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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 replication-incompetent recombinant adeno-associated virus (rAAV) vector carrying a gene cassette that can express human Prominin1
Date Designated: 06/08/2026
Orphan Designation: treatment of PROM1-associated retinal dystrophy
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Langxin Qisheng (Suzhou) Biopharmaceutical Co., Ltd.
Room 101/201/301, Building C31, Bio-bay, No. 218, Xinghu Street, 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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