ExCellThera Secures German NUB Status 1 Listing for Zemcelpro

Why It Matters

The NUB listing paves the way for early reimbursement and clinical uptake in Germany, the EU’s largest stem‑cell transplant market, accelerating access to a novel donor‑independent therapy. This could reshape treatment pathways for high‑risk blood‑cancer patients and boost ExCellThera’s commercial trajectory.

Key Takeaways

• Received German NUB Status 1 listing for Zemcelpro.
• Interest from 220 German hospitals for 2026 use.
• EC granted conditional marketing authorisation for blood cancers.
• Therapy uses UM171‑expanded CD34+ cells from cord blood.
• Regulatory submissions planned for US, Canada, Switzerland, UK.

Pulse Analysis

The emergence of UM171‑expanded cord‑blood cell products marks a turning point in hematopoietic stem‑cell transplantation. Zemcelpro combines expanded CD34+ progenitors with unexpanded CD34‑ cells, delivering a donor‑independent graft that can bridge the shortage of matched donors. Clinical data from more than 120 patients across Canada, Europe and the United States demonstrate comparable engraftment kinetics and safety profiles to traditional bone‑marrow transplants, positioning the therapy as a viable option for high‑risk hematologic malignancies.

Germany’s Neue Untersuchungs‑ und Behandlungsmethoden (NUB) programme offers a fast‑track pathway for innovative therapies, and a Status 1 listing signals both clinical relevance and potential reimbursement. With 220 hospitals indicating intent to use Zemcelpro by 2026, the listing could unlock a sizable market segment, given that Germany accounts for roughly 30% of Europe’s allogeneic transplant volume. Early adoption through individual NUB applications will also generate real‑world evidence, feeding into post‑market registries that support long‑term pricing and guideline inclusion.

Looking ahead, ExCellThera’s strategy extends beyond Europe. Parallel submissions to health authorities in the United States, Canada, Switzerland and the United Kingdom aim to replicate the German momentum on a global scale. Strategic partnerships are being explored to accelerate commercial rollout, while ongoing data collection will address payer concerns around cost‑effectiveness. If successful, Zemcelpro could set a new standard for off‑the‑shelf stem‑cell therapies, influencing both clinical practice and the broader biotech investment landscape.

ExCellThera secures German NUB Status 1 listing for Zemcelpro

Image description: A gloved hand uses a pipette to transfer liquid into a test tube, amidst a lab setting with racks of test tubes and other scientific equipment.

Over 120 patients with haematologic malignancies took part in clinical trials across Canada, Europe, and the US. Credit: Anamaria Mejia / Shutterstock.com.

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 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.

More than 120 patients with haematologic malignancies took part in clinical trials across Canada, Europe, and the US.

ExCellThera CEO David Millette said:

“NUB Status 1 represents a significant milestone for ExCellThera and Cordex 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.”

In August 2025, ExCellThera announced that the EC had granted conditional marketing authorisation for its Zemcelpro cell therapy to treat blood‑cancer patients without access to suitable donor cells.