Junshi Biosciences Announces Acceptance of the NDA for Roconkibart (IL-17A) for the Treatment of Moderate to Severe Plaque Psoriasis

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[{"type":"image","alt":"Junshi Biosciences","displaySize":"","headline":null,"caption":"Junshi Biosciences","className":"","disableSlideshowImg":false,"size":{"original":{"width":150,"height":56,"url":"https://media.zenfs.com/en/globenewswire.com/971d658a30455dfc9bd856efb4c84acc"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/4euD1KvxSTvPpofaq76LRQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIxMDtoPTc4O2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/971d658a30455dfc9bd856efb4c84acc","width":150,"height":56}},"lazy":false},{"type":"text","content":"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”).","length":660,"tagName":"p","attribs":{}},{"type":"text","content":"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.","length":810,"tagName":"p","attribs":{}},{"type":"text","content":"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 Uni...

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