Recently, the NMPA (National Medical Products Administration) announced the launch of Johnson & Johnson's nicarlimumab injection (trade name: Anliwei® ), for use in combination with conventional therapies to treat adult patients and adolescents older than 12 years with autoantibodies-positive generalized myasthenia gravis (gMG). This marks another significant milestone for nicarlimumab globally, following its FDA approval last April and subsequent approval by the European Commission, and also signifies the arrival of a strong new competitor in the field of precision treatment for gMG in China.
In August 2020, Johnson & Johnson announced its acquisition of Momenta Pharmaceuticals for approximately $6.5 billion, with its core objective being this investigational FcRn antibody. On April 30, 2025, nicarlimumab received initial FDA approval in the United States (trade name IMAAVY®) for the treatment of patients aged 12 years and older with positive anti-AChR or anti-MuSK antibodies in generalized myasthenia gravis. Subsequently, the European Commission also approved the drug for marketing in Europe. Now, nicarlimumab has been successfully approved in China, taking only about a year from application to approval—a remarkably fast process.
It is worth mentioning that nicarlimumab is currently the first and only FcRn antagonist approved in China for patients with gMG who are positive for both anti-AChR and anti-MuSK antibodies, and its indication covers adolescents aged 12 years and older, which is unprecedented among similar products already on the market. For a long time, treatment options for gMG have been relatively limited. Traditional cholinesterase inhibitors, glucocorticoids, and immunosuppressants, while still the basic regimens, have slow onset of action, significant side effects, and a considerable proportion of patients fail to achieve satisfactory disease control. In recent years, with a deeper understanding of the pathogenesis of gMG, targeted biologics have begun to reshape the treatment landscape. In recent years, targeted therapy for generalized myasthenia gravis (gMG) in China has entered a multi-mechanism approach. In 2023, eculizumab (Shulirui®) and egamod α (Weiweijia®) were successively approved in China for gMG, with egamod becoming the first approved FcRn antagonist in China. Subsequently, rozeliximab (Udig®), relliximab (Velixi®), teltascept (Taia®), and zelucibram sodium (Zobeco®) were approved in 2025; in 2026, inelliximab (Xinyue®) was further added to the domestic treatment lineup.
For the entire FcRn market, the approval of nicarlimumab further validates the clinical value and commercial potential of this target. With egamod, rozeliximab, and nicarlimumab forming a "three-way competition" in China, and with more drugs in development, gMG treatment is moving from a phase of "drug scarcity" to one of "drug availability." Ultimately, patients will benefit from this increased competition.

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