Zemcelpro (dorocubicel) Receives NUB Status 1 in Germany and Expands Asia Access
Zemcelpro (dorocubicel) has achieved NUB Status 1 in Germany, enabling hospitals to seek temporary reimbursement, while Cordex Biologics expanded access to Asia and Argentina through a distribution deal with FarmaMondo. The cell therapy holds conditional EU authorization for certain blood cancers.
Zemcelpro (dorocubicel), a personalized cryopreserved haematopoietic stem cell transplantation product, has been granted NUB Status 1 in Germany, a designation that enables hospitals to immediately apply for temporary, supplementary reimbursement for its use. Concurrently, Cordex Biologics, a subsidiary of ExCellThera, has entered into a distribution agreement with FarmaMondo to provide early access to the therapy in Argentina, Hong Kong, and Singapore.
The NUB Status 1 listing, announced by ExCellThera on Feb. 16, 2026, reflects growing clinical evidence supporting Zemcelpro. Already, 220 hospitals across Germany have expressed interest in accessing Zemcelpro through this mechanism for the 2026 calendar year.
Under the distribution agreement, FarmaMondo will use its regulatory, market access and specialty distribution capabilities to support early access programmes in the covered territories. Hong Kong and Singapore are specialist healthcare hubs with advanced haematology and transplant services, where access to novel cell therapies can depend on regulatory pathways, specialist centre readiness and commercial distribution partners.
Zemcelpro, also known as UM171 Cell Therapy, contains two cellular components derived from the same cord blood unit: UM171-expanded CD34+ cells and unexpanded CD34- cells. It has received conditional marketing authorization from the European Commission for adults with haematological malignancies requiring allogeneic haematopoietic stem cell transplantation after myeloablative conditioning and who have no suitable donor cells available.
The product has been evaluated in 120 patients with haematologic malignancies in clinical trials in the United States, Europe and Canada. It holds FDA orphan drug and regenerative medicine advanced therapy (RMAT) designations, as well as EMA orphan medicinal product, advanced therapy medicinal product (ATMP) classification and priority medicines (PRIME) designation.
Cordex plans additional regulatory filings with health authorities including the United States, Canada, the United Kingdom and Switzerland. A pivotal Phase 3 trial is planned in patients with high- and very high-risk acute leukaemias and myelodysplasias, who have limited treatment options with low survival outcomes and high incidence of relapse under current standard of care. The company will also invest in post-market registry participation and evidence generation to support longer-term reimbursement and inclusion in clinical guidelines in Germany.
The CEO of ExCellThera described NUB Status 1 as a significant milestone that reflects the innovative nature of Zemcelpro and its benefit in addressing a pressing unmet medical need in allogeneic haematopoietic stem cell transplantation. Under its initial label, Zemcelpro is indicated for patients with life-threatening blood cancers who have limited therapeutic options.
Cordex is actively seeking strategic partnerships to support the commercialization of Zemcelpro in Europe and other international markets. The product’s safety and efficacy have not yet been established by the U.S. FDA.