Tides Express | Janssen's Oral IL-23R Antagonist Icotrokinra Nominated for Priority Review in China

Nov 20, 2025 09:26 CST Updated 09:26

Johnson & Johnson

Medical Device R&D and Manufacturer

｜Edited by the Content Team of Zhong Peptide Biochemical

2025YearNovember 19，The CDE website shows that Johnson & Johnson's oral IL-23R antagonist Icotrokinra (Ikebairosi) is proposed to be included in the priority review for the treatment ofModerate to Severe Patients Receiving Systemic Therapy or PhototherapyPlaque PsoriasisAdult patients and pediatric patients aged 12 years and older。

Icotrokinra isProtagonist collaborates with Johnson & Johnson to developATargetedIL-23Rfirst-in-classOral peptide drugs, itsThe binding affinity with IL-23R can reachSingle-digit pM levels and exhibit in human T cellsIL-23 Signaling PathwayPotent selective inhibitory activity. Therefore, the drug canSelective blockade of IL-23R, thereby inhibiting IL-23-mediatedInflammatory response. Since Phase II clinical trials, Johnson & Johnson has held the global exclusive rights for the development and commercialization of Icotrokinra.

TargetingPlaque Psoriasis,Icotrokinra has completed four Phase III studies, including ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2.

ICONIC-LEADThe research results show that, inModerate to SevereIn patients with plaque psoriasis,Icotrokinra GroupSuccessfully achieved "Investigator's Global Assessment (IGA) score of 0/1 (clear or almost clear skin)" at Week 16.Proportion of PatientsSignificantly higher than the placebo group (65% vs 8%), and the proportion of patients achieving "at least 90% improvement in Psoriasis Area and Severity Index (PASI 90)" was also significantly higher than in the placebo group (50% vs 4%).

CONIC-TOTALThe research results show that,On the scalp,High-impact areas such as the genitals, hands, and feet are present.Among patients with psoriasis,The Icotrokinra group successfully achieved an "IGA score of 0/1 and a minimum 2-point improvement from baseline" at Week 16.The proportion of patients was significantly higher than that in the placebo group.（56.7% vs 5.8%）。

ICONIC-ADVANCE 1 andICONIC-ADVANCE 2The research results show that,InModerate to SevereIn patients with plaque psoriasis,Icotrokinra GroupSuccessfully achieved "IGA score of 0/1" at Week 16And the score improved by at least 2 points from the baseline.”Proportion of PatientsSignificantly higher than the placebo group andDeucravacitinib Group (ICONIC-ADVANCE 1：68% vs 11% vs 50%；ICONIC-ADVANCE 12:70% vs 9% 54%），And the proportion of patients achieving "PASI 90" was also significantly higher thanPlacebo group andDeucravacitinib Group (ICONIC-ADVANCE 1：55% vs 4% vs 30%；ICONIC-ADVANCE 2：57% vs 1% vs 34%）。

Source:

1.Medicine Cube