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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 recombinant tri-specific T cell engager (TCE) targeting the T cell antigen CD3, BCMA and GPRC5D
Date Designated: 01/13/2026
Orphan Designation: treatment of multiple myeloma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Biotle Biotechnology (Hangzhou) Co., Ltd.
Room 10121, 1st Floor, No. 6899, Wentao Road, Puyan Sub-district, Binjiang District
Hangzhou, Zhejiang
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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