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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: messenger ribonucleic acid (mRNA) encoding for GPC3xCD3 bispecific T-cell engagers, encapsulated in lipid nanoparticle (LNP)
Date Designated: 11/14/2025
Orphan Designation: treatment of hepatocellular carcinoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Beijing Jitai Life Sciences Ltd.
4th Floor, 101, Building 9, Courtyard 9, Yongteng North Road, Haidian District
Beijing
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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