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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 single recombinant plasmid-derived DNA-based therapeutic vaccine specifically targeting the E6 and E7 antigens of both HPV 6 and HPV 11
Date Designated: 01/15/2026
Orphan Designation: treatment of recurrent respiratory papillomatosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Advaccine Biopharmaceuticals Suzhou Co., Ltd.
Room 308, Building B1, No.218 Xinghu Street
Suzhou 215125
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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