• Zdravlje announces signing of agreement with Celltrion Healthcare, a leading global biopharmaceutical company, for regional product rights to regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19
• 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
• A marketing authorization application for regdanvimab (CT-P59) has been accepted by the European Medicines Agency (EMA) in early October

22 October 2021, Belgrade, Serbia – Approximately six months into new ownership Zdravlje A.D. (“Zdravlje”) is proud to announce the signing of a new agreement with Celltrion Healthcare Hungary Kft. (“Celltrion Healthcare”), a leading force in the biopharmaceutical industry. This agreement will make regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19, available for patients in Serbia and in the ex-Yugoslavia region.

The global Phase III clinical trial was a randomised, double-blind, placebo-controlled clinical trial studying regdanvimab for the treatment of adult patients with mild to moderate COVID-19 and was conducted in multiple countries including Korea, United States, Spain, and Romania. Data showed regdanvimab significantly reduced the risk of COVID-19 related hospitalisation or death by 72% in patients at a high-risk of progressing to severe COVID-19 and 70% for all patients. In addition, pre-clinical data for regdanvimab demonstrated strong neutralising activity against the Delta variant (B.1.617.2, first identified in India) with results showing 100% survival rate and virus eradication from all animals treated with a therapeutic dosage of regdanvimab.

In March 2021 the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive scientific opinion for regdanvimab as a treatment option which may be considered for patients at a high risk of progressing to severe COVID-19 and based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm. In addition, in June 2021, the European Commission (EC) announced Celltrion’s regdanvimab to be a part of its COVID-19 therapeutics portfolio for authorisation for the treatment of COVID-19 patients as part of its strategy for COVID-19 therapeutics.

In October 2021 Celltrion submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking full approval for regdanvimab. The indication applied for is the treatment of confirmed COVID-19 in adults (18 years or older) who do not require supplemental oxygen therapy and who are at an increased risk of progressing to severe COVID-19.

“This is a very exciting time for Zdravlje and all the patients in the region,” said Kiren Naidoo, CEO of Zdravlje. “We are committed to increasing the odds in the fight against COVID-19 and bringing patients the most recent life-saving treatments. This also represents Zdravlje’s expansion into the innovative biopharmaceutical arena.” Zdravlje will initiate the marketing approval process for the product in Serbia and the surrounding region.

About Zdravlje Pharmaceutical Company Zdravlje AD Leskovac was founded in 1953 and manufactures pharmaceuticals for approximately 40 international markets located in Western and Eastern Europe, United Kingdom, Asia-Pacific, South Africa and Latin America. The Company manufactures a wide range of products for the treatment of various serious and chronic diseases including cardiovascular, central nervous and respiratory disorders.

About Celltrion 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 endeavors 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 neutralises 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. Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.