Argenx and Zai Lab Receive Approval for Efgartigimod Alfa Injection in China for Generalized Myasthenia Gravis
Tuesday, July 16, 2024
Argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) announced today that China’s National Medical Products Administration (NMPA) has granted approval for the Biologics License Application (BLA) of efgartigimod alfa injection (efgartigimod SC) on July 16, 2024. This approval allows efgartigimod SC, a subcutaneous injection used as an add-on therapy for adult patients with generalized myasthenia gravis (gMG) who are positive for anti-acetylcholine receptor (AChR) antibodies, to be marketed in China.
Argenx, highlighted the significance of this milestone in expanding access to innovative treatments for severe autoimmune diseases globally. He emphasized the success of their partnership with Zai Lab in rapidly introducing VYVGART IV treatment to 2,700 new patients in early 2024, underscoring the substantial unmet medical need for gMG therapies in China. The approval of efgartigimod SC, with its flexible subcutaneous administration, is expected to enhance treatment options and patient convenience across the country.
Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab, echoed these sentiments, noting that the approval of efgartigimod SC represents a significant advancement for gMG patients in China. He highlighted the potential for efgartigimod SC to simplify treatment regimens and improve accessibility within the patient community, addressing the critical medical need in China.
Prof. Xueqiang Hu, M.D., Ph.D., from the Third Affiliated Hospital of Sun Yat-sen University, emphasized the clinical benefits of efgartigimod SC based on the Phase 3 ADAPT-SC study results. He noted that the flexibility of subcutaneous administration allows for more personalized treatment approaches without compromising efficacy or safety, offering new hope to patients affected by this debilitating disease.
The approval of efgartigimod SC in China was supported by robust clinical data from the global Phase 3 ADAPT-SC study, demonstrating its noninferiority and consistent safety compared to the intravenous formulation. The therapy’s safety profile was generally favorable, with mild to moderate injection site reactions being the most common adverse events observed.
Efgartigimod SC, developed using Halozyme’s ENHANZE® drug delivery technology, is also under evaluation for potential applications in other autoimmune disorders. The therapy’s approval marks a significant step forward in addressing the complex treatment challenges associated with gMG and underscores the commitment of both argenx and Zai Lab to advancing healthcare innovation in China and beyond.
Source: globenewswire.com
