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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: human HER2 intracellular domain-encoding plasmid DNA cancer vaccine
Date Designated: 06/17/2026
Orphan Designation: treatment of gastric cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Aston Sci. Inc.
A916-917, C Dong, 520, Misa-daero
Hanam-si, N/A 12925
South Korea

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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