China’s CDE accepts Zai Lab sBLA for efgartigimod alfa injection for CIDP

Zai Lab announced that the Center for Drug Evaluation CDE of the China National Medical Products Administration NMPA has accepted the supplemental Biologics License Application sBLA or efgartigimod alfa injection for the treatment of chronic inflammatory demyelinating polyneuropathy . 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..”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 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.”