Celltrion Receives Korean MFDS Approval to Initiate Phase I Trial of COVID-19 Antiviral Antibody Treatment Candidate, CT-P59, in Patients
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
CSG Xponent Sweeps Up Top-Tier Analyst, Industry Recognition for Customer Journey Management, Analytics10.12.2025 15:30:00 EET | Press release
CSG® (NASDAQ: CSGS) today announced that its flagship customer engagement platform, CSG Xponent, has earned multiple honors for journey management, customer analytics and personalization. This third-party recognition underscores the strength of CSG Xponent as a full-service engagement platform – one that seamlessly combines in-depth journey analytics with real-time orchestration. In the past month alone, CSG Xponent has been named: A Leader in QKS Group’s SPARK Matrix™: Customer Journey Management, 2025. Winner for “Best Personalisation and User Experience Solution” in the FinTech Futures 2025 Banking Tech Awards. A Core Performing provider in CMP Research’s Prism for Customer Analytics. “CSG Xponent moves beyond broad segmentation to pinpoint each customer’s journey state, whether stalled, at-risk or ready to convert, and then quantifies the financial impact of each intervention,” said Tanuj Paulose, Analyst, QKS Group. “By unifying analytics, real-time orchestration, identity and omn
AI Power Surge and Energy Transition Push Global Project Finance into a New Era10.12.2025 15:30:00 EET | Press release
Global project finance is entering a transformative era, driven by soaring demand for energy capacity, accelerated digitalization and large-scale infrastructure upgrades, reshaping investment priorities worldwide. These insights come from new research commissioned by CSC, based on responses from 200 project finance professionals, revealing a market shifting toward more complex, capital-intensive projects and a greater reliance on private capital. CSC’s latest report, Project Finance at an Inflection Point: Adapting to New Realities1, reveals a sector that is rapidly expanding in both scale and complexity driven by capital increasingly targeting long-term, strategically critical assets. Infrastructure emerged as the strongest area for future growth, identified by 70% of respondents, followed by renewables (48%), and technology, media, and telecommunications (TMT) with 43%. Within renewables, wind tops expectations at 50%, while renewable natural gas and green hydrogen each stand at 41%,
Slate Asset Management Announces Partner and Managing Director Promotions10.12.2025 15:00:00 EET | Press release
Slate Asset Management (“Slate”), a global alternative investment platform focused on essential real estate and infrastructure, today announced three senior leadership promotions, effective January 1, 2026. Molly Mahoney has been elevated to Partner, and John Murray and Sayed M. Alaali have been promoted to Managing Directors. “Molly, John, and Sayed have demonstrated outstanding dedication, skill, and leadership over the years and each has contributed meaningfully to Slate’s reputation as a proven investor and a trusted partner to leading global institutions,” said Brady Welch, Co-Founding Partner at Slate. “We are very pleased to welcome them to the highest ranks of our firm’s leadership.” Blair Welch, Co-Founding Partner at Slate, added: “In a year of significant growth, these individuals have consistently delivered exceptional outcomes for Slate’s clients, partners, and communities. They are unwavering in their commitment to excellence, integrity, and teamwork, and we look forward
Kingswood Capital Management Enters Into a Definitive Agreement to Acquire Safran Passenger Innovations10.12.2025 15:00:00 EET | Press release
Kingswood Capital Management, LP (together with its affiliates, “Kingswood”) announced today that it has entered into a definitive agreement to acquire Safran Passenger Innovations (“SPI” or the “Company”) from Safran, an international high-tech company operating in the aviation, defense, and space markets. SPI is a leading global provider of in-flight entertainment and connectivity solutions for airlines and airplane manufacturers worldwide. Matt Smith will continue to serve as SPI’s CEO, and the entire SPI leadership team will remain in place. The transaction is expected to close early next year, subject to customary legal and regulatory requirements. Headquartered in Brea, California, SPI created and designed an award-winning in-flight entertainment and connectivity platform known as RAVE, recognized for its intuitive design, reliability, and innovative approach. Kingswood’s acquisition of SPI is driven by a shared vision of positioning the company to deliver transformative, next-ge
Armis Partners with KODE Labs and IntelliBuild to Streamline Security Operations Across the Building Management Lifecycle10.12.2025 15:00:00 EET | Press release
Armis, the cyber exposure management & security company, today announced a strategic partnership with KODE Labs and IntelliBuild to help organizations unify cybersecurity, operational intelligence and governance for building lifecycle management. The joint offering combines Armis’ continuous asset intelligence with KODE Labs’ performance trends and analytics, which are then operationalized by IntelliBuild’s governance and reporting. By translating accurate, verified intelligence into accountable action, organizations can streamline the operations of building management systems – from thermostats, lighting and badge readers to elevator controllers and security cameras – and proactively strengthen their cyber defenses. “To achieve real security in the new age of connected environments, you must have comprehensive, real-time protection across the entire attack surface,” said Nadir Izrael, CTO and Co-Founder at Armis. “This integration addresses the growing complexity, risk and fragmentati
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