First and only NMPA-approved subcutaneous injectable FcRn blocker for gMG patients in China

Consistent clinical benefit and safety profile of efgartigimod SC compared to IV demonstrated in Phase 3 ADAPT-SC study

argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) on July 16, 2024 for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg (5.6ml)/vial indicated as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

“The NMPA approval for efgartigimod SC is yet another key milestone on our journey to expand into new patient populations around the world with our transformative medicine.” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We celebrate this achievement with our partner, Zai Lab, who shares our mutual passion for bringing needed innovation to patients with gMG in China. We are impressed by the team’s incredible launch execution, bringing 2,700 new patients onto VYVGART IV treatment in the first quarter of 2024, which underscores the high unmet need that remains for gMG patients. The addition of a flexible 30-to-90second subcutaneous injection opens the door for new patients in China, while taking into account personal preference and convenience. We look forward to continuing our partnership and expanding our footprint in one of the world’s fastest growing markets to reach more people living with severe autoimmune diseases.” 

“We are pleased to receive NMPA approval for efgartigimod SC, marking an important milestone as we bring another first-in-class option to gMG patients in China,” said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. “The addition of a new treatment option for gMG patients enhances flexibility for patients, potentially further simplifying the regimen and making therapy more accessible within the community. We appreciate the NMPA for their thorough assessment and recognition of the therapy’s differentiated profile and the large unmet medical need in China.”

“There are approximately 170,000 people living with gMG in China¹,” said Prof. Xueqiang Hu, M.D., Ph.D., Chief Physician of Department of Neurology, the Third Affiliated Hospital of Sun Yat-sen University. “Compared to fixed infusion schedules, the availability of efgartigimod SC allows a more individualized and flexible treatment approach based on patient needs without sacrificing clinical benefit or safety. In the global Phase 3 ADAPT-SC study, efgartigimod SC demonstrated consistent benefit and safety compared to the intravenous product. This is a meaningful advancement for the patient community, and we are grateful to Zai Lab for supporting patients who have been devastated by this disease for so long.”

The BLA approval is supported by positive results from the global Phase 3 ADAPT-SC study, a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of intravenous VYVGART in adult gMG patients. In the ADAPT-SC study, the primary endpoint of noninferiority was met (p< 0.0001), and efgartigimod SC demonstrated mean total IgG reduction of 66.4% from baseline at day 29, compared to 62.2% with efgartigimod IV. Additional key secondary endpoints were also met, which were consistent with efficacy measures from the ADAPT study identifying the correlation between total IgG reduction and clinical benefit in gMG.

The safety profile for efgartigimod SC was also consistent with the ADAPT study. Efgartigimod SC 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.

Efgartigimod SC is also being evaluated for the potential treatment of additional autoimmune disorders. In May 2024, the NMPA accepted a supplemental Biologics License Application (sBLA) with priority review for efgartigimod SC in chronic inflammatory demyelinating polyneuropathy (CIDP). The U.S. Food and Drug Administration (FDA) approved efgartigimod SC in June 2024 for adults with CIDP.