ExCellThera secures German NUB Status 1 listing for Zemcelpro

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.

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