Business Wire

Celltrion Receives CHMP Positive Opinion for regdanvimab (CT-P59) as One of the First Monoclonal Antibodies Recommended as a Treatment for COVID-19 by the CHMP

Share

Celltrion Group announced today that the European Medicine’s Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive scientific opinion recommending marketing authorisation for regdanvimab (CT-P59), a monoclonal antibody treatment for adults with COVID-19 that do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The CHMP positive opinion is a scientific recommendation to the European Commission (EC), which authorises marketing approval in the European Union.

“We have accumulated the safety and efficacy data of regdanvimab in the treatment of patients infected with COVID-19 and its associated variant strains, including the more virulent Delta variant,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “At Celltrion, we are proud to play our part in tackling the unprecedented global threat of COVID-19 and believe regdanvimab offers an important addition to the treatment arsenal. Using our stable supply system and commercial network, we will expedite required process and continue to work with stakeholders globally to ensure eligible patients can benefit from this treatment as quickly as possible. Currently, we are in discussions with regulatory agencies and companies from approximately 30 countries around the world, to supply our monoclonal antibody treatment for COVID-19 and those will be our top priorities in the coming months.”

The positive CHMP opinion was supported by data from the global Phase III clinical trial in which Celltrion enrolled more than 1,315 people to evaluate the efficacy and safety of regdanvimab in 13 countries including the U.S., Spain, and Romania. Data showed regdanvimab significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high-risk of progressing to severe COVID-19.

“The primary benefits of monoclonal antibodies are their high specificity and safety – they are highly specific for a single target, so these monoclonal antibodies rarely cause undesirable side effects,” said Oana Sandulescu, MD, PhD, Associate Professor of Infectious Diseases at the Carol Davila University of Medicine and Pharmacy in Romania. “An infusion of an hour of monoclonal antibodies like regdanvimab can ease COVID-19 symptoms and reduce complications in recently diagnosed, non-hospitalised people at high risk, and thus plays an important role in preventing further spread of the virus.”

Rolling review of regdanvimab had been initiated by the EMA on February this year and the announcement of the CHMP positive opinion for regdanvimab follows the submission of a marketing authorisation application (MAA) to the EMA seeking approval of regdanvimab in October 2021.

As of November 2021, more than 21,366 people have been treated with regdanvimab in 127 hospitals in the Republic of Korea.

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 regdanvimab (CT-P59)

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 neutralise the wild type and mutant variants of concern. 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 and Phase II/ III clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild-to-moderate symptoms of COVID-19.1 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.

References

______________

1

Celltrion Data on file

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Holly Barber hbarber@hanovercomms.com
+44 (0) 07759 301620

Donna Curran
dcurran@hanovercomms.com
+44 (0) 7984 550312

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

Sunny Varkey Launches Tmrw, a New Learning Operating System (LearnOS) for Global Education to Bring a Quality Education Within Reach of Every Child7.12.2021 17:48:00 EET | Press release

Tmrw, a new and scalable Learning Operating System (LearnOS) for global education with a mission to help bring a quality education to every child, was launched this month. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211207005768/en/ Sunny Varkey, Chairman and Founder of Tmrw (Photo: Business Wire) Its interoperable All-In-One Integrated Platform is built to be accessible and affordable for Government funded schools operating in both the developed and developing world settings. In particular, it seeks to reach all students irrespective of their background or their ability to pay. It is designed to cater to the needs of every curriculum, context and mode of learning, whether brick and mortar, virtual or blended. Tmrw’s vision over time is to underpin learning, teaching, and the operational needs of K12 education, higher education and life-long learning. Sunny Varkey, who also founded the Global Teacher Prize, has ensured th

Nexo Expands Institutional Access to Crypto in Collaboration with Fidelity Digital Assets7.12.2021 17:30:00 EET | Press release

Nexo , the leading regulated institution for digital assets, today announced its collaboration with Fidelity Digital AssetsSM, a leading institutional focused execution and custody services platform provider, to revolutionize institutional access to digital assets by together offering best-in-class custodial and lending services, including the launch of innovative institutional-focused products. Nexo, a pioneer of cryptocurrency-collateralized credit, and Fidelity Digital Assets as custodian and collateral agent, will develop a comprehensive product suite and compliant infrastructure for institutional investors seeking exposure to digital assets. As a first step, the collaboration with Fidelity Digital Assets will expand Nexo’s ability to service and enhance its growing portfolio of assets under management and will provide an additional custody layer to Nexo’s military-grade security infrastructure. This latest development gives institutional investors who currently custody their digit

Percona Platform Unifies Open Source Databases, Supports Private Database-as-a-Service Deployments7.12.2021 17:20:00 EET | Press release

Percona, a leader in open source database software and services, today announced Percona Platform to bring together database distributions, support expertise, services, management and automated insights into a single product. Building on the company’s expertise with databases including MySQL, PostgreSQL and MongoDB, the new Percona Platform will simplify how users monitor, manage and optimize their database instances across any infrastructure. In addition, Percona Platform will enable developers and database administrators to run their own private Database-as-a-Service (DBaaS) instances. This launch will preview the Percona Platform, allowing users to unify the entire database experience from packages and backup to monitoring and management, with general availability in early 2022. Percona brings together distributions of MySQL, PostgreSQL and MongoDB including a range of open source tools for data backup, availability and management. It also includes Percona Monitoring and Management

Zencity Accelerates Collaboration Between Communities and Local Governments by Acquiring Civil Space7.12.2021 17:16:00 EET | Press release

Zencity, the leading global community engagement technology platform for local governments, announced the acquisition of cutting edge digital engagement startup Civil Space, based in Vancouver, Canada. The deal immediately adds to Zencity’s powerful suite the capability to create and capture deep, meaningful, equitable, two-way conversations between governments and their residents. With its acquisition of Civil Space, Zencity emerges as the most effective, inclusive and wide-reaching community engagement platform available for local governments, built around two core principles: Lowering the barriers to participation by meeting residents where they are and hearing many more voices; and Making it easier for governments to turn the resulting, broadened community input into action. The combination of Zencity’s analysis of broad community input with Civil Space’s direct engagement platform will enable local leaders to further enhance the feedback they are leveraging. The information will b

MCR Acquires Cloud-Based Hotel Management Platform Optii7.12.2021 17:00:00 EET | Press release

MCR, the 4th-largest hotel owner-operator in the United States and one of Fast Company’s 10 Most Innovative Travel Companies of 2020, has acquired Optii, the only predictive, cloud-based technology for improved hotel operations. Optii will continue to be a standalone company with its existing management team of CEO Katherine Grass, Founder and CSO Soenke Weiss and CRO Deborah Pevenstein. MCR’s portfolio of 140 branded and independent hotels will be arms-length customers of Optii, which will continue to offer its product to forward-thinking hotel companies. No data will be shared with MCR. MCR will mobilize its 4,000 hotel team members — who will utilize Optii for 20,000 guestrooms per day — to push for innovative product enhancements. Stayntouch property management system software, another standalone company owned by MCR, will integrate with Optii. A data-driven platform powered by artificial intelligence, Optii has revolutionized housekeeping technology, optimizing labor and cleaning

Alation Forges Strategic Partnerships With Bigeye and Soda7.12.2021 17:00:00 EET | Press release

Alation, Inc., the leader in enterprise data intelligence solutions, today announced formal partnership agreements with Bigeye and Soda, leading data observability vendors. The partnerships provide customers with the choice to select the best data observability partner for their organisation’s needs. Alation’s active data governance helps organisations drive data culture by providing all data users, regardless of technical skillset, with access to quality data. Bigeye’s data observability platform helps detect data quality issues and ensures reliable data pipelines. Soda’s data observability platform allows teams to discover, prioritise, and collaboratively resolve data issues. The platforms are invaluable for alerting technical users to deeper data quality issues, such as the trustworthiness of the data or its usability. Alation’s integrations with Bigeye and Soda provide all data consumers, from business users to data scientists, with a single-pane-of-glass view into the trustworthin

Acadia and Capitolis Launch SA-CCR Optimization Service7.12.2021 16:30:00 EET | Press release

Acadia, the leading industry provider of integrated risk management services for the derivatives community, and Capitolis, the leading SaaS platform that drives financial resource optimization for capital markets, today announced the launch of SA-CCR Optimization. SA-CCR Optimization will bring considerable cost savings to firms subject to the Standard Approach to Counterparty Credit Risk (SA-CCR) regulations, focusing on specific FX products such as FX forwards, options, deliverable swaps and cross-currency swaps. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211207005660/en/ With SA-CCR Optimization, banks and participating financial institutions provide trade data, which Acadia and Capitolis process and use to generate a series of FX transactions that reduce capital requirements, leaving each client’s net FX risk profile largely unchanged. “The newest wave of capital regulation is pushing firms to be more mindful of capi

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