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Experimental COVID antibody treatment successful in trials

Celltrion has announced positive top-line data for its experimental antibody COVID-19 treatment, with Phase III trials finding it safe and effective, reducing treatment periods by up to five days.

Regdanvimab (CT-P59) is an anti-COVID-19 monoclonal antibody treatment that, at a clinically relevant dose, results in a significant reduction in viral load of SARS-CoV-2.

Celltrion’s COVID-19 treatment shows promise against South African variant

Scientist with a test tube

Celltrion’s regdanvimab treatment for COVID-19 has shown itself to be effective against the South African variant of the virus, according to preliminary results from a pre-clinical trial.

Celltrion's inflammatory disease drug Yuflyma gets EU approval for 13 indications

The European Commission (EC) has granted marketing authorisation for Celltrion’s Yuflyma, an adalimumab biosimilar, across all thirteen intended indications for the treatment of multiple chronic inflammatory diseases.

South Korea approves Celltrion's COVID-19 treatment Regdanvimab for emergency use

The South Korean Ministry of Food and Drug Safety (MFDS) has granted a conditional marketing authorisation (CMA) for the emergency use of Celltrion’s Regdanvimab (CT-P59), a monoclonal antibody COVID-19 treatment candidate.

The CMA allows for emergency 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.

Celltrion announces positive top-line results from COVID-19 treatment trial

Celltrion Group has announced that top-line results from its global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, show the drug significantly reduced the risk of coronavirus-related hospitalisation and oxygenation.

Part one of the randomised, double-blind, and placebo-controlled trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three treatment groups, in which approximately 60% of patients with moderate symptoms suffered from coronavirus-related pneumonia.

Celltrion's Humira biosimilar is comparable in treating rheumatoid arthritis

Celltrion has revealed new Phase 3 data demonstrating that its high concentration (100mg/mL) and citrate-free biosimilar CT-P17 proved comparable to its reference product, AbbVie’s best-selling Humira (adalimumab), in the treatment of rheumatoid arthritis (RA).

Revealed at the American College of Rheumatology (ACR) Convergence 2020, the findings compared Celltrion’s product to Humira in terms of efficacy, safety and pharmacokinetics. In the trial, 648 moderate-to-severe RA patients were randomly given either Celltrion or AbbVie’s drug fortnightly for 24 weeks.

Celltrion's infliximab biosimilar Remsima secures European approval in five indications

The subcutaneous (SC) formulation of Remsima, Celltrion’s biosimilar version of infliximab, has secured approval from the European Commission covering five indications, according to the company, including ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.

The approval means that Remsima SC will be available in 120mg doses to adult patients for the treatment of one of the above conditions, regardless of their body weight.

Takeda jettisons non-core portfolio in Asia Pacific to Celltrion for a potential $278 million

Takeda continues its mission to reduce its debt in the wake of its $49 billion acquisition of Shire in January last year, announcing that it will sell a portfolio of non-core over-the-counter and prescription therapies to South Korea-based Celltrion in a deal worth up to $278.3 million.

The deal breaks down into an upfront payment from Celltrion of $266 million in cash, plus another potential $12 million in legal and regulatory milestone payments.

FDA greenlights Celltrion HIV drug manufacturing facility in South Korea

South Korean biopharma firm Celltrion has revealed that one of its key manufacturing facilities has been given the all-clear by the FDA following an on-site inspection in January.

The visit to the site in Cheongju, the largest city in the nation’s North Chungcheong Province, was for an additional inspection in order to review new technology which was omitted in the facility’s most recent Current Good Manufacturing Practice (CGMP) report, with the FDA finding no issues requiring intervention.  

Europe approves first subcutaneous version of biosimilar infliximab

The European Commission has chosen to authorise Celltrion Healthcare’s Remsima SC, a biosimilar of infliximab and the first subcutaneous formulation of the therapy, it has emerged.

The therapy was approved in combination with methotrexate (MTX) for the treatment of active rheumatoid arthritis in adult patients who have seen inadequate response with disease-modifying anti-rheumatic drugs (DMARDs), including MTX, and additionally in patients with severe, active and progressive forms of the disease who have not been previously treated with MTX or other DMARDs.

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