ExCellThera and its wholly owned subsidiary Cordex Biologics have received a Status 1 listing from the Neue Untersuchungs- und Behandlungsmethoden (NUB) programme in Germany for Zemcelpro (dorocubicel), also known as UM171 Cell Therapy.
This follows growing clinical evidence for Zemcelpro and interest from 220 hospitals in the country for potential use through the NUB mechanism from 2026.
The European Commission (EC) recently granted conditional marketing authorisation to Zemcelpro for use in adults with haematological malignancies needing allogeneic stem cell transplantation after myeloablative conditioning, where no other suitable donor cells are available.
With NUB status, Cordex plans to work with German transplant centres on individual NUB applications and expand clinical adoption.
The company will also participate in post-market registries and generate data to facilitate long-term reimbursement and the inclusion of Zemcelpro in clinical guidelines.
The availability of the therapy in individual European countries depends on various factors such as the completion of national reimbursement procedures.
Further regulatory submissions are planned for the US, Canada, Switzerland, and the UK. Cordex is pursuing strategic partnerships to support the global commercialisation of Zemcelpro.
The cryopreserved haematopoietic stem cell therapy is composed of UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, both sourced from a single cord blood unit.
More than 120 patients with haematologic malignancies took part in clinical trials across Canada, Europe, and the US.
ExCellThera CEO David Millette said: “NUB Status 1 represents a significant milestone for ExCellThera and Cordex and reflects both the innovative nature of Zemcelpro (dorocubicel) and its benefit in addressing a pressing unmet medical need in allogeneic haematopoietic stem cell transplantation.
“Under its initial label, Zemcelpro (dorocubicel) is indicated for patients with life-threatening blood cancers who have limited therapeutic options.”
In August 2025, ExCellThera announced that the EC granted conditional marketing authorisation for its Zemcelpro cell therapy to treat blood cancer patients without access to suitable donor cells.
