ExCellThera Inc. subsidiary Cordex Biologics announced exclusive licensing and supply agreements granting Avanzanite Bioscience B.V. commercialization rights for Zemcelpro across 32 European countries on November 9, 2026.
The deal covers the European Economic Area, the United Kingdom, and Switzerland, according to a corporate press release. Zemcelpro, also known as UM171 Cell Therapy or dorocubicel, is a personalized cryopreserved hematopoietic stem cell transplantation product designed to treat blood cancers like leukemias and myelodysplasias.
Commercial Rights Across 32 Territories
Under the terms of the agreement, Amsterdam-headquartered Avanzanite will assume responsibility for regulatory activities, market access, pricing, reimbursement, medical affairs, commercial operations, and distribution. Cordex will continue leading global development while managing the manufacturing and supply of the cell therapy. Once regulatory transfers are complete, Avanzanite will hold the existing European Union marketing authorization.
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The European Commission previously granted conditional marketing authorization to Zemcelpro for adult patients with haematological malignancies who require allogeneic haematopoietic stem cell transplantation following myeloablative conditioning when no suitable donor is available. Avanzanite also intends to submit marketing authorization applications in the UK and Switzerland.
This partnership reflects why Avanzanite was founded: to unlock the full potential of innovative medicines for patients with rare diseases, said Adam Plich.
Plich added that the company shares Cordex’s commitment to bringing the treatment to blood cancer patients who have an urgent need and no other suitable options.
Funding Phase 3 Development
The transaction structure includes development fees, commercial milestone payments, and royalties. These financial provisions establish a shared economic interest in the product’s commercial performance while directly supporting the funding of a planned Phase 3 clinical trial.
This upcoming study will evaluate Zemcelpro in patients with high- and very high-risk acute leukemias and myelodysplastic syndromes. The trial aims to generate confirmatory evidence of efficacy and safety to support a potential indication expansion for patient groups facing low survival outcomes and high relapse rates under current standards of care.
These agreements with Avanzanite represent an important milestone in bringing Zemcelpro to patients across Europe with significant unmet medical needs and advancing our global commercialization strategy, said Cordex CEO David Millette.
Millette noted that Avanzanite’s pan-European presence and expertise in rare disease treatment launches and market access make the company a strong strategic fit as Cordex continues to actively pursue additional strategic partnerships to support and accelerate the commercialization of Zemcelpro in the U.S. and other international markets.
| Partner | Role | Territory |
|---|---|---|
| Cordex Biologics | Global Development & Manufacturing | Global (Supply to Europe) |
| Avanzanite Bioscience | Commercialization & Regulatory Operations | EEA, UK, and Switzerland (32 Countries) |
Zemcelpro has undergone evaluation in more than 120 patients across clinical trials in the United States, Europe, and Canada. The product holds orphan drug designation and regenerative medicine advanced therapy (RMAT) status from the FDA, alongside orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification, and PRIority MEdicines (PRIME) designation from the European Medicines Agency.
