Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: antibody-conjugate, consisting of a N1-methylpseudoruine-modified mRNA encoding the anti-CD19 CAR and a targeting ligand, a single domain antibody fragment conjugated to the LNP surface
Date Designated: 10/14/2026
Orphan Designation: treatment of autoimmune hemolytic anemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Vivacta Biotechnology (Shanghai) Co., Ltd.
No. 778, Chuangxin West Road, Pilot Free Trade Zone
Shanghai, Shanghai 200120
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-