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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: humanised monoclonal antibody-drug conjugate delivering an mTOR inhibitor payload
Date Designated: 12/09/2025
Orphan Designation: treatment of idiopathic pulmonary fibrosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bionevix Ltd
New Burlington House
1075 Finchley Road
London, London NW11 0PU
United Kingdom

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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