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Zemcelpro® distribution agreement announced for Argentina, Hong Kong and Singapore

16 luglio 2026 | 13.01

LETTURA: 4 minuti

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MONTREAL, July 16, 2026 /PRNewswire/ -- ExCellThera Inc. ("ExCellThera"), a global leader in blood stem cell expansion and metabolic fitness technologies and parent company of Cordex Biologics ("Cordex"), today announced that Cordex has entered into an agreement granting FarmaMondo SA ("FarmaMondo") distribution rights for Zemcelpro^® (dorocubicel), also known as UM171 Cell Therapy, in Argentina, Hong Kong and Singapore.

Zemcelpro^® is a novel personalized cryopreserved hematopoietic stem cell transplantation product containing two cellular components: UM171-expanded CD34+ cells (dorocubicel); and unexpanded CD34- cells, each derived from the same cord blood unit. It is indicated in the European Union for the treatment of adult patients with hematological malignancies requiring allogeneic hematopoietic stem cell transplantation following myeloablative conditioning where no suitable donor is available.

Under the agreement, FarmaMondo will support early access programs for Zemcelpro^® in the agreed territories by leveraging its expertise in regulatory, market access and specialty distribution services for innovative medicines across international and emerging markets. The agreement is intended to facilitate access to Zemcelpro^® for eligible patients through applicable early access pathways in the covered territories.

This agreement represents a further step in Cordex's global access strategy for Zemcelpro^®. Cordex continues to pursue additional pathways and strategic partnerships to support and accelerate access to Zemcelpro^® across Europe and international markets.

"This agreement with FarmaMondo represents an important milestone in our early access strategy and reflects our continued commitment to advance Zemcelpro^® for patients with significant unmet medical needs," said David Millette, CEO of Cordex. "We continue to see significant interest from physicians, transplant centers and commercial partners in innovative therapies that address persistent unmet needs in blood cancers and stem cell transplantation," added Mr. Millette. "Our priority remains to enable responsible patient access while advancing our global regulatory and commercial strategy for Zemcelpro^®."

"We are pleased to partner with Cordex to support access to Zemcelpro^® in Argentina, Hong Kong and Singapore," said Yaron Spigel, CEO of FarmaMondo. "This collaboration aligns with FarmaMondo's mission to help deliver innovative, specialty and life-saving medicines to eligible patients in markets where access pathways can be complex. We look forward to working closely with Cordex to support treating physicians and transplant centers."

About Zemcelpro^®

Zemcelpro^® (dorocubicel), also known as UM171 Cell Therapy, is a novel personalized cryopreserved haematopoietic stem cell transplantation product developed by Cordex, containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit.

Zemcelpro^® has recently received conditional marketing authorization from the European Commission for the treatment of adults with haematological malignancies requiring allogeneic haematopoietic stem cell transplantation following myeloablative conditioning, for whom no other suitable donor cells are available. For complete product information, including warnings and precautions for use and adverse reactions (and their appropriate management), please refer to the EU Summary of Product Characteristics (SmPC) for Zemcelpro^®.

Additional regulatory filings are planned for Zemcelpro^® with other health authorities, including in the US, Canada, the UK, and Switzerland.

Zemcelpro^® has been evaluated in over 120 patients with haematologic malignancies in clinical trials in the United States, Europe and Canada. Zemcelpro^® has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designations from the FDA as well as orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification and priority medicines (PRIME) designation from the EMA.

Zemcelpro^® has been tested in Phase 2 trials in patients with high- and very high-risk acute leukemias and myelodysplasias who have limited treatment options with low survival outcomes and high incidence of relapse under the current standard of care, including patients with TP53 mutations or other genetic abnormalities, patients requiring a second transplant, and patients with refractory or active disease. A pivotal Phase 3 trial in this patient population will be initiated as soon as possible.

The use of Zemcelpro^® in other patient populations, including pediatric patients and patients with non-malignant haematological diseases, is also being investigated.

For more information, visit zemcelpro.com

Zemcelpro^® is a registered trademark of Cordex or its related companies.

About FarmaMondo

FarmaMondo is an international commercialisation partner specialising in enabling access to innovative and complex therapies in emerging and underserved markets. By combining global coordination with local execution, FarmaMondo supports pharmaceutical and biotechnology companies in delivering treatments through structured and compliant pathways while actively managing the regulatory, pricing, market access, medical affairs and operational risks associated with expansion, enabling access to medicines where patient needs remain unmet. For more information, visit farmamondo.com.

About ExCellThera and UM171 Technology

ExCellThera is a world leader in enhanced blood stem cell therapies. ExCellThera's proprietary Enhance^TM platform for cell expansion and metabolic fitness is designed to deliver a greater dose of functional therapeutic stem cells by expanding haematopoietic stem cells (HSCs) from any source and counteracting the effects of culture or gene editing induced stress. ExCellThera partners with biopharmas to help them develop best-in-class cell and gene therapies by leveraging the technologies that form the Enhance^TM platform, including the proprietary molecule UM171 which has a first-in-class mechanism of action for ex vivo expansion and metabolic fitness of HSCs. For additional information, visit excellthera.com, and follow us on LinkedIn.