Junshi Biosciences Announces Acceptance of the NDA for Roconkibart (IL-17A) for the Treatment of Moderate to Severe Plaque Psoriasis
MWN-AI** Summary
Junshi Biosciences has announced that the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for Roconkibart (JS005), a recombinant humanized monoclonal antibody targeting IL-17A, for treating moderate to severe plaque psoriasis in adults. This chronic immune-mediated condition, significantly prevalent in China, is marked by substantial physical and psychological impacts on patients, including increased risks for metabolic syndromes and mental health issues.
The NDA acceptance is primarily supported by results from a pivotal randomized, double-blind, placebo-controlled Phase 3 clinical trial led by Professor Jianzhong Zhang at Peking University People’s Hospital. Conducted across 60 sites in China, the study evaluated 747 patients, demonstrating that after 12 weeks of roconkibart treatment, participants experienced significant improvements in the Psoriasis Area and Severity Index (PASI) and the static Physician Global Assessment (sPGA) score, outperforming the placebo group. A favorable safety profile was also observed throughout the 52-week study period.
Dr. Jianjun Zou, CEO of Junshi Biosciences, described the NDA acceptance as a milestone in advancing the company's efforts in autoimmune therapies, highlighting Roconkibart as a significant innovation in this therapeutic area. With its selective targeting of IL-17A, Roconkibart effectively blocks inflammatory pathways associated with psoriasis and other autoimmune diseases.
Junshi Biosciences, founded in 2012 and driven by innovation, has a diverse pipeline leveraging over 50 drug candidates across multiple therapeutic areas, including cancer and autoimmune diseases. The acceptance of the NDA for Roconkibart signifies a potential new treatment option for patients suffering from chronic psoriasis, promising to improve clinical outcomes and patient quality of life.
MWN-AI** Analysis
The recent acceptance of the New Drug Application (NDA) by the National Medical Products Administration (NMPA) for Junshi Biosciences’ roconkibart (JS005), a monoclonal antibody targeting IL-17A, marks a pivotal moment for both the company and the psoriasis treatment landscape in China. This development signifies not only the potential for enhanced therapeutic options for patients suffering from moderate to severe plaque psoriasis but also places Junshi Biosciences in a strong competitive position within the pharmaceutical industry.
RoConkibart's strong efficacy demonstrated in the Phase 3 trial, with substantial improvements in the Psoriasis Area and Severity Index (PASI) scores, coupled with a favorable safety profile, indicates that this product could become a go-to treatment for psoriasis, expanding Junshi's footprint in the autoimmune disease market. Given the increasing prevalence of psoriasis in China, the timing of this announcement positions Junshi advantageously to capitalize on unmet clinical needs.
From an investment perspective, the acceptance of the NDA is likely to drive a positive reaction in Junshi's stock performance due to heightened investor confidence and expected market entry. Investors should closely monitor upcoming announcements regarding the drug's approval timeline and potential market launch activities. Furthermore, as Junshi’s portfolio includes a diverse range of drug candidates across various therapeutic areas, the successful rollout of roconkibart could bolster the company's overall valuation and market position.
In summary, Junshi Biosciences stands at a crucial intersection of opportunity and growth. Stakeholders should consider maintaining or increasing their positions in the stock as the company advances through the regulatory process, potentially transforming the treatment landscape for psoriasis in China and beyond. Investors should also watch for the results of ongoing studies in other indications, which may further enhance Junshi's market appeal.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
SHANGHAI, Dec. 05, 2025 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the new drug application (“NDA”) for the company’s product, roconkibart injection (a recombinant humanized anti-IL-17A monoclonal antibody injection, product code: JS005), for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy has been accepted by the National Medical Products Administration (“NMPA”).
Psoriasis is a common chronic, recurrent, inflammatory, and systemic disease mediated by the immune system. According to the Guideline for the Diagnosis and Treatment of Psoriasis in China (2023 edition), the prevalence of psoriasis in China reached 0.47% in 2008, significantly higher than the 0.12% recorded in 1984. Psoriasis can be accompanied by other systemic abnormalities, patients with moderate-to-severe psoriasis have an increased risk of developing metabolic syndrome and atherosclerotic cardiovascular disease. Mental health conditions such as depression, anxiety, and suicidal tendencies caused by physical and psychological distress are also relatively common among the patients with psoriasis. Therefore, psoriasis is a disease that seriously affects the physical and mental health of patients.
The NDA is mainly based on the multi-center, randomized, double-blind, parallel and placebo-controlled pivotal registrational phase 3 clinical study (study number: JS005-005-III-PsO). Led by Professor Jianzhong ZHANG from the Peking University People’s Hospital, the study was conducted in 60 clinical sites across China, and a total of 747 patients with moderate to severe plaque psoriasis were enrolled.
The study results showed that, treatment for 12 weeks with roconkibart significantly improved the Psoriasis Area and Severity Index (PASI) of 75/90/100 and the static Physician Global Assessment (sPGA) score of 0 or 1. The efficacy was significantly superior to that of the placebo group and remained stable throughout the 52-week treatment, with an overall favorable safety profile. The relevant study results will be announced at future international academic conferences.
Prof. Jianzhong ZHANG from the Peking University People’s Hospital said, “Roconkibart, as a highly selective monoclonal antibody targeting IL-17A, acts directly on the core inflammatory pathway of psoriasis. Pivotal Phase 3 clinical data confirm that roconkibart achieves rapid and profound clearance of psoriatic lesions while demonstrating a favorable safety profile, offering a new clinical treatment option that balances efficacy and safety. The acceptance of this NDA marks a critical step in transitioning this therapy from clinical research to real-world practice. We anticipate its early approval to provide a significant new treatment choice for adults in China with moderate-to-severe plaque psoriasis, which will further enrich and optimize current clinical strategies.”
Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “The acceptance of the NDA by the NMPA for roconkibart in the treatment of moderate-to-severe plaque psoriasis marks a significant milestone in advancing our autoimmune disease pipeline. As the first innovative achievement in this core therapeutic area, roconkibart demonstrates our technological expertise and R&D capabilities in biologic innovation. We will actively collaborate with regulatory authorities during the review process, spare no effort to advance the product’s market approval, and strive to bring this new therapeutic option to patients at the earliest opportunity—fulfilling our patient-centric commitment.”
About Roconkibart Injection
JS005 is a specific anti-IL-17A monoclonal antibody independently developed by Junshi Biosciences. IL (interleukin)-17A is a pleiotropic cytokine, and the disordered secretion of which is closely related to the occurrence and progression of autoimmune diseases such as psoriasis, rheumatoid arthritis and ankylosing spondylitis. By binding to IL-17A with high affinity and selectively blocking the binding of IL-17A with its receptor IL-17RA/IL-17RC, JS005 blocks the activation of downstream signaling pathways and the release of inflammatory factors, thereby effectively alleviating the symptoms of autoimmune diseases. So far, the NDA for roconkibart for the treatment of moderate to severe plaque psoriasis has been accepted by the NMPA. All subjects in the phase 2 clinical study of roconkibart for the treatment of active ankylosing spondylitis have completed the treatment and entered the safe follow-up period.
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five 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, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 40 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of 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 is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com.
Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
+ 86 021-6105 8800
PR Team:
Junshi Biosciences
Zhi Li
+ 86 021-6105 8800
FAQ**
What are the key growth drivers for Shanghai Junshi Biosciences (SHJBF) after the acceptance of the NDA for roconkibart, and how might this impact their market share in the psoriasis treatment sector?
How does the NDA acceptance for roconkibart position Shanghai Junshi Biosciences (SHJBF) competitively against other biopharmaceutical companies focusing on anti-IL-17 therapies?
What potential challenges might Shanghai Junshi Biosciences (SHJBF) face in the regulatory review process for roconkibart, and how can they mitigate these risks?
With the ongoing development pipeline at Shanghai Junshi Biosciences (SHJBF), what other therapeutic areas are they focusing on to strengthen their position in the biopharmaceutical market?
**MWN-AI FAQ is based on asking OpenAI questions about Shanghai Junshi (OTC: SHJBF).
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