By Fineline Cube 
China-based Zai Lab Limited’s (NASDAQ: ZLAB, HKG: 9688) Dutch partner argenx SE (NASDAQ: ARGX) announced that the European Commission (EC) has approved Vygart (efgartigimod alfa) 1000mg subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) who have previously received corticosteroids or immunoglobulin therapy.
Mechanism of Action
Efgartigimod SC is a human IgG1 antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies. It works by binding to the neonatal Fc receptor (FcRn) and blocking IgG recycling. As the world’s first approved FcRn blocker, it is marketed under various names including Vygart Hytrulo in the U.S. and China for generalized myasthenia gravis (gMG) and CIDP, Vygart in Japan for gMG and CIDP, and Vygart in other regions for gMG and CIDP.
Drug Formulation and Technology
The subcutaneous formulation combines efgartigimod alfa with recombinant human hyaluronidase PH20 (rHuPH20). It leverages Halozyme’s ENHANZE drug delivery technology to enable subcutaneous administration of biologics.
Partnership and Licensing
Zai Lab entered into an exclusive licensing agreement with argenx in 2021 to develop and commercialize efgartigimod in Greater China, including Mainland China, Hong Kong, Macau, and Taiwan.-Fineline Info & Tech