EMA issues advice on the use of Celltrion’s anti-COVID-19 monoclonal antibody treatment regdanvimab (CT-P59) for COVID-19 patients in the European Union
Celltrion Group today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for the company’s anti-COVID-19 monoclonal antibody treatment candidate, regdanvimab (CT-P59). The CHMP recommends that regdanvimab can be considered a treatment option for patients at high risk of progressing to severe COVID-19, based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm.1
Under Article 5 (3) of Regulation 726/2004, the CHMP’s scientific opinion provides a harmonised EU- level opinion on the efficacy, quality and safety of antibodies. The scientific opinion can be considered by EU member states when making decisions on the possible use of monoclonal antibody therapies at a national level prior to a marketing authorisation.
The EMA has also initiated a rolling review of regdanvimab based on data from animal studies (non- clinical data) and clinical trials, in addition to data on the quality of the medicine. The EMA uses its rolling review process to accelerate the assessment of a promising medicine during a public health emergency and once finalised it will provide the basis of an EU marketing authorisation for the monoclonal antibody treatment.
“Today’s CHMP positive scientific opinion by the EMA takes us a significant step closer to providing a safe and effective monoclonal antibody treatment against COVID-19 worldwide. Based on clinical data and CHMP’s positive scientific opinion, regdanvimab has been adopted and contracts for initial supplies have been made with distributors towards Nordic countries including Denmark, Norway, Sweden and Finland,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We believe the CHMP’s positive opinion will accelerate reviews and authorisations by national authorities who may take evidence-based decisions on the use of our therapy. We will also continue to work in close collaboration with the EMA to complete the rolling review and marketing authorisation process.”
Regarding mutations, the Korea Disease Control and Prevention Agency (KDCA) has independently confirmed that CT-P59 successfully neutralised the SARS-CoV-2 variants first identified in the UK (B.1.1.7) in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). They also added that cocktail therapy of CT-P59 with another monoclonal antibody candidate demonstrated neutralising capability against the UK (B.1.1.7) and South African (B.1.351) variants.
Global Principal Investigator Professor Adrian Streinu-Cercel, MD, PhD, Professor of Infectious Diseases at the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, commented, “CT-P59 has demonstrated its ability to shorten time to clinical recovery and reduce rate of progression to severe COVID-19. From the clinical trial, one of my patients with COVID-19 aged 85 and with an underlying condition, has recovered from the virus within 48 hours of being treated with CT-P59. The antibody treatment candidate would be most useful within 3-5 days of testing positive for the virus. This will greatly aid efforts to address the current burden on healthcare systems and resources.”
- 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 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. In vitro and in vivo pre-clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralize the wild type and mutant viruses of concern including the UK variant (B.1.17). In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I clinical trial of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.2 Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.
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.
1EMA issues advice on use of regdanvimab for treating COVID-19 | European Medicines Agency (europa.eu). Last accessed 26 March 2021.
2 Celltrion Data on file
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
+44 (0) 07759 301620
+44 (0) 7984 550312
About Business Wire
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
Prosus FAQ's Regarding the Voluntary Share Exchange Offer to the Holders of Naspers N Ordinary Shares30.7.2021 19:00:00 CEST | Press release
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO ANY JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. PLEASE SEE THE IMPORTANT DISCLAIMERS AT THE END OF THIS ANNOUNCEMENT. Shareholders are referred to the prospectus (Prospectus) published by Prosus N.V. (Prosus) on 12 July 2021 in respect of the voluntary share exchange offer by Prosus to Naspers (JSE:NPN) (LSE:NPSN) N Shareholders (Exchange Offer). Further to the announcement issued by Prosus today, shareholders are advised that since the publication of the Prospectus Prosus has received certain frequently asked questions regarding the Exchange Offer and has therefore made certain materials available today at www.share-exchange-offer.com, where these frequently asked questions have been addressed by Prosus. Cape Town South Africa 30 July 2021 About Naspers Established in 1915, Naspers has transformed itself to become a global consumer internet compan
Prosus FAQ's Regarding the Voluntary Share Exchange Offer to the Holders of Naspers N Ordinary Shares30.7.2021 18:59:00 CEST | Press release
Shareholders are referred to the prospectus (Prospectus) published by Prosus on 12 July 2021 in respect of the voluntary share exchange offer by Prosus to Naspers N Shareholders (Exchange Offer). Since the publication of the Prospectus Prosus has received certain frequently asked questions regarding the Exchange Offer and has therefore made certain materials available today at www.share-exchange-offer.com, where these frequently asked questions have been addressed. About Prosus Prosus is a global consumer internet group and one of the largest technology investors in the world. Operating and investing globally in markets with long-term growth potential, Prosus builds leading consumer internet companies that empower people and enrich communities. The group is focused on building meaningful businesses in the online classifieds, food delivery, payments and fintech, and education technology sectors in markets including India, Russia, and Brazil. Through its ventures team, Prosus invests in
I’mbesideyou Inc. Launched “UNION OF EMOTIONS” Service Using AI to Visualize Cheering Each Other Across National Borders30.7.2021 16:25:00 CEST | Press release
I’mbesideyou Inc. (Setagaya-ku, Tokyo CEO: Shozo Kamiya, hereinafter referred to as I'mbesideyou) launched the "UNION OF EMOTIONS" service on July 23, 2021, the opening day of an international sporting event. This is the first time we have been able to visualize people cheering each other with emotion analysis AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210730005404/en/ A visualization of the emotions of cheers flying around the world: Click on each cheer to learn more about that country. (Photo: Business Wire) More than 20,000 cheers have already been sent from more than 79 cities across more than 14 countries around the world, and the sight of the cheers flying across the globe has moved many people on social media. UNION OF EMOTIONS, is the world's first example of people's emotions connecting in real time across countries with the help of AI. It is scheduled to be available until August 8, when the closing ceremon
Palace Bidco Oy (“WSIP Bidco”) Has Received Necessary Regulatory Approval Concerning the Recommended Cash Offer to the Shareholders of Adapteo Plc (“Adapteo”)30.7.2021 14:23:00 CEST | Press release
This announcement is not an offer, whether directly or indirectly, in Australia, Canada, Hong Kong, Japan, New Zealand or South Africa or in any other jurisdiction where such offer pursuant to legislation and regulations in such relevant jurisdiction would be prohibited by applicable law. Shareholders not resident in Sweden or Finland who wish to accept the Offer (as defined below) must make inquiries concerning applicable legislation and possible tax consequences. Shareholders should refer to the offer restrictions included in the section titled “Important information” at the end of this announcement and in the offer document which was published on 23 June 2021. Shareholders in the United States should also refer to the section titled “Special notice to shareholders in the United States” at the end of this announcement and in the offer document. On 17 May 2021, WSIP Bidco, a private limited liability company formed on behalf of, and indirectly wholly owned by, West Street Global Infra
Taipei Exchange Launches Pioneer Stock Board to Support Innovative Enterprises30.7.2021 10:00:00 CEST | Press release
The Taipei Exchange, TPEx, launched Pioneer Stock Board (PSB) on July 20, 2021, which welcomed its first company on July 26. Pioneer Stock Board marks the evolution of the stock market into an innovation-friendly ecosystem. It aims to facilitate entry to capital markets for more innovative enterprises. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210730005008/en/ Taipei Exchange launches Pioneer Stock Board to support innovative enterprises (Photo: Business Wire) At the PSB Launch Ceremony, Premier Su Tseng-chang delivered the opening speech, emphasizing the government’s support. Su said, “Taiwan’s capital market breaks new ground today, by establishing this board. PSB will support innovative enterprises, a key driver of economic transformation, by providing companies with quick access to capital needed for continued growth.” Dr. Tien-mu Huang, Chairperson of Financial Supervisory Commission, remarked, “Innovation underpin
ITRS Group Continues Expansion With the Acquisition Of Opsview30.7.2021 10:00:00 CEST | Press release
ITRS Group, a leading provider of real-time monitoring and analytics software, has acquired 100% of Opsview Limited, a modern, scalable monitoring platform, which provides unified insight into dynamic IT operations on-premises, in the Cloud or hybrid. Opsview will remain and operate as a separate brand and entity. The purchase of Opsview aligns well with ITRS’ strategy to build, buy and partner to deliver smart, automated and predictive end-to-end monitoring solutions for increasingly complex IT estates across industries. This development follows the successful strategic acquisitions of Sumerian, OP5 and Uptrends. Guy Warren, CEO of ITRS commented: “Opsview is trusted by hundreds of businesses, government organisations and service providers globally. This acquisition will enhance our technological innovation, increase our portfolio capability, and provide continued expansion across our global support services.” Mike Walton, CEO and founder of Opsview said: “Partnering with ITRS represe
Schneider Electric Moves Forward With Its Sustainability Impact Targets, Mobilizing Support From Employees, Partners and Customers30.7.2021 08:32:00 CEST | Press release
Schneider Electric, the leader in the digital transformation of energy management and automation, published today its half-year progress overview on setting up and advancing on its 2021-2025 sustainability impact targets. Schneider Electric, named as the world’s most sustainable corporation 2021 by the Corporate Knights Global 100 Index, announced the acceleration of its sustainability strategy in January, aligned to its commitments regarding climate, resources, trust, equal opportunities, generations, and local communities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729006295/en/ Schneider Sustainability Impact - H1 Results (Graphic: Business Wire) Since then, the Group has successfully launched The Zero Carbon Project, its initiative to halve carbon emissions of its top supply chain partners by 2025, a call to action already joined by 91% of them. By engaging, training, and supporting the sustainable transformation
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