Business Wire

Celltrion’s Monoclonal Antibody Treatment regdanvimab, Approved by the European Commission for the Treatment of COVID-19

Share

Celltrion Group announced today that the European Commission (EC) has approved Regkirona (regdanvimab, CT-P59), one of the first monoclonal antibody treatments granted marketing authorisation from the European Medicines Agency (EMA). The EC granted marketing authorisation for adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The decision from the EC follows a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on November 11th, 2021.1

“Today’s achievement, coupled with CHMP positive opinion for regdanvimab, underscores our ongoing commitment to addressing the world’s greatest health challenges,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Typically, the recommendations from the CHMP are passed on to the EC for rapid legally binding decisions within a month or two, however, given the unprecedented times, we have received the EC approval within a day. As part of our global efforts to accelerate access, we have been communicating with the governments and contractors in 30 countries in Europe, Asia and LATAM. We will continue working with all key stakeholders to ensure COVID-19 patients around the world have access to safe and effective treatments.”

Monoclonal antibodies are proteins designed to attach to a specific target, in this case the spike protein of SARS-CoV-2, which works to block the path the virus uses to enter human cells. The EC approval is based on the global Phase III clinical trial involving 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.

Emergency use authorisations are currently in place in Indonesia and Brazil, and the monoclonal antibody treatment is fully approved in the Republic of Korea. In the U.S., regdanvimab has not yet been approved by the Food and Drug Administration (FDA), but the company is in discussion with the FDA to submit applications for an Emergency Use Authorisation (EUA).

As of November 12th, 2021, more than 22,587 people have been treated with regdanvimab in 129 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-19.2 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.

References

1 European Medicines Agency. COVID-19: EMA recommends authorisation of two monoclonal antibody medicines. Available at https://www.ema.europa.eu/en/news/covid-19-ema-recommends-authorisation-two-monoclonal-antibody-medicines [Last accessed November 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.

Contact information

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

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

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Wemade Holds Spectacular Event to Celebrate 100 Days Since Global Launch of MIR430.11.2021 03:34:00 CET | Press release

Wemade’s masterpiece mobile MMORPG ‘MIR4’ will hold a spectacular event starting on November 30th, to celebrate the 100th day of its global release. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211129005798/en/ Wemade’s masterpiece mobile MMORPG ‘MIR4’ holds a spectacular event starting on November 30th, to celebrate the 100th day of its global release. It will be held for two weeks and special rewards will be given including Divine Dragon’s Blessing, Enhancement Stones, Summoning Tickets, and a special box containing various materials. While hunting monsters on the Mir continent, players can obtain Dragon Fruits. In addition, Wayfarer Travel tickets will be updated that allow for transfers to a different server. New Spirits will also be updated including Bloodtip Drago, a legendary-grade fire element Spirit, and Leocrat Khun, an epic-grade earth element Spirit. To commemorate the release of new spirits, a Spirit Special S

LabGenius Appoints Dr. Gino Van Heeke as Chief Scientific Officer30.11.2021 01:00:00 CET | Press release

LabGenius, the machine learning (ML)-driven protein engineering company, today announced the appointment of Gino Van Heeke Ph.D. as Chief Scientific Officer (CSO). In this role, Gino will leverage his wealth of drug discovery and development experience to direct LabGenius’ scientific strategy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211129005436/en/ Dr. Gino Van Heeke Appointed as LabGenius' CSO (Photo: Business Wire) “I’m extremely pleased to welcome Gino to the company as CSO,” said Dr. James Field, Founder and CEO of LabGenius. “Gino is an accomplished scientific leader with an impressive track record of successfully advancing drug candidates into pre-clinical and clinical development.” Gino joins LabGenius from Engitix Therapeutics, where, as CSO, he established a portfolio of projects and initiated the company’s first drug discovery campaign. Before this, Gino was Senior Director, Discovery and Early Development

InVeris Training Solutions Unveils SRCE™ – a Revolutionary, Augmented Reality Training System29.11.2021 20:00:00 CET | Press release

InVeris Training Solutions, the leading provider of integrated live-fire and virtual weapons training systems for military, law enforcement agencies and commercial shooting ranges, today unveils SRCE™ (See, Rehearse, Collectively Experience or "Source"), a groundbreaking, augmented reality-based, untethered weapons training simulator. InVeris Training Solutions provides the most advanced augmented reality technology available in a military and law enforcement training simulator, a feat previously thought to be years away by many in the industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211129005628/en/ SRCE is the only untethered AR training solution on the market—allowing up to 4 participants to train with simulated weapons and tactical gear. (Photo: Business Wire) "Augmented reality delivers the best of the virtual and real worlds in a way that's fully lifelike, seamless, customizable and economical," said InVeris CE

Verimatrix Launches Streamkeeper To Offer Industry’s First Battle-Ready Cybersecurity Solution Engineered to Hunt Down and Take Out Video Piracy29.11.2021 17:45:00 CET | Press release

Regulatory News: Verimatrix, (Euronext Paris: VMX) (Paris:VMX), the leader in powering the modern connected world with people-centered security, today announced the launch of its new Verimatrix StreamkeeperSM solution, a cybersecurity and anti-piracy gamechanger for the media & entertainment industry. Streamkeeper empowers customers to hunt down and take out OTT pirates who steal content such as live sports and premium movie as they are distributed from the source to the endpoint (mobile app/user level). The solution includes Verimatrix's all-new CounterspySM technology -- the autonomous injection of an anti-piracy and app protection security agent that utilizes the company’s proprietary zero code technology which allows customers to add deep, defensive countermeasures, plus monitor their clients without the hassle of a huge integration effort. Integration efforts have also been reduced dramatically, from months to minutes, accompanying numerous operator benefits ranging from a reducti

Introducing ThreatConnect 6.4 - Improving Threat Intelligence Processes and SOC Metrics29.11.2021 17:31:00 CET | Press release

ThreatConnect Inc.®, the leader in enabling a risk led and intelligence-driven security is announcing ThreatConnect 6.4, which introduces new capabilities that allow security operations and cyber threat intelligence (CTI) analysts to get useful context faster during investigations and to better measure team efficiencies. ThreatConnect combines its Threat Intelligence Platform (TIP) and Security Orchestration and Automation platform (SOAR), creating a continuous feedback loop that helps make Intelligence-Driven Operations a reality. This latest product release builds upon the foundation of Intelligence-Driven Operations, empowering the workflow of threat intelligence and security operations teams individually and together. The 6.4 release helps CTI and security operations center (SOC) teams get more context quickly, enabling faster investigations for both. CTI teams are enabled to more easily build and maintain a dynamic threat library, while updated dashboards allow SOC and IR leaders

ESI Group Unveils Its New Leadership Team29.11.2021 17:00:00 CET | Press release

Regulatory News: ESI Group (ISIN Code: FR0004110310, Symbol: ESI) (Paris:ESI) announces today the completion of its new leadership team from seasoned professionals from the current organization and the appointment of Ajit Gokhale as Executive Vice-president Engineering. Cristel de Rouvray, Chief Executive Officer of ESI Group says: "With the release of our “OneESI 2024 – Focus to Grow” plan two months ago, we are engaged in a profound transformation. To lead our Group and this transformational effort, I can count on the full support of my new Leadership Team which is composed of nine impressive, complementary and highly experienced individuals. I’m also proud to welcome in our team Ajit Gokhale who will play a key role in our organization and more specifically in our software engineering strategy and execution. Together, we are entirely committed to bring our company to the next level and to transform it as one of the key leading software partners for industry.” Creation of a new leade

Gilead and AWS Collaborate on Development and Delivery of New Medicines for Patients29.11.2021 15:00:00 CET | Press release

Today, Amazon Web Services, Inc. (AWS), an Amazon.com, Inc. company (NASDAQ: AMZN), announced that Gilead Sciences, Inc. (Nasdaq: GILD), a biopharmaceutical company advancing innovative medicines to prevent and treat life-threatening diseases, has selected AWS as its preferred cloud provider. Innovating on AWS and with the help of AWS experts and partners in healthcare and life sciences, Gilead provides its data scientists with the latest advances in machine learning and analytics. These capabilities fuel data-driven decision making across the organization—from biomarker discovery through manufacturing and clinical trial recruitment—and deliver insights that can help Gilead refine its drug pipeline. The company also relies on AWS to host all workloads for its enterprise resource planning (ERP) transformation project to implement SAP S/4HANA. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211129005047/en/ “With AWS as our pre