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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: induced pluripotent stem cell (iPSC)-derived platelet injection
Date Designated: 12/19/2025
Orphan Designation: treatment of Bernard-Soulier syndrome
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
HemaCell Biotechnology Inc.
No. 21 Dongyanli Road, Bio-medicine Industrial Park Phase V,
Area B, Building 5, 5th Floor
Suzhou Industrial Park, Jiangsu Province
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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