Zai Lab Limited announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the supplemental Biologics License Application (sBLA) for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The CDE granted priority review on May 11, 2024 and Breakthrough Therapy Designation for efgartigimod SC for the treatment of patients with CIDP on September 18, 2023. The sBLA application is based on the ADHERE (NCT04281472) study, a multicenter, randomized, double-blind, placebo-controlled trial evaluating efgartigimod SC for the treatment of CIDP.

Zai Lab enrolled patients into the ADHERE trial in Greater China and treatment response in these participants was consistent with global study outcomes. Subgroup analysis of Chinese participants demonstrated a 69% reduction in relapse rates with efgartigimod SC compared to placebo. In addition, 78% of Chinese participants treated in the open-label portion of the study demonstrated evidence of clinical improvement (ECI), further confirming the role IgG autoantibodies play in the underlying biology of CIDP.

The favorable safety and tolerability profile of efgartigimod SC weekly dosing (up to 1 year) in the Chinese patient cohort was consistent with global trial participants. In September 2023, Zai Lab launched VYVGART® (efgartigimod alfa injection) for generalized myasthenia gravis (gMG) in mainland China, with VYVGART becoming the first and only approved FcRn antagonist for these gMG patients. In July 2023, Zai Lab announced that the CDE has accepted the BLA for efgartigimod SC for gMG in China.