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 starting in 2026.
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.
Mechanism and Composition
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.
Clinical Data: More than 120 patients with haematologic malignancies took part in clinical trials across Canada, Europe, and the US, supporting the therapy's profile.
Regulatory Landscape
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.
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, as Cordex pursues strategic partnerships to support global commercialisation.
