Junshi Biosciences' psoriasis drug application accepted in China

Shanghai Junshi Biosciences Co., Ltd. announced the National Medical Products Administration has accepted its New Drug Application (NDA) for roconkibart injection. Roconkibart (product code: JS005), a recombinant humanized anti-IL-17A monoclonal antibody, is for adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The accepted specifications include 150 mg (1 ml) in both single-dose pre-filled syringes and autosyringes.

The NDA is supported by a multi-center, randomized, double-blind, placebo-controlled pivotal registrational phase III clinical study (JS005-005-III-PsO). This study enrolled 747 patients across 60 clinical sites in China and demonstrated significant improvements in Psoriasis Area and Severity Index (PASI) of 75/90/100 and static Physician Global Assessment (sPGA) scores of 0 or 1 after 12 weeks of treatment.

Roconkibart's efficacy was superior to placebo and remained stable over 52 weeks, with a favorable safety profile. The company also noted that all subjects in a Phase II clinical study for active ankylosing spondylitis have completed treatment and are in the follow-up period.