Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced the filing of a supplemental Biologics License Application (sBLA) in China for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). The sBLA seeks to expand Vygart’s indication to include the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), and the application has been granted both breakthrough therapy designation (BTD) and priority review status.
Vygart Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment sold under the brand name Vygart, and recombinant human hyaluronidase PH20 (rHuPH20). It utilizes Halozyme’s Enhanze drug delivery technology to facilitate the subcutaneous injection of biologics. Originally licensed from the US firm Argenx for development in Greater China in a deal inked in 2021, Zai received initial approval for the drug to treat generalized myasthenia gravis (MG) in September 2023.
CIDP is a rare neurological disease that affects an estimated 50,000 individuals, with only a fraction responding adequately to the standard treatment of corticosteroids.- Flcube.com
