Celltrion’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59) becomes the first authorized COVID-19 treatment approved from the Korean Ministry of Food and Drug Safety (MFDS)
Celltrion Group announced that the Korean Ministry of Food and Drug Safety (MFDS) approved regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19 for the extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition (the obese, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, and patients with immunosuppressive agents) with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19. This marks the first time a monoclonal antibody treatment for COVID-19 has received a full approval to treat patients with COVID-19 from the Korean MFDS.
In February, the Korean MFDS granted a Conditional Marketing Authorisation (CMA) for the emergency use of regdanvimab (CT-P59) and allowed the use of CT-P59 in adult patients aged 60 years and over, or with at least one underlying medical condition (cardiovascular, chronic respiratory disease, diabetes, high blood pressure) with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19.
The administration time for the recommended dosage of regdanvimab (CT-P59), a single intravenous (IV) infusion of 40 mg/kg, has been reduced from 90 minutes to 60 minutes.
Celltrion has successfully enrolled more than 1,315 people in its global Phase III clinical trial, which evaluated the efficacy and safety of regdanvimab (CT-P59) in 13 countries including the U.S., Spain, and Romania. Data showed regdanvimab (CT-P59) significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high- risk of progressing to severe COVID-19 and 70% for all patients. In addition, pre- clinical data for regdanvimab (CT-P59) demonstrated strong neutralising activity against the Delta variant (B.1.617.2, first identified in India) with results showing 100% survival rate with virus eradication from all animals treated with therapeutic dosage of CT-P59.
“Recent clinical data have helped improve healthcare professionals’ and public health authorities’ understanding of the potential role of regdanvimab in the treatment of patients with mild-to-moderate symptoms of COVID-19,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Regdanvimab is the first of its kind for the treatment of COVID-19, so the efficacy and safety profile should be assessed thoroughly. Along with a continuous and positive feedback from expert scientists and clinicians, we are encouraged by the decision of regulatory agency to confirm this treatment is safe and effective. Celltrion group remains in diligent communication with other regulatory authorities worldwide.”
As of September 2021, more than 14,857 people have been treated with regdanvimab (CT-P59) in 107 hospitals in the Republic of Korea.
- 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.
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 including the Alpha variant (B.1.1.7, first identified in the UK). 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 II 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.
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.
+44 (0) 7759 301620
+44 (0) 7984 550312
About Business Wire
(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
Amedeo and AURA AERO Announce a Strategic Partnership Agreement and a Letter of Intent to Purchase 200 Electric Regional Aircraft (“ERA”)19.10.2021 19:21:00 CEST | Press release
AURA AERO has created a clean sheet design while integrating new technologies, as well as existing technologies such as fly by wire, and is driving digital efficiencies to build revolutionary momentum in creating an electrical aircraft. With its current prototype aircraft, INTEGRAL, AURA AERO is achieving design and production maturity at a fraction of the cost and will carry that to the commercially sized 19- seater, Electric Regional Aircraft named ‘ERA’. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211019006068/en/ “Amedeo are delighted to have signed an LOI for 200 Electric Regional Aircraft ‘ERA,’ that draws the commercial aviation industry closer to achieving its goal of net-zero by 2050. We are very pleased to be partnered with AURA AERO in leading such an important climate supporting initiative for the future. For Amedeo, sustainable aviation is more than aspirational and we are committed and focused on partnership
JAB and BNP Paribas Cardif Announce Strategic Pet Healthcare Alliance19.10.2021 18:37:00 CEST | Press release
JAB and insurer BNP Paribas Cardif today announced a strategic alliance to deliver a range of pet insurance services throughout the UK, EMEA and Latin America, with a vision to offer additional pet healthcare services over time. As part of the agreement, JAB will hold a majority stake in a new holding company to which BNP Paribas Cardif will contribute Cardif Pinnacle, its subsidiary focused on the rapidly growing pet insurance sector. BNP Paribas Cardif will remain significantly involved in the pet healthcare activity, supporting the development of this alliance through a continued stake in the business. The transaction is expected to close in Q2 2022, subject to customary closing conditions, including applicable regulatory approvals. Cardif Pinnacle has built a leading pet insurance business providing solutions to partners and pet owners based on innovation and a scalable platform. The Company’s business proposition leverages digital services, artificial intelligence and continuous i
Leading South Korean Furniture Manufacturer Empowered to Focus on IT Modernization Goals After Switching to Rimini Street Support19.10.2021 18:00:00 CEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that ENEX, a leading furniture manufacturer in South Korea, has switched to Rimini Street Support for its mission-critical SAP system. As a result of switching support providers, ENEX was able to immediately reduce its annual support fees and redirect its internal IT personnel to focus on higher value business initiatives, including plans to update and modernize its IT infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211019005188/en/ Leading South Korean Furniture Manufacturer Empowered to Focus on IT Modernization Goals After Switching to Rimini Street Support (Photo: Business Wire) Switching to Ultra-Responsive Support and Maintenance Helps Drive Digital Transformation Founded in 1971, ENEX is
ElectReon and Gotland Partners Announce First Fully Operational Electric Bus Utilizing Wireless Electric Road System in Sweden19.10.2021 17:38:00 CEST | Press release
ElectReon (TASE: ELWS.TA), the leading provider of in-road wireless electric vehicle charging technology for commercial, public service, and passenger vehicles, announced today the successful launch of the first fully operational bus utilizing the company’s wireless charging infrastructure in the city of Visby in Gotland, Sweden. Implemented by a consortium of partners, the Smartroad Gotland project began operations in early 2020 and is one of four Electric Road demonstration projects currently being funded by the Swedish Transport Administration, Trafikverket. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211019005925/en/ The Smartroad Gotland project is the first fully operational bus utilizing wireless charging infrastructure in the city of Visby in Gotland, Sweden. (Photo: Business Wire) Having supported Electric Road Systems (“ERS”) R&D programs for over a decade, Sweden is a pioneer in pursuing multiple ERS demonstrat
Berkshire Hathaway Specialty Insurance Elevates Multinational Capabilities, Creating Global Network Across 170 Countries19.10.2021 15:30:00 CEST | Press release
Berkshire Hathaway Specialty Insurance (BHSI) today announced that it has expanded its global network to encompass owned offices and network partners that can provide BHSI customers with locally admitted insurance policies in 170 countries worldwide. “We are very pleased to welcome so many outstanding partners around the globe to the BHSI family,” said David Valzania, Head of Multinational, BHSI. “Each of these carriers share BHSI’s values, and align with our product offerings, focus on excellent customer service, and commitment to the CLAIMS IS OUR PRODUCT® philosophy.” BHSI undertook a rigorous search, evaluation and due diligence process to select the carrier partners best suited to represent the Berkshire Hathaway brand and our customers. Policies issued by network partners receive the backing of BHSI’s financial strength. “Our multinational capabilities have been growing rapidly. With our expanded network, we look forward to providing consistently world-class products and services
Andersen Global Continues Asia Expansion with One of Indonesia’s Largest Tax Firms19.10.2021 15:30:00 CEST | Press release
Andersen Global enters the Indonesian market with collaborating firm Soewito, Fajar & Partners, operating as TaxPrime, one of the largest tax firms in the country. TaxPrime was founded in 2012 by Senior Partner Soewito and Managing Partner Muhamad Fajar Putranto, who previously served as tax officers for Indonesia’s Directorate General of Taxes (DGT). With three offices, the Jakarta-based firm operates with nine Partners, three Senior Advisors and more than 170 professionals, focusing on multinational companies with full-service capabilities in tax and customs compliance, tax and customs advisory, transfer pricing, tax and customs dispute resolution, international tax and structuring transactions. “Our firm is committed to delivering best-in-class service, and we constantly aim to expand our expertise,” Fajar said. “Our collaboration with Andersen Global emphasizes our commitment to serving clients with global operations in a seamless manner, and we look forward to working with the lik
JAB Expands Pet Insurance Platform Through Acquisition of Figo Pet Insurance19.10.2021 15:00:00 CEST | Press release
JAB is pleased to announce that Independence Pet Holdings (formerly Iguana Capital), JAB’s U.S. pet insurance platform, has entered into a definitive agreement to acquire Figo, one of the leading U.S. providers of pet insurance. As part of the agreement, the shareholders of Figo will roll a portion of their proceeds into PetPartners, the consumer-facing portion of JAB’s pet insurance platform. The acquisition is expected to close by the end of the year. Since its founding in 2015, Figo has quickly established a strong pet insurance brand and leading InsurTech position in the United States. Its modern pet insurance experience includes a simple, easy-to-follow consumer journey coupled with its Pet Cloud app, a cloud-based platform that provides 24/7 access to live veterinarians, customer support, claims processing, digital pet record management, and a social network for pet parents, all of which has driven impressive company growth, earning Figo the title of “Top InsurTech Leader” by A.M