TST001 Wins US FDA Orphan Drug Designation

Release Date: 12-Sep-2021

US FDA has granted Orphan Drug Designation to TST001 for the treatment of gastric cancer or gastroesophageal junction (GC/GEJ). Gastric cancer is a rare disease in US but has a higher incidence in Asian countries such as China and Japan. It is the third leading cause of cancer deaths in the whole world.


TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being established globally after Zolbetuximab (IMAB362). TST001 can kill Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which additionally improved the ADCC-mediated tumor killing activity of TST001. TST001 displayed more potent anti-tumor activities than IMAB362 analog in mouse xenograft experiments. TST001 is a high-affinity recombinant humanized monoclonal antibody targeted Claudin18.2.


The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S and it also gives several benefits, like tax credits for qualified clinical trials, potential seven years of market exclusivity after approval and exemption from user fees.

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