Celltrion Submits Amendment to European Phase 3 Clinical Trial Plan for CT-P44 Darzalex Biosimilar Part 1 and 2 Simultaneously
On July 13, 2026, Celltrion submitted an amendment to its global Phase 3 clinical trial plan for CT-P44, a biosimilar of Darzalex for multiple myeloma, to the European Medicines Agency EMA. The amendment adjusts the target number of subjects according to the licensing strategy and notably submits both Part 1 evaluating clinical design and methodology and Part 2 evaluating clinical sites and implementation simultaneously.
The trial will involve 394 patients with relapsed or refractory multiple myeloma over two years, comparing the efficacy and safety of subcutaneous CT-P44 plus lenalidomide and dexamethasone versus Darzalex Faspro. This disclosure involves no capital changes or shareholder dilution.
Celltrion had previously submitted Part 1 in November 2024 with approval in April 2025, followed by Part 2 submission in June 2025 and approval in September 2025. This amendment represents a procedural step under the revised EU clinical trial regulation, demonstrating continuity in biosimilar development.
[AI Summary]This disclosure is an administrative follow-up to a protocol amendment after prior clinical trial approvals, with limited direct impact on capital markets; it is assessed as a neutral signal confirming the progress of biosimilar development. Given the statistical 10% probability of clinical success, investors should manage risk until efficacy data is released.
KOSPI Filing Information
Major Management Matters Related to Investment Decision (CTP44 (Darzalex Biosimilar) Application for Change of European Phase 3 Clinical Trial Plan (Part1&2))