Leveraging FarmaMondo’s international specialty commercialization capabilities and experience facilitating access to innovative medicines, ExCellThera Inc. (“ExCellThera”), a global leader in blood stem cell expansion and metabolic fitness technologies, together with its wholly owned subsidiary Cordex Biologics International Ltd (“Cordex”) have announced a new commercial partnership in Singapore, Hong Kong and Argentina, expanding availability in markets where patients have limited treatment options, initially through Named Patient Sales.
This partnership reflects a shared commitment to addressing unmet medical needs and ensuring that patients, regardless of location, can access innovative therapies through structured, compliant access pathways.
Zemcelpro® is a groundbreaking stem cell therapy indicated for adult patients with blood cancers, including acute leukemias and myelodysplasias, who require a donor stem cell transplant but for whom no suitable matched donor cells is available. For these patients, Zemcelpro® may be the only viable option to undergo a potentially curative stem cell transplant.
Cell therapies demand a higher level of operational excellence and precision across medical, regulatory, quality, supply chain, and local market functions. FarmaMondo’s agility, learning capacity and cross-functional capabilities will play a meaningful role in this journey, helping patients with life-threatening conditions reach a treatment that could genuinely change their outlook.
Supporting access to therapies in complex markets
As healthcare systems become increasingly fragmented and access pathways more complex, partnerships that combine global integration with local execution are essential. Through this agreement, FarmaMondo will provide:
- A centralised access model covering regulatory, compliance and supply
- Local expertise to navigate market-specific access and reimbursement environments
- A structured framework ensuring safe, ethical and compliant delivery to patients
This approach helps mitigate the operational and regulatory challenges often associated with delivering therapies across diverse and evolving healthcare systems, creating the conditions for successful launch execution, broader and faster patient access, and meaningful health outcomes for local populations with significant unmet medical needs.
Looking ahead
This partnership represents an important step in broadening access to Zemcelpro® and reinforces the importance of collaborative models that prioritise patient need while maintaining strong governance and compliance.
As demand for innovative therapies continues to grow beyond core markets, such partnerships will play a critical role in ensuring that medical advances reach the patients who need them most.
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 www.zemcelpro.com.
Zemcelpro® is a registered trademark of Cordex or its related companies.
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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, offering their partners peace of mind. FarmaMondo plays a critical role in ensuring that patients with high unmet need can access life changing therapies safely and efficiently.
For more information, visit www.farmamondo.com.
About ExCellThera and UM171 Technology
ExCellThera is a world leader in enhanced blood stem cell therapies. ExCellThera’s proprietary EnhanceTM 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 EnhanceTM 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.
