Junshi Biosciences Reports Positive Phase 3 Results for IL-17 Psoriasis Drug

Junshi Biosciences, a Shanghai-based pharmaceutical company, has announced successful phase 3 trial results for its interleukin-17 (IL-17) antibody in treating moderate to severe plaque psoriasis. The positive outcome sets the stage for the company to pursue regulatory approval in China, potentially introducing a new treatment option for millions of patients.

Trial Design and Results

The placebo-controlled study, conducted across 60 sites in China, evaluated the efficacy and safety of JS005, Junshi's anti-IL-17A monoclonal antibody. The trial met its co-primary and secondary endpoints, demonstrating statistically significant improvements in psoriasis symptoms compared to placebo.

Key findings include:

• A significantly higher proportion of patients treated with JS005 achieved at least a 90% improvement in their Psoriasis Area and Severity Index (PASI 90) score compared to the placebo group.
• The JS005 group showed a notably higher percentage of patients with skin deemed "clear" or "almost clear" relative to the placebo cohort.
• The drug exhibited a favorable safety profile, according to the company.

Professor Jianzhong Zhang from Peking University People's Hospital, who led the study, emphasized the drug's "superior efficacy in achieving deep symptom remission, sustained therapeutic effects, and improved quality of life."

Market Implications and Future Plans

While Junshi has not yet released detailed data, the positive results position JS005 as a potential competitor to established IL-17 inhibitors such as Novartis' Cosentyx, UCB's Bimzelx, and Eli Lilly's Taltz. The company plans to present comprehensive trial data at an upcoming medical conference.

Junshi CEO Jianjun Zou, M.D., Ph.D., stated that the trial results "not only brings new hope to patients with moderate-to-severe psoriasis but also marks our innovation breakthrough in the autoimmune field." The company is now focused on collaborating with regulators to accelerate the drug's availability to patients.

In addition to psoriasis, Junshi is exploring JS005's potential in other inflammatory conditions, with an ongoing phase 2 study in ankylosing spondylitis.

Competitive Landscape in China

Junshi's announcement comes amid growing competition in China's psoriasis treatment market. Notably, Akeso Biopharma, a Hong Kong-based company, is currently awaiting regulatory decision on its own IL-17A monoclonal antibody, gumokimab, for psoriasis treatment. Akeso reported positive phase 3 data for gumokimab last year, claiming "superior outcomes" in their trial.

As these developments unfold, the expanding array of treatment options signals potential advancements in care for psoriasis patients in China, where traditional treatments have been described as limited by researchers involved in these studies.