Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for efgartigimod, the world’s first FcRn antagonist, targeting generalized myasthenia gravis (MG).
Drug Profile
Efgartigimod, developed by Netherlands-based Argenx and licensed to Zai Lab in January 2024 for up to $175 million, is a first-in-class antibody fragment targeting the neonatal Fc receptor (FcRn). The drug prevents immunoglobulin G (IgG) degradation and is under study for autoimmune diseases driven by pathogenic IgG antibodies, including MG, pemphigus vulgaris, immune thrombocytopenia (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).
Regulatory and Market Context
- US Approval: Efgartigimod was approved in the US in December 2021 as the first therapy for MG via pathogenic antibody reduction.
- China Availability: The drug became available in China’s Bo’Ao Lecheng Medical Tourism Pilot Zone in June 2022.-Fineline Info & Tech
