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.
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Illumina's GRAIL divestment plan receives EC approval
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Ondine Biomedical's Steriwave approved for use by HCA UK
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML