InnoCare Wins OK to Trial BCL2 Drug Mesutoclax for MDS

InnoCare Wins OK to Trial BCL2 Drug Mesutoclax for MDS

By, Admin 30 May 2025

InnoCare Pharma has received approval from the Centre for Drug Evaluation (CDE) under the China National Medical Products Administration (NMPA) to begin clinical trials of mesutoclax (ICP-248), a selective B-cell lymphoma-2 (BCL2) inhibitor, for the treatment of myeloid malignancies, including myelodysplastic syndromes (MDS).

Mesutoclax is an orally administered, selective inhibitor of BCL2, a protein that plays a central role in regulating apoptosis. Abnormal overexpression of BCL2 contributes to the development of various hematologic cancers. By targeting BCL2, mesutoclax seeks to restore programmed cell death in malignant cells, offering potential anti-tumour effects.

Addressing Unmet Needs in MDS

Myelodysplastic syndromes are a group of clonal blood disorders characterized by ineffective hematopoiesis, genetic abnormalities, and the potential to progress to acute myeloid leukaemia (AML). MDS primarily affects older adults, particularly those over the age of 70, and has an estimated incidence of 4 cases per 100,000 people annually.

The newly approved clinical trial will explore mesutoclax’s safety and efficacy in this challenging disease area, where therapeutic options remain limited.

Expanding Clinical Development Across Blood Cancers

Mesutoclax is already undergoing evaluation in multiple hematologic malignancies:

  • It has received Breakthrough Therapy Designation in China for BTKi-treated relapsed or refractory mantle cell lymphoma, the first BCL2 inhibitor to achieve this status in the country.
  • A Phase III trial is currently assessing its combination with orelabrutinib as a first-line treatment for chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).
  • A separate clinical trial is investigating its use in acute myeloid leukaemia (AML).

This latest approval marks the fourth clinical indication for mesutoclax, reinforcing InnoCare’s commitment to advancing innovative treatments for blood cancers in China and globally.

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