Today, argenx and Zai Lab announced that China’s National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous) on July 16, 2024. This 1,000mg (5.6ml)/vial treatment is indicated as an add-on to standard therapy for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
Tim Van Hauwermeiren, CEO of argenx, celebrated the milestone, stating, “The NMPA approval for efgartigimod SC represents a significant step in our global expansion efforts. We’re thrilled to partner with Zai Lab in bringing this transformative medicine to gMG patients in China. The impressive launch of VYVGART IV, with 2,700 new patients in Q1 2024, highlights the ongoing need for effective treatments. The new subcutaneous option will offer greater convenience and flexibility for patients.”
Rafael G. Amado, M.D., President of Global Research and Development at Zai Lab, added, “Receiving NMPA approval for efgartigimod SC is a significant achievement, providing gMG patients in China with another first-in-class treatment option. This flexibility could simplify treatment regimens and improve accessibility.”
Prof. Xueqiang Hu, M.D., Ph.D., Chief Physician of Neurology at the Third Affiliated Hospital of Sun Yat-sen University, noted, “With approximately 170,000 people living with gMG in China, efgartigimod SC offers a more flexible and individualized treatment approach. The positive results from the Phase 3 ADAPT-SC study underscore its clinical benefits and safety.”
The BLA approval is supported by positive data from the global Phase 3 ADAPT-SC study, which demonstrated noninferiority compared to the intravenous formulation and met additional efficacy endpoints. The safety profile was consistent with previous studies, with mild to moderate injection site reactions being the most common adverse events.
Efgartigimod SC is also being evaluated for other autoimmune disorders, including chronic inflammatory demyelinating polyneuropathy (CIDP). In May 2024, the NMPA accepted a supplemental Biologics License Application for CIDP, following its FDA approval in June 2024.
About VYVGART® and Efgartigimod SC
VYVGART (efgartigimod alfa injection) is a human IgG1 antibody fragment that reduces circulating IgG autoantibodies by binding to the neonatal Fc receptor (FcRn). Efgartigimod SC, a subcutaneous formulation, includes recombinant human hyaluronidase PH20 (rHuPH20) to facilitate delivery. It is administered as a single 1,000 mg injection over 30-to-90 seconds, with weekly cycles for four weeks. The product is already approved in the U.S., EU, and Japan.
About Myasthenia Gravis in China
Myasthenia gravis (MG) is a chronic autoimmune disease that causes severe muscle weakness. In China, around 170,000 people live with gMG, with 85% having confirmed AChR antibodies. Symptoms include weakness, fatigue, and difficulties with vision, speech, swallowing, and breathing. Current treatments often provide only partial relief.
