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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 humanized IgG1 monoclonal antibody targeting human glypican-3 (GPC3) protein conjugated with exatecan via the MCC-AAQ linker
Date Designated: 12/09/2025
Orphan Designation: treatment of hepatocellular carcinoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Lepu Biopharma Co., Ltd.
No.1628, Suzhao Rd., Minhang District
Shanghai 201114
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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