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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: recombinant human IL12/15-PDL1B HSV-1 oncolytic virus injection
Date Designated: 11/19/2025
Orphan Designation: treatment of hepatocellular carcinoma (HCC)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Virogin Biotech Canada Ltd
150-13511 Commerce Parkway
Richmond, BC V6V2J8
Canada

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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