BRIEF—Speedy review for Ascentage candidate in China

Ascentage Pharma has won priority review status from the Chinese regulator for its oncology candidate olverembatinib (HQP1351).

The firm’s subsidiary, Guangzhou Healthquest Pharma, has submitted for approval based on two pivotal studies in chronic myeloid leukemia (CML) and accelerated phase CML.

The decision means that China’s regulatory authority will prioritize the review and evaluation resources, to expedite the outcome of the process.

Ascentage chief medical officer Yifan Zhai said: "Olverembatinib is the drug candidate of Ascentage Pharma's first NDA submission, which will become the first third-generation BCR-ABL inhibitor therapeutics in China.”

Ascentage is focused on developing novel therapies for cancers, hepatitis B and age-related diseases.