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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 universal platelet-promoting megakaryocyte derived from umbilical cord blood
Date Designated: 01/13/2026
Orphan Designation: treatment of post-hematopoietic stem cell transplantation thrombocytopenia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
HemaNiche Biotech Co., Ltd
Shangdi Information Road, Haidian District
Room A203, 2nd Floor, Building 1, No. 12
Beijing, Beijing 100084
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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