SHANGHAI, Sept. 07, 2025 — Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a prominent innovation-driven biopharmaceutical firm committed to discovering, developing, and commercializing novel treatments, announced that its recombinant humanized anti-IL-17A monoclonal antibody product (code: JS005) demonstrated positive results in a multi-center, randomized, double-blind, parallel, placebo-controlled pivotal registrational Phase 3 clinical study (study number: JS005-005-III-PsO) designed for the treatment of moderate to severe plaque psoriasis. Both the co-primary and key secondary endpoints achieved statistically significant and clinically meaningful improvements. Junshi Biosciences intends to submit a new drug application for this product to regulatory authorities in the near future.
Psoriasis is a prevalent chronic, recurring, inflammatory, and systemic condition mediated by the immune system. Its prevalence varies significantly by region: globally, the overall prevalence of psoriasis ranges from 2.0% to 3.0%, while in China, it is 0.47%. According to data released by the World Psoriasis Day Consortium, approximately 125 million people worldwide are affected by psoriasis, a number that continues to grow year-on-year. Psoriasis can be accompanied by other systemic abnormalities; patients with moderate-to-severe psoriasis face an elevated risk of developing metabolic syndrome and atherosclerotic cardiovascular disease. Mental health issues such as depression, anxiety, and suicidal ideation, arising from physical and psychological distress, are also relatively common among psoriasis patients. Therefore, psoriasis is a disease that severely impacts patients’ physical and mental health and represents a global health challenge requiring urgent attention.
To date, the multi-center, randomized, double-blind, parallel, placebo-controlled pivotal registrational Phase 3 study (study number: JS005-005-III-PsO) of JS005 has been successfully completed, meeting both the co-primary and key secondary endpoints. Professor Jianzhong ZHANG from Peking University People’s Hospital led the study, which was conducted across 60 clinical sites in China. Its primary objective was to determine if the proportion of participants achieving at least a 90% improvement in Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (the “sPGA”) score of 0 or 1 at Week 12 in the JS005 group was superior to that of the placebo group.
The study results revealed that, compared to placebo, JS005 significantly improved the area and severity of psoriasis lesions in participants. Additionally, the proportion of participants achieving an sPGA score of 0 or 1 was also markedly higher, and JS005 demonstrated a favorable safety profile in participants with moderate to severe plaque psoriasis. The detailed study results will be disclosed at future international academic conferences.
Professor Jianzhong ZHANG from Peking University People’s Hospital remarked, “Patients suffering from moderate-to-severe psoriasis endure long-term recurrent skin lesions and pruritus, leading to substantial physical and mental burdens. Traditional treatments remain limited, making the successful completion of this Phase 3 study for JS005 a significant milestone. The results underscore JS005’s superior efficacy in achieving deep symptom remission, sustained therapeutic effects, and an improved quality of life. We anticipate that this therapy will soon benefit millions of patients, thereby further advancing China’s psoriasis treatment landscape.”
Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, stated, “We extend our sincere appreciation to the patients, investigators, and the R&D team for their exceptional contributions in achieving the primary endpoints of JS005’s Phase 3 study. This milestone not only offers new hope to patients living with moderate-to-severe psoriasis but also signifies our innovative breakthrough in the autoimmune field. Moving forward, we will actively collaborate with regulatory bodies to accelerate the availability of this innovative therapy, ensuring earlier patient access.”
About JS005
JS005 is an anti-IL-17A monoclonal antibody independently developed by Junshi Biosciences. IL (interleukin)-17A is a pleiotropic cytokine, and its irregular secretion is strongly linked to the onset and progression of autoimmune diseases such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis. By binding to IL-17A with high affinity and selectively blocking IL-17A’s interaction with its receptor IL-17RA/IL-17RC, JS005 inhibits the activation of downstream signaling pathways and the release of inflammatory factors, thereby effectively alleviating the symptoms of autoimmune diseases. To date, the Phase 3 clinical study of JS005 for the treatment of moderate to severe plaque psoriasis has met its co-primary and key secondary endpoints. All subjects in the Phase 2 clinical study of JS005 for the treatment of active ankylosing spondylitis have completed their primary endpoint visits and entered the extension treatment period.
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company committed to the discovery, development, and commercialization of innovative therapeutic solutions. The company has established a diverse R&D pipeline encompassing over 50 drug candidates, with five strategic therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, notably toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in 40 countries and regions, including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively fulfilled its social responsibilities as a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19.
With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences operates under the philosophy of “In China, For Global.” Currently, the company employs approximately 2,500 individuals across its locations in the United States (Maryland) and various cities in China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com.
Junshi Biosciences Contact Details
Investor Relations Team:
Junshi Biosciences
+ 86 021-6105 8800
Public Relations Team:
Junshi Biosciences
Zhi Li
+ 86 021-6105 8800
