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Cybernet Data Systems Inc.

Zai Lab and argenx Announce NMPA Approval of VYVGART in China

Strategic Insights

— 2 min read

Zai Lab Limited and its partner argenx have announced the approval of VYVGART (efgartigimod alfa injection) by China's National Medical Products Administration for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. This approval marks a significant milestone in the treatment of gMG in China, a complex and difficult-to-control autoimmune disease affecting over 200,000 people in the country.

Key Takeaways:

  • VYVGART is the first approved FcRn blocker for gMG patients in China and the first-and-only FcRn antagonist approved for this indication globally.
  • The Biologics License Application (BLA) for VYVGART was approved by the NMPA following a comprehensive review and assessment of the product's safety and efficacy profile.
  • Zai Lab will work with the National Healthcare Security Administration (NHSA) for National Reimbursement Drug List (NRDL) inclusion to enable broad access to VYVGART for patients in China.
  • The approval of VYVGART in China reinforces the therapeutic potential of FcRn antagonism in treating gMG, a condition characterized by debilitating and potentially life-threatening muscle weakness.
  • Clinical studies have demonstrated the safety and efficacy of VYVGART, with significantly more responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale and the Quantitative Myasthenia Gravis (QMG) scale following treatment with VYVGART compared to placebo.
  • VYVGART has a well-tolerated safety profile, with the most commonly reported adverse reactions being upper respiratory tract infections and urinary tract infections.
  • The approval of VYVGART in China marks a significant step forward in the treatment of gMG and provides an innovative solution for patients in China who face many challenges living with this complex and difficult-to-control autoimmune disease.

Statistics:

  • Over 200,000 people in China are living with myasthenia gravis (MG), a chronic autoimmune disease characterized by debilitating and potentially life-threatening muscle weakness.
  • VYVGART has been shown to be effective in treating gMG patients, with significantly more responders on the MG-ADL scale and QMG scale following treatment with VYVGART compared to placebo.
  • The ADAPT clinical trial demonstrated the safety and efficacy of VYVGART, with VYVGART showing a well-tolerated safety profile.

Sources:

  • Zai Lab Limited press release: "First-and-only approved FcRn antagonist for gMG patients by NMPA Zai Lab to seek National Reimbursement Drug List (NRDL) inclusion for VYVGART"
  • argenx press release: "argenx and Zai Lab Announce Approval of VYVGART by China's National Medical Products Administration"
  • "Approval process has been completed and the certificate is under preparation" (NMPA system update)
  • Nationwide population-based epidemiological study of myasthenia gravis in Taiwan, 2010
  • Howard JF et al. Lancet Neurol 2021;20(7):526-536.

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