Celltrion, Next Step After 'Rekkirona'... Developing 'Inhalable Cocktail Therapy'

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

[Asia Economy Reporter Lee Chun-hee] Celltrion is accelerating the development of inhalable cocktail antibody treatments and next-generation messenger RNA (mRNA) vaccine platforms to prepare for various COVID-19 variants and the potential future pandemics of new infectious diseases.

On the 24th, Celltrion announced that it is currently developing treatments targeting various variants based on Korea's first COVID-19 antibody treatment, Regkirona (CT-P59). Following preclinical results from the U.S. National Institutes of Health (NIH) showing efficacy against Omicron and stealth Omicron, Celltrion is hastening preparations to release an inhalable cocktail antibody treatment combining CT-P63.

Inhalon Biopharma, a U.S. biotech company contracted by Celltrion to jointly develop the inhalable antibody treatment, demonstrated safety in a Phase 1 clinical trial of the Regkirona inhalable treatment in Australia. Additionally, CT-P63 proved safe in a Phase 1 intravenous (IV) clinical trial conducted in Poland. These results have accelerated the development of the combined inhalable cocktail antibody treatment. On the 3rd, Celltrion submitted clinical trial applications (IND) for Phase 3 studies in three countries?Bosnia, Serbia, and North Macedonia?and plans to expand the number of countries to enroll a total of 2,200 COVID-19 patients to verify the efficacy and safety of the inhalable cocktail antibody treatment.

Currently, health authorities have decided to halt additional supplies of Regkirona, citing reduced effectiveness against Omicron. The Central Disease Control Headquarters announced, "New supplies of Regkirona have been suspended since the 18th," and "remaining stocks can be used for cases confirmed as Delta until the 28th." The headquarters explained, "This decision reflects pharmacological test results showing low neutralizing potential of Regkirona against Omicron variants."

Celltrion's COVID-19 Antibody Treatment 'Rekkirona'

Furthermore, Celltrion recently completed a license-in agreement with the UN-backed Medicines Patent Pool (MPP) and Merck to produce generic versions of the oral COVID-19 treatment Molnupiravir. The company plans to manufacture and supply Molnupiravir generics to up to 105 low- and middle-income countries.

Vaccine development is also progressing rapidly. Celltrion is currently developing an Omicron-specific vaccine in partnership with a U.S. company. The focus is on mRNA vaccine development, aiming to create a next-generation platform applicable to potential future viruses. However, as COVID-19 is expected to transition to an endemic phase soon, the company plans to decide on the commercialization of the Omicron-specific vaccine based on future market conditions. The Diatrust line of COVID-19 antigen rapid test kits is also demonstrating strong detection capabilities against variants and is targeting overseas markets including the U.S.

A Celltrion representative stated, "To comprehensively respond to a wider range of variants, we have entered global Phase 3 clinical trials for the inhalable cocktail antibody treatment and will accelerate the supply of diagnostic kits and the establishment of the mRNA vaccine platform."

This content was produced with the assistance of AI translation services.