CelltrionHealthcare

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

2021-08-12

Celltrion Healthcare’s anticancer therapeutics Herzuma® (trastuzumab) and Truxima® (rituximab) win Brazilian tender for two consecutive years

Celltrion Healthcare’s anticancer therapeutics Herzuma® (trastuzumab) and Truxima® (rituximab) win Brazilian tender for two consecutive years ·         Celltrion Healthcare signs exclusive contract to supply Herzuma® (trastuzumab) to the Federal Government in Brazil, which accounts for about 80 percent of Brazil's trastuzumab market ·         Celltrion Healthcare’s Truxima® (rituximab) wins 8 state bids, including Sao Paulo, which is the largest of Brazil’s state bids ·         The company aims to lead market position in the Central- South American biosimilar market August 3 2021, INCHEON, KOREA – Celltrion Healthcare today announced that the company has signed a contract to supply its two anticancer therapeutics - Herzuma® (trastuzumab) and Truxima® (rituximab) to the Brazilian market. The company won the order in an open bidding held by the Ministry of Health of Federal Government of Brazil marking two consecutive years of winning the bid. Under the contract, the company will supply Herzuma® (trastuzumab) to the public market, which accounts for approximately 80 percent of Brazil's trastuzumab market. The company has won a total of eight state bids for Truxima®(rituximab) this year, including a bid in Sao Paulo, which is the largest of Brazil's state bids. “There is a great demand to substitute expensive original pharmaceuticals with biosimilar drugs with proven safety and efficacy to reduce health care costs in Central and South America,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We are excited to win one of the most important bids in Brazil for two consecutive years and will continue to expand our presence in the Central and Southern American market with our anticancer biosimilar products.” Based on its successful bid in Brazil, Celltrion Healthcare plans on expediting its market expansion into the Latin American Market. As part of these efforts, in March 2021, Celltrion Healthcare has initiated direct sales of Remsima® (infliximab) in Colombia and plans to additionally adopt the direct sales model for Truxima® (rituximab) and Herzuma® (trastuzumab) in June and July respectively. In addition, Celltrion Healthcare plans to expand its direct sales business model to Peru and Chile in the third quarter of this year. -        ENDS     -  Notes to Editors: About Herzuma® (trastuzumab) Herzuma® is a humanised monoclonal antibody that is designed to bind selectively to the extracellular domain of an antigen called human epidermal growth factor reception 2 (HER2). Herzuma® is indicated for the treatment of adult patients with early breast cancer, metastatic breast cancer, and metastatic gastric cancer and was approved by the European Medicines Agency (EMA) in February 2018 and the US Food and Drug Administration (FDA) in December 2018. Similarity of Herzuma® to the reference product, Herceptin® was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials. About Truxima® (rituximab)[1],[2] Truxima® is a mAb that targets CD20, a transmembrane protein found on the surface of most B-cells. By binding specifically to CD20, Truxima® depletes B-cells by three main mechanisms: induction of apoptosis, stimulation of CDC (complement-dependent cytotoxicity) and stimulation of ADCC (antibody-dependent cell-mediated cytotoxicity). Truxima® is approved in the EU and US for the treatment of patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. Truxima® is the first rituximab similar biotherapeutic product to be prequalified by the World Health Organization (May 2020). 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. [1] European Medicines Agency Summary of Product Characteristics (SmPC). Truxima. Available at https://www.ema.europa.eu/en/documents/product-information/truxima-epar-product-information_en.pdf Last accessed July 2021 [2] First rituximab similar biotherapeutic products prequalified. World Health Organization. Available at: https://extranet.who.int/prequal/news/first-rituximab-biotherapeutic-products-prequalified Last accessed July 2021

2021-08-03

Celltrion’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59), demonstrates strong neutralising activity against Delta variant

Celltrion’s Monoclonal Antibody Treatment for COVID-19, regdanvimab (CT-P59), Demonstrates Strong Neutralising Activity Against Delta Variant  Pre- clinical data for regdanvimab (CT-P59) demonstrates strong neutralising activity against the Delta variant (B.1.617.2, first identified in India); results show 100% survival rate with virus eradication from all animals treated with therapeutic dosage of CT-P59 Regdanvimab (CT-P59) also retained its neutralisation potency against the Lambda variant (C.37, first identified in Peru) using a pseudo-virus neutralisation assay Celltrion announces results from the global Phase III clinical trial of regdanvimab (CT-P59) at ECCMID 2021; data met all primary and key secondary endpoints July 16, 2021 01:34 AM Eastern Daylight Time INCHEON, Korea--(BUSINESS WIRE)--Celltrion Group today announced new results from an in vivo efficacy study showing that regdanvimab (CT-P59) has a strong neutralising effect against the rapidly spreading Delta variant (B.1.617.2, first identified in India). According to the World Health Organization (WHO), the Delta variant has been reported in 96 countries becoming the most common variant.1 The pre- clinical in vivo study assessed the neutralisation effect of CT-P59 against the Delta variant, using a clinically relevant dose. The study demonstrated that CT-P59 treatment results in a 100% survival rate from COVID-19 compared to 0% for the placebo group, with significant protection against body weight loss shown after viral challenge also seen. In addition, a therapeutic dosage of CT-P59 significantly reduced the viral load of SARS-CoV-2 and inflammation in the lungs compared to non-treated controls with virus eradication from all animals treated with CT-P59. Taken together, CT-P59 has shown in vivo efficacy against Delta variant following Beta (B.1.351, first identified in South Africa)2 and Gamma variant (P.1, first identified in Brazil)3, which was comparable to that against wild type SARS-CoV-2, thus demonstrating that despite the reduced in vitro neutralising activity against Variants of Concern (VOC), CT-P59 retained its therapeutic potency in in vivo setting. The monoclonal antibody 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. “These new data are encouraging and reinforcing our body of both pre- clinical and clinical data,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “The Delta variant is a highly transmissible and contagious variant that could prompt further waves of infection around the world. It is important to expand the arsenal of monoclonal antibody therapies that are hoped to remain effective against the emerging COVID-19 variants.” Celltrion announced its full Phase III data at the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) which took place online from 9 -12 July 2021. During the oral session, 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. 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 U.S. FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.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-19.4 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 World Health Organization. Coronavirus disease (COVID-19)/Media resources/Science in 5/Episode #45 - Delta variant. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/media-resources/science-in-5/episode-45---delta-variant [Last accessed July 2021] 2 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 July 2021] 3 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 4 Celltrion Data on file

2021-07-16

Celltrion’s monoclonal antibody treatment for COVID-19, regdanvimab, demonstrates efficacy in neutralising against Gamma variant (P.1, Brazil variant)

  Celltrion’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59), demonstrates high efficacy in neutralising against SARS-CoV-2 variant first identified in Brazil (P.1) ·        Pre-clinical data for Regdanvimab(CT-P59) shows significant reduction in viral load of SARS-CoV-2 and protected body weight loss against Gamma variant (P.1, formerly ‘Brazilian’ variant) ·        Celltrion simultaneously assessed therapeutic neutralising antibodies against the Delta variant(B.1.617.2, formerly ‘Indian’ variant); data expected shortly   July 5 2021, INCHEON, KOREA – Celltrion Group today announced preliminary pre- clinical results for regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19, with data showing that CT-P59 has a neutralising effect against the Gamma variant in an in vivo model. The pre-clinical study assessed the neutralisation effect of CT-P59 against the Gamma variant, using a clinically relevant and lower dose in SARS-CoV-2 infected mice. The study demonstrated that CT-P59 treatment results in a significant reduction in viral load from lungs and 100% survival rate from COVID-19 compared to placebo animal model of 0%. In addition, significant protection was shown in body weight loss after viral challenge. CT-P59 is known to successfully neutralise the SARS-CoV-2 Variants of Concerns (VoC) including Alpha variant (B.1.1.7, first identified in the UK) and Beta variant (B.1.351, first identified in South Africa)[1] as well as Variant of Interests (VOIs) including lineages B.1.427/B.1.429, B.1.526, P.2, B.1.525 and B.1.617.1 in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). The company plans to additionally study in vivo neutralising activity against the Delta variants (B.1.617.2, formerly ‘Indian’ variant) in the coming days. "Treatment with regdanvimab, even at low doses than in human clinical trial design, led to reduction in viral load,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We are encouraged by the results with regdanvimab against SARS-CoV-2 variants as these findings add to the growing body of our pre-clinical data. We remain committed to continue with further testing for antiviral activity against other emerging variants including the Delta variant.” In June, the European Commission (EC) announced Celltrion’s regdanvimab to be part of the COVID-19 therapeutics portfolio for authorization for the treatment of COVID-19 patients as part of its strategy for COVID- 19 therapeutics.   -       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) and clinical trials 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.   References [1] 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 July 2021] [2] Celltrion Data on file

2021-07-05

Celltrion announces positive top-line results from global Phase III trial of regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment

Celltrion announces positive top-line results from global Phase III trial of regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment Regdanvimab (CT-P59) (40mg/kg) achieved statistically significant and clinically meaningful results in four main endpoints including primary and three key secondary endpoints; the company anticipates full Phase III data to be released in the coming months 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 Patients who were treated with regdanvimab (CT-P59) reported a significantly shortened time to clinical recovery by at least 4.7 days quicker for patients at high- risk of progressing to severe COVID-19 and by 4.9 days quicker compared to placebo for all patients According to the recently published article from Biochemical and Biophysical Research Communications, sufficient antiviral effect in B.1.351 variant (now classified by the WHO as Beta)-infected animals was confirmed with a clinical dosage of regdanvimab (CT-P59)1 INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group today announced top-line efficacy and safety data from the global Phase III clinical trial, demonstrating that anti-COVID-19 monoclonal antibody treatment candidate, regdanvimab (CT-P59), met all primary and key secondary endpoints in patients with mild- to- moderate symptoms of COVID-19 (n=1,315). Results showed that CT-P59 significantly reduced the risk of hospitalisation or death by 72% for patients at high- risk of progressing to severe COVID-19 up to Day 28, compared to placebo, meeting the primary efficacy endpoint [3.1 vs. 11.1 %, p-value The trial also met the other key secondary endpoints, including faster and persistent reduction in symptom duration. Patients treated with CT-P59 (40mg/kg) recovered at least 4.7 days earlier than those in the placebo-treated patients [median 9.3 vs. minimum 14 days, p-value Top-line results also showed CT-P59 to have a positive safety profile, with no clinically meaningful differences between patients treated with CT-P59 (40mg/kg) and placebo-treated patients. Infusion related reactions were mild and transient, with most patients recovering within 1~3 days. “We continue to be challenged by the COVID-19 pandemic and new variants of concern,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “As many hospitals across the globe now exceed their ability to accommodate patients due to COVID-19, it is critical that we use every resource to reduce the burden on the healthcare system. This well-controlled trial provides conclusive results demonstrating that CT-P59 can improve outcomes in people with mild- to- moderate COVID-19 and also significantly reduce the risk of hospitalisation and death. We look forward to continuing to work with regulators around the world to make CT-P59 available to more patients in need.” Therapeutic effect of CT-P59 against B.1.351 variant (first identified in South Africa, now classified by the WHO as Beta) was updated through the publication from Biochemical and Biophysical Research Communications. According to the article, in vivo ferret challenge studies demonstrated that a therapeutic dosage of CT-P59 was able to decrease B.1.351 viral load in the upper and lower respiratory tracts, comparable to that observed for the wild type virus.1 Celltrion plans to release full Phase III data in the coming months and plans to present the data at an oral session at the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), which will take place online from 9 -12 July 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 regdanvimab (CT-P59) and clinical trials 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 UK variant (B.1.17). In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I 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. The research for Celltrion’s clinical trials was supported by a grant as part of the Korea Health Technology R&D Project from the Korea Health Industry Development Institute (KHIDI), funded by the ministry of Health & Welfare, Republic of Korea (grant number: HQ2xC00xx). 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 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 June 2021] 2 Celltrion Data on file

2021-06-14

Celltrion Healthcare presents the first real-world data for Truxima® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA

Celltrion Healthcare presents the first real-world data for Truxima® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress The multi-country retrospective post-approval study is the first to investigate the safety and effectiveness of Truxima® (biosimilar rituximab, CT-P10) in patients with diffuse large B-cell lymphoma (DLBCL) in a real-world setting. INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today presented new data from its post-approval study evaluating the real-world clinical effectiveness and safety of Truxima® (biosimilar rituximab, CT-P10) in patients with diffuse large B-cell lymphoma (DLBCL) at the European Hematology Association (EHA) 2021 Virtual Congress.1 CT-P10 was granted European Medicines Agency approval in 2017 for the treatment of rheumatoid arthritis (RA) and specific blood cancers, including non-Hodgkin’s lymphoma (NHL).2 DLBCL is the most common subtype of NHL, representing an estimated 30-40% of adult cases.3,4,5,6 This non-interventional post-authorisation safety study (PASS) involved the collection of patient-level data from hospital medical records for patients with DLBCL who received CT-P10 treatment in five European countries (United Kingdom, Spain, France, Germany and Italy). CT-P10 treatment pattern data were collected retrospectively during the 30-month observation period and patients were selected based on the treatment they received as part of their standard clinical care in a real-world setting. The primary endpoints were overall survival (OS), progression free survival (PFS) and summary of best responses and secondary endpoints included safety profile and CT-P10 treatment pathways. At 30-months post-index, amongst patients taking first-line CT-P10, 67% (95% confidence interval [CI] 61.3–72.1) had not experienced disease progression, with 74% (95% CI 69.2–79.1) overall survival. Of the 382 patients observed, over three quarters initiated on CT-P10 achieved complete or partial response by 30 months, with 82% having recorded a complete response (n=312). Partial response was seen in 12% (n=46), no response or stable disease in 4% (n=16) and progressive disease in 2% (n=8). CT-P10 also appeared to be generally well tolerated by patients, with adverse events (AEs) consistent with those reported for reference rituximab. Overall, 90% (n=351) of patients reported at least one AE (total AEs n=2,504); 65% (n=253) experienced a grade 3 or higher AE, and 28% (n=109) were recorded as definitely, probably, or possibly related to CT-P10. “This is the first multi-country retrospective post-approval study to investigate the effectiveness and safety of CT-P10 treatment in patients with DLBCL in a real-world setting across Europe,” said Dr. Mark Bishton, Consultant Haematologist and Honorary Clinical Associate Professor at the University of Nottingham, School of Medicine. “Over three quarters of patients initiated on CT-P10 achieved complete or partial response by 30 months. The response rates, survival rates and overall safety profile for CT-P10 appears consistent with those reported for reference rituximab, which could support the use of CT-P10 in combination with chemotherapy as a therapeutic option for DLBCL.” Celltrion Healthcare also presented real-world data on rapid infusion of CT-P10 in patients with non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukaemia (CLL) at the EHA Updates-in-Hematology.7 The study was the first multi-country study to investigate the safety and effectiveness of rapid infusion of CT-P10 in a real-world setting. Safety results suggest that rapid infusion of CT-P10 was generally well tolerated, with only 10% (n=20; 95% CI: 6 – 15%) of patients experiencing an infusion-related reaction (IRR). The majority of IRRs were grade 1 or 2 (96%), with the most common IRR being fatigue (35% n=7/20 of the patients with index IRRs), followed by nausea (30% n=6/20) and vomiting (15% n=3/20). In terms of response, the majority of patients achieved a complete response (74% n=142/192) or partial response (22% n=42/192) over the 6-month observation period. “The recommended protocol for rituximab infusion in Europe is a slow initial infusion rate with a gradual upward titration. Rapid infusion is often used in subsequent infusions for patients who had no serious complications related to the first infusion,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We are encouraged by the results of the study as Truxima has demonstrated a similar IRR rate to reference rituximab. This will allow informed, evidence-based decisions on cost-effective treatment strategy for patients with CLL or NHL.” - ENDS - Notes to Editors: About diffuse large B-cell lymphoma (DLBCL)3,4,5,6 There are more than 60 different subtypes of non-Hodgkin’s lymphoma (NHL), however diffuse large B-cell lymphomas (DLBCLs) are the most common subtype accounting for 30-40% of adult NHLs. Global epidemiological data is limited, however it is thought that the incidence is 7 cases per 100,000 people. DLBCL is an aggressive condition and it is common to find patients with advanced disease at the point of diagnosis. The most commonly exhibited symptom is one or more painless swellings, and other general symptoms include heavy sweating at night, high temperatures that arise with no obvious cause and weight loss. Of DLBCL patients, 30-40% are thought to relapse and 10% of patients have refractory disease. Patients with relapsed refractory DLBCL if left untreated have a life expectancy of 3 to 4 months. About Truxima® (biosimilar rituximab)8,9 Truxima® is a mAb that targets CD20, a transmembrane protein found on the surface of most B-cells. By binding specifically to CD20, Truxima® depletes B-cells by three main mechanisms: induction of apoptosis, stimulation of CDC (complement-dependent cytotoxicity) and stimulation of ADCC (antibody-dependent cell-mediated cytotoxicity). Truxima® is approved in the EU for the treatment of patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. Truxima® is the first rituximab similar biotherapeutic product to be prequalified by the World Health Organization (May 2020). About Celltrion Healthcare Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us References 1 Bishton. M., et al. Real World Clinical Effectiveness and Safety of CT-P10 in Patients with Diffuse Large B-Cell Lymphoma: Results from a European Non-Interventional Post Authorization Safety Study. EHA 2021, Abstract #EP529.

2021-06-12

Celltrion Healthcare Presents Positive One-Year Data for the First High-Concentration, Low-Volume and Citrate-Free Biosimilar Adalimumab YuflymaTM

Celltrion Healthcare Presents Positive One-Year Data for the First High-Concentration, Low-Volume and Citrate-Free Biosimilar Adalimumab, YuflymaTM (CT-P17) in Patients With Rheumatoid Arthritis at EULAR 2021 One-year data have shown equivalent efficacy and comparable safety for Yuflyma™ (CT-P17) against reference adalimumab in patients with moderate-to-severe active rheumatoid arthritis (RA) Sustained and comparable efficacy in terms of ACR20/50/70 response rates was achieved in patients receiving maintenance therapy (CT-P17 or reference-adalimumab) and also in patients switched at week 26 from reference-adalimumab to CT-P17 up to one year Celltrion Healthcare has also received marketing authorisation for its subcutaneous formulation of infliximab, Remsima® SC, for direct use of subcutaneous therapy without IV loading in adults with RA June 01, 2021 07:40 PM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today presented positive results from the Phase III CT-P17 3.1 trial comparing the efficacy and safety of biosimilar adalimumab, Yuflyma™, with reference adalimumab in patients with active rheumatoid arthritis (RA) at the Annual European Congress of Rheumatology 2021 (EULAR Virtual Congress 2021). The trial met its primary and secondary endpoints, demonstrating that the efficacy, pharmacokinetics (PK), safety and immunogenicity of CT-P17, a high-concentration (100mg/mL), low-volume and citrate-free adalimumab biosimilar, is comparable to reference adalimumab in the treatment of patients with moderate-to-severe active RA up to one year. The abstract has been published in an official supplement of the Annals of Rheumatic Diseases (ARD).1 The randomised, double-blind, Phase III study has demonstrated therapeutic equivalence of CT-P17 to reference adalimumab in 648 patients with active moderate-to-severe RA, despite methotrexate treatment, who were randomised (1:1) to receive either 40mg of CT-P17 or reference adalimumab every two weeks up to week 24.2 Prior to dosing at week 26, 608 patients were randomised again to either maintaining their treatment or being switched from reference adalimumab to CT-P17. After the second randomisation, 303 patients continued with CT-P17, 153 patients continued with reference adalimumab and 151 patients were switched from reference adalimumab to CT-P17 up to week 48. Results demonstrated comparable efficacy in terms of ACR20/50/70 response rates, both in patients receiving maintenance therapy and in patients switched from reference adalimumab to CT-P17 up to week 52. With respect to PK, mean Ctrough levels were maintained after week 24 in all three treatment groups with the observed mean Ctrough levels recorded within the reported therapeutic ranges of reference adalimumab trough levels (5-8 µg/ml) in RA patients. The safety profile among the three treatment groups was comparable, with the most common treatment-emergent adverse event (TEAE) being neutropenia and similar proportions seen across all treatment groups experiencing at least one TEAE: injection site reactions, hypersensitivity/allergic reactions and infections. Anti-drug antibody (ADA) and neutralising antibody (NAb) results were also similar among the three treatment groups; the proportions of patients who had ADA/NAbs were 28.4%/24.8% in CT-P17 maintenance, 27.0%/24.3% in reference adalimumab maintenance and 28.3%/26.3% in switched to CT-P17 groups. Professor Jonathan Kay of the University of Massachusetts Medical School and Principal Investigator of the trial said, “CT-P17 is administered at 100 mg/mL, reflecting the high-concentration formulation of reference adalimumab, and is also citrate-free, which could lessen discomfort during injection. Demonstration of equivalent efficacy and comparable safety of CT-P17 to EU-sourced adalimumab in this study supports the ongoing clinical evaluation of CT-P17 as an adalimumab biosimilar.” Celltrion are also pleased to announce that the European Commission (EC) has granted marketing authorisation for Remsima® SC (infliximab) to be used without IV infusion both for new and existing RA patients.3 The EC approval follows a positive Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), opinion issued for direct use of subcutaneous therapy without IV loading in adults with RA in March 2021. “Celltrion now has biosimilars of both infliximab and adalimumab with value-added features, and thus CT-P17 could be used sequentially with Remsima® SC to bring clinical benefit for chronic diseases which require long- term treatment,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Having both Remsima® SC and Yuflyma™ in our product pipeline furthers our efforts to deliver value-added medicines to both payers and patients.” - ENDS - Notes to Editors: About CT-P17 (biosimilar adalimumab) CT-P17 is the first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar. CT-P17 is indicated for the treatment of patients with rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), enthesitis-related arthritis (ERA), ankylosing spondylitis (AS), axial spondyloarthritis without radiographic evidence of AS (nr-axSpA), psoriatic arthritis (PsA), psoriasis (PsO), paediatric plaque psoriasis (pPsO), hidradenitis suppurativa (HS), Crohn’s disease (CD), paediatric Crohn’s disease (pCD), ulcerative colitis (UC), uveitis (UV) and paediatric uveitis (pUV). CT-P17 is a recombinant human monoclonal antibody that contains the active ingredient adalimumab. Adalimumab is a fully human anti–tumour necrosis factor α (anti-TNF-α) monoclonal antibody. CT-P17 provides pain-reducing features as it has a citrate-free formulation, meaning it causes less pain upon injection. About Remsima® CT-P13 subcutaneous (SC) formulation4,5 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 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 Celltrion Healthcare Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us. References 1 Ann Rheum Dis, volume 80, supplement 1, year 2021, page 1123 2 Furst D, et al. Efficacy and Safety after Transition from Reference Adalimumab to CT-P17 (Adalimumab Biosimilar: 100mg/mL) in comparison with the Maintained Treatment (CT-P17 or Reference Adalimumab) in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 1-Year Result. Abstract 325. Presented at EULAR 2021. 3 European Medicines Agency Summary of Product Characteristics (SmPC) Available at https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf [Last accessed May 2021]. 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.

2021-06-02

Celltrion Confirms Neutralising Potency Against Emerging SARS-CoV-2 Variants With Anti-COVID-19 Monoclonal Antibody Treatment regdanvimab (CT-P59)

Celltrion Confirms Neutralising Potency Against Emerging SARS-CoV-2 Variants With Anti-COVID-19 Monoclonal Antibody Treatment regdanvimab (CT-P59) CT-P59 demonstrated neutralising capability against key emerging mutations, including SARS-CoV-2 variants first identified in New York (B.1.526), Nigeria (B.1.525) and India (B.1.617)1 Evaluation of other emergent variants of concern (first identified in Brazil P.1)2 is ongoing; data expected in the coming months Celltrion is committed to assess the therapeutic neutralising antibodies against a wide array of emerging variants to end the pandemic May 18, 2021 02:39 AM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group today announced that CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, has confirmed neutralising potency against emerging variants first identified in New York (B.1.526), Nigeria (B.1.525) and India (B.1.617).1 The Korea Disease Control and Prevention Agency (KDCA) has assessed the test by combining the antibody with recent emerging variants first identified in New York (B.1.526), Nigeria (B.1.525) and Brazil (P.1); infecting the host cell with this combination to identify neutralising effect against the variants with CT-P59. The monoclonal antibody candidate CT-P59 demonstrated strong neutralising capability against the New York (B.1.526) and Nigeria (B.1.525) variants and produced neutralising titers against the Indian variant (B.1.617) in an in-vitro pseudo virus assay.1 The company plans to study neutralising titers against additional emerging strains, including the Brazil variant (P.1)2, in order to proactively address the pandemic as the virus continues to evolve. CT-P59 is known to successfully neutralise the SARS-CoV-2 variants first identified in the UK (B.1.1.7), California (B.1.427/B.1.429), Brazil (P.2), in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). “The emergence of SARS-CoV-2 variants has created great concern across the globe. We are encouraged by these results, which reinforce our confidence that CT-P59 should be effective against these newly detected variants.” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Monoclonal antibodies have the potential to alleviate symptoms and prevent progression to severe disease in patients with mild to moderate COVID-19. It’s clear there is an urgent need to improve access to treatments like regdanvimab, as emerging variants continue to threaten efforts to curb the spread of the virus around the world.” Celltrion has successfully enrolled more than 1,300 people and its global Phase III clinical trial to further evaluate the efficacy and safety of CT-P59 in 13 countries including the U.S., Spain and Romania is on track with data expected in the coming months. As of May 2021, more than 3,000 people have been treated with regdanvimab 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/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 including the UK variant (B.1.17). In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I clinical trial of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.1 Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2. References 1 Celltrion Data on file 2 SARS-CoV-2 variants of concern as of 11 May 2021. European Centre for Disease Prevention and Control. Available from: https://www.ecdc.europa.eu/en/covid-19/variants-concern

2021-05-18

Celltrion’s anti-COVID 19 monoclonal antibody treatment, regdanvimab, demonstrates neutralising effect against the South African variant (B.1.351)

Celltrion’s anti-COVID 19 monoclonal antibody treatment, regdanvimab (CT-P59), demonstrates neutralising effect against the South African variant (B.1.351) Pre-clinical data for Celltrion’s monoclonal antibody treatment regdanvimab (CT-P59) shows significant reduction in viral load of SARS-CoV-2, with no significant difference observed in the neutralisation titres against wild type SARS-CoV-2 Celltrion has completed patient enrolment of 1,300 people in a global Phase III clinical trial to evaluate the efficacy and safety of CT-P59 Celltrion to commence further investigation into neutralisation activity of CT-P59 against other emerging COVID-19 variants April 29, 2021 04:56 AM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group today announced preliminary pre-clinical results for regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment, with data demonstrating that CT-P59 has a neutralising effect against the South African variant in an in vivo model. The study demonstrated that CT-P59 treatment, at a clinically relevant dose, results in a significant reduction in viral load of SARS-CoV-2. The manuscript describing this pre-clinical data is available on the pre-print server bioRxiv and is concurrently undergoing scientific peer-review for potential publication. This pre-clinical study assessed the neutralisation effect of CT-P59 against the South African variant, using a clinically relevant dose. CT-P59 demonstrated reduction in the binding affinity against the receptor binding domain (RBD) in the three mutations (K417N, E484K and N501Y substitutions) of the South African variant. In addition, CT-P59 showed a reduced susceptibility against the South African variant in a live virus and pseudo-virus assay in vitro study. However, there was no significant difference observed in the respiratory viral infection in the upper and lower respiratory tracts when exposed with SARS-CoV-2 wild type and the South African variants in the study. Taken together, the reduced effect in in vitro neutralisation of CT-P59 is unlikely to compromise the in vivo therapeutic potency against the variant in the respiratory tract, especially at a clinical dose. “We are encouraged by the new data, which reinforces that Celltrion’s CT-P59 treatment could be effective against the South African variant and variant mutations,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Faced with the rapid spread of COVID-19 variants, global access to effective antibody treatment is fundamentally important to reduce the disease progression rate to severe COVID-19 and help outpatients avoid hospitalisation and alleviate the burden on the health care system. We have commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging strains in the UK and South Africa and we will continue to further investigate the neutralising antibodies and other responses to protect against current SARS-CoV-2 strains and emerging variants .” Celltrion’s global Phase III clinical trial to further evaluate the efficacy and safety of CT-P59 is ongoing in 13 countries including the U.S., Spain and Romania, having recently completed patient enrolment of 1,300 people. - 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 neutralise the wild type and mutant variants of concern including the UK variant (B.1.17). In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I clinical trial of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.1 Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2. References 1 Celltrion Data on file

2021-04-29

Celltrion Healthcare receives positive CHMP opinion for Remsima® SC for direct use of subcutaneous therapy without IV loading

Celltrion Healthcare receives positive CHMP opinion for subcutaneous formulation of infliximab, Remsima® SC, for direct use of subcutaneous therapy without IV loading in adults with rheumatoid arthritis The Committee for Medicinal Products for Human Use (CHMP) recommends that Remsima® SC can be initiated without IV loading in patients with rheumatoid arthritis (RA) The recommended new posology is to start Remsima® SC 120mg weekly up to week 4 and inject every 2 weeks thereafter; For patients currently on infliximab IV, Remsima® SC can be administered after 8 weeks from last dose without additional IV loading The availability of the subcutaneous induction therapy could potentially shorten drug administration time, reduce healthcare practitioner time, and offer additional flexibility for patients March 31, 2021 05:04 AM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Remsima® SC for direct use of subcutaneous therapy without IV loading in patients with rheumatoid arthritis (RA).1 As a result of the CHMP opinion, if agreed by European Commission (EC), Remsima® SC 120 mg can be used without IV infusion both for new and existing RA patients. The recommended posology for newly diagnosed or newly infliximab-initiated patients, suggests that Remsima® SC should be initiated as a subcutaneous injection at week 0 and additional injections will be given at week 1, 2, 3 and 4 after the first injection. Then, maintenance therapy will be followed every 2 weeks thereafter. For existing patients, Remsima® SC is administered without additional IV loading 8 weeks after last administration of the infliximab IV. “IV administration of infliximab requires frequent hospital visits which can pose a challenge to some patients especially given the current COVID-19 pandemic,” said Professor Roberto Caporali, Professor of Rheumatology at the University of Milan and Head of Rheumatology Unit of Gaetano Pini Hospital, Milan Italy. “The direct subcutaneous induction of the SC formulation of infliximab could potentially shorten drug administration time via self-administration at home, reduce healthcare practitioner time and burden on healthcare system, as well as offering additional flexibility and convenience for patients.” Previous pharmacoeconomic model which estimates delivering subcutaneous infliximab with IV induction regimen yields savings of 21 million GBP compared to IV infliximab when treating British RA patients in one-year time frame. Remsima® SC without IV induction can generate additional saving of 14 million GBP. All models project potential savings from IV administration costs thus societal gain may be greater than the estimates.2 “Today’s positive CHMP opinion marks a step forward in our goal to provide flexible treatment schedules to patients with rheumatoid arthritis especially under COVID-19 situation,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. "If the recommendation of EMA is agreed by EC, Remsima® SC could be used without IV infusion for newly initiated patients as well as patients currently on infliximab treatment.” - ENDS - Notes to Editors: About Remsima® (CT-P13) intravenous (IV) formulation1Remsima® IV is usually given as 3 mg per kg/body weight in rheumatoid arthritis (RA) and as 5 mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. About Remsima® CT-P13 subcutaneous (SC) formulation3,4A 120 mg fixed dose of Remsima® SC has been granted marketing authorisation in the EU, in adults regardless of body weight, in all previously approved indications for the IV formulation. Remsima® SC has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration. About CT-P13 (biosimilar infliximab)CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 96 countries (as of March 2021) including the US, Canada, Japan and throughout Europe. About Celltrion HealthcareCelltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us References 1 Opinion of the committee for medicinal products for human use on a type II variation to the terms of the marketing authorisation | European Medicines Agency (europa.eu). [Last accessed 29 March 2021] 2 M. Perry et al. Budget Impact Analysis of Introducing subcutaneous infliximab CT-P13 SC from the UK payer perspective. Abstract presented at EULAR 2020 3 Yoo DH, Jaworski J, Matyska-Piekarska E et al. A Novel Formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: One-year results from part one of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (FRI0128). Presented at EULAR 2019. 4 Westhovens R, Wiland P, Zawadzki M et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 30-week results from part two of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (SAT0170). Presented at EULAR 2019.

2021-03-31