Johnson & Johnson's Guselkumab Receives Dual Submissions in China for New Indications in Psoriatic Arthritis and Ankylosing Spondylitis

Apr 16, 2026 15:50 CST Updated 15:50

Johnson & Johnson

Medical Device R&D and Manufacturer

On April 16, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that Johnson & Johnson's Xi'an Janssen had submittedGuselkumab Injection (Trade Name: TREMFYA®)Two New Indication Marketing Applications Officially Accepted (Acceptance Numbers: JXSS2600036, JXSS2600037), Both Classified as Category 3.1 Imported New Drugs. This represents another significant milestone in China for the world's first IL-23 p19 targeted monoclonal antibody, signifying the comprehensive expansion of its indications and offering Chinese patients with autoimmune diseases a broader range of treatment options.

From Psoriasis to the Full Spectrum of Autoimmune Diseases: The "Path to Dominance" of Guselkumab

Guselkumab is the world's first approvedMonoclonal Antibody Targeting the IL-23 p19 SubunitBy precisely blocking IL-23, a core "upstream" inflammatory factor in autoimmune diseases, it suppresses the inflammatory cascade reaction at its root, achieving long-term disease control.

In 2020, Guselkumab was approved for the first time in China forAdults with moderate to severe plaque psoriasis suitable for systemic treatment or phototherapyWith its "four injections per year" ultra-long dosing cycle and excellent long-term efficacy, it has quickly become the benchmark drug for psoriasis treatment:

After 16 weeks of treatment, over 80% of patients achieved PASI 90 (90% or more reduction in skin lesions).
After 5 years of treatment, over 90% of patients maintained a PASI 90 response, with sustained efficacy and no attenuation.
Excellent safety profile, with extremely low risk of infection over long-term use, significantly superior to traditional TNF-α inhibitors.

The application for these two new indications is a crucial step in its comprehensive layout in the autoimmune field. Based on global clinical data, the likelihood of the applied indications being approved is high.Active Psoriatic Arthritis (PsA)andActive Ankylosing Spondylitis (AS)These two inflammatory arthritic conditions highly associated with psoriasis present a significant unmet need among the patient population in China.

Targeting Psoriatic Arthritis and Ankylosing Spondylitis, Filling the Treatment Gap

Psoriatic arthritis is the most common complication of psoriasis, with about 30% of psoriasis patients experiencing joint damage. If not treated in time, it can lead to irreversible joint deformities and disabilities. Ankylosing spondylitis, on the other hand, is a chronic disease centered on inflammation of the axial joints. Patients suffer from long-term lower back pain and morning stiffness, significantly impacting their quality of life.

Currently, the treatment of these two types of diseases in China is still dominated by TNF-α inhibitors, but there are issues such as insufficient response rates, long-term efficacy attenuation, and high infection risks. The arrival of Guselkumab provides patients with a better option:

Psoriatic Arthritis (PsA)

Global Phase IIIDISCOVER-1/2Studies show that treatment with Guselkumab for active psoriatic arthritis can simultaneously improve skin lesions and joint symptoms:

After 24 weeks of treatment, the ACR20/50/70 response rates were significantly better than placebo.
The proportion of patients achieving PASI 90 exceeds 70%, truly realizing the "skin + joints" dual benefits.
Significantly inhibit radiographic progression, prevent joint structural damage, and avoid disability.

Ankylosing Spondylitis (AS)

Global Phase IIICOAST-V/AXStudy Confirms Guselkumab Highly Effective for Active Ankylosing Spondylitis:

After 16 weeks of treatment, the ASAS40 response rate was significantly higher than that of the placebo, with over 50% of patients achieving significant symptom improvement.
Rapidly relieve core symptoms such as lower back pain and morning stiffness, significantly improving patients' physical function and quality of life.
Long-term treatment can sustain response, with safety consistent with psoriasis indications.

Johnson & Johnson's Autoimmune Pipeline Upgraded Again, Accelerating Layout in the Chinese Market

As the absolute leader in the global autoimmune field, Johnson & Johnson has consistently focused on the IL-23/IL-17 pathway, building a comprehensive product portfolio. Guselkumab, as its core product, further solidifies its leading position in the autoimmune sector with this new indication submission.

This dual approval also reflects Johnson & Johnson's high regard for the Chinese market. Through the localized commercial team of Xi'an Janssen, Guselkumab has rapidly covered major hospitals across China, becoming one of the preferred treatment options for psoriasis patients. With the approval of new indications, its market coverage will further expand to rheumatology and immunology departments, achieving comprehensive penetration from dermatology to rheumatology.

Industry Outlook: IL-23 Target Becomes the Gold Standard for Autoimmune Treatment

IL-23 is an "upstream regulator" of autoimmune diseases and is widely recognized as one of the optimal targets for autoimmune treatment. Compared with IL-17 inhibitors, IL-23 inhibitors offer more durable efficacy and better safety; compared with TNF-α inhibitors, they exhibit higher specificity and lower infection risk.

With the continuous expansion of indications for IL-23 inhibitors such as Guselkumab, the IL-23 target is gradually becoming the gold standard for first-line treatment of diseases like psoriasis, psoriatic arthritis, and ankylosing spondylitis. For Chinese patients, this means more treatment options, more convenient administration methods, and longer-lasting disease control.

We will continue to monitor the approval progress of the new indications for Guselkumab, which is expected to be approved by the end of 2026 at the earliest. At that time, it will bring new treatment hope to millions of patients with psoriatic arthritis and ankylosing spondylitis in China.

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