Chinese regulators to review batoclimab’s approval request for gMG
The National Medical Products Administration (NMPA) of China has agreed to consider approving batoclimab (HBM9161) for treating generalized myasthenia gravis (gMG). Submitted as a biologics license application (BLA), the request is supported by positive top-line data from a Phase 3 clinical trial (NCT05039190) from China. The trial…