Zai Lab Announces Acceptance by China’s NMPA of the BLA for Efgartigimod Alfa Injection (Subcutaneous Injection) for Patients with Generalized Myasthenia Gravis

SHANGHAI, China and CAMBRIDGE, Mass., July 10, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous (SC) injection, 1000mg (5.6ml)/vial) for the treatment of adult patients with generalized myasthenia gravis (gMG).

“We are pleased to have the NMPA’s acceptance of the BLA for efgartigimod alfa injection for subcutaneous use. We’re excited about the potential of efgartigimod to offer patients multiple ways to receive treatment through various administrations and an individualized dosing schedule,” said Dr. Harald Reinhart, President and Head of Global Development, Neuroscience, Autoimmune & Infectious Diseases, Zai Lab. “As a company focused on developing innovative medicines for diseases in need of more effective treatment options, we look forward to bringing another first-in-class option for gMG patients in Greater China.”

The BLA submission is supported by positive results from the global Phase 3 ADAPT-SC study, demonstrating noninferior total IgG reduction from baseline at day 29 with SC administered efgartigimod compared to intravenous (IV) administered efgartigimod in adult patients with gMG. Patients treated with efgartigimod SC achieved mean total IgG reduction of 66.4% from baseline at day 29, compared to 62.2% reduction with efgartigimod IV.

The safety profile for efgartigimod SC was also consistent with the ADAPT study. It was generally well-tolerated; the most frequent adverse event being injection site reactions (ISRs), commonly observed with biologics administered subcutaneously. All ISRs were mild to moderate and resolved over time.

In June 2023, efgartigimod alfa injection (VYVGART) for IV use was approved by China’s NMPA as an add on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody positive.

In June 2023, VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) was approved by the U.S. Food and Drug Administration (FDA) for SC use for the treatment of adult patients with gMG who are anti-AChR antibody positive.

About Efgartigimod (brand name VYVGART)

Efgartigimod is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is being investigated in several autoimmune diseases known to be mediated by disease-causing IgG antibodies, including neuromuscular disorders, blood disorders, and skin blistering diseases, in both an IV and SC formulation. SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology.