Today (April 23),The latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA),Johnson & Johnson's Class 1 New Drug ApplicationNicalimab InjectionThe listing application has been accepted. According to publicly available information, Nicallimab (Nipocalimab) is aAntibody Therapy Targeting Neonatal Fc Receptor (FcRn). The product has been submitted to the U.S. FDA for market approval, intended for the treatment of generalized myasthenia gravis (gMG), with a PDUFA date ofApril 29It is worth mentioning that this therapy was also listed by the industry media Evaluate as one of the therapies expected to be launched this year at the beginning of this year.Top 10 Potential Blockbuster TherapiesOne of. In China, the product was officially included in the priority review by the CDE in October last year.Indications for UseAdult and adolescent (over 12 years old) patients with generalized myasthenia gravis (gMG) who are seropositive for autoantibodies (positive for anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK], or anti-low-density lipoprotein receptor-related protein 4 [LRP4]).Screenshot source: CDE official websiteNicalimabIs a targeted newbornFcReceptor Antibody Therapy.The ProductBy binding to FcRn, autoantibodies taken up by monocytes and endothelial cells are prevented from being released back into the bloodstream and are instead degraded within the cells. Existing studies have shown,It can reduce the level of IgG, including pathogenic autoantibodies in the blood circulation, by more than 75%.。PathogenicityIgGIs considered to be one of the root causes of autoimmune diseases.Previously, Johnson & Johnson had successively submitted a marketing authorization application for Nicarlimab to the FDA and the European Medicines Agency (EMA), seekingGeneralized Myasthenia Gravis (gMG)The approval of indications. Nicarelimab has previously been included in the breakthrough therapy category by the CDE and granted priority review status by the FDA for the treatment of gMG.In addition, nipocalimab was granted Breakthrough Therapy Designation by the FDA due to the results of the Phase 2 clinical trial DAHLIAS for the treatment of moderate to severe Sjögren's syndrome.'%20fill='%23FFFFFF'%3E%3Crect%20x='249'%20y='126'%20width='1'%20height='1'%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
In January 2025, Johnson & Johnson announced in The Lancet Sub-JournalThe Lancet NeurologyThe results of its pivotal Phase 3 clinical trial, Vivacity-MG3, have been published. This study evaluatedTherapies under researchThe efficacy of Nicalimab in adult patients with generalized myasthenia gravis (gMG) who are broadly antibody-positive (anti-AChR, anti-MuSK, and anti-LRP4).The study met its primary endpoint within 24 weeks, with participants receivingPatients treated with Nicalimab showed statistically significant and clinically meaningful improvements in the gMG disease indicator Activities of Daily Living score (MG-ADL).
Specifically, the phase 3 study data show that, from baseline,NicalimabCan reduce the median level of total IgG by up to 75%. In addition, a significant decrease in the levels of common pathogenic IgG (such as anti-AChR antibodies and anti-MuSK antibodies) was observed within 24 weeks.The study did not observe changes in total IgE, IgA, and IgM, indicating that the protective immune system may remain fully functional even after a reduction in pathogenic IgG autoantibody levels.
Nicalimab combined with standard of care (SOC) showed a significantly higher MG-ADL response (≥2-point improvement from baseline) compared to placebo combined with SOC.For patients with gMG, a 1 to 2 point change in MG-ADL from baseline may represent a significant difference, such as progressing from normal eating to frequent swallowing difficulties, or from shortness of breath at rest to requiring ventilator support.Myasthenia gravis is a rare disease in which autoantibodies block neuromuscular synaptic signal transmission.Caused by autoantibodies targeting acetylcholine receptors, muscle-specific kinase, or other acetylcholine receptor-associated proteins on the postsynaptic membrane, approximately 85% of patients develop symptoms beyond ocular muscles, progressing to generalized myasthenia gravis (gMG).For myasthenia gravis, there is a significant unmet clinical need.We look forward to the early approval and market launch of Johnson & Johnson's breakthrough antibody therapy, benefiting more patients.
References:
[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved Apr 23, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c
[2]Findings from pivotal nipocalimab Phase 3 study in a broad antibody positive population of people living with generalised myasthenia gravis published in The Lancet Neurology. Retrieved January 23, 2025, from https://www.globenewswire.com/news-release/2025/01/23/3014089/0/en/Findings-from-pivotal-nipocalimab-Phase-3-study-in-a-broad-antibody-positive-population-of-people-living-with-generalised-myasthenia-gravis-published-in-The-Lancet-Neurology.htmlCopyright Statement: This article is welcome to be shared by individuals on their WeChat Moments. Unauthorized reproduction by media or organizations in any form on other platforms is prohibited. For reprint authorization or other cooperation requests, please contact wuxi_media@wuxiapptec.com.
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