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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bispecific antibody-drug conjugate composed of a topoisomerase inhibitor conjugated by a cleavable linker to a fully humanized anti-MUC1/HER3 IgG1 bispecific antibody
Date Designated: 08/05/2026
Orphan Designation: treatment of small cell lung cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
3F, C29 Building, Biomedical Industrial Park, No.218 Xinghu Street
Suzhou, Jiangsu 215123
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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