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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: an antibody-drug conjugate composed of a humanized monoclonal antibody PM-012C against fibroblast growth factor receptor 2b (FGFR2b) conjugated to exatecan (topoisomerase I inhibitor) through a cleavable linker Pym-PEG8-Val-Ala-PAB
Date Designated: 02/09/2026
Orphan Designation: treatment of gastric cancer, including gastroesophageal junction 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, China 310011
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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