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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Autologous synthetic NKG2D receptor armored CLDN18.2 specific CAR-T cell injection
Date Designated: 08/15/2023
Orphan Designation: Treatment of gastric cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Suzhou Immunofoco Biotechnology Co., Ltd
Unit 504-506, Bldg A3, Creative Industry Park, Xinghu Street
Suzhou Industrial Park, Jiangsu Province
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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