Antengene Announces ATG-101 Granted Orphan Drug Designation by the US FDA – QNT Press Release


SHANGHAI and BUCKS COUNTY, Pa., Sept. 18, 2022 /PRNewswire/ — Antengene Corporation Limited (“Antengene” SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, today announced that ATG-101, the company’s in-house developed novel PD-L1/4-1BB bispecific antibody, has been granted an Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This ODD will help Antengene facilitate regulatory communication with the FDA, accelerate the clinical development and the future registration of ATG-101.

At present, no PD-L1/4-1BB bispecific antibody has been approved for the treatment of pancreatic cancer worldwide.

Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. Orphan Drug Designations by the US FDA are meant to support the development of drug candidates that could potentially bring substantial therapeutic benefits to patients with rare diseases (a condition with a prevalence of less than 200,000 in the US), and to provide incentives to the subsequent development, registration and commercialization to designated drugs. Those incentives include tax credit on…

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