SHANGHAI, China, Dec 5, 2025 — 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.”