ExCellThera Inc. and its wholly owned subsidiary Cordex Biologics have achieved a significant milestone in Germany for their novel blood stem cell therapy Zemcelpro® (dorocubicel) by obtaining a Status 1 listing under the Neue Untersuchungs- und Behandlungsmethoden (NUB) programme.
This designation, recognised by the German hospital reimbursement system, permits hospitals to initiate temporary, supplementary reimbursement applications for the therapy while broader payment pathways continue to be reviewed.
Zemcelpro®—also referred to as UM171 Cell Therapy—is designed for patients with life-threatening haematological malignancies who require allogeneic haematopoietic stem cell transplantation but lack suitable donor cells. The NUB Status 1 decision reflects an assessment that the treatment is backed by a substantive and expanding body of clinical evidence, a prerequisite for hospitals to seek provisional reimbursement within the German statutory healthcare system. Interest in accessing Zemcelpro® through the NUB mechanism has already been expressed by more than 220 German hospitals for the 2026 calendar year.
Earlier in 2025, the European Commission granted conditional marketing authorisation for Zemcelpro® for adult patients in need of stem cell transplantation after intensive conditioning, where no alternative donor cells are available, marking an important regulatory step for cell-based therapies in the European Union.
Germany’s NUB programme is designed to support the early adoption of innovative treatments by enabling supplementary reimbursement while formal assessment and national pricing negotiations continue. With this status in place, Cordex plans to work closely with leading stem cell transplant centres across Germany to support individual hospital applications and broaden clinical use. Parallel activities include participation in post-market registries and generation of clinical and health economic evidence to support longer-term reimbursement decisions and potential inclusion in clinical practice guidelines.
Zemcelpro® is a personalised, cryopreserved haematopoietic stem cell transplantation product composed of UM171-expanded CD34+ cells (dorocubicel) combined with unexpanded CD34- cells from the same cord blood unit. The therapy has been evaluated in clinical trials involving patients with high-risk leukemias and myelodysplastic syndromes in the United States, Europe and Canada, and is being investigated for broader applications, including pediatric and non-malignant haematological diseases.
Additional regulatory filings for Zemcelpro® are planned in other major markets, including the United States, Canada, the United Kingdom and Switzerland, and Cordex continues to pursue strategic partnerships to support global commercialisation efforts.
This NUB Status 1 listing strengthens Zemcelpro®’s market access foundation in Germany and could serve as a bridge toward more permanent reimbursement frameworks, potentially expediting patient access to this advanced cell therapy for serious blood cancers.
