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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: antibody-drug conjugate consisting of a recombinant humanized anti-FGFR2b monoclonal antibody and the DNA topoisomerase I inhibitor exatecan
Date Designated: 04/08/2026
Orphan Designation: treatment of gastric cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Shanghai Allink Biotherapeutics Co., Ltd
10/F, Building 2, Jinchuang Building, 4560 Jinke Road
Pudong New Area
Shanghai, Shanghai 201210
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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