By Fineline Cube 
China-based Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) and its Dutch partner argenx SE (NASDAQ: ARGX) have achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approval of a prefilled syringe option for Vygart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc). This new administration method offers added flexibility for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and those with chronic inflammatory demyelinating polyneuropathy (CIDP).
Vygart Hytrulo: Innovation in Treatment
Vygart Hytrulo is the first and currently the only CIDP therapy available in China. The drug combines efgartigimod alfa, a human IgG1 antibody fragment marketed as Vygart, with recombinant human hyaluronidase PH20 (rHuPH20), leveraging Halozyme’s Enhanze drug delivery technology to facilitate subcutaneous (SC) injection. This advancement provides patients with greater convenience and flexibility in managing their conditions.
Zai Lab’s Role and Market Expansion
Zai Lab secured the rights to Vygart Hytrulo through a licensing agreement with argenx in 2021. Following this, the drug received marketing approval in China for the treatment of generalized myasthenia gravis (gMG) in July of last year. The recent FDA approval of the prefilled syringe option further strengthens Zai Lab’s position in the global market, offering patients a self-administration alternative and expanding the therapeutic landscape for these debilitating conditions.-Fineline Info & Tech