ExCellThera secures German NUB Standing 1 itemizing for Zemcelpro
ExCellThera and its wholly owned subsidiary Cordex Biologics have acquired a standing 1 itemizing from the New Analysis and Therapy Strategies (NUB) program in Germany for Zemcelpro (dorocubicel), also referred to as UM171 cell remedy.
This follows rising medical proof for Zemcelpro and curiosity from 220 hospitals within the nation for potential use by way of the NUB mechanism from 2026.
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The European Fee (EC) just lately granted a conditional advertising authorization to Zemcelpro to be used in adults with haematological malignancies requiring allogeneic stem cell transplantation after myeloablative conditioning, the place no different appropriate donor cells can be found.
With NUB standing, Cordex plans to collaborate with German transplant facilities on particular person NUB functions and develop medical adoption.
The corporate will even take part in post-marketing registries and generate knowledge to facilitate long-term reimbursement and inclusion of Zemcelpro in medical tips.
The provision of the remedy in particular person European nations depends upon a number of elements, such because the completion of nationwide reimbursement procedures.
Additional regulatory filings are deliberate for the US, Canada, Switzerland and the UK. Cordex is dedicated to strategic partnerships to assist the worldwide commercialization of Zemcelpro.
The cryopreserved hematopoietic stem cell remedy consists of UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34 cells, each derived from a single umbilical twine blood unit.
Greater than 120 sufferers with hematological malignancies participated in medical trials in Canada, Europe and the US.
ExCellThera CEO David Millette mentioned: “NUB Standing 1 represents a major milestone for ExCellThera and Cordex and displays each the progressive nature of Zemcelpro (dorocubicel) and its profit in addressing an pressing unmet medical want within the discipline of allogeneic hematopoietic stem cell transplantation.
“Underneath its unique label, Zemcelpro (dorocubicel) is indicated for sufferers with life-threatening blood cancers who’ve restricted therapeutic choices.”
In August 2025, ExCellThera introduced that the EC has granted conditional advertising authorization for its Zemcel professional cell remedy for the therapy of blood most cancers sufferers with out entry to acceptable donor cells.
