Ascentage Pharma (AAPG) said Sunday it has received clearance from the US Food and Drug Administration and the European Medicines Agency to conduct a phase 3 study of its drug lisaftoclax in combination with azacitidine for the treatment of patients with newly diagnosed higher-risk myelodysplastic syndrome.

The study is now enrolling patients at participating centers in China, the US and Europe, the company said.

The randomized, double-blind study marks the second registrational phase 3 study of the drug to receive clearance from both the FDA and EMA, the company said.

Myelodysplastic syndrome is a disease originating from hematopoietic stem cells that can lead to acute myeloid leukemia.