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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) composed of a humanized immunoglobulin G1 (IgG1) antibody targeting tissue factor (TF) and YL0010014, a topoisomerase I inhibitor
Date Designated: 11/17/2025
Orphan Designation: treatment of pancreatic cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Evopoint Biosciences USA, Inc.
300 Baker Avenue, Suite 300
Concord, Massachusetts 01742
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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