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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 IgG1 bispecific antibody targeting CD33 and CD123
Date Designated: 01/05/2026
Orphan Designation: treatment of acute myeloid leukemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Nanjing RegeneCore Biotech Co., Ltd.
Building 07, 16 Treehouses, No. 73 Tanmi Road, Jiangbei New  Area
Nanjing
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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