Zai Lab Limited (NASDAQ: ZLAB) and argenx (NASDAQ: ARGX) today announced that China’s National Medical Products Administration (NMPA) approved the supplemental Biologics License Application (sBLA) for VYVGART Hytrulo 1,000mg (5.6ml)/vial [Efgartigimod Alfa Injection (Subcutaneous Injection)] for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (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.
“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.
ZLAB hiked 95 cents, or 3.1%, to $31.57, while those for ARGX faded $1.05 to $594.95.
