Quanxin Bio-B (02509): Results of the phase III clinical study of ortotibalizumab (QX005N) for prurigo nodular were released in EADV 2026 in the form of a groundbreaking oral report

Zhitong Finance App News, Quanxin Bio-B (02509) issued an announcement. Recently, the results of the Chinese phase III clinical study on the treatment of prurigo nodularis (PN) with ortotibimab (QX005N) were successfully selected for the 35th Annual Meeting of the European Society of Dermatology and Venereology (EADV Congress 2026) in Vienna, Austria, and presented an oral report (Oral) Presentation) format debut. The EADV annual conference is the largest in Europe and one of the most influential international conferences in the field of dermatology and venereology.

This study is a multi-center, randomized, double-blind, placebo-controlled phase III clinical study. Professor Zhang Jianzhong of Peking University People's Hospital was the presenter to share the findings on behalf of the research team during the conference. The study included a treatment period of 52 weeks (24 weeks of double blindness treatment period and 28 weeks of open treatment period) and an 8-week safety follow-up period. 62 research centers in China enrolled a total of 412 patients, who were randomly assigned to the 450 mg ortocibizumab group or placebo group (subcutaneous administration every 2 weeks) according to a 1:1 ratio.

The main end point of this study was the proportion of subjects with a weekly average of the most severe itching numerical assessment scale (WI-NRS) of week 24 decreased by at least 4 points from the baseline, and the key secondary endpoint was the proportion of subjects with an overall evaluation-nodular prurigo stage (IGA PN-S) score of “0” or “1” in week 24. Research results showed that ortocibizumab showed continuous and multi-dimensional clear clinical benefits in terms of pruritus control, removal of skin damage, and improvement of quality of life and mental state, with poor efficacy in topical drugs such as moderate-potent corticosteroids (TCS) or unsuitable for TCS treatment, as well as good safety and tolerability.