China’s first and currently only[1,2,3,4]FcRn antagonist approved for the treatment of generalized myasthenia gravis (gMG) in adolescents aged 12 and older and adults with positive autoantibodies (AChR or MuSK)
In pivotal clinical studies in adult and adolescent patients, Anliwei® rapidly and significantly reduced immunoglobulin G (IgG) levels—a key antibody underlying myasthenia gravis[5,6]
In the Vivacity-MG3 pivotal study and its ongoing open-label extension, patients with generalized myasthenia gravis treated with Anliwei® achieved sustained and stable disease control and symptom improvement for up to 20 months[5,7]
BeijingMay 21, 2026 /PRNewswire/ — 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 for the treatment of generalized myasthenia gravis. This approval provides a new treatment option for a broad population of patients with generalized myasthenia gravis (adolescents aged 12 and older and adults with positive anti-acetylcholine receptor [AChR] antibodies or positive anti-muscle-specific receptor tyrosine kinase [MuSK] antibodies), enabling sustained and stable disease control[5,6,7]. The new drug application received priority review and approval status from the Center for Drug Evaluation of the National Medical Products Administration[8]. Additionally, Anliwei® is the first imported biological product approved in China to implement a pilot program for segmented domestic production of the drug substance, with the drug substance manufactured domestically and the formulation and packaging completed overseas[9].
Generalized myasthenia gravis (gMG) is a chronic, disabling autoimmune disease for which there remains an unmet clinical need for effective therapies that provide sustained and stable disease control with a well-defined safety profile[5,6,10,11]. Patients with positive anti-AChR and anti-MuSK antibodies account for 90% or more of all antibody-positive gMG patients[5]. Anliwei® is an FcRn antagonist whose mechanism of action significantly reduces levels of immunoglobulin G (IgG), including harmful IgG autoantibodies, without detectable additional effects on other adaptive and innate immune functions[5].
This approval is based on data from the pivotal Vivacity-MG3 study. Among all registered clinical trials of FcRn antagonists for adult gMG, this study had the longest primary endpoint to date. Study highlights include[1-5,11,12]:
- As measured by improvement in MG-ADL scores, Anliwei® combined with standard of care demonstrated superior disease control compared to placebo combined with standard of care throughout the 24-week treatment period. This enabled patients to improve basic daily functions including chewing, swallowing, speech, and breathing.
- In the ongoing open-label extension study for gMG, patients receiving Anliwei® combined with standard of care maintained sustained symptom improvement over a follow-up period of up to 20 months.
- Anliwei® demonstrated rapid and sustained stable reduction in autoantibody levels: total IgG antibody levels decreased by up to approximately 75% two weeks after the first dose and were maintained over 24 weeks.
Results from the ongoing Phase 2/3 Vibrance-MG study in adolescent patients aged 12 to 17 years with positive anti-AChR and anti-MuSK antibodies showed that Anliwei® combined with standard of care met the primary endpoint: serum total IgG levels decreased by approximately 69% over the 24-week treatment period, while secondary endpoints of improvement in MG-ADLa and QMGb scales were also achieved.[6]
Anliwei® demonstrated a consistent safety profile in the Vivacity-MG3 study and the ongoing Vibrance-MG study, with comparable tolerability in adult and adolescent patients.[5,6,13]
Cherry Huang, President of Johnson & Johnson Innovative Medicine China, stated: “The launch of Anliwei® marks a critical step for Johnson & Johnson in advancing the treatment of rare diseases. This drug offers sustained and stable disease control for a broad population of myasthenia gravis patients, with the potential to improve their treatment experience and help them regain control of their lives. This important milestone is the result of Johnson & Johnson’s years of in-depth scientific exploration of nipocalimab, cross-sector collaborative innovation, and unwavering commitment. We look forward to this innovative therapy benefiting more Chinese patients as soon as possible, helping them regain health and hope.”
In April 2025, the U.S. Food and Drug Administration first approved Anliwei® for the treatment of gMG patients[14]; in September of the same year, health regulatory authorities in Brazil and Japan subsequently approved the therapy[15,16]; in December, the European Commission granted marketing authorization in the European Union[15,16]. Currently, multiple health regulatory authorities worldwide are reviewing marketing applications for Anliwei® for the treatment of gMG.
Notes:
- MG-ADL (Myasthenia Gravis Activities of Daily Living scale) is used to clinically assess symptoms affecting patients’ daily living activities, with scores ranging from 0 to 24; higher scores indicate more severe symptoms.[17]
- QMG (Quantitative Myasthenia Gravis scale) consists of 13 items assessed by clinicians to quantify the severity of myasthenia gravis, with total scores ranging from 0 to 39; higher scores indicate more severe disease.[17]
About Generalized Myasthenia Gravis (gMG)
Myasthenia gravis (MG) is an autoimmune disease in which the patient’s immune system mistakenly produces antibodies (such as anti-acetylcholine receptor [AChR] antibodies, anti-muscle-specific receptor tyrosine kinase [MuSK] antibodies) that act at the neuromuscular junction, blocking or interfering with normal nerve-to-muscle signal transmission, thereby affecting or preventing muscle contraction[4]. There are approximately 700,000 MG patients worldwide[18]. MG can occur in men and women of all ages and across various races and ethnic groups, but it is more common in young women and older men[19].
Early symptoms of MG are typically ocular, but approximately 85% of patients progress to generalized myasthenia gravis (gMG), which can manifest as severe muscle weakness and may be accompanied by symptoms such as speech and swallowing difficulties.[4,17]
About the Phase 3 VIVACITY-MG3 Study[5]
The Phase 3 Vivacity-MG3 study (NCT04951622) was designed to evaluate the efficacy and safety of continuous dosing in gMG, an unpredictable chronic disease with high unmet patient needs. The study enrolled adult gMG patients with an inadequate response to current standard of care (SOC) (MG-ADL ≥6), regardless of antibody status. A total of 199 patients were enrolled, including 153 antibody-positive patients, in a 24-week double-blind, placebo-controlled trial. Patients were randomized 1:1 to receive nipocalimab combined with current SOC (30 mg/kg intravenous loading dose, followed by 15 mg/kg every two weeks) or placebo combined with current SOC. Baseline demographics were balanced between the two groups (77 patients in the nipocalimab group, 76 in the placebo group). The primary efficacy endpoint was the mean change in total MG-ADL score from baseline to the average of weeks 22, 23, and 24 between the two groups. Key secondary endpoints included changes in QMG scores. Additionally, an ongoing open-label extension (OLE) study will continue to assess long-term efficacy and safety.
About the Phase 2/3 Vibrance-MG Study[6,20]
The Phase 2/3 Vibrance-MG study (NCT05265273) is an ongoing open-label study designed to evaluate the efficacy of nipocalimab in children aged 2 to <12 years and adolescents aged 12 to <18 years with gMG. The study enrolled 7 gMG patients aged 12-17 years, with MGFA classification II-IV at screening and an inadequate response to current stable SOC. Enrolled patients were required to be positive for anti-AChR or anti-MuSK antibodies. The study includes a screening period of up to four weeks, a 24-week open-label active treatment period (during which patients receive intravenous nipocalimab every two weeks), and a long-term extension period; a safety follow-up assessment will be conducted 8 weeks after the last dose. The primary endpoints are the effect of nipocalimab on total serum IgG in adolescent gMG patients over 24 weeks, drug safety, and tolerability. Secondary endpoints include changes in MG-ADL and QMG scores over 24 weeks.
About Anliwei® (Nipocalimab Injection)
Anliwei® (nipocalimab injection) is a monoclonal antibody designed to bind with high affinity to and block FcRn, thereby reducing circulating levels of immunoglobulin G (IgG) without detectable additional effects on other adaptive and innate immune functions[5]. These IgG antibodies are the primary pathogenic factor in generalized myasthenia gravis (gMG)[4]. Anliwei® has been approved in China for use in combination with conventional therapies for the treatment of gMG in adults and adolescents aged 12 and older with positive anti-acetylcholine receptor (AChR) antibodies or positive anti-muscle-specific receptor tyrosine kinase (MuSK) antibodies.
Nipocalimab is being further investigated in three key areas of autoantibody-related diseases, including rare autoantibody diseases, maternal-fetal diseases mediated by maternal alloantibodies, and rheumatic diseases.[21-29] This investigational monoclonal antibody is designed to bind with high affinity to and block FcRn, thereby reducing circulating levels of auto- and allogeneic IgG antibodies without detectable additional effects on other adaptive and innate immune functions[30].
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted nipocalimab several important designations[14], including:
- October 2019: EMA granted orphan drug designation for hemolytic disease of the fetus and newborn (HDFN)
- July 2019: FDA granted Fast Track designation for HDFN and warm autoimmune hemolytic anemia (wAIHA); December 2021 for generalized myasthenia gravis (gMG); March 2024 for fetal and neonatal alloimmune thrombocytopenia (FNAIT); March 2025 for Sjögren’s disease (SjD)
- December 2019: FDA granted orphan drug designation for wAIHA; June 2020 for HDFN; February 2021 for gMG; October 2021 for chronic inflammatory demyelinating polyneuropathy (CIDP); December 2023 for FNAIT
- February 2024: FDA granted Breakthrough Therapy designation for HDFN; November 2024 for Sjögren’s disease
- Q4 2024: FDA granted Priority Review designation for gMG
References
- https://cn.zailaboratory.com/products/
- https://www.ucbchina.com/About-UCB/%E4%B8%BB%E8%A6%81%E4%BA%A7%E5%93%81
- https://www.cde.org.cn/main/xxgk/listpage/2f78f372d351c6851af7431c7710a731
- Neurology Branch of the Chinese Medical Association, Neuroimmunology Group. Chinese Journal of Neurology, 2025; 58(7): 721–741.
- Strober J et al. Safety and effectiveness of nipocalimab in adolescent participants in the open label Phase 2/3 Vibrance-MG clinical study. Presentation at American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. October 2024.
- Antozzi, C et al., Long-Term Safety and Efficacy of Nipocalimab in Generalized Myasthenia Gravis: Vivacity-MG3 Open-Label Extension Phase Results. Abstract #022 for poster presentation at 2025 American Academy of Neurology Congress. April 2025
- https://www.cde.org.cn/main/xxgk/listpage/2f78f372d351c6851af7431c7710a731
- IMAAVYTM U.S. Prescribing Information.
- https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-fda-approval-for-imaavytm-nipocalimab-aahu-a-new-fcrn-blocker-offering-long-lasting-disease-control-in-the-broadest-population-of-people-living-with-generalized-myasthenia-gravis-gmg
- https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-european-commission-approval-of-imaavy-nipocalimab-a-new-fcrn-blocker-offering-sustained-disease-control-in-a-broad-population-of-people-living-with-generalised-myasthenia-gravis-gmg