ExCellThera has announced that the European Commission (EC) has granted conditional marketing authorisation for its Zemcelpro cell therapy to treat blood cancer patients without access to suitable donor cells.
The approval was granted to the company’s subsidiary, Cordex Biologics.
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Zemcelpro is intended for adults with haematological malignancies who require allogeneic haematopoietic stem cell transplantation after myeloablative conditioning.
This authorisation enables the distribution of Zemcelpro across European Union (EU) member states, as well as in Iceland, Norway and Liechtenstein.
Also referred to as UM171 Cell Therapy, Zemcelpro combines UM171-expanded CD34+ cells and unexpanded CD34- cells derived from the same cord blood unit. It aims to offer a transplant option for patients lacking suitable donor cells.
Zemcelpro is a therapy developed to increase access to life-saving transplants, potentially reducing healthcare burdens associated with blood cancers.
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By GlobalDataExCellThera and Cordex Biologics CEO David Millette stated: “This authorisation marks a pivotal milestone in delivering on the therapeutic promise of Zemcelpro for adults battling life-threatening haematological malignancies.
“As the first and only cell therapy approved for patients without access to suitable donor cells, Zemcelpro offers a vital new stem cell transplant option — and renewed hope — for those who have been left without one.”
The approval follows a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in June 2025. The committee acknowledged Zemcelpro’s ability to induce neutrophil and platelet engraftment based on two Phase II clinical studies.
Cordex Biologics has tested Zemcelpro on 120 patients in trials across the US, Europe and Canada. The treatment has received several regulatory designations, including orphan drug status from the US Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) designation from the EMA.
ExCellThera plans further regulatory submissions in the US, the UK, Canada and Switzerland.
Cordex Biologics is engaging with national health authorities to expedite early patient access before reimbursement processes are finalised.
The future availability of Zemcelpro will depend on national reimbursement outcomes. A Phase III trial targeting high-risk acute leukaemias and myelodysplasias is planned. The safety profile of Zemcelpro aligns with that of conventional allogeneic stem cell transplantation methods.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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