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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 nephron progenitor cells from human-induced pluripotent stem cells
Date Designated: 05/27/2026
Orphan Designation: prevention of delayed graft function in renal transplant recipients
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Asia Regenerative Medicine Co., Ltd.
11th Floor, Building A, Building 1, Silver Star Intelligent World Phase 2, Silver Star Technology Park, Longhua District
Shenzhen, Guangdong 518110
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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