By Fineline Cube 
Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) announced that its proprietary recombinant humanized anti‑IL‑17A monoclonal antibody JS005 achieved clinically meaningful, statistically significant results in a pivotal, multicenter, randomized, double‑blind, placebo‑controlled Phase III registration trial (study number: JS005‑005‑III‑PsO) for moderate‑to‑severe plaque psoriasis.
Study Highlights
| Endpoint | Result | Clinical Impact |
|---|---|---|
| Co‑primary endpoints | Statistically significant improvement in both PASI 90 and PASI 75 response rates | Demonstrates robust efficacy comparable to leading IL‑17 inhibitors |
| Key secondary endpoints | Significant reduction in Investigator Global Assessment (IGA) score and itch severity | Enhances patient‑reported outcomes and quality of life |
- Population – 1,200 patients across 48 sites in China and the U.S.
- Duration – 12‑week double‑blind treatment period followed by 12‑week safety follow‑up.
- Safety profile – No new safety signals; adverse events consistent with the IL‑17 inhibitor class.
Path Forward
Junshi Biosciences plans to submit a marketing authorization application (MAA) to regulatory authorities (NMPA, FDA, EMA) in the near term, leveraging the robust Phase III data and the growing demand for selective IL‑17A therapies in dermatology.
Why IL‑17A Matters
- Biological role – IL‑17A is a pleiotropic cytokine driving neutrophilic inflammation and keratinocyte hyperproliferation in psoriasis.
- Clinical relevance – Dysregulated IL‑17A is implicated not only in psoriasis but also in rheumatoid arthritis and ankylosing spondylitis, underscoring the therapeutic potential of selective IL‑17A blockade.-Fineline Info & Tech