By Fineline Cube 
Beijing-headquartered biotech company InnoCare Pharma (HKG: 9969, SHA: 688428) announced that it has received clinical approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This approval paves the way for the company to evaluate its pipeline B-cell lymphoma-2 (BCL2) inhibitor, ICP-248, in combination with azacitidine for the treatment of myeloid malignancies, including myelodysplastic syndromes (MDS).
ICP-248: A Novel BCL2 Inhibitor
ICP-248 represents a novel, oral, and highly selective BCL2 inhibitor. BCL2 is a pivotal regulatory protein in the apoptosis pathway, and its abnormal expression is implicated in the development of various hematological malignancies. ICP-248 selectively inhibits BCL2, restoring programmed cell death in tumor cells and thereby exerting its anti-tumor effects.
Clinical Progress and Regulatory Milestones
InnoCare Pharma’s ICP-248 has been granted Breakthrough Therapy Designation (BTD) by the CDE for the treatment of patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who are resistant to BTK inhibitors. This makes it the first BCL2 inhibitor in China to receive BTD status. Additionally, the company is accelerating patient enrollment for a regulatory Phase III study of mesutoclax in combination with orelabrutinib as first-line treatment for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and clinical trials for acute myeloid leukemia (AML).-Fineline Info & Tech