Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: FC-fusion bispecific antibody targeting extracellular domains II and IV of HER 2 and FC-fusion bispecific IgG1 antibody inhibiting PD-L1 and CTLA-4
Date Designated: 12/21/2020
Orphan Designation: Treatment of Gastric Cancer, including Cancer of the Gastroesophageal Junction
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Jiangsu Alphamab Biopharmaceuticals Co., Ltd.
Bldg. C23, 218 Xinghu Street
SIP
SuZhou
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-