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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 comprised of a humanized anti-MUC1/HER3 bispecific antibody linked to a topoisomerase I inhibitor (BCPT02)
Date Designated: 02/11/2026
Orphan Designation: treatment of pancreatic cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
Room 301, Building C29, No.218 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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