InnoCare Gains Approval to Launch Clinical Trial of BCL2 Inhibitor Mesutoclax for Myelodysplastic Syndromes
Thursday, May 29, 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 B-cell lymphoma-2 (BCL2) inhibitor, for the treatment of myeloid malignancies, including myelodysplastic syndromes (MDS).
Mesutoclax is an oral, selective BCL2 inhibitor. BCL2 is a key protein involved in regulating cell death (apoptosis), and its abnormal expression is linked to the development of various blood cancers. By targeting BCL2, mesutoclax aims to restore normal cell death processes in cancer cells, showing potential anti-tumour effects.
MDS is a group of complex blood disorders marked by abnormal growth of blood-forming stem cells, genetic changes, poor blood cell production, and a risk of developing into acute myeloid leukaemia (AML). It affects around 4 in 100,000 people each year, with higher rates in older adults, especially those over 70.
Mesutoclax has already received Breakthrough Therapy Designation in China for treating BTKi-treated relapsed or refractory mantle cell lymphoma, making it the first BCL2 inhibitor to achieve this recognition in the country. The drug is currently undergoing a Phase III trial in combination with orelabrutinib as a first-line therapy for chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL). A separate trial is also underway for its use in treating AML.
This newly approved study represents the fourth clinical indication for mesutoclax, with the company continuing to advance its development across several blood cancers both in China and internationally.
Source: businesswire.com
