Cordex Biologics, a subsidiary of ExCellThera, is expanding global access to its next-generation stem cell therapy Zemcelpro (dorocubicel), also known as UM171 Cell Therapy, through a new distribution agreement covering Argentina, Hong Kong and Singapore.

 

Under the agreement, international specialty medicines company FarmaMondo SA will receive distribution rights for Zemcelpro and support early access programs in the three markets, using its expertise in regulatory affairs, market access and specialty distribution to help bring the therapy to eligible patients.

 

Zemcelpro is a personalized, cryopreserved hematopoietic stem cell transplantation product designed for patients with certain blood cancers who require an allogeneic stem cell transplant but do not have access to a suitable donor. 

 

The therapy has received conditional marketing authorization from the European Commission for adults with hematological malignancies following myeloablative conditioning when no other suitable donor cells are available.

 

The partnership marks another step in Cordex’s strategy to broaden access to Zemcelpro across international markets while pursuing additional regulatory and commercial pathways worldwide.

 

"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 Millette. "Our priority remains to enable responsible patient access while advancing our global regulatory and commercial strategy for Zemcelpro."

 

FarmaMondo CEO Yaron Spigel said the collaboration would help expand access to advanced therapies in markets where navigating treatment pathways can be challenging.

 

"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."

 

Zemcelpro combines two cellular components derived from the same cord blood unit: UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells. The therapy is being developed to address longstanding challenges in stem cell transplantation, including donor availability and treatment options for patients with high-risk hematological malignancies.