Antengene (HKG:6996) said China's National Medical Products Administration has approved an Investigational New Drug (IND) application for a Phase I study of ATG-201, according to a voluntary filing on the Hong Kong Stock Exchange on Wednesday.
The ATG-201 is a CD19/CD3 bispecific T-cell engager antibody targeting B-cell-related autoimmune diseases.
The company plans to promptly initiate the Phase I trial in China while concurrently preparing for clinical development in Australia.
Antengene has secured 33 IND approvals in the U.S. and Asia, 10 NDA approvals across Asia-Pacific markets, and its lead asset XPOVIO (selinexor) is approved in 10 markets and included in five national insurance schemes.
The Group cautions that it cannot guarantee ATG-201 will be successfully developed and marketed.