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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: a humanized MUC18-targeting IgG1 antibody conjugated with exatecan, a topoisomerase I inhibitor
Date Designated: 03/05/2026
Orphan Designation: treatment of soft tissue sarcoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Multitude Therapeutics Inc.
No. 159, Tianzhou Road, Xuhui District
Shanghai 200233
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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