Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a China-based biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has approved its Biologics License Application (BLA) for Vyvgart (efgartigimod alfa injection). Vyvgart, a first-in-class neonatal Fc receptor (FcRn) antagonist, is now approved for use as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
Exclusive Rights and Regional Development
Zai Lab holds exclusive development and commercialization rights to efgartigimod in mainland China, Hong Kong, Macau, and Taiwan (Greater China) through a license agreement with argenx (NASDAQ: ARGX), which was signed in July 2022. This strategic partnership positions Zai Lab to bring innovative treatments to patients in Greater China.
Global Approvals and Implications for gMG Treatment
Vyvgart has made history as the first approved FcRn blocker in the United States, EU, and China for the treatment of adults with gMG who are anti-AChR antibody positive. Additionally, it is approved in Japan for the treatment of adults with gMG who do not have a sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). These approvals underscore the potential impact of Vyvgart on the global treatment landscape for gMG.-Fineline Info & Tech
