Research & Development
Ascentage Pharma receives USFDA approval for APG-115
15 September 2020 -

It was reported on Monday that Ascentage Pharma (6855.HK), a clinical stage biotechnology company, has received approval from the US Food and Drug Administration (USFDA) for an orphan drug designation for its APG-115, a novel MDM2-p53 inhibitor aimed at treating gastric cancer.

The orphan drug designation provides various development incentives, including a tax credit on expenditures incurred in clinical studies, waiver of the New Drug Application fee, a research grant, and seven years of US market exclusivity should the product hit the market.

The product is an orally administered, selective, small-molecule inhibitor of the MDM2-p53 protein-protein interaction with strong binding affinity to MDM2, aimed at activating tumour suppression activity of p53 by blocking the MDM2-p53 PPI. Preclinical studies were promising.