Zemcelpro

Opinion

EMA has issued an opinion on this medicine

allogeneic umbilical cord-derived CD34- cells, non-expanded / dorocubicel

Overview

On 19 June 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional¹marketing authorisation for the medicinal product Zemcelpro², intended for the treatment of adults with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation for whom no other type of suitable donor cells is available.

As Zemcelpro is an advanced therapy medicinal product, the CHMP positive opinion is based on an assessment by the Committee for Advanced Therapies. The applicant for this medicinal product is Cordex Biologics International Limited.

The two active substances of Zemcelpro, dorocubicel and non-expanded CD34- cells are stem cells from umbilical cord blood (ATC code: B05AX04). Dorocubicel consists of CD34+ cells expanded ex-vivo. Zemcelpro will be available as a ≥0.23 x 10⁶ viable CD34+ cells/ml / ≥0.53 x 10⁶ viable CD3+ cells/ml dispersion for infusion. Once infused to the patient, the cells from Zemcelpro migrate to the bone marrow where they divide, mature and differentiate in all haematological cell lineages.

The benefit of Zemcelpro is its ability to induce neutrophil and platelet engraftment, as observed in two single-arm, open label, phase 2 clinical studies. The most common side effects with Zemcelpro include lymphopenia, infections, anaemia, neutropenia, thrombocytopenia, leukopenia, hypogammaglobulinaemia, febrile neutropenia, hypertension, engraftment syndrome, pneumonia, and graft-versus-host disease (GvHD).

The full indication is:

Zemcelpro is indicated for the treatment of adult patients with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available.

Zemcelpro should be administered in a qualified transplant centre with expertise in haematopoietic stem cell transplant by a physician with experience in the treatment of haematological malignancies.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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¹ A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is expected to provide comprehensive clinical data at a later stage.

² This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained.

CHMP summary of positive opinion for Zemcelpro

AdoptedReference Number: EMA/CHMP/189609/2025

Product details

• Name of medicine:
  Zemcelpro
• Active substance:
  • allogeneic umbilical cord-derived CD34- cells, non-expanded
  • dorocubicel
• International non-proprietary name (INN) or common name:
  • allogeneic umbilical cord-derived CD34- cells, non-expanded
  • dorocubicel
• Therapeutic area (MeSH):
  • Hematologic Neoplasms
  • Hematopoietic Stem Cell Transplantation
• Anatomical therapeutic chemical (ATC) code:
  B05AX04
• EMA product number:
  EMEA/H/C/005772
• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• PRIME: priority medicine:

  This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.

• Marketing authorisation applicant:
  Cordex Biologics International Limited
• Opinion adopted:
  19/06/2025
• Opinion status:
  Positive