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: envafolimab
Date Designated: 12/12/2025
Orphan Designation: treatment of gastric cancer and gastro-esophageal junction cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
3D Medicines (Sichuan) Co., Ltd
No. 318 Huazhaobi Xishun Street, Jinniu District
Room 1201, Unit 1, Building 1,
Chengdu, Sichuan 610036
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-