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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: humanized anti-B7H3 IgG1 monoclonal antibody covalently linked to a topoisomerase inhibitor
Date Designated: 04/24/2026
Orphan Designation: treatment of small cell lung cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
CSPC Megalith Biopharmaceutical Co., Ltd.
No.896 Zhongshan East Road, High-tech Development Zone
Shijiazhuang, Hebei Province 050035
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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