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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: a bispecific antibody targeting CD3 and CLDN18.2
Date Designated: 03/23/2026
Orphan Designation: treatment of pancreatic cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Anova Innovation Limited
Room 1911, Lee Garden One, 33 Hysan Avenue
Causeway Bay 999077
Hong Kong

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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