Johnson & Johnson's Novel FcRn Antagonist Vyvgart Hytrulo Approved in China for Generalized Myasthenia Gravis, Offering Sustained and Stable Disease Control

Johnson & Johnson announced today that its fully human neonatal Fc receptor (FcRn) antagonist, Anliwei (Nipocalimab Injection), has been approved by the National Medical Products Administration for use in combination with conventional therapies to treat generalized myasthenia gravis.

This approval provides a new treatment option for a broad patient population with generalized myasthenia gravis (positive for anti-acetylcholine receptor (AChR) antibodies or anti-muscle-specific receptor tyrosine kinase (MuSK) antibodies, aged 12 years and above, including adolescents and adults), enabling sustained and stable disease control. The new drug application received priority review and approval status from the Center for Drug Evaluation of the National Medical Products Administration, while Anliwei...^®It is also an imported biological product approved for pilot production of bulk liquid in segments within China. The bulk liquid of this drug is produced in China, while the formulation and packaging are produced overseas.

Generalized Myasthenia Gravis (gMG) is a chronic, debilitating autoimmune disease. There are still unmet clinical needs for this condition, requiring effective therapies that can provide sustained and stable disease control with well-established safety. Patients positive for anti-AChR and anti-MuSK antibodies account for 90% or more of all antibody-positive gMG patients. Anliwei^®It is an FcRn antagonist whose mechanism of action significantly reduces immunoglobulin G (IgG) levels (including harmful IgG autoantibodies) without causing detectable additional effects on other adaptive and innate immune functions.

This approval is based on data from the pivotal Vivacity-MG3 study. Among all registrational clinical trials for FcRn antagonists in adult gMG, this study has set the longest primary endpoint to date. Key highlights of the study include: measured by improvements in MG-ADL scores, Anliwei demonstrated sustained efficacy throughout the 24-week treatment period.^®Compared with placebo combined with standard treatment, the combination of standard treatments demonstrated superior disease control effects. This allows patients to improve basic daily functions such as chewing, swallowing, speech, and breathing. In the ongoing open-label extension study of gMG, patients receiving Anliwei (Efgartigimod)...^®Patients receiving combined standard therapy maintained symptom improvement throughout a follow-up period of up to 20 months. Anliwei^®Demonstrates rapid and sustained steady reduction in autoantibody levels: Total IgG antibody levels decreased by up to approximately 75% two weeks after the first dose and remained consistently low over 24 weeks.

The results of the ongoing Phase 2/3 study, Vibrance-MG, in patients aged 12 to 17 who are positive for anti-AChR and anti-MuSK antibodies show that Anliwei^®The combination standard therapy reached the primary endpoint: serum total IgG levels decreased by approximately 69% during the 24-week treatment period, while also achieving secondary endpoints with improvements in the MG-ADLa and QMGb scales.

Anliwei^®In the Vivacity-MG3 study and the ongoing Vibrance-MG study, a consistent safety profile was demonstrated, with comparable tolerability in both adult and adolescent patients.

Cherry Huang, President of Johnson & Johnson Innovative Medicine China, said: "Anliwei^®The launch marks a critical step forward for Johnson & Johnson in advancing the treatment of rare diseases. This medication offers sustained and stable disease control for a broad population of patients with severe myasthenia gravis, with the potential to enhance treatment experiences and help patients regain control of their lives. The achievement of this significant milestone is the result of Johnson & Johnson's years of deep scientific exploration of nicarelimab, cross-disciplinary collaborative innovation, and unwavering commitment. We look forward to this innovative therapy quickly benefiting more patients in China, helping them regain health and hope.

In April 2025, the U.S. Food and Drug Administration (FDA) approved Anliwei for the first time.^®Used to treat gMG patients; in the same year, September, health regulatory agencies in Brazil and Japan successively approved this therapy; in December, the European Commission granted it marketing authorization within the EU. Currently, multiple health regulatory agencies worldwide are reviewing 安力威.^®Marketing application for the treatment of gMG.