Janssen's Nipocalimab, Acquired for $6.5 Billion, Gains Approval in China for Generalized Myasthenia Gravis

May 21, 2026 16:09 CST Updated 16:09

Johnson & Johnson

Medical Device R&D and Manufacturer

Momenta Pharmaceuticals

Immune Disease Drug Developer

May 21,Johnson & Johnson announced"Nicalimab"Approved for marketing in China for the first time"，For the treatment of autoantibody-positiveGeneralized Myasthenia Gravis（gMG）Adult patients and adolescent patients over 12 years old。Previously, the product had been granted priority review by the CDE.

Screenshot source: Johnson & Johnson Official WeChat

Nicalimab（Nipocalimab）YesAn FcRn antibody.Unlike efgartigimod and rozanolixizumab, which also belong to FcRn antagonists, this drug belongs to FcRn Blocker,Binds to FcRn with high affinity, blocking its interaction withImmunoglobulin G (IgG) Binding of antibodies, reducing the recovery and circulation of IgG antibodies, fundamentally decreasing the level of autoantibodies in the blood., while maintaining immune function without causing widespread immunosuppression。

Screenshot from: Johnson & Johnson official materials

In August 2020, Johnson & Johnson$6.5 billionAcquisition Momenta Pharmaceuticals, Inc., Secures This Blockbuster New Drug. In April 2025, the drug will be launched for the first time inUnited StatesApproved for marketing, becoming theThe first and only FcRn blocker approved for the treatment of anti-AChR antibody and anti-MuSK antibody positive adult and pediatric gMG patients aged 12 years and above.and then successively inEU, Japan, UKApproved for marketing.

Status of Rights Transfer (I)

Global Approval History (Continued)

Screenshot source: Insight Database Web Version

At that time, the FDA's approval of Nicarlimab wasBased on IIIPhase Clinical TrialVivacity-MG3 Positive Results(Registration Number: NCT04951622/CTR20212693)。

This is aRandomized, Double-blind, Placebo-controlled Phase III Clinical Trial, enrolled patients wereFor the current standard of care（SOC）Poorly Responsive Antibody PositiveAdult gMG patients. The primary endpoint was the Myasthenia Gravis Activities of Daily Living score during treatment weeks 22, 23, and 24 in antibody-positive patients.（MG-ADL）Changes from baseline, secondary endpoints include Quantitative Myasthenia Gravis Score (QMG) etc.

Key Research History Timeline

Screenshot source: Insight Database Web Version

KeyClinical trial results show:

At weeks 22, 23, and 24 of treatment, patients receiving "Nicalimab"+SOC" of patientsMG-ADL score improved by 4.70 points, significantly higher than the 3.25-point improvement in the "placebo + SOC" group（P=0.002）；
In terms of the secondary endpoint QMG, compared with placebo + SOC, nicarlimab + SOCQMG score improved by 4.86 points(vs placebo group 2.05 points), the strength and function of different muscle groups in patients have significantly improved.（P<0.001）；
Nicalimab + SOC GroupThe proportion of MG-ADL score improvement ≥2 points is 68.8%., while the value for the placebo + SOC group was 52.6%.（P=0.021）, further indicating that treatment with Nicalizumab can reduce the impact of gMG on patients' daily lives.
In terms of safety, nicarlimab was generally well-tolerated, with an overall incidence of adverse events similar to that of the placebo + SOC group.

Nicalimab treatment for gMG also demonstrates long-term efficacy and safety. Ongoing Phase III open-label extension study（OLE）The results showed that gMG patients receiving nicarlimab in combination with standard therapy remained in good condition during a follow-up period of up to 20 months.

At the same time, Johnson & Johnson is also conducting a Phase II/III pediatric study for adolescent gMG patients aged 12-17 who are positive for anti-AChR and anti-MuSK antibodies.（Vibrance-MG）. The research data shows,Nicalimab Combined with SOC Therapy Achieves Primary Endpoint, i.e., within 24 weeksSerum total IgG levels decreased by 69%, secondary endpoints MG-ADL and QMGc scores both improved.

Myasthenia gravis is a rare, chronic autoimmune disease.The immune system mistakenly attacks proteins at the neuromuscular junction, producing antibodies.（For example, anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK], or anti-low-density lipoprotein receptor-related protein 4 [LRP4]）, these antibodies can interfere with or disrupt normal function, preventing signals from being transmitted from nerves to muscles.In China, gMG has been included in the "First Batch of Rare Disease Catalog".

According to a Frost & Sullivan report, there are approximately 1.2 million patients with myasthenia worldwide.Among them, there are about 220,000 patients in China, indicating a huge unmet clinical need.In recent years, the emergence of biologics has brought new hope to this disease area, especially C5 complement inhibitors and FcRn monoclonal antibodies, which have been particularly active in this field.

Conclusion

According to statistics from the Insight database, there are currently over60 ProductsBiologics for Myasthenia Gravis(Only active status is counted)Has entered clinical development.And there have been only 7 approved products previously in China.：

AstraZenecaThe two generations of C5 complement inhibitors, "Eculizumab" and "Ravulizumab";
Argenx/Zai LabThe FcRn monoclonal antibody "Efgartigimod" and its subcutaneous injection;
UCBThe FcRn monoclonal antibody "Rozelimab" and the C5 complement inhibitor "Zelucure Sodium"；
Rongchang BioTheBLyS/APRIL Dual-Target Fusion Protein"Telitacicept";
Hansoh PharmaThe imported CD19 monoclonal antibody "Inebilizumab".

Among them, five are newly approved in 2025 and beyond, making these two years a "burst year" for new myasthenia gravis drugs in China.Among the new drugs applied for marketing also includeShiyao Group/Harbour BioMedThe FcRn monoclonal antibody "Batroliumab" andAstraZenecaC5/Albumin Nanobody "Golimumab".

It can be seen that the current treatments for myasthenia gravis mainly focus on the C5 and FcRn targets, with major pharmaceutical companies making in-depth and differentiated layouts around this disease: AstraZeneca is pursuing iterative and profound development targeting the C5 complement; UCB has adopted a dual-mechanism approach, potentially exploring combination therapy; Argenx/Zai Lab, as the first-in-class, are advancing the development of subcutaneous injection formulations; RemeGen is breaking new ground with an innovative mechanism. Among products in clinical development, CD19 and CD20 monoclonal antibodies are increasingly appearing, and CAR-T therapies targeting CD19 and BCMA also show considerable promise.

For Johnson & Johnson, the autoimmune sector is a key business area in its pharmaceuticals division. According to its financial report, the autoimmune sector generated significant revenue for Johnson & Johnson in 2025.$15.728 billionHowever, due to patent expiration and strong competition, Johnson & Johnson's revenue in this field has been declining for two consecutive years.

Therefore, the recently approved Nicallimab is also one of the future pillars that Johnson & Johnson has high hopes for.In addition to gMG, Johnson & Johnson is also exploring the drug's efficacy in treating various autoimmune diseases in clinical trials, including idiopathic inflammatory myopathies, Sjögren's syndrome, rheumatoid arthritis, hemolytic disease of the newborn, autoimmune hemolytic anemia, and chronic inflammatory demyelinating polyneuropathy, among others.

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