Junshi Biosciences Announces Phase 3 Win for IL-17A Drug JS005 in Psoriasis, Prepares China NDA Submission
Junshi Biosciences' anti-IL-17A monoclonal antibody JS005 demonstrated statistically significant and clinically meaningful efficacy in a pivotal phase 3 trial for moderate to severe plaque psoriasis123.
The multicenter, randomized, double-blind, placebo-controlled study showed JS005 achieved deep symptom remission, sustained therapeutic effects, and improved quality of life1.
Key endpoints included a significant improvement in the percentage of patients achieving at least a 90% reduction in Psoriasis Area and Severity Index (PASI 90) and a higher rate of "clear" or "almost clear" skin versus placebo2.
Safety profile for JS005 was reported as good, with no major new safety issues25.
The company plans to submit a New Drug Application (NDA) for JS005 to Chinese regulatory authorities soon12.
This positions JS005 to potentially join other approved IL-17 inhibitors, such as Novartis' Cosentyx, UCB's Bimzelx, and Eli Lilly's Taltz, although direct comparative data with global benchmarks has not been disclosed2.
Psoriasis is a prevalent, chronic immune-mediated disease with significant impacts on physical and mental health and is considered an urgent global health issue1.
Sources:
1. https://www.globenewswire.com/news-release/2025/09/07/3145717/0/en/Junshi-Biosciences-Announces-the-Phase-3-Study-of-JS005-IL-17A-for-the-Treatment-of-Moderate-to-Severe-Plaque-Psoriasis-Met-Primary-Endpoints.html
2. http://ftp.digitalpharmainnovation.com/biotech/junshi-heralds-phase-3-psoriasis-win-il-17-drug-prepares-push-chinese-regulators
3. https://www.biopharmaboardroom.com/news/1/3742/junshi-biosciences-il-17a-antibody-js005-achieves-positive-phase-3-results-in-moderate-to-severe-plaque-psoriasis.html