Qyuns Therapeutics Co., Ltd. (HKG: 2509) announced that results of the China Phase III clinical study of Oturkibart (QX005N), its innovative IL‑4Rα monoclonal antibody, for the treatment of prurigo nodularis (PN) were selected for the Late‑Breaking News (LBN) session and presented as an oral presentation at the 35th European Academy of Dermatology and Venereology Congress (EADV Congress 2026) in Vienna, Austria – one of Europe’s largest and most influential international dermatology conferences.
Study Snapshot
| Item | Detail |
|---|---|
| Asset | Oturkibart (QX005N) – humanized anti‑IL‑4Rα monoclonal antibody |
| Indication | Prurigo nodularis (moderate‑to‑severe; inadequate response to or inappropriate for medium‑to‑high potency topical corticosteroids) |
| Setting | China Phase III, multicenter, randomised, double‑blind, placebo‑controlled |
| Enrollment | 412 patients across 62 clinical research centers in China |
| Regimen | Oturkibart 450 mg vs. placebo, subcutaneous, once every two weeks (1:1) |
| Design | 52‑week treatment (24‑week double‑blind + 28‑week open‑label) + 8‑week safety follow‑up |
| Primary Endpoint | ≥4‑point reduction from baseline in weekly average WI‑NRS at Week 24 – met |
| Key Secondary Endpoint | IGA PN‑S score of “0” or “1” at Week 24 – met |
| Presenter | Professor Zhang Jianzhong, Peking University People’s Hospital |
| Forum | EADV Congress 2026 LBN session, Vienna, Austria |
Drug Profile & Mechanism of Action
- Molecule: Oturkibart – an innovative humanized monoclonal antibody targeting IL‑4Rα.
- Mechanism: By specifically binding IL‑4Rα, Oturkibart blocks IL‑4Rα interaction with both IL‑4 and IL‑13 and inhibits signaling pathways and biological effects mediated by these cytokines, exerting therapeutic effects in type 2 inflammatory allergic diseases.
- Clinical Positioning: Demonstrated sustained and multidimensional benefits across itch control, lesion clearance, quality of life and mental state in adult PN patients, with a favourable safety and tolerability profile.
- Regulatory Pipeline: Phase III trials in both prurigo nodularis and atopic dermatitis have met their primary endpoints; new drug applications are expected to be submitted within 2026.
Clinical Evidence – China Phase III Trial
| Endpoint | Week 24 – Oturkibart | Week 24 – Placebo | Statistical Result |
|---|---|---|---|
| WI‑NRS ≥4‑point reduction (primary) | 74.5 % | 29.0 % | P < 0.0001 |
| IGA PN‑S “0” or “1” (key secondary) | 34.7 % | 11.1 % | P < 0.0001 |
| TEAEs / SAEs incidence | Similar to placebo; most TEAEs mild‑to‑moderate | – | Favourable overall safety |
| Response at Week 52 | Continuous Treatment Group | Placebo‑to‑Drug Group |
|---|---|---|
| WI‑NRS ≥4‑point reduction | 95.5 % | 90.6 % |
| WI‑NRS ≤2 (deep itch relief, post‑hoc) | 76.7 % | 63.5 % |
| WI‑NRS ≤1 (deep itch relief, post‑hoc) | 55.1 % | 41.3 % |
| IGA PN‑S “0” or “1” | 66.9 % | 49.2 % |
Additional findings:
- Durable and delayed responses: Among Week 24 itch responders, the long‑term itch response maintenance rate at Week 52 was close to 100 %; Week 24 itch non‑responders achieved an 81.6 % response rate when treatment was extended to Week 52. Among Week 24 lesion responders, the long‑term maintenance rate at Week 52 was 95.1 %; lesion non‑responders reached a 51.8 % response rate with extended treatment.
- Early multidimensional benefit: Quality of life, anxiety and depression measures improved significantly as early as Week 4 (P < 0.05), with continued improvement through Week 52.
- Long‑term safety: No new safety risks were identified during long‑term treatment.
Market Impact & Outlook
- Unmet Need in PN: Prurigo nodularis is a chronic, intensely pruritic type 2 inflammatory skin disease; Oturkibart’s sustained efficacy positions it as a promising new treatment option enabling long‑term stable control and comprehensive management of symptoms and clinical signs.
- Late‑Breaking Validation: Selection for the LBN session at EADV 2026 – a top‑tier global dermatology forum – provides third‑party scientific validation of the Phase III dataset.
- Registration Timeline: The Company stated it will accelerate the registration and filing process, striving for early approval and market launch; NDAs in both PN and atopic dermatitis are expected within 2026.
- Franchise Strategy: Success across two type 2 inflammatory indications would establish Oturkibart as a dual‑franchise asset competing in both the prurigo nodularis and atopic dermatitis markets.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the clinical development of Oturkibart (QX005N), new drug application submissions and timing, regulatory review and approval, and commercial launch expectations. Actual results may differ materially from those expressed or implied due to risks and uncertainties inherent in clinical development and regulatory review.-Fineline Info & Tech
