On April 16, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced on its website that Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson , had officially accepted two new marketing applications for gusejinumab injection (trade name: Tenoya®) for new indications (acceptance numbers: JXSS2600036 and JXSS2600037), both classified as Class 3.1 imported new drugs. This marks another important milestone for this world's first IL-23 p19 targeted monoclonal antibody in China, signifying a comprehensive expansion of its indications and providing Chinese patients with autoimmune diseases with more comprehensive treatment options.
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From psoriasis to the entire autoimmune spectrum: the "Royal Path" of gasediumab.
Gusekimumab is the world's first approved monoclonal antibody targeting the IL-23 p19 subunit . By precisely blocking IL-23, a core "upstream" inflammatory factor in autoimmune diseases, it inhibits the inflammatory cascade response at its source and achieves long-term control of the disease.
In 2020, gusejinumab was approved in China for the first time for the treatment of moderate to severe plaque psoriasis in adults who are suitable for systemic therapy or phototherapy . With its ultra-long dosing cycle of "4 injections per year" and its outstanding long-term efficacy, it has rapidly become a benchmark drug for psoriasis treatment.
After 16 weeks of treatment, more than 80% of patients achieved PASI 90 (more than 90% clearance of skin lesions).
After 5 years of treatment, over 90% of patients maintained a PASI 90 response, demonstrating durable and undiminished efficacy.
It has an excellent safety profile, with an extremely low risk of infection with long-term use, and is significantly superior to traditional TNF-α inhibitors.
The application for these two new indications marks a crucial step in its comprehensive strategy in the autoimmune field. Based on global clinical data, the indications for which this application is submitted are most likely active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS) . These two inflammatory joint diseases, which are highly associated with psoriasis, represent a significant unmet need among Chinese patients.
Targeting psoriatic arthritis and ankylosing spondylitis, filling a treatment gap.
Psoriatic arthritis is the most common complication of psoriasis, affecting approximately 30% of psoriasis patients. Without timely treatment, it can lead to irreversible joint deformities and disability. Ankylosing spondylitis, on the other hand, is a chronic disease centered on axial joint inflammation. Patients suffer from chronic back pain and morning stiffness, severely impacting their quality of life.
Currently, the treatment of these two types of diseases in China still mainly relies on TNF-α inhibitors, but these methods suffer from problems such as insufficient response rates, long-term efficacy attenuation, and high risk of infection. The arrival of gusejinumab provides patients with a better option:
Psoriatic arthritis (PsA)
The global Phase III DISCOVER-1/2 study showed that gusejinumab treatment for active psoriatic arthritis can simultaneously improve skin lesions and joint symptoms:
After 24 weeks of treatment, the ACR20/50/70 response rate was significantly better than that of placebo.
Meanwhile, over 70% of patients achieved PASI 90, truly achieving dual benefits for both the skin and joints.
Significantly inhibits radiographic progression, prevents joint structural damage, and avoids disability.
Ankylosing spondylitis (AS)
The global Phase III COAST-V/AX study confirmed that gusejinumab has a potent therapeutic effect on active ankylosing spondylitis.
After 16 weeks of treatment, the ASAS40 response rate was significantly better than that of placebo, with over 50% of patients achieving significant symptom improvement.
It quickly relieves core symptoms such as lower back pain and morning stiffness, and significantly improves patients' physical function and quality of life.
Long-term treatment can maintain a sustained response, and its safety profile is consistent with that of psoriasis indications.
Johnson & Johnson upgrades its immune pipeline and accelerates its expansion in the Chinese market.
As the undisputed leader in the global autoimmune field, Johnson & Johnson has consistently focused on the IL-23/IL-17 pathway, building a comprehensive product portfolio. Gusekimumab, as its core product, further solidifies its leading position in the autoimmune field with this new indication application.
This dual approval demonstrates Johnson & Johnson's strong commitment to the Chinese market. Through Janssen's localized commercialization team, gusejinumab has rapidly gained widespread coverage in major hospitals across China, becoming one of the preferred treatment options for psoriasis patients. With the approval of this new indication, its market reach will further expand to rheumatology and immunology, achieving comprehensive penetration from dermatology to rheumatology.
Industry Outlook: IL-23 Target Becomes the Gold Standard for Autoimmune Therapy
IL-23 is an "upstream regulator" of autoimmune diseases and is widely recognized as one of the optimal targets for autoimmune therapy. Compared with IL-17 inhibitors, IL-23 inhibitors have more durable efficacy and better safety; compared with TNF-α inhibitors, they have higher specificity and lower risk of infection.
With the expanding indications for IL-23 inhibitors such as gusejinumab, the IL-23 target is gradually becoming the gold standard for first-line treatment of diseases such as psoriasis, psoriatic arthritis, and ankylosing spondylitis. For Chinese patients, this means more treatment options, more convenient administration methods, and more durable disease control.
We will continue to monitor the approval progress of the new indication for gusejinumab, which is expected to be approved as early as the end of 2026, bringing new hope for treatment to millions of patients with psoriatic arthritis and ankylosing spondylitis in China.

https://mp.weixin.qq.com/s/ltlyNX64JZnPhV-gdUYOuw