Antengene Secures China IND Approval for Autoimmune Disease Drug

MT Newswires Live

Jun 10

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.

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