Availability of VYVGART® and self-administered VYVDURA demonstrates continued commitment to providing more choice and flexibility for gMG patients in Japan Jan. 18, 2024, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) injection for subcutaneous (SC) use for the treatment of adult patients with generalized myasthenia gravis (gMG), who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs).

VYVGART®和自我管理的VYVDURA的可用性表明，日本继续致力于为gMG患者提供更多的选择和灵活性。2024年1月18日，荷兰中部时间阿姆斯特丹上午7:00–argenx SE（Euronext&Nasdaq:ARGX），一家致力于改善患有严重自身免疫性疾病的人的生活的全球免疫公司，今天宣布，日本厚生劳动省（MHLW）批准VYVDURA®（efgartigimod alfa和透明质酸酶qvfc）皮下注射（SC）用于治疗对类固醇或非类固醇免疫抑制疗法（IST）反应不足的成年全身性重症肌无力（gMG）患者。

Following this decision, VYVGART is now approved in Japan for both intravenous (IV) and self-administered SC use. “Today’s approval of VYVDURA marks a significant milestone for the gMG community in Japan and furthers our commitment to deliver innovative treatments to autoimmune patients globally,” said Hermann Strenger, General Manager, argenx Japan.

根据这一决定，VYVGART现在在日本被批准用于静脉注射（IV）和自我管理的SC使用。argenx Japan总经理Hermann Strenger表示：“今天批准VYVDURA标志着日本gMG社区的一个重要里程碑，并进一步推动了我们为全球自身免疫患者提供创新治疗的承诺。”。

“Bringing VYVDURA to Japan means there are now two formulations available for gMG patients, including the possibility to self-inject at home, allowing patients and their healthcare providers to choose the best option to meet their treatment needs.” The approval of VYVDURA is based on positive results from the Phase 3 ADAPT-SC study.

“将VYVDURA带到日本意味着现在有两种配方可用于gMG患者，包括在家自我注射的可能性，使患者及其医疗保健提供者能够选择最佳选择来满足他们的治疗需求。”VYVDURA的批准是基于第三阶段ADAPT-SC研究的积极结果。

ADAPT-SC established the efficacy of VYVDURA by demonstrating a reduction in percent change from baseline in total immunoglobulin G (IgG) levels comparable to VYVGART IV in adult gMG patients. ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of VYVGART in Japan in January 2022.

ADAPT-SC通过证明成年gMG患者的总免疫球蛋白G（IgG）水平与VYVGART IV相当，从基线变化百分比降低，从而确定了VYVDURA的疗效。ADAPT-SC是第三阶段ADAPT研究的桥梁研究，该研究为2022年1月在日本批准VYVGART奠定了基础。

About the ADAPT-SC Trial The Phase 3 ADAPT-SC trial was a multicenter, ra.

关于ADAPT-SC试验，第3阶段ADAPT-SC试验是一项多中心ra。