“We are pleased to receive NMPA approval for VYVGART Hytrulo, marking a groundbreaking milestone for CIDP patients in China,” said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. “This approval brings a much-needed treatment option to patients who have been suffering from CIDP for far too long. We appreciate the NMPA for their thorough assessment and recognition of the therapy’s differentiated profile and the large unmet patient medical need in China. We will continue to work with argenx to explore the potential in other Immunoglobulin G (IgG)-mediated autoimmune indications.”

“VYVGART Hytrulo is a precision therapy for patients living with CIDP, many of whom have been waiting for a new treatment innovation,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We are grateful to our partners at Zai Lab for collaborating with argenx to reach CIDP patients in China, and to the NMPA for approving VYVGART Hytrulo for CIDP. Zai has a strong record of impeccable execution and a shared value of doing all that we can, together, for patients in need. We look forward to continuing our partnership with Zai as argenx continues to reach more patients in one of the world’s fastest growing markets.”

“CIDP is a serious and debilitating disease with approximately 50,000 diagnosed patients in China¹, with only a small fraction of patients able to achieve remission on corticosteroids and plasma-derived therapies, the current standard of care.” said Prof. Ting Chang, M.D., Deputy Chief Physician and Associate Professor, Department of Neurology, Tangdu Hospital. “In addition, existing treatment options are problematic and challenging for some patients. VYVGART Hytrulo provides a new, safe and effective treatment option that can meaningfully improve and stabilize disease symptoms and potentially lessen the burden of treatment for these patients. This is an important advancement for the patient community, and we are grateful to Zai Lab for their work supporting patients who have been devastated by this disease for so long.”

The NMPA approval is supported by the positive results from the ADHERE (NCT04281472) study, a multicenter, randomized, double-blind, placebo-controlled trial evaluating VYVGART Hytrulo for the treatment of CIDP. The ADHERE study included an open-label period to identify responders who then entered a randomized-withdrawal, double-blinded period. 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 the risk of relapse with VYVGART Hytrulo compared to placebo. In addition, 78% of Chinese participants treated in the open-label period of the study demonstrated evidence of clinical improvement, further confirming the role IgG autoantibodies play in the underlying biology of CIDP. The favorable safety and tolerability profile of VYVGART Hytrulo dosed weekly in the Chinese patient cohort was consistent with what was shown in global trial participants.

In May 2024, Zai Lab announced that the Centre for Drug Evaluation (CDE) accepted the sBLA with priority review designation for VYVGART Hytrulo for CIDP in China. The CDE granted the Breakthrough Therapy Designation for the treatment of patients with CIDP in September 2023.