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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bi-functional antibody fusion protein targeting both cluster of differentiation 39 (CD39) and transforming growth factor beta (TGF-beta)
Date Designated: 02/15/2026
Orphan Designation: treatment of desmoid tumors
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Elpiscience (Suzhou) Biopharma, Ltd.
Unit E729, 5F, Lecheng Square, 218 Sangtian St., SIP
Suzhou, Jiangsu 215127
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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