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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: an engineered immunoglobulin variable (IgV) domain of human SIRPalpha fused to human IgG4 Fc protein
Date Designated: 02/12/2026
Orphan Designation: treatment of gastric cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
FBD Biologics Limited
Room 5, Flat 02-03, 20/F, Empress Plaza
17-19 Chatham Road South
Tsim Sha Tsui, Kowloon 999077
Hong Kong

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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