Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE (NASDAQ: ARGX) have announced that China’s National Medical Products Administration (NMPA) has granted Biologic License Application (BLA) approval for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). Vygart Hytrulo is indicated for use in combination with conventional therapy for the treatment of acetylcholine receptor (AChR) antibody positive generalized myasthenia gravis (gMG) .
Efgartigimod alfa is a first-in-class neonatal Fc receptor (FcRn) antagonist, which has been approved in the US, European Union, and China for the treatment of AChR positive gMG. The subcutaneous formulation of the drug, listed in the US and EU under the trade name VYVGART Hytrulo, is also under regulatory review in China for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) .
The approval by the NMPA is based on positive results from the global Phase III ADAPT-SC trial, which confirmed the reduction of immunoglobulin G (IgG) levels and showed consistent safety with previous ADAPT studies. The overall tolerability of patients receiving efgartigimod alfa subcutaneous injection was favorable .
Vygart Hytrulo combines efgartigimod alfa with Halozyme’s Enhanze drug delivery technology to facilitate the subcutaneous injection of biologics. This new formulation offers a potential alternative to intravenous administration, providing more flexibility for patients and healthcare providers .
Zai Lab and argenx’s collaboration highlights the potential of global partnerships in advancing treatments for severe autoimmune diseases. With the approval of Vygart Hytrulo, patients with gMG in China now have access to a novel treatment option that has the potential to improve their quality of life .- Flcube.com
