Zai Lab Announces Acceptance of Supplemental Biologics License Application with Priority Review for Efgartigimod Alfa Injection (Subcutaneous Injection) in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in China

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today 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 acceptance with priority review designation brings us one step closer to providing a treatment option for patients with CIDP in China, a serious disease that affects approximately 50,000 diagnosed patients, with only a small fraction of patients able to achieve remission on corticosteroids and intravenous immunoglobulin (IVIg) treatment, the current standard of care. Achieving this milestone helps demonstrate our capabilities and commitment to develop and deliver meaningful and differentiated therapies to patients in China with our partner argenx,” said Dr. Harald Reinhart, President and Head of Global Development, Neuroscience, Autoimmune & Infectious Diseases, Zai Lab. “Our collaboration with argenx is generating a robust pipeline of indications with the potential to improve care for many patients who live with autoimmune diseases, including CIDP.”

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.