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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bispecific Fc fusion protein containing a CD80 ectodomain and an IL-2v3 moiety
Date Designated: 06/10/2024
Orphan Designation: treatment of soft tissue sarcoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
GI Innovation, Inc.
A-1116 Tera Tower, 167
Songpa-daero Songpa-gu
Seoul, Seoul 05855
South Korea

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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