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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 (ADC) composed of the humanized monoclonal antibody against CDH17, conjugated to exatecan (a topoisomerase (TOP) I inhibitor)
Date Designated: 03/09/2026
Orphan Designation: treatment of gastric cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd
866 Moganshan Road
Hangzhou, Zhejiang 310011
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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