Celltrion completes enrolment for global Phase II clinical trial with COVID-19 treatment candidate CT-P59
25.11.2020 14:13:00 EET | Business Wire | Press release
Celltrion Group today announced enrolment completion of 327 patients with mild-to-moderate symptoms of SARS-CoV-2 infection in the global Phase II clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. Celltrion anticipates submission for emergency use authorisation (EUA) to the Korean Ministry of Food and Drug Safety (MFDS), conditional on results from the global Phase II pivotal trial.
The global Phase II clinical trial is a randomised, double-blind, placebo-controlled and parallel-group trial designed to evaluate the efficacy and safety of CT-P59 in combination with standard of care in patients with SARS-CoV-2 infection. The trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three groups (placebo, low concentration, high concentration) and Celltrion is set to obtain the results for global Phase II trial. In addition, Celltrion plans to initiate a global Phase III clinical trial in more than 10 countries in order to obtain more comprehensive safety and efficacy results of CT-P59.
“We managed to successfully enrol 327 patients for the global Phase II trial and the results from the trial are expected in the coming weeks. We plan to compile a robust data set to support the planned emergency use application, expected as early as the end of the year, subject to positive study results,” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. “In order to respond to the global pandemic threat, we are moving forward with our clinical development with the highest urgency and as a key priority.”
In an effort to further address the pandemic, Celltrion has also initiated a post-exposure prophylaxis clinical trial to evaluate the preventive effect and safety of CT-P59 and identify whether this antibody treatment candidate can elicit a neutralising antibody response to prevent the virus from infecting human cells.
Celltrion is also working to increase its manufacturing capabilities to meet the current global and domestic demand for the anti-COVID-19 monoclonal antibody treatment candidate, ensuring potential delivery for as many as 2 million people per year globally.
- 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.
About CT-P59 (Regdanvimab)
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.3
References
1 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: November 2020
2 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: November 2020
3 Celltrion. Data on file
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/20201125005558/en/
Contact information
Sophia Eminson
seminson@hanovercomms.com
+44 (0) 7751 116252
Zuzanna Grzeskiewicz
zgrzeskiewicz@hanovercomms.com
+44 (0) 7506 339043
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
European Wealth Firms Build Private Markets Capability Faster Than They Communicate It, Peregrine Report Finds20.10.2026 11:15:00 EEST | Press release
Europe's leading wealth managers have built genuine private markets capability but most have yet to explain it to the clients they built it for, according to The Wealth 30, a new report from Peregrine Communications. The study analyses how 30 leading UK and European wealth managers and private banks position private markets. It concludes that communication, not product, is now the biggest barrier to differentiation in the wealth channel. Capability outpaces explanation 73% of the Wealth 30 engage in private markets yet only 40% operate a dedicated landing page explaining what private markets are, why they matter and how clients can access them. Just 23% combine explainers, a destination and repeatable house-view content. Swiss private banks set the benchmark, supported by house views, outlooks and heritage narratives. Pictet, UBP, Lombard Odier and Julius Baer all back their positioning with repeatable insight content, and Coutts is the clearest UK example. UK firms more often communic
Infobip and Yamaha Power Conversational Customer Engagement in Indonesia’s Automotive Sector20.10.2026 11:00:00 EEST | Press release
Global AI-first cloud communications platform Infobip strengthens its collaboration with Yamaha Indonesia Motor Manufacturing (YIMM) to transform customer engagement through WhatsApp-powered conversational experiences designed to drive stronger personalization and faster customer interactions. As Indonesia’s consumers increasingly adopt digital-first purchasing behaviors, Yamaha Indonesia is evolving how it connects with customers across the buying journey. Today’s motorcycle buyers often research products through Yamaha’s social media, websites, and video reviews on YouTube before visiting dealerships, raising expectations for brands to deliver fast, seamless, and highly personalized communication. For more than two years, Infobip has supported Yamaha Indonesia in building connected customer engagement strategies that integrate WhatsApp across the company’s wider digital ecosystem, including its websites, social media platforms, and customer touchpoints. The collaboration reflects the
Finsei Selects Thredd to Power New Debit Offering20.10.2026 10:00:00 EEST | Press release
Thredd, the AI-first issuer processing platform, today announced a new partnership with Finsei, a London-based payments company, to power the processing infrastructure behind Finsei’s new Mastercard debit offering. The partnership reflects a shared focus on simplifying an increasingly complex payments environment. Businesses operating across markets often rely on multiple providers to manage accounts, payments, foreign exchange, cards and expenses. Finsei is designed to bring those capabilities together, while Thredd provides the underlying payment technology and infrastructure needed to deliver a secure, digital-first debit experience at scale. At launch, physical and virtual cards will be available, followed by both Apple Pay and Google Pay. “Businesses increasingly expect their financial tools to work together rather than operate as a collection of disconnected services,” said Jim McCarthy, CEO of Thredd. “Finsei is building around that expectation, bringing payments, currency manag
BRG Survey Finds 71% of Competition Lawyers Say Global Antitrust Policies Grew More Fragmented over Past Year20.10.2026 10:00:00 EEST | Press release
Global antitrust enforcement is pulling apart along national lines, with 71% of senior competition attorneys reporting that policy became more fragmented across jurisdictions over the past 12 months, according to BRG’s inaugural Global Antitrust & Competition Report. Nearly four in five (78%) also cite cross-border antitrust requirements as a significant or recurring challenge. The report draws on a survey of 155 senior antitrust and competition attorneys across the U.S., Europe and Asia-Pacific (APAC) and in-depth interviews with 18 leading lawyers. It also finds that about 60% of respondents expect antitrust enforcement to expand in scope and intensity over the next 12 months. “Domestic politics and geopolitical considerations increasingly influence the application of competition law across jurisdictions”, said David Parker, a managing director at BRG. “As a result, deal timelines and risk assessments often now have to be built jurisdiction by jurisdiction, from the earliest stage of
Murata Develops World’s Smallest 008004-inch Size (0.25mm × 0.125mm) NTC Thermistor for Space-Constrained Temperature Sensing20.10.2026 05:00:00 EEST | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) announces the development of the world’s smallest* 008004-inch size (0.25mm × 0.125mm) NTC thermistor, the NCU01 series. Compared with Murata’s previous smallest 01005-inch size (0.4mm × 0.2mm) product, the new series reduces mounting area by approximately 60% while achieving equivalent temperature-sensing performance, with resistance tolerance of ±1% and B-constant tolerance of ±1%. Its ultra-compact size enables temperature sensing to be positioned in increasingly restricted spaces and closer to heat-generating components, supporting more accurate and responsive thermal monitoring in smartphones, wearable devices, and other densely integrated electronic devices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019189089/en/ [Murata Manufacturing Co., Ltd.] World’s smallest 008004-inch size (0.25mm × 0.125mm) NTC thermistor Murata plans to begin sample shipm
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