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Anliwei approved in China! Johnson & Johnson takes a key step forward in advancing rare disease treatment

Johnson & Johnson announced today that its fully human neonatal Fc receptor (FcRn) antagonist, Anliwei (Nicalimab Injection), has received approval from the National Medical Products Administration for use in combination with standard therapy to treat generalized myasthenia gravis (gMG). This approval provides a new treatment option for a broad group of patients with gMG (including adolescents and adults aged 12 and above who are positive for anti-acetylcholine receptor (AChR) antibodies or anti-muscle-specific receptor tyrosine kinase (MuSK) antibodies), enabling sustained and stable disease control.

The new drug application has been granted priority review by the Center for Drug Evaluation of the NMPA. Additionally, Anliwei is the first imported biological product approved in China to conduct domestic segmented production of the raw material, with the raw material produced domestically and formulation and packaging produced abroad.

gMG is a chronic, potentially disabling autoimmune disease. Currently, there remains an unmet clinical need for therapies that can provide sustained and stable disease control with clear safety profiles. Over 90% of antibody-positive gMG patients are positive for either anti-AChR or anti-MuSK antibodies. Anliwei is an FcRn antagonist that significantly reduces immunoglobulin G (IgG) levels, including harmful autoantibodies, without detectable additional effects on other adaptive or innate immune functions.

This approval is based on data from the pivotal Vivacity-MG3 study. Among all FcRn antagonist registration trials in adults with gMG, this study set the longest primary endpoint to date. Using MG-ADL score improvement as a measure, during the 24-week treatment period, Anliwei combined with standard therapy demonstrated superior disease control compared to placebo combined with standard therapy. This allows patients to improve basic daily functions such as chewing, swallowing, speech, and breathing.

Results from the ongoing Phase 2/3 Vibrance-MG study in adolescents aged 12 to 17 with anti-AChR and anti-MuSK antibody-positive gMG show that Anliwei combined with standard therapy achieved the primary endpoint: approximately 69% reduction in serum total IgG levels over 24 weeks, along with improvements in MG-ADL and QMGb scales as secondary endpoints.

Anliwei demonstrated consistent safety profiles in both the Vivacity-MG3 and ongoing Vibrance-MG studies, with tolerability comparable in adult and adolescent patients.

Huang Chen, President of Johnson & Johnson Innovation China, stated: “The approval of Anliwei marks a key step forward for Johnson & Johnson in advancing treatment for rare diseases. This medication offers sustained and stable disease control for a broad group of myasthenia gravis patients, potentially improving their treatment experience and helping them regain control of their lives. This milestone is the result of Johnson & Johnson’s years of in-depth scientific research on Nicalimab, cross-sector collaborative innovation, and unwavering commitment. We look forward to bringing this innovative therapy to more Chinese patients as soon as possible, helping them regain health and hope.”$JNJ