Celltrion Receives Korean MFDS Approval to Initiate Phase I Trial of COVID-19 Antiviral Antibody Treatment Candidate, CT-P59, in Patients
26.8.2020 16:58:00 EEST | Business Wire | Press release
Celltrion Group announced today that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application for a Phase I clinical trial of CT-P59, a COVID-19 antiviral antibody treatment candidate. Celltrion has initiated enrolment of patients with mild symptoms of SARS-CoV-2 infection and the clinical trial is set to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59.
Celltrion anticipates global pivotal study results from the Phase II and III trials in patients with mild symptoms, the Phase III trial in patients with moderate-to-severe COVID-19, and the prevention clinical trial, by the end of the year. Celltrion plans to enrol people that are in close contact with COVID-19 patients and those with no symptoms as part of a prevention clinical trial to evaluate whether CT-P59 can elicit a neutralising antibody response to prevent the virus from infecting human cells.
“We have initiated an in-human global Phase I clinical trial of CT-P59 in mild COVID-19 patients and we plan to conduct further global Phase II and III trials in this patient group. In addition, Celltrion plans to combine Phase II and III trials in patients with moderate-to-severe COVID-19 with the prevention clinical trials.” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. “We are extremely encouraged by the consistent progress we are making in preparation for our CT-P59 clinical trials in various settings, and we remain on track to reach our upcoming milestones.”
In July, Celltrion initiated a Phase I trial of CT-P59 in the UK following the approval of the clinical trial authorisation (CTA) application from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Celltrion has also completed an infusion and initial safety assessment for the Phase I study in healthy volunteers in Korea and the study is set for completion by Q3 this year as originally planned.
- ENDS -
Notes to Editors:
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us
About COVID-191,2
Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.
The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19.
Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1
FORWARD LOOKING STATEMENT
Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.
These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control.
Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.
Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.
Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
References
1 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: August 2020
2 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: August 2020
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200826005516/en/
Contact information
Zuzanna Grzeskiewicz
zgrzeskiewicz@hanovercomms.com
+44 (0) 7506 339043
Sophia Eminson
seminson@hanovercomms.com
+44 (0) 7751 116252
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Swedish Court Further Reschedules Delivery of Judgment in PriceRunner Vs Google Antitrust Case24.6.2026 21:55:00 EEST | Press release
Klarna Group plc (NYSE: KLAR) wishes to update investors that the Patent and Market Court in Stockholm, Sweden (Patent- och marknadsdomstolen) has again postponed publication of its judgment in the antitrust damages proceedings brought by PriceRunner, a Klarna subsidiary, against Google. The Court has rescheduled publication of its judgment from June 26, 2026 to July 1, 2026 at 13:00 CET. As with the Court's two previous notifications, the rescheduling is a procedural decision by the Court and relates solely to the timing of the judgment delivery. In its notification, the Court cited high workload as the reason for needing additional time to finalize the judgment. No inference about the outcome should be drawn from it. Important Notice The outcome of the proceedings is inherently uncertain. No assurance can be given that PriceRunner will succeed on liability or quantum. Any award would be subject to appeal by Google, to sharing arrangements with former PriceRunner shareholders and Klar
Vertex Energy Announces 6,000 bpd Group III Base Oil Expansion Project24.6.2026 17:00:00 EEST | Press release
Vertex Energy, Inc. (“Vertex” or the “Company”) today announced it is advancing a project at its Mobile, Alabama refinery to produce crude-derived conventional Group III base oils through the Company’s existing hydrocracker and related processing infrastructure, providing lubricant manufacturers and blenders with an additional domestic source of high-quality Group III supply. The project is designed to add an incremental 6,000 barrels per day of conventional Group III production capacity and support production of 4 cSt, 6 cSt, and 8 cSt Group III base oils using an existing crude-derived hydrocracked vacuum gas oil stream produced at the Company’s Mobile, Alabama refinery. Combined with the Company’s existing re-refined Group III base oil production, this additional capacity is expected to make Vertex the leading Group III producer in North America. Vertex has completed preliminary design work and has procured a high-pressure lubricants hydrotreating unit. The Company plans to start pr
Taktile Secures $110M in Goldman Sachs-led Series C to Power AI Transformation in Financial Institutions24.6.2026 16:30:00 EEST | Press release
Taktile, the leader in AI transformation for financial institutions, today announced its $110 million Series C fundraise. Growth Equity at Goldman Sachs Alternatives led the round, with participation from Balderton Capital, Index Ventures, Tiger Global, Y Combinator, and Dig Ventures. Taktile Fast Facts Taktile enables banks and insurers to transform into AI-native organizations that are increasingly powered by autonomous agents. Demand for Taktile accelerated in 2025, as AI models became capable of automating high-stakes decisions that previously required hours of manual work—from underwriting business loans and assessing claims to catching financial crime. Customers automate and optimize decisions with Taktile by combining its financial services expertise and product built for sector-specific AI use cases. One of the world’s largest insurers is running multiple use cases on Taktile, with projected cost efficiencies of over $90M in claims processing alone. Taktile’s team has a proven
New MetLife Study Reveals a 72% “Confidence Gap” in Ability to Recover from Life's Setbacks24.6.2026 16:25:00 EEST | Press release
A new multinational study from MetLife reveals a striking “confidence gap”: while most adults describe themselves as resilient, their confidence drops by 72% when faced with real-life setbacks. The Confident Pathways Report, conducted across the United States, United Kingdom, Japan, and Mexico, was designed to better understand how confidence is built and sustained throughout life. The findings underscore the role of opportunity, preparedness, and support in building confidence - factors that help people navigate uncertainty, recover from setbacks and pursue their goals. At a time when soccer is bringing people and communities together around the world, the findings also highlight how early childhood experiences such as sports, education, and mentorship can help foster resilience and gain confidence from a young age. Key findings across the four countries surveyed include: Confidence drops by 72% when adults consider their ability to recover from setbacks. Respondents were far more lik
StatLab Launches CytoPath Disc, Advancing Standardized Cell Block Preparation Worldwide24.6.2026 16:08:00 EEST | Press release
StatLab Medical Products, a leading global developer and manufacturer of pathology supplies and equipment, today announced the global launch of the CytoPath Disc, an innovative cell block preparation technology designed to standardize and simplify cell block preparation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260624368623/en/ Developed as an alternative to traditional cell block methods, which convert concentrated cells suspended in fluid into a paraffin-embedded format for slide-based evaluation, the patent‑pending CytoPath Disc offers a more streamlined and efficient approach. The CytoPath Disc absorbs concentrated cells within a simple, sponge-like matrix, which is then processed, embedded, stained, and sectioned using standard histology workflows. Traditional cell block preparation methods often present challenges in achieving consistent results due to complex procedures, as well as the need for additional equipm
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom