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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 consisting of a B7-H3-directed monoclonal antibody conjugated to MF-6
Date Designated: 07/15/2024
Orphan Designation: Treatment of small cell lung cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Mabwell (Shanghai) Bioscience Co., Ltd.
230 Cailun Road, China (Shanghai) Pilot Free Trade Zone
RM105, Building 2
Shanghai
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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