as 5 mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. About Remsima® CT-P13 subcutaneous (SC) formulation4,5A 120 mg fixed dose of Remsima® SC has been granted marketing authorisation in the EU, in adults regardless of body weight, in all previously approved indications for the IV formulation. Remsima® SC has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration. About CT-P13 (biosimilar infliximab)CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 94 countries (as of July 2020) including the US, Canada, Japan and throughout Europe. About Celltrion HealthcareCelltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us Forward-looking statement disclaimerCertain information set forth in this press release contains statements related to our future business and financial performance, and future events or developments involving Celltrion Healthcare, that may constitute forward-looking statements, under pertinent securities laws. These statements may be identified by words such as “will”, “has potential to”, “brings”, “if approved”, “would”, “could”, “opportunity”, “hope”, “is considering” 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 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 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 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 Summary of Product Characteristics (SmPC). Remsima. 2 Reinisch W, et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a Phase 1 open-label randomised controlled trial in patients with active Crohn’s disease. European Crohn’s and Colitis Organisation 2019. Abstract no: A-1103. 3 Ben-Horin S, et al. A novel subcutaneous infliximab (CT-P13): 1-year results including switching results from intravenous infliximab (CT-P13) in patients with active Crohn’s disease and ulcerative colitis. Oral presentation (OP24). Presented at ECCO 2020. 4 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. 5 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.

2020-07-27

Celltrion Launches Human Clinical Trial of Potential COVID-19 Antiviral Antibody Treatment Following Positive Pre-Clinical Results

Celltrion launches human clinical trial of potential COVID-19 antiviral antibody treatment following positive pre-clinical results ·        The Phase I study of Celltrion’s COVID-19 antiviral antibody treatment candidate in healthy volunteers is set for completion by Q3 this year ·        Celltrion’s COVID-19  antiviral antibody treatment candidate has been proven to be effective in neutralising different kinds of coronavirus related strains including the mutated G-variant strain of SARS-CoV-2 (D614G variant) ·        Further human studies across Europe including the UK are planned – the company anticipates promising preliminary results from pivotal studies in mild and moderate COVID-19 patients by the end of the year   JULY 17th 2020, INCHEON, KOREA – Celltrion Group today announced the launch of its Phase I human clinical trial investigating a potential antiviral antibody treatment for patients with COVID-19. The in-human study follows positive pre-clinical results for the treatment candidate and subsequent approval of the Investigational New Drug application by the Korean Ministry of Food and Drug Safety (MFDS). The potential treatment will also be investigated for use as a preventative measure. The Phase I clinical trial aims to enroll 32 healthy volunteers in collaboration with Chungnam National University Hospital.  The study will evaluate the safety of the antiviral antibody treatment candidate in healthy participants who have not been diagnosed with COVID-19. The trial’s completion is expected by Q3 of this year. Celltrion is set to conduct a further in-human Phase I clinical trial of the antiviral treatment candidate in mild COVID-19 patients across Europe, including the UK,which will be followed by global Phase II/III trials in patients with mild and moderate COVID-19. Celltrion anticipates promising preliminary results from pivotal studies by the end of the year. In addition, a clinical trial investigating the use of the potential antiviral antibody treatment as a preventative measure, by enrolling people in close contact with COVID-19 patients globally, is also planned. The top line data for this trial is anticipated in Q1 of 2021. Furthermore, Celltrion has previously demonstrated its antiviral antibody treatment to be effective in neutralising the mutated G-variant strain (D614G variant),[1] which is associated with the increased viral transmission and wide spread of COVID-19.[2] “The initiation of this in-human clinical trial is a key milestone in the development of our antiviral antibody treatment,” said Dr. Sang Joon Lee,Senior Executive Vice President of Celltrion. “We were encouraged by the positive safety and efficacy results in our pre-clinical studies, and we are now ready to move into in-human clinical trials as we originally planned. We remain committed to carrying out local and global clinical studies with the goal of commencing mass production of the therapeutic antibody treatment in the latter half of this year.” -       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 COVID-19[3],[4] Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.   The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19.   There are currently no specific vaccines or treatments approved for COVID-19.   Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_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 usesuch 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 causeactual 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] Data on file. Celltrion Healthcare [2] Newer variant of COVID-19–causing virus dominates global infections. Los Alamos National Laboratory. Available at https://www.lanl.gov/updates/sars-cov-2-variant.php Last accessed: July 2020 [3] Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: July 2020 [4] Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: July 2020

2020-07-17

Celltrion Healthcare receives positive CHMP opinion for an additional five indications for Remsima® SC including for use in inflammatory bowel disease

Celltrion Healthcare receives positive CHMP opinion for an additional five indications for Remsima® SC including for use in inflammatory bowel disease and ankylosing spondylitis ·       The positive Committee for Medicinal Products for Human Use (CHMP) opinion recommends expanding the marketing authorisation for the subcutaneous (SC) formulation of Remsima® for use in an additional five indications,including for the treatment of inflammatory bowel disease (IBD) and ankylosing spondylitis (AS); the CHMP’s positive opinion for the SC formulation applies to all previously approved indications for the intravenous (IV)formulation in adult patients ·       The CHMP opinion is based on pivotal data evaluating the pharmacokinetics, efficacy and safety between the IV and SC formulations of Remsima® in people with active Crohn’s disease and ulcerative colitis ·       The availability of the novel SC formulation of Remsima® could provide patients with an alternative, more personalised and convenient treatment option   FRIDAY 26 JUNE - INCHEON, SOUTH KOREA - Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the existing marketing authorisation for the subcutaneous (SC) formulation of Remsima® (CT-P13) in an additional five indications: for the treatment of patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis. This follows the EU marketing authorisation for Remsima® SC for the treatment of people with rheumatoid arthritis issued in November 2019.[1] “Today’s positive CHMP opinion marks an important step forward in furthering our ability as clinicians to meet the needs of people with autoimmune diseases. Remsima®SC could offer patients an alternative administration method that provides adequate exposure during maintenance treatment with infliximab and takes significantly less time than the current intravenous formulation, thereby reducing the time patients need to be in medical settings with infusion administrations,” said Professor Walter Reinisch, Director of the Clinical IBD Study Group, Department of Gastroenterology and Hepatology, Medizinische Universität Wien. “Given the current COVID-19 pandemic, this is timely and welcome news,particularly for immunocompromised patients who must take extra precaution and only visit hospitals when absolutely necessary.” The subcutaneous formulation can be administered by patients themselves, thereby providing alternative treatment options giving them greater flexibility and control. The positive CHMP opinion was supported by data from a pivotal study comparing the pharmacokinetics,efficacy and safety of the subcutaneous and intravenous (IV) formulations of Remsima®in people with active Crohn’s disease and ulcerative colitis, throughout a 1-year treatment period.[2],[3] Part one of the study showed a comparable overall clinical response of CT-P13 SC to CT-P13 IV as indicated by the Crohn’s Disease Activity Index (CDAI-70) with similar scores, whereas clinical remission was numerically higher in the SC cohorts at week 54. The safety profiles of CT-P13 in the SC cohorts was comparable to CT-P13 IV up to week 54.2 In part two of the study, 131 patients were randomised at the maintenance phase (66 to the SC arm and 65 to the IV arm), of which 105 (80.2%)patients completed the week 54 visit (55 in the SC arm and 50 in the IV arm).After loading doses of IV 5 mg/kg at weeks 0 and 2, patients were randomised at week 6 to receive either SC 120 mg (From week 30 onwards, the IV 5 mg/kg group were switched to either SC 120 or 240 mg based on the patients’ body weight.3 The results showed that both the mean CDAI and partial Mayo scores for ulcerative colitis disease activity decreased over time in both arms until week 30, while comparable improvement in clinical activity was observed at week 54 – after switching the remaining IV patients to SC from week 30 of the trial. The rates of clinical response and remission at week 54 were maintained, and the rate of mucosal healing in Crohn’s disease and ulcerative colitis combined was further improved at week 54. After switching, the mean pre-dose serum concentrations in the IV arm increased to a level comparable to the SC arm, and maintained consistent levels until week 54. The overall safety profile during the maintenance phase, and on or after week 30, was comparable between both the SC and IV arms.3 Based on the above results, a 120 mg fixed dose of Remsima® SC has been recommended for use by the CHMP, in adults regardless of the body weight, in both existing and newly added indications. “Since its first launch, Remsima® has been used for more than 5 years in over 90 countries. This positive CHMP opinion is very encouraging and brings us closer to improving outcomes for more patients who are eligible to receive the subcutaneous formulation,” said Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “If approved by the EMA, Remsima® will be the first infliximab to have both intravenous and subcutaneous formulations to treat patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.” Celltrion has completed its application process for patent protection for the Remsima®SC formulation and dosage, until 2037 and 2038 respectively in approximately 100 countries throughout the US, Europe and Asia. -       ENDS   -     Notesto Editors: About CT-P13 intravenous (IV) formulation[4] CT-P13 IV is usually given as 3 mg per kg/body weight in RA and as 5 mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.   About CT-P13 subcutaneous (SC) formulation[5],[6] A 120 mg fixed dose of CT-P13 SC has been recommended for use by the CHMP, in adults regardless of the body weight, in both existing and newly added indications. CT-P13 SC has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.   About CT-P13 (biosimilar infliximab) CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC).It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 94 countries (as of June 2020) including the US, Canada, Japan and throughout Europe. About Celltrion HealthcareCelltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 120 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us Forward-looking statement disclaimerCertain information set forth in this press release contains statements related to our future business and financial performance, and future events or developments involving Celltrion Healthcare,that may constitute forward-looking statements, under pertinent securities laws. These statements may be identified by words such as “will”, “has potential to”, “brings”, “if approved”, “would”, “could”, “opportunity”,“hope”, “is considering” 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 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 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 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. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2020. Available at: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-june-2020. Last accessed June 2020. [2] Reinisch W, et al. A novel formulation of CT-P13(infliximab biosimilar) for subcutaneous administration: 1-year result from a Phase1 open-label randomised controlled trial in patients with active Crohn’s disease. European Crohn’s and Colitis Organisation 2019. Abstract no: A-1103.22. [3] Ben-Horin S, et al. A novel subcutaneous infliximab (CT-P13): 1-year results including switching results from intravenous infliximab (CT-P13) in patients with active Crohn’s disease and ulcerative colitis. Oral presentation (OP24). Presented at ECCO 2020. [4] European Medicines Agency Summary of Product Characteristics (SmPC). CT-P13. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf. Last accessed June 2020. [5] 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. [6] 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.

2020-06-29

Celltrion to expand COVID-19 testing portfolio to include both antigen and antibody testing kits

Celltrion to expand COVID-19 testing portfolio to include both antigen and antibody testing kits Celltrion plans to launch point-of-care antigen testing (POCT) kit in July in collaboration with BBB, a South Korean healthcare technology company that specialises in lab-on-a-chip technology Celltrion also plans to distribute a second test, a COVID-19 rapid antibody diagnostic test (RDT) kit, through an agreement with Humasis, a South Korean in-vitro diagnostic company By developing both antigen and antibody testing kits, as well as an antiviral treatment, Celltrion is seeking to lead global action in fighting the coronavirus pandemic with its comprehensive portfolio June 15, 2020 09:41 PM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group today announced plans to expand its diagnostic portfolio for SARS-CoV-2, the virus causing COVID-19, in its efforts to improve access to COVID-19 testing and help prevent the further spread of coronavirus infection worldwide. Celltrion has completed development of a point-of-care antigen testing (POCT) kit for COVID-19 together with South Korean healthcare company BBB, which specialises in blood testing and lab-on-a-chip technology. The POCT kit is a portable and highly sensitive device for use in rapid point of care testing to support early detection of COVID-19 positive patients in clinical settings. Promising early results for a prototype of Celltrion’s POCT kit for COVID-19 showed more than 95% sensitivity. The kit uses lab-on-a-chip technology consisting of a microfluidic electrochemical biosensor which aims to give fast and accurate results. The kit is designed to show results within 15-20 minutes, and Celltrion anticipates receiving a CE mark in Europe later this month, ahead of the expected launch in July. Celltrion has also entered into a distribution agreement with Humasis, a South Korean in-vitro diagnostic company, to distribute and sell a rapid diagnostic test globally this month. This test is a COVID-19 rapid antibody diagnostic test (RDT) kit, which could offer a cost-effective option and can be used by hospitals to confirm patients to be discharged. Celltrion and Humasis will also cooperate in the development of an upgraded rapid antibody diagnostic test and a rapid antigen diagnostic test, for which Celltrion will apply its proprietary COVID-19 antibody-antiviral technology to enhance detection sensitivity. Celltrion plans to leverage its advanced therapeutic technologies to expand the range of co-developed diagnostic devices beyond SARS-CoV-2 to a number of other infectious diseases as it progresses cooperation with Humasis. “We are keen to drive early diagnosis of COVID-19 through the availability of our testing portfolio,” said Ki-Sung Kwon, Head of R&D Unit at Celltrion. “We have successfully built solid partnerships with local device companies that are prominent in the field of diagnostic testing. We are committed to providing flexibility for testing needs as the pandemic evolves, and are using our expertise and past experience developing antibody treatments and targeting coronaviruses to fight this pandemic.” In addition to progress in diagnostic methods for COVID-19, Celltrion announced positive pre-clinical results for its antiviral antibody treatment last month.1 - 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 COVID-192,3 Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak. The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19. There are currently no specific vaccines or treatments approved for COVID-19. Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_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 Announces Positive Pre-clinical Results for COVID-19 Antiviral Antibody Treatment, Showing Improvement in Recovery Time [Press Release] Retrieved from https://www.businesswire.com/news/home/20200531005014/en/Celltrion-Announces-Positive-Pre-clinical-Results-COVID--19 Last accessed: June 2020 2 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: June 2020 3 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: June 2020

2020-06-16