Chinese Biopharmaceutical Company: Zopotinib Once Again Receives Breakthrough Therapy Designation from the CDE

date
21/08/2025
Chinese biopharmaceutical company announced that Zusanli (Zu Ai Ti Ni) is a selective HER2 small molecule inhibitor developed by Boehringer Ingelheim, which is orally administered and binds to valsely. Previously, it has been granted priority review and breakthrough therapy designation by the CDE for the treatment of HER2-mutant advanced non-small cell lung cancer. In August of this year, Zusanli (Zu Ai Ti Ni) received accelerated approval from the US FDA.