Clinical Trial of JS005 (IL-17A) by Junshi Biosciences Achieves Main Goals in Treatment of Moderate to Severe Psoriasis

Junshi Biosciences, a leading biotech company in China specializing in the development of innovative biopharmaceuticals, particularly monoclonal antibodies, has announced that it will soon submit a new application for its product JS005 to the National Medical Products Administration (NMPA) in China.

JS005 is a recombinant humanized anti-IL-17A monoclonal antibody, targeting Interleukin-17A (IL-17A), an immunological target that plays a central role in inflammatory diseases such as psoriasis and spondyloarthritis.

Background

Junshi Biosciences has been at the forefront of biotechnology in China, focusing on the development of innovative biopharmaceuticals, especially monoclonal antibodies. The active ingredient JS005 is designed to combat IL-17A, a key target in inflammatory diseases like psoriasis and spondyloarthritis.

Phase 3 Study Results

The phase 3 clinical study of JS005 for moderate to severe plaque psoriasis has met its co-primary and key secondary endpoints. The study, conducted in 60 clinical sites across China, aimed to determine whether JS005 is superior to a placebo in achieving at least a 90% improvement in Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of 0 or 1 at Week 12.

Compared to the placebo, JS005 significantly improved the area and severity of psoriasis lesions in participants and increased the proportion of participants achieving a sPGA score of 0 or 1. The study results will be announced at future international academic conferences.

Safety and Efficacy

In addition to showing statistically significant and clinically meaningful improvements, JS005 demonstrated good safety in participants with moderate to severe plaque psoriasis.

Global Impact

Five of Junshi Biosciences' products have received approvals in China and international markets, including toripalimab, China's first domestically produced and independently developed anti-PD-1 monoclonal antibody.

During the COVID-19 pandemic, Junshi Biosciences has been involved in the development of etesevimab, MINDEWEI, and other novel therapies for the prevention and treatment of COVID-19.

Company Overview

Junshi Biosciences employs approximately 2,500 people in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). The company is an innovation-driven biopharmaceutical company with a diversified R&D pipeline, focusing on cancer, autoimmune, metabolic, neurological, and infectious diseases.

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, expressed gratitude for the contributions of patients, investigators, and the R&D team in achieving the primary endpoints of JS005's Phase 3 study and stated that this milestone marks Junshi Biosciences' innovation breakthrough in the autoimmune field.

The exact date for the submission of the new application to the NMPA has not been disclosed yet, but it is expected to happen soon, according to the company's communication. This development brings new hope to patients with moderate-to-severe psoriasis and may further advance China's psoriasis treatment landscape.