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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: a humanized bispecific monoclonal antibody against PD-L1 and 4-1BB
Date Designated: 11/20/2024
Orphan Designation: treatment of neuroendocrine carcinoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Nanjing Leads Biolabs Co., Ltd.
122 Huakang Road
Building 5, Jiangbei New Area
Nanjing, Jiangsu 210031
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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