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  • 6
    Celltrion to expand COVID-19 testing portfolio to ..
    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
  • 5
    Celltrion Healthcare showcases positive 1-year dat..
    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 (<25kg/m2), overweight (≥25kg/m2, <30kg/m2), 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
  • 4
    Celltrion announces positive pre-clinical results ..
    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 toanalysespecimens 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 toroll 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 coronavirusSARS-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_1Last accessed: May 2020 [2]Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at:https://www.niaid.nih.gov/diseases-conditions/coronavirusesLast accessed: May 2020
    2020-06-01
  • 3
    Celltrion completes neutralisation test on candida..
    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 toneutralise 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 theKCDC, 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 coronavirusSARS-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/coronavirusLast accessed: April 2020
    2020-04-13
  • 2
    Celltrion’s COVID-19 Antiviral Treatment Enters th..
    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 coronavirusSARS-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/coronavirusLast accessed: April 2020
    2020-04-03
  • 1
    Celltrion accelerates development of COVID-19 anti..
    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 inneutralising 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

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