Ascentage Pharma's New Leukemia Drug Approved In China

Ascentage Pharma has received approval from the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region of China for olverembatinib, its innovative BCR-ABL1 tyrosine kinase inhibitor. This approval covers its use in treating adults with chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) who have developed resistance to tyrosine kinase inhibitors (TKIs) harboring the T315I mutation, as well as adults with CML-CP who are resistant to or intolerant of first- and second-generation TKIs.

The company highlighted that this approval represents a significant achievement for olverembatinib, building on its earlier approvals in mainland China for the specified indications. Ascentage Pharma and Innovent Biologics are collaborating on the joint commercialization of olverembatinib in China. It's important to note that all lead drug candidates are currently under investigation and have not received approval in the U.S. Olverembatinib has received Orphan Drug Designations and Fast Track Designation from the U.S. Food and Drug Administration (FDA), as well as Orphan Designation from the European Medicines Agency (EMA) in the European Union.