CelltrionHealthcare

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

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

New Phase II data indicate regimen of Truxima® (biosimilar rituximab), lenalidomide and acalabrutinib (R2A) may be well tolerated and effective in rel

New Phase II data indicate regimen of Truxima® (biosimilar rituximab), lenalidomide and acalabrutinib (R2A) may be well tolerated and effective in relapsed/refractory aggressive B-cell lymphoma Data from a Phase II trial show a regimen of Truxima® (biosimilar rituximab), lenalidomide and acalabrutinib (R2A) was well tolerated in people with relapsed/refractory aggressive B-cell lymphoma1 Biosimilars have the potential to enable access to novel drugs and regimens by reducing the overall cost burden of treatment Celltrion Healthcare is committed to driving innovative research within haematology to support patients June 14, 2020 08:00 PM Eastern Daylight Time INCHEON, South Korea--(BUSINESS WIRE)--Data presented as part of the Virtual Edition of the 25th EHA Annual Congress (EHA25 Virtual Congress) show that a regimen of Truxima® (biosimilar rituximab), lenalidomide and acalabrutinib (R2A) may be well tolerated and effective in relapsed/refractory aggressive B-cell lymphoma.1 Lenalidomide and Bruton’s tyrosine kinase (BTK) inhibitors have shown potential in the treatment of aggressive B-cell lymphoma, and recent studies suggest both agents may be particularly effective in a subset of large B-cell lymphomas. The objective of this Phase II clinical trial was to evaluate the toxicity and efficacy of the R2A regimen in relapsed/refractory aggressive B-cell lymphoma.1 Between the first enrolment in July 2019 and the data cut-off in February 2020, a total of 22 patients were treated with a median follow up of 3.2 months. The majority of patients (73%) had non-germinal centre B-cell like diffuse large B-cell lymphoma (non-GCB DLBCL). In each cycle of treatment, patients were treated with rituximab 375mg/m2 day 1 intravenous injection, lenalidomide 20mg day 1 to day 21 once daily, and acalabrutinib 100mg day 1 to day 28 twice daily. Each cycle of treatment was delivered over 4 weeks (28 days), and each patient received 6 cycles. Acalabrutinib maintenance therapy was then given in responders for up to one year.1 The primary endpoint for this single arm, multicenter, investigator-initiated study was the overall response rate (ORR) and secondary endpoints included complete remission (CR) rate, progression free survival (PFS), overall survival (OS) and safety profile. In the 13 patients who underwent disease assessment following the R2A regimen, objective response was observed in 69% of patients and CR was observed in 31% of patients. The 6-month PFS rate was 83% and only one patient experienced disease progression after the initial objective response.1 Throughout the study, out of 22 patients, dose reduction was performed in 3 and 1 patients for lenalidomide and acalabrutinib respectively due to haematologic toxicities. 3 patients experienced higher than grade 2 toxicity and the most common adverse event regardless of grade was skin toxicity, observed in 4 patients. The data indicate that the R2A regimen was therefore well tolerated in Korean relapse/refractory B-cell lymphoma patients, with initial analysis in non-GCB DLBCL patients showing a promising response.1 Combination regimens can improve patient outcomes, however, combining high-cost treatments can make the cost unsustainable. Payers are therefore increasingly looking for new pricing models and ways to manage the budget impact of combination treatments.2 The introduction of biosimilar rituximab to the R2A regimen may have the potential to reduce the overall cost of treatment. Youngil Koh, Associate Professor at Seoul National University Hospital and principal investigator of the trial, said, “Despite the introduction of new drugs for the treatment of lymphoma, there has been rising concern over the cost of treatment. Biosimilars have the potential to explore better treatment regimens and increase access to novel drugs and new regimens. By incorporating biosimilar rituximab into combination therapies alongside new drugs, the overall cost burden can be reduced, enhancing patient access.” Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare said, “There is a rising interest towards lenalidomide and acalabrutinib in the haematology community and Celltrion Healthcare is committed to continuing its innovative research into new regimens such as R2A combination therapy to support patient care.” Recently, the WHO recognised the importance of access to rituximab and awarded prequalification to Truxima®, making this the first rituximab similar biotherapeutic product to be prequalified by the organisation.3 Mr Kim said, “The prequalification of this treatment marks another step forward in making this medicine available in many countries around the world as an affordable therapeutic option.” -- ENDS -- Notes to Editors: About diffuse large B-cell lymphoma (DLBCL) 4,5,6,7 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)3,8 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® approved in the EU for the treatment of patients with Non-Hodgkin lymphoma (NHL), chronic lymphocytic leukaemia, rheumatoid arthritis, 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 References1 Koh, Y., Park, C., Byun, J., et al. Rituximab, lenalidomide and acalabrutinib (R2A) for relapsed/refractory aggressive B-cell lymphoma: Interim analysis reporting good tolerability and potential durable response. Poster presented at: EHA25 Virtual Congress; June 12, 2020 2 Sherwin, G et al. Payer Management Of High-Cost Brand-On-Brand Combination Therapies In Oncology. Value in Health. 2017;20(9):A461. Doi: https://doi.org/10.1016/j.jval.2017.08.3573 First rituximab similar biotherapeutic products prequalified. World Health Organization. Available at: https://extranet.who.int/prequal/news/first-rituximab-biotherapeutic-products-prequalified Last accessed June 2020 4 NHL subtypes. Leukemia & Lymphoma Society. Available at: https://www.lls.org/lymphoma/non-hodgkin-lymphoma/diagnosis/nhl-subtypes Last accessed June 2020 5 Raut LS, Chakrabarti PP. Management of relapsed-refractory diffuse large B cell lymphoma. South Asian J Cancer. 2014;3(1):66‐70. doi:10.4103/2278-330X.126531 6 Vivek Kumar, Sarvadaman Makardhwaj Shrivastava, Trishala Meghal and Binod Abhinav Chandra (June 27th 2018). Recent Advances in Diffuse Large B Cell Lymphoma, Hematology - Latest Research and Clinical Advances, Margarita Guenova and Gueorgui Balatzenko, IntechOpen, DOI: 10.5772/intechopen.74263. Available from: https://www.intechopen.com/books/hematology-latest-research-and-clinical-advances/recent-advances-in-diffuse-large-b-cell-lymphoma Last accessed June 2020 7 Diffuse large B cell lymphoma. Cancer Research UK. Available at: https://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/types/diffuse-large-B-cell-lymphoma Last accessed June 2020 8 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 June 2020

2020-06-15

Celltrion Healthcare showcases positive 1-year data and budget impact analysis for novel subcutaneous formulation of infliximab in patients

Celltrion Healthcare showcases positive 1-year data and budget impact analysis for novel subcutaneous formulation of infliximab in patients with rheumatoid arthritis at the European E-Congress of Rheumatology 2020 1-year data from a randomised controlled trial in patients with rheumatoid arthritis (RA) show no impact of body mass index (BMI) on clinical response to subcutaneous infliximab (Remsima® SC / CT-P13 SC)1 Additional data show no differences in clinical response between CT-P13 SC and intravenous infliximab (CT-P13 IV) in terms of immunogenicity over one year2 Remsima® SC has the potential to offer substantial cost savings to healthcare systems as shown by new budget impact analysis data3 INCHEON, South Korea--(BUSINESS WIRE)--At the European E-Congress of Rheumatology 2020 (The European League Against Rheumatism (EULAR) 2020 E-Congress), Celltrion Healthcare today showcased three sets of data relating to a subcutaneous formulation of infliximab, Remsima® SC. The first study demonstrated no impact of body mass index (BMI) on clinical response to CT-P13 SC in patients with active rheumatoid arthritis (RA).1 The post-hoc study investigated the impact of BMI on clinical response to CT-P13 SC in part 2 of a phase I/III randomised controlled trial (RCT) in 165 patients throughout a 1-year treatment period.1 Patients were categorized into 3 groups; under/normal weight (2), overweight (≥25kg/m2, 2), and obesity (≥30kg/m2) based on the WHO BMI classification. The three groups received at least one full dose of CT-P13 SC (after IV induction) in the initial treatment stage before week 30. The data show that the mean change from baseline of DAS28 (CRP) (-3.3, -3.1, -3.3 at week 54), duration of low disease activity (LDA) up to Week 54 (26.2, 29.2, 27.9 weeks), and the good or moderate EULAR responder rates (84.1%, 80.3%, 90.2% at week 54) were all comparable among all groups and there were no statistically significant differences.1 Rene Westhovens, rheumatologist and one of the lead investigators of the trial, Emeritus Professor at the KU Leuven, Belgium said, “The post-hoc results showed that there was no impact of BMI on the clinical responses of CT-P13 SC 120 mg biweekly in RA patients. Therefore, Remsima® SC could be a promising therapeutic option regardless of BMI in RA patients.” The second study presented contained 1-year data from a multicenter, randomised, controlled, pivotal trial evaluating correlation between the magnitude of anti-drug antibody (ADA) positivity and clinical outcomes in RA patients. The results indicated that clinical analysis of both ADA positivity and titer are clinically meaningful in the prediction of pharmacokinetic (PK) profile and clinical response. CT-P13 SC administration did not result in a greater incidence of ADA compared to CT-P13 IV and there were no clinical differences between the formulations.2 A third study presented at EULAR, assessing budget impact analysis (BIA) data, indicated that the introduction of CT-P13 SC could lead to substantial cost savings for healthcare systems. The analysis compared a market scenario where a proportion of patients were treated with CT-P13 SC, to an alternative scenario where CT-P13 SC was not available and all patients were treated with IV formulations.3 The data show that introduction of CT-P13 SC resulted in potential cost savings of £39.6 million in the UK over a 5-year period, equating to 4,466 additional patients who could be treated with the SC formulation. In a second scenario which took into account IV dose-escalation up to 5mg/kg to reflect the real-world setting, the savings increased to £279.6 million over a 5-year period, equating to 30,839 additional patients able to be treated with CT-P13 SC.3 “Self-injection will significantly reduce the burden on healthcare delivery allowing resource to be spent elsewhere,” said Dr. Martin Perry at Royal Alexandra Hospital, United Kingdom. “With the pressure of meeting patient need and the increasing burden on healthcare systems, there is a greater demand than ever to deliver new and innovative treatment options that enable patients to live more independently, reduce the time spent in hospitals and in turn, lessen the pressures put on healthcare systems.” “Remsima® SC has the potential to offer patients a more convenient method of administration, whilst retaining the same clinical benefits found in the IV formulation of Remsima®,” said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “This should not only bring improvements to quality of life for patients, but also to healthcare systems who we anticipate could experience both time and cost savings by enabling home administration of Remsima® SC.” -- ENDS -- Notes to Editors About CT-P13 (biosimilar infliximab)4,5,6 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 inflammatory bowel disease (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 June 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 has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and EU marketing authorisation for the treatment of people with RA. Celltrion has submitted a further variation to the marketing authorisation of CT-P13 SC to extend the indication to other disease areas including inflammatory bowel disease. In the United States, CT-P13 SC will be reviewed through the new drug pathway with the expectation of receiving US Food and Drug Administration (FDA) approval 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 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 Yoo DH, Westhovens R et al. Impacts of Body Mass Index on Clinical Response of Novel Subcutaneous Infliximab (CT-P13 SC) in Patients with Active Rheumatoid Arthritis: 1-Year Results from a Part 2 of Phase I/III Randomized Controlled Trial. Poster. Presented at EULAR 2020 E-Congress. 2 Westhovens R, Yoo DH et al. Clinical Evaluation of the Immunogenicity to CT-P13 for Subcutaneous Use in Patients with Active Rheumatoid arthritis: 1-Year Clinical Results from a Multicenter, Randomized Controlled Pivotal Trial. Poster. Presented at EULAR 2020 E-Congress. 3 Perry M and Chung SI. Budget Impact Analysis of Introducing subcutaneous infliximab CT-P13 SC from the UK payer perspective. Poster. Presented at EULAR 2020 E-Congress. 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. 6 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 May 2020].

2020-06-04

Celltrion announces positive pre-clinical results for COVID- 19 antiviral antibody treatment, showing improvement in recovery time

Celltrion announces positive pre-clinical results for COVID- 19 antiviral antibody treatment, showing improvement in recovery time ·        Pre-clinical data for Celltrion’s antiviral antibody treatment candidate demonstrate a 100-fold reduction in viral load of SARS-CoV-2 (COVID-19), as well as improvement in lung lesions ·        The antiviral activity at the pre-clinical stage indicates Celltrion’s candidate could be a potential treatment for COVID-19 if the results are replicated in clinical trials ·        The first in-human clinical trials for Celltrion’s antiviral antibody candidate are set to start in July   JUNE 1 2020, 10:00 KST, INCHEON, KOREA – Celltrion Group today announced positive pre-clinical results for its COVID-19 antiviral antibody treatment, with data demonstrating a 100-fold reduction in the viral load of SARS-CoV-2, the virus causing COVID-19. The treatment was also able to show improvement in lung lesions to a normal activity level in animal models. The pre-clinical study was conducted in an animal model in collaboration with one of the Korean National Universities, Chungbuk National University College of Medicine. The trial set out to assess the efficacy of two dosage amounts (low and high) for the antiviral antibody treatment. In comparison to the placebo-controlled group, the research team observed improved recovery in terms of clinical symptom scores such as runny nose, cough and body aches, after the first day of treatment. From the fifth day, significant clinical remission was observed. Reverse transcriptase polymerase chain reaction (RT-PCR) measurement and cell culture-based viral diagnosis were used to analyse specimens from the upper respiratory tract (nasal discharge and nasal turbinate) and the lungs. The samples from the high-dose group saw the viral load reduce by 100-fold. Furthermore, lung biopsy showed that both dosage groups saw inflammation returning to normal lung tissue histopathology within 6 days as well as a shortened recovery time, whereas the placebo-controlled group experienced sustained levels of lung inflammation and complications. This announcement follows the identification of antibody candidates for an antiviral treatment which Celltrion completed in April. In response to these positive results, Celltrion will now conduct additional efficacy and toxicity testing in pre-clinical settings and anticipates starting first-in-human clinical trials in July. “Celltrion is drawing on its expertise, innovation and previous experience in coronaviruses, such as efforts researching the efficacy of CT-P38, an investigational antibody to treat Middle East Respiratory Syndrome (MERS), as well as CT-P27, a multi-antibody drug for influenza which is being tested in a phase 2b study, to develop a safe and effective treatment for COVID-19,” said Ki-Sung Kwon, Head of R&D Unit at Celltrion. “Celltrion is leveraging its advanced technologies to lead efforts to develop a novel antiviral antibody treatment containing potent therapeutic antibodies that can neutralise the virus. Celltrion hopes to commence first-in-human clinical trials in July and has the capability to roll out mass production of the therapeutic antibody treatment once it is ready.”    -       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[1],[2] Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). 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] Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: May 2020 [2] Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: May 2020

2020-06-01

New data show first-line triplet regimen of pembrolizumab, Herzuma® and chemotherapy are effective in treatment of HER2-positive AGC

New data show first-line triplet regimen of pembrolizumab, Herzuma® (biosimilar trastuzumab) and chemotherapy are effective in treatment of HER2-positive advanced gastric cancer Data from a phase Ib/II trial show a first-line triple combination therapy of pembrolizumab, Herzuma® (biosimilar trastuzumab) and chemotherapy was effective in patients with HER2-positive advanced gastric cancer (AGC)1 Patients experienced clinically significant tumour shrinkage regardless of PD-L1 status with no new safety signals observed 1 Access to a first-line immunotherapy/chemotherapy combination with Herzuma® (biosimilar trastuzumab) has the potential to improve patient outcomes whilst reducing overall treatment costs for healthcare systems FRIDAY 29TH MAY 2020– 08:01 KST, INCHEON, SOUTH KOREA – Data presented today as part of the ASCO20 Virtual Scientific Program show that a first-line triplet regimen comprising of pembrolizumab, Herzuma®(biosimilar trastuzumab)  and chemotherapy is effective in patients with HER2-positive advanced gastric cancer (AGC). The PANTHERA trial (a phase Ib/II study of first line pembrolizumab in combination with trastuzumab, capecitabine, and cisplatin in HER2-positive gastric cancer), sponsored by Celltrion Inc. and MSD, is investigating the potential of a first-line immunotherapy/chemotherapy combination with biosimilar trastuzumab. This is in light of a growing body of evidence that the immune system contributes to the therapeutic effects of monoclonal antibodies such as biosimilar trastuzumab in treating solid tumours.1 A total of 43 patients were treated with a median follow up of 18 months. Patients were treated with pembrolizumab 200mg via IV infusion D1, biosimilar trastuzumab 6mg/kg (after 8mg/kg load) D1, capecitabine 1000mg/m2  bid D1-D14 and cisplatin 80mg/m2 D1 every 3 weeks.1 The primary endpoint for phase II was the overall response rate (ORR), measured in line with the RECIST 1.1 guidelines. The results showed a significant tumour shrinkage of 95.3% with an ORR of 76.7%. Of these patients, 16.3% exhibited complete response (CR) and 60.5% partial response (PR). Furthermore, PD-L1 status at diagnosis did not have an effect on overall survival (OS) and the data also indicate a disease control rate (DCR) of 97.7%.1   Secondary endpoints for the trial included progression-free survival (PFS), OS, duration of response (DoR) and safety.  Molecular analysis was carried out through targeted next generation sequencing (NGS). The median PFS was 8.6 months (95% CI 7.2-16.4) and the median OS was 19.3 months (95% CI 16.5-NA).1  The median duration of response (DOR) was 10.8 months (95% CI 7.17-NA). Whilst carrying out the study, the investigators did not observe any new safety signals. The most common haematologic adverse events included a decreased neutrophil count, as seen in 46.5% of patients, and anaemia which was experienced by 32.6%. Other frequently reported adverse events included anorexia (39.5%) and nausea (32.6%), and the most observed immune-related adverse event was hypothyroidism (11.6%).1 “According to our study, patients with HER2-positive AGC treated with this first-line triplet regimen experienced clinically meaningful improvements in tumour shrinkage regardless of PD-L1 status,” said Professor Sun Young Rha at Yonsei Cancer Center , Yonsei University College of Medicine. “Enabling access to the first immunotherapy/chemotherapy combination with Herzuma® (biosimilar trastuzumab) in the first-line setting will make a real difference to patients.” Prof Rha added, “With the costs of oncology treatments being so burdensome, the availability of biosimilar trastuzumab could reduce the overall cost by combination treatment with innovative new drugs and chemotherapy. High quality treatments at reduced overall treatment cost could imply a benefit to health systems worldwide.”   -- ENDS --   Notes to Editors:   About metastatic (advanced) gastric cancer[1],[2],[3],[4] Gastric cancer is a leading cause of cancer-related deaths worldwide, with over a million new cases of gastric cancer diagnosed each year. HER2 overexpression has been reported in 7-34% of gastric cancers. Gastric cancer commonly begins in the inner lining of the upper part of the stomach and can spread through the walls of the stomach. The cancer can then invade other organs or spread to the lymph vessels and nodes. Gastric cancer can be staged from 0 to IV depending on its progression. As the stage number increases, the larger the cancer growth and the further the cancer has spread. Clinical trials have evaluated trastuzumab in combination with chemotherapy as first-line treatment for metastatic (advanced) gastric cancer.   About Herzuma® (biosimilar trastuzumab)[5]   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.   Similarity of Herzuma® to the reference product, Herceptin® was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials.   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   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] Rawla P, Barsouk A. Epidemiology of gastric cancer: global trends, risk factors and prevention. Prz Gastroenterol. 2019;14(1):26‐38. doi:10.5114/pg.2018.80001 [2] Rüschoff J, Hanna W, Bilous M, et al. HER2 testing in gastric cancer: a practical approach. Mod Pathol. 2012;25(5):637‐650. doi:10.1038/modpathol.2011.198 [3] Kanayama K, Imai H, Usugi E, Shiraishi T, Hirokawa YS, Watanabe M. Association of HER2 gene amplification and tumor progression in early gastric cancer. Virchows Arch. 2018;473(5):559‐565. doi:10.1007/s00428-018-2433-y [4] Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial [published correction appears in Lancet. 2010 Oct 16;376(9749):1302]. Lancet. 2010;376(9742):687‐697. doi:10.1016/S0140-6736(10)61121-X [5] European Medicines Agency Summary of Product Characteristics (SmPC). Herzuma. Available at https://www.ema.europa.eu/en/documents/product-information/herzuma-epar-product-information_en.pdf Last accessed May 2020

2020-05-29

Celltrion completes neutralisation test on candidate monoclonal antibodies (mAbs) for COVID-19 antiviral antibody treatment

Celltrion completes neutralisation test on candidate monoclonal antibodies (mAbs) for COVID-19 antiviral antibody treatment ·        Celltrion completes selection of therapeutic antibodies which are most potent for neutralising the virus ·        Celltrion expects cell-line development to commence this week ·        Celltrion also plans to develop a super-antibody or an antibody cocktail therapy, to target potential mutations of SARS-CoV-2   APRIL 13 2020, 09:00 BST, INCHEON, KOREA – Celltrion Group today announced that the company has successfully selected the most potent antibody candidates to neutralise SARS-CoV-2, the virus causing COVID-19.   Through a partnership with the Korea Centers for Disease Control and Prevention (KCDC), Celltrion initially identified and secured 300 different types of antibodies that bind to the SARS-CoV-2 antigen. These were then screened based on their ability to bind to the virus spike protein. Celltrion was then able to capture a total of 38 potent neutralising antibodies, of which, 14 are powerful neutralising antibodies against SARS-CoV-2.   Following the selection of antibody candidates which demonstrate high potency in neutralising SARS-CoV-2, Celltrion will begin cell-line development. Once this is completed, Celltrion aims to roll out mass production of the therapeutic antibody and, together with the KCDC, Celltrion will conduct efficacy and toxicity testing in mice and non-human primates.   Ki-Sung Kwon, Head of R&D Unit at Celltrion said, “We are bringing our full resources and expertise to overcome this global health crisis and are glad to have identified these antibodies sooner than previously expected. These antibodies can recognise multiple epitopes, thus increasing the probability of neutralisation against viral mutations. Given the expedited development process of our antiviral antibody treatment, we anticipate moving to first-in-human clinical trials in July. We are also on track with the development of a ‘super antibody’ or ‘an antibody cocktail’ and the launch of a rapid diagnostic kit in the summer 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[1] Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.   Common signs of COVID-19 include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In severe cases, infection can lead to pneumonia, severe acute respiratory syndrome, kidney failure and ultimately death.   Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/emergencies/diseases/novel-coronavirus-2019.   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 Last accessed: April 2020

2020-04-13

Celltrion’s COVID-19 Antiviral Treatment Enters the Next Phase of Development

Celltrion’s COVID-19 antiviral treatment enters the next phase of development ·        Celltrion initiates the 2nd  stage; selecting the therapeutic antibodies which are most potent for neutralising the infection ·        Celltrion completed the 1st phase of screening 300 potential antibody candidates to treat COVID-19 ·        Celltrion aims to initiate a clinical trial in July 2020   APRIL 03 2020, 09:00 BST, INCHEON, KOREA – Celltrion Group today announced its successful transition to the second phase of development for an antiviral treatment to fight the novel coronavirus (COVID-19) pandemic, following the completion of the first phase of securing 300 different types of antibodies that bind to the antigen last month. The library of antibodies was created using the blood of recovered patients in Korea.   In cooperation with the Korea Centers for Disease Control and Prevention (KCDC), Celltrion will be screening the antibodies to find the ones most effective in neutralising SARS-CoV-2, the virus responsible for COVID-19. Celltrion anticipates the candidate screening for the therapeutic monoclonal antibody (mAb) will be complete by mid-April, sooner than originally expected.   Ki-Sung Kwon, Head of R&D Unit at Celltrion said, “Once we have selected the one that most effectively neutralizes the COVID-19 virus among hundreds of the screened antibodies, we will roll out mass production of the therapeutic antibody treatment, with a view to starting human trials this July. Due to the urgent need for a COVID-19 antiviral treatment, we have expedited the overall development process of our antiviral therapy to help infected patients fight this emerging virus and halt further spread of the disease.”   -       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[1] Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.   Common signs of COVID-19 include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In severe cases, infection can lead to pneumonia, severe acute respiratory syndrome, kidney failure and ultimately death.   Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/emergencies/diseases/novel-coronavirus-2019.   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 Last accessed: April 2020

2020-04-03

Celltrion accelerates development of COVID-19 antiviral treatment and aims to launch rapid self-testing kit

Celltrion accelerates development of COVID-19 antiviral treatment and aims to launch rapid self-testing kit Celltrion completes first step of developing an antiviral treatment to fight COVID-19 and hopes to begin human clinical trials in the third quarter of 2020  Celltrion aims to launch the rapid self-testing diagnostic kit for COVID-19 this summer: the kit is designed to provide results within 15-20 min of self-testing Leveraging its world-class expertise in biologics, Celltrion Group remains committed to supporting patients and healthcare systems throughout the pandemic MARCH 23RD 2020, 06:30 GMT, INCHEON, KOREA – Celltrion Group today announced key milestones in its efforts to fight the 2019 novel coronavirus (COVID-19) pandemic. As part of its emergency preparedness plan to address the outbreak, which has infected over 200,000 people worldwide,[1],[2] Celltrion has successfully completed the first step of developing an antiviral treatment to fight COVID-19 and aims to launch a rapid self-testing diagnostic kit that could provide results within 15-20 minutes.   Celltrion has been selected as a preferred developer for a monoclonal antibody project to treat and prevent COVID-19 by the Korea Centers for Disease Control (KCDC). Korea was one of the first countries to be affected by the global pandemic.[3] Celltrion has identified the library of antibodies sourced from the blood of recovered patients in Korea, which are thought to be involved in neutralising the virus and may contribute to recovery from COVID-19. These antibodies are undergoing further screening processes to identify those that are most effective in neutralising the virus causing COVID-19. Once identified these will form the basis of the antiviral treatment to be tested through pre-clinical and clinical trials around the world in the third quarter of 2020.   Furthermore, Celltrion plans to develop a ‘super antibody’ that can attach and neutralise all kinds of coronavirus related strains, such as those causing COVID-19 and SARS, enabling further protection against unforeseen or unexpected mutations. Celltrion hopes the ‘super antibody’ candidate could contribute towards preparedness for potential future pandemic situations.   Alongside therapeutic antibody development, Celltrion aims to launch a rapid self-testing diagnostic kit in the summer of this year. The kit will focus on the gene that encodes the surface spike (S) protein; an essential glycoprotein for viral entry into human host cells. The kit is designed to show results within 15-20 minutes, with optimised sensitivity, specificity and improved accuracy features. Once it has gained a CE mark, the rapid self-testing diagnostic kit will become available throughout Europe through Celltrion Healthcare. Celltrion plans to apply for device authorisation from the FDA in the US and other regulatory authorities after acquiring relevant data.   Ki-Sung Kwon, Head of R&D Division at Celltrion said, “Our COVID-19 antiviral treatment is designed to train the immune system to make antibodies that recognise and block the spike protein that the virus uses to enter human cells. Antibodies that bond to the COVID-19 antigen will also be used to develop a diagnostic kit. We implemented an emergency preparedness plan at the very start of the COVID-19 outbreak leveraging our unique antibody discovery, development and manufacturing technologies. We remain dedicated to supporting healthcare systems across the world and innovating to support patients throughout this pandemic.”   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[4] Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.   Common signs of COVID-19 include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In severe cases, infection can lead to pneumonia, severe acute respiratory syndrome, kidney failure and ultimately death.   Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/emergencies/diseases/novel-coronavirus-2019.   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 COVID-19 Global Cases by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU). John Hopkins University. Available at: https://coronavirus.jhu.edu/map.html Last accessed: March 2020 [2] Novel Coronavirus (COVID-19) Situation. World Health Organization. Available at: https://experience.arcgis.com/experience/685d0ace521648f8a5beeeee1b9125cd Last accessed: March 2020 [3] Novel Coronavirus – Republic of Korea (ex-China). World Health Organization. Available at: https://www.who.int/csr/don/21-january-2020-novel-coronavirus-republic-of-korea-ex-china/en/ Last accessed: March 2020 [4] Coronavirus. World Health Organizaton. Available at: https://www.who.int/health-topics/coronavirus Last accessed: March 2020

2020-03-23