The China National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) has approved United States-based Ascentage Pharma's (6855.HK) phase IIa clinical study of the firm's MDM2-p53 inhibitor APG-115, as a single agent or in combination with the company's novel Bcl-2 inhibitor APG-2575 intended for the treatment of patients with relapsed/refractory T-cell prolymphocytic leukaemia (r/r T-PLL), it was reported on Tuesday.

The United States Food and Drug Administration (FDA) has approved the study, prior to the clearance in China.

This global multicentre, open-label Phase IIa clinical study was aimed at assessing the safety, pharmacokinetics, and preliminary efficacy of the product as a single agent or in combination with APG-2575 for the treatment of patients with r/r T-PLL. The product is an orally administered, selective, small-molecule inhibitor of the MDM2 protein and has strong binding affinity to MDM2 and is aimed at activating tumour suppression activity of p53 by blocking the MDM2-p53 protein-protein interaction. It is the first MDM2-p53 inhibitor entering clinical development in China, with multiple ongoing clinical studies in solid tumours and hematologic malignancies in China and the United States.