Overview

• The European Commission authorized Zemcelpro for adults with hematologic malignancies who require allogeneic HSCT after myeloablative conditioning when no suitable donor cells are available.
• The conditional marketing authorization permits distribution across all 27 EU member states plus Iceland, Norway and Liechtenstein.
• Zemcelpro is a cryopreserved cord‑blood product that combines UM171‑expanded CD34+ cells with unexpanded CD34− cells from the same unit to make smaller cord blood grafts viable for adults.
• Across two prospective studies, the therapy showed estimated 2‑year overall survival of 67% and progression‑free survival of 63%, with nonrelapse mortality of 19%, relapse of 18%, grade 3–4 acute GVHD of 16% and moderate‑to‑severe chronic GVHD of 7%.
• ExCellThera plans additional filings in the United States, United Kingdom, Canada and Switzerland, is advancing a registrational phase 3 program, and its subsidiary Cordex is working with national authorities to enable early access where possible.