Zemcelpro Receives NUB Status 1 in Germany, Enabling Hospital Reimbursement Applications

ExCellThera Inc., a global leader in blood stem cell expansion and metabolic fitness, and its wholly owned subsidiary Cordex Biologics announced that Zemcelpro (dorocubicel), also known as UM171 Cell Therapy, has been granted Status 1 listing by the NUB (Neue Untersuchungs- und Behandlungsmethoden) program in Germany. The NUB designation enables hospitals to immediately apply for temporary, supplementary reimbursement for its use while broader reimbursement pathways continue to be evaluated.

Notably, 220 hospitals across Germany have expressed interest in accessing Zemcelpro (dorocubicel) through the NUB mechanism for the 2026 calendar year. The NUB designation is a recognition that Zemcelpro (dorocubicel) is supported by a relevant and growing body of clinical evidence.

The CEO stated that NUB Status 1 represents a significant milestone 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.

Zemcelpro (dorocubicel) recently received conditional marketing authorization from the European Commission for the treatment of adults with haematological malignancies requiring allogeneic hematopoietic stem cell transplantation following myeloablative conditioning, and for whom no other suitable donor cell type is available.

With NUB status in place for Zemcelpro (dorocubicel), Cordex will work closely with leading German stem cell transplant centres to support individual NUB applications and further expand clinical adoption. In parallel, the company will invest in post-marketing registries and the generation of clinical and health economic data to support longer-term reimbursement and the inclusion of Zemcelpro (dorocubicel) in clinical guidelines. Together, these elements strengthen the commercial base of Zemcelpro (dorocubicel) in Germany and constitute a constructive bridge towards future permanent reimbursement under the health insurance scheme.

The availability of Zemcelpro (dorocubicel) in each European country depends on several factors, including the completion of national reimbursement procedures. In the meantime, Cordex is working closely with national health authorities to enable early access for eligible patients before the reimbursement process, and will cooperate with leading stem cell transplant centers to establish a network of treatment centers for the future administration of Zemcelpro (dorocubicel).

Zemcelpro, also known as UM171 cell therapy, is a novel cryopreserved hematopoietic stem cell transplant product comprising two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit.

Zemcelpro (dorocubicel), developed by Cordex, a wholly owned subsidiary of ExCellThera, has been evaluated in 120 patients with serious blood disorders in several clinical trials in the United States, Europe, and Canada. Zemcelpro (dorocubicel) has received Orphan Drug Designation and Advanced Therapy in Regenerative Medicine (RMAT) designation from the FDA, as well as Orphan Drug Designation, Advanced Therapy Medicinal Product (ATMP) classification, and Priority Medicine (PRIME) designation from the EMA.

Zemcelpro (dorocubicel) has been evaluated in phase 2 studies in patients with high- and very-high-risk acute leukaemias and myelodysplastic syndromes who have limited treatment options, poor survival outcomes, and a high relapse rate according to current standards of care. These studies include patients with refractory or active disease, patients requiring a second transplant, and patients with TP53 mutations or other genetic abnormalities. A pivotal phase 3 study in this patient population will be initiated as soon as possible.

The use of Zemcelpro (dorocubicel) in other patient populations, including paediatric patients and patients with non-malignant haematological diseases, is also under investigation.

Additional regulatory filings are planned for Zemcelpro (dorocubicel) with other health authorities, including in the United States, Canada, the United Kingdom and Switzerland. Cordex is also actively seeking strategic partnerships to support and accelerate the commercialization of Zemcelpro (dorocubicel) in Europe and other international markets.