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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 humanized anti-HER2 monoclonal antibody
Date Designated: 03/17/2025
Orphan Designation: treatment of gastric cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Shanghai Henlius Biotech, Inc.
Room 901, 9th Floor, Building 1, No. 367 Shengrong Road
China (Shanghai) Pilot Free Trade Zone
Shanghai, Shanghai 201203
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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