Celltrion Publishes Phase 3 Efficacy Results of 'Aptozuma' in International Journal

Securing Approvals in Major Countries
Accelerating Entry into the Global Market

Celltrion announced on July 16 that the results of a 52-week global Phase 3 clinical trial of 'Aptozuma (CT-P47)', a biosimilar of the rheumatoid arthritis (RA) treatment 'Actemra', have been published in the international journal 'Clinical Drug Investigation'.

The published study contains the 52-week results of a Phase 3 clinical trial evaluating the efficacy, pharmacokinetics, safety, and immunogenicity of the intravenous (IV) formulation of CT-P47 in 471 patients with rheumatoid arthritis.

The clinical trial was conducted by dividing patients into two groups: an initial CT-P47 treatment group and an original drug treatment group. From week 24, the original drug group was further randomized into a maintenance group and a switching group that transitioned to CT-P47, resulting in a total of three groups for comparative evaluation.

The results showed that all three groups?the group continuously treated with CT-P47, the group maintained on the original drug, and the switching group transitioned to CT-P47?demonstrated similar levels of key indicators, including efficacy, pharmacokinetics, safety, and immunogenicity. This confirms that CT-P47 can be a stable treatment option for both long-term therapy and in switching scenarios.

Actemra, the reference drug for Aptozuma, is an interleukin inhibitor that reduces inflammation by inhibiting the interleukin (IL)-6 protein, which is involved in causing inflammation in the body. Last year, it recorded global sales of approximately 2.645 billion Swiss francs (about 4 trillion KRW).

Additionally, Celltrion obtained domestic approval for Aptozuma at the end of last year, and has since received product approvals in both the United States and Europe earlier this year, accelerating its efforts to target the global market.

A Celltrion official stated, "It is significant that this announcement allows us to demonstrate both the efficacy and safety of Aptozuma in long-term treatment and switching scenarios," and added, "Based on the published data, we plan to accelerate the expansion of prescriptions and market share in the global market."