By Fineline Cube Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced the availability of efgartigimod, the world’s first FcRn antagonist, via the Bo’Ao Lecheng Medical Tourism Pilot Zone for the treatment of myasthenia gravis (MG).
Understanding Myasthenia Gravis
Myasthenia gravis is a rare and chronic autoimmune disease caused by the dysfunction of nerve muscle junction transmission. It is characterized by a long course, difficulty in cure, and a tendency to relapse. Included in the first batch of rare diseases in China in 2018, MG poses significant challenges in disease management and clinical control, with patients often experiencing repeated fluctuations in condition. Long-term use of immunosuppressive drugs can lead to serious side effects.
Efgartigimod’s Development and Mechanism
Efgartigimod, originated by Netherlands-based biotech company Argenx and licensed to Zai in January this year in a deal worth up to USD 175 million, is a first-in-class investigational antibody fragment. It targets the neonatal Fc receptor (FcRn), a protein that protects immunoglobulin G (IgG) from degrading. The drug is currently undergoing exploratory studies in various autoimmune diseases driven by pathogenic IgG antibodies, including myasthenia gravis (MG), pemphigus vulgaris and deciduous pemphigus (PV and PF), immune thrombocytopenia (ITP), chronic inflammatory demyelinating polyneuropathy (CIDP), large vesicular pemphigoid, and idiopathic inflammatory myopathy.
Global Approval and Significance
Efgartigimod received approval in the US in December 2021, becoming the first therapy for myasthenia gravis through the endogenous reduction of pathogenic antibodies. Its availability in China via the Boao Lecheng Medical Tourism Pilot Zone marks a significant advancement in the treatment landscape for MG patients in the region.-Fineline Info & Tech