QYUNS-B (02509.HK): Oturkibart PN Phase III data at EADV 2026

NewTimeSpace News: On 2 October 2026, Qyuns Therapeutics Co., Ltd. (stock code: 02509) announced on a voluntary basis that the results of the China Phase III clinical study of Oturkibart (QX005N) for the treatment of prurigo nodularis (PN) were selected for the Late-Breaking News (LBN) session of the 35th European Academy of Dermatology and Venereology Congress (EADV Congress 2026) held in Vienna, Austria, and were presented as an oral presentation.

The announcement disclosed that the study is a multicentre, randomised, double-blind, placebo-controlled Phase III clinical study, with Professor Zhang Jianzhong of Peking University People's Hospital presenting the results on behalf of the research team. The study comprised a 52-week treatment period (a 24-week double-blind period and a 28-week open-label period) and an 8-week safety follow-up period, enrolling a total of 412 patients across 62 clinical research centres in China, randomly assigned 1:1 to the 450mg Oturkibart group or the placebo group (subcutaneous administration, once every two weeks). The primary endpoint was the percentage of subjects achieving a reduction of ≥4 points from baseline in the weekly average Worst Itch Numerical Rating Scale (WI-NRS) at Week 24, and the key secondary endpoint was the percentage of subjects with an Investigator's Global Assessment Prurigo Nodularis Stage (IGA PN-S) score of "0" or "1" at Week 24.

The announcement stated that the study met its primary endpoint at Week 24, with 74.5% of subjects in the Oturkibart group achieving a reduction of ≥4 points from baseline in the weekly average WI-NRS, significantly higher than 29.0% in the placebo group (P<0.0001); at the same time point, 34.7% achieved an IGA PN-S score of "0" or "1", versus 11.1% for placebo (P<0.0001). At Week 52, 95.5% (Continuous Treatment Group) and 90.6% (Placebo-to-Drug Group) of subjects achieved a ≥4-point WI-NRS reduction, while 66.9% and 49.2% reached an IGA PN-S score of "0" or "1", with long-term itch and lesion response maintenance rates close to 100% and 95.1% respectively. Oturkibart is an innovative humanised monoclonal antibody targeting IL-4Rα, and its Phase III trials for prurigo nodularis and atopic dermatitis have both met their primary endpoints, with new drug applications expected to be submitted within 2026.

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