Celltrion announced in a regulatory filing on the 3rd that it has applied to the Ministry of Food and Drug Safety (MFDS) for an amendment to the Phase 3 clinical trial plan in Korea for its Darzalex biosimilar 'CT-P44'.

According to the filing, the date of the factual occurrence is August 3, 2026, when the application for the clinical trial plan amendment was submitted to the Korean MFDS. This amendment application is intended to adjust the number of subjects in the global Phase 3 clinical trial due to a change in the approval strategy. The clinical trial is being conducted on patients with relapsed or refractory multiple myeloma. It is a global Phase 3 clinical trial employing a double-blind, randomized, active-controlled, and parallel-group design to compare the efficacy and safety of the subcutaneous injection CT-P44, administered in combination with lenalidomide and dexamethasone, with those of the original drug Darzalex Faspro. The total number of clinical trial subjects is 394, and the trial period is two years.

Celltrion plans to demonstrate biosimilarity by comparing the efficacy and safety of CT-P44 with those of the original drug Darzalex through this Phase 3 trial.

Additionally, Celltrion cautioned investors about investment risks. The company stated, "It is known that the statistical probability of a clinical trial drug receiving final approval as a pharmaceutical product is approximately 10%." It added, "Results during the clinical trial and product approval process may not meet expectations, and accordingly, there is a possibility of changing or abandoning commercialization plans." It further noted, "Investors should make investment decisions carefully by comprehensively considering the investment risks disclosed through periodic filings and business reports."