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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: recombinant fully human IgG1 anti-PDL1 monoclonal antibody conjugated to a DNA topoisomerase I inhibitor
Date Designated: 10/16/2025
Orphan Designation: treatment of thymic epithelial tumors
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Shanghai Henlius Biotech, Inc.
No. 367 Shengrong Road, China (Shanghai) Pilot Free Trade Zone
Room 901, 9th floor, Building 1
Shanghai, Shanghai 201210
China

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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