On May 29, InnoCare Pharma announced that the company's independently developed new BCL2 inhibitor Mesutoclax (ICP-248) combined with azacitidine was approved by the National Medical Products Administration (NMPA) Drug Review Center (CDE) to conduct clinical studies for the treatment of myeloid malignancies, including but not limited to myelodysplastic syndrome (MDS).

It is understood that ICP-248 is a new oral, highly selective BCL2 inhibitor. BCL2 is an important regulatory protein in the cell apoptosis pathway, and its abnormal expression is associated with the occurrence and development of a variety of malignant blood tumors. ICP-248 selectively inhibits BCL2 and restores the programmed cell death mechanism of tumor cells, thereby exerting anti-tumor efficacy.

Myelodysplastic syndrome (MDS) is a myeloid neoplasm characterized by clonal proliferation of hematopoietic stem cells, recurrent genetic abnormalities, myeloid cell dysplasia, ineffective hematopoiesis, peripheral blood cell reduction, and a high risk of transformation to acute myeloid leukemia (AML). Approximately one-third of MDS patients progress to AML.

Currently, Mesutoclax has been granted Breakthrough Therapy Designation by the CDE for the treatment of patients with relapsed/refractory mantle cell lymphoma (R/R MCL) after resistance to BTK inhibitors. In addition, the Phase III registration clinical trial of Mesutoclax combined with Obtunib as the first-line treatment for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and the clinical trial for the treatment of AML are accelerating the enrollment of patients.

Dr. Cui Jisong, co-founder, chairman and CEO of InnoCare Pharma , said: "Mesutoclax is an important asset with global competitiveness in the field of hematological malignancies. We are very pleased to see that the fourth indication of Mesutoclax has been approved for clinical trials. We will speed up the clinical trials of Mesutoclax in multiple centers and indications in China and around the world to benefit patients as soon as possible."

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