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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: anti-CDH17 monoclonal antibody-DNA topoisomerase I inhibitor conjugate
Date Designated: 09/11/2026
Orphan Designation: treatment of gastric cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Wealth Venture US Inc
16192 Coastal Highway
Lewes, Delaware 19958
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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