On the 14th, Celltrion announced in a regulatory filing that it has submitted an application to the European Medicines Agency (EMA) to amend the protocol for its European global Phase 3 clinical trial for 'CT-P44', a biosimilar candidate for Darzalex.

This amendment application reflects an adjustment in the number of trial subjects due to a change in the regulatory approval strategy. In accordance with the European Clinical Trial Regulation, the company simultaneously submitted Part 1 (evaluation of clinical design and research methodology) and Part 2 (evaluation of clinical trial sites and execution), with the submission completed on July 13, 2026, local time. Since the revised Clinical Trial Regulation was applied in Europe on January 31, 2023, the approval process has been divided into two stages, and clinical trials can only proceed after receiving final approval through Part 2.

CT-P44 is a subcutaneous injection intended for use in combination with lenalidomide and dexamethasone in patients with refractory or relapsed multiple myeloma. The primary objective of this global Phase 3 clinical trial is to demonstrate biosimilarity by comparing the efficacy and safety of CT-P44 with those of the original drug, Darzalex Faspro.

The trial will be conducted as a double-blind, randomized, active-controlled, parallel-group study. A total of 394 patients are expected to participate, with the trial duration set at approximately two years.

Meanwhile, alongside this disclosure, Celltrion provided a cautionary notice for investors. The company stated, "The statistical probability of a clinical trial drug receiving final product approval is approximately 10%." It noted that if the results during the clinical trial and approval process fall short of expectations, there is a possibility that commercialization plans may be altered or discontinued.