Ascentage Pharma (HKG:6855) received clearance from the US Food and Drug Administration and the European Medicines Agency to begin a Phase 3 trial of its Bcl-2 inhibitor Lisaftoclax for newly diagnosed higher-risk myelodysplastic syndrome, according to a Monday Hong Kong bourse filing.

The global study, called GLORA-4, will test Lisaftoclax with azacitidine against standard treatment.

Enrollment has started in China and Europe, the filing said.

Earlier data showed a 75% response rate for the combo, far above current therapies.