Zai Lab, Argenx announce China NMPA approval for Vyvgart Hytrulo sBLA

Zai Lab (ZLAB) and Argenx (ARGX) announced that China’s National Medical Products Administration, or NMPA, approved the supplemental biologics license application, or sBLA, for Vyvgart Hytrulo 1,000mg for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy, or CIDP. Vyvgart Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. It is the first and only therapy approved in China for the treatment of CIDP, a debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system.