GO Main Menu Go Main Contents Go Bottom Menu

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

등록일 2020-07-30
  • 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 initiatea Phase I trial of CT-P59, a potential COVID-19 antiviral antibody treatment

    · Celltrion’s Phase I trial will enroll patients with mild symptomsof SARS-CoV-2 infection to evaluate the safety, tolerability, efficacy,pharmacokinetics and immunogenicity of CT-P59; a Phase I clinical trial in healthyvolunteers is ongoing in South Korea

    · Celltrion anticipates results from Phase II/III trials by the endof the year with commercial production set to commence this September

    JULY 30th 2020, INCHEON, KOREA – Celltrion Group announced that the UK Medicines andHealthcare products Regulatory Agency (MHRA) has approved the company’sClinical Trial Authorisation (CTA) application for a Phase I clinical trialwith CT-P59, a COVID-19 antiviral antibody treatment candidate, in patientswith mild symptoms of SARS-CoV-2 infection. The clinical trial is set toevaluate the safety, tolerability, efficacy, pharmacokinetics andimmunogenicity of CT-P59.

    Celltrion plans to conduct further global Phase II/IIItrials in patients with mild and moderate COVID- 19 and anticipates resultsfrom these pivotal studies by the end of the year. Furthermore, a clinical trialinvestigating the use of CT-P59 as a preventative measure, by enrolling peoplein close contact with COVID-19 patients globally, is also planned and thetopline data for this trial are anticipated in Q1 of 2021.

    Celltrion will start the full-scale commercial productionof CT-P59 in September this year and is securing sufficient manufacturingcapacity to produce enough of the potential COVID-19 treatment for up to 5million patients a year.

    “This is a timely approval from the UK regulatoryauthority for the Phase I clinical trial with CT-P59 as the global pandemiccontinues to grow and there remains a significant need for a safe and effectivetreatment for COVID-19,” said Dr. Sang Joon Lee, Senior Executive VicePresident of Celltrion. “We are rapidly advancing our COVID-19 programme withCT-P59, including a Phase I clinical trial in healthy volunteers in Korea.Furthermore, we are making efforts to ensure that if the clinical trial programmeis successful we are able to scale up manufacturing appropriately.”

    CT-P59 was identified as a potential treatment forCOVID-19 through screening of antibody candidates and selecting those thatshowed the highest potency in neutralising the SARS-CoV-2 virus including themutated G-variant strain (D614G variant). In pre-clinical data the treatment candidatedemonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as areduction in lung inflammation.1

    - ENDS -

    Notes to Editors:

    About Celltrion Healthcare

    Celltrion Healthcare is committed to delivering innovativeand affordable medications to promote patients’ access to advanced therapies.Its products are manufactured at state-of-the-art mammalian cell culturefacilities, designed and built to comply with the US FDA cGMP and the EU GMPguidelines. Celltrion Healthcare endeavours to offer high-qualitycost-effective solutions through an extensive global network that spans morethan 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 toillnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2is responsible for the disease COVID-19, this new strain, discovered in 2019,is behind the ongoing pandemic outbreak. The most common signs of COVID-19include fever, dry cough and tiredness; however, people may

    also experience other symptoms including shortness ofbreath and breathing difficulties. Most people infected with the virus willexhibit mild to moderate symptoms however older people, and those with existingunderlying conditions such as cardiovascular disease and diabetes are more likelyto develop a more severe form of COVID-19.

    Please find up to dateinformation about the outbreak via the World Health Organization at



    Certain information set forth in this press releasecontains statements related to our future business and financial performanceand future events or developments involving

    Celltrion/Celltrion Healthcare that may constituteforward-looking statements, under pertinent securities laws. These statementsmay be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plansto”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “withthe aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “becomeavailable”, “has potential to”, the negative of these words or such othervariations thereon or comparable terminology.

    In addition, our representatives may make oralforward-looking statements. Such statements are based on the current expectationsand certain assumptions of Celltrion/Celltrion Healthcare's management, ofwhich many are beyond its control.

    Forward-looking statements are provided to allow potentialinvestors the opportunity to understand management’s beliefs and opinions inrespect of the future so that they may use such beliefs and opinions as onefactor in evaluating an investment. These statements are not guarantees offuture performance and undue reliance should not be placed on them.

    Such forward-looking statements necessarily involve knownand unknown risks and uncertainties, which may cause actual performance andfinancial results in future periods to differ materially from any projectionsof future performance or result expressed or implied by such forward-looking statements.

    Although forward-looking statements contained in thispresentation are based upon what management of Celltrion/Celltrion Healthcarebelieves are reasonable assumptions, there can be no assurance thatforward-looking statements will prove to be accurate, as actual results andfuture events could differ materially from those anticipated in suchstatements. Celltrion/Celltrion Healthcare undertakes no obligation to updateforward-looking statements if circumstances or management’s estimates or opinionsshould change except as required by applicable securities laws. The reader iscautioned not to place undue reliance on forward-looking statements.


    1Celltrion. Data on file

    2 Coronavirus. World HealthOrganization.Available at: https://www.who.int/healthtopics/coronavirus#tab=tab_1Last accessed: July 2020

    3 Coronaviruses. National Institute ofAllergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronavirusesLast accessed: July 2020

Cookie technology helps us bring you the best possible experience when you visit this website. If you continue without changing your settings, you are agreeing to the cookies on this website. To learn more about our policy on cookies, please review our privacy policy via the link at the bottom of the page.