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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: antibody-drug conjugate (ADC) consisting of a humanized anti-trophoblast cell surface antigen-2 (TROP2) antibody and a protease-cleavable linker-payload N-PM-0022 (BCN-GGVA-PAB(PEG24)-exatecan)
Date Designated: 12/04/2025
Orphan Designation: treatment of gastric cancer, including gastroesophageal junction cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
OBI Pharma USA Inc.
4275 Executive Square
Suite 200
La Jolla, California 92037
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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