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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 composed of an anti-B7-H3 IgG1 monoclonal antibody covalently linked to a topoisomerase I inhibitor (P1021)
Date Designated: 08/26/2024
Orphan Designation: treatment of small cell lung cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
DualityBio, Inc.
3524 Silverside Rd Suite 35B
Wilmington, Delaware 19810
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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