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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Humanized, Low-fucose Anti-Claudin 18.2 IgG1 Antibody with Enhanced ADCC
Date Designated: 07/26/2021
Orphan Designation: Treatment of gastric cancer including cancer of gastroesophageal junction
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Suzhou Traoscenta Therapeutics Co., Ltd.
218 Xinghu Street,Biobay, building B6-501
Suzhou, Jiangsu 215123
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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