Celltrion "Post-Marketing Clinical Results of 'Truxima' Published in International Journal"

Safety and Efficacy Reconfirmed in Prestigious SCI-Level Academic Journal

[Asia Economy Reporter Myunghwan Lee] Celltrion announced on the 15th that the post-marketing clinical trial results of the blood cancer treatment drug 'Truxima (generic name Rituximab)' have been published in a prestigious international academic journal.

Truxima.
Photo by Celltrion

The journal in which these results were published, 'Expert Opinion on Biological Therapy,' is recognized as an SCI (Science Citation Index) level journal primarily covering the field of biological therapies.

The study analyzed data collected over approximately four years from November 2016 to November 2020 at 27 centers across South Korea. It was a post-marketing clinical trial that administered Truxima to 677 patients with indications approved in Korea, including non-Hodgkin lymphoma, rheumatoid arthritis, chronic lymphocytic leukemia, Wegener's granulomatosis, and microscopic polyangiitis, to verify safety and efficacy.

According to the results, Truxima demonstrated a safety profile comparable to that of the original drug and the clinical trial results used for Truxima's approval. Celltrion explained that the study showed high response rates not only in the non-Hodgkin lymphoma and rheumatoid arthritis indications, which had already secured significant data through previous clinical trials, but also across all indications approved domestically.

Celltrion expects that these research results will have a positive impact on the future expansion of Truxima prescriptions. Previously, in December last year, Celltrion disclosed the abstract of this study through a poster presentation at the '2022 American Society of Hematology' held in Louisiana, USA.

Truxima obtained domestic sales approval from the Ministry of Food and Drug Safety in 2016, followed by approval from the European Medicines Agency (EMA) in 2017 and the U.S. Food and Drug Administration (FDA) in 2018, and is being supplied to major markets.

A Celltrion official stated, "We hope that the publication of these research results in an international academic journal will serve as meaningful evidence for the expansion of Truxima prescriptions in medical practice in the future," adding, "We will continue to do our best to ensure that patients have access to high-quality medicines through ongoing post-marketing data monitoring."

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