Janssen Submits NDA in China for Icotrokinra, the World’s First Oral IL-23R Antagonist, for Moderate-to-Severe Plaque Psoriasis

On November 19, the CDE website showed that Johnson & JohnsonClass 1 New DrugEltrombopag Hydrochloride TabletsSubmission for Market Approval, Applicable for TreatmentAdult patients with moderate to severe plaque psoriasis and pediatric patients aged 12 years and older who are candidates for systemic therapy or phototherapyOn the same day, the indication was also included in the proposed priority review by the CDE.

Screenshot source: CDE official website

Eltrombopag Hydrochloride Tablets（Icotrokinra）Johnson & Johnson investedNearly 1 billion US dollarsFirst-in-class introduced from ProtagonistOralPeptide drug (IL-23R antagonist). The drug was submitted for marketing approval in the United States this July and in Europe this September. Notably, Icotrokinra is currentlyThe world's first and onlyAn IL-23R-targeted oral drug reported to be on the market. Johnson & Johnson has high hopes for it, with projected peak annual sales expected to reachMore than 50 billion US dollars。

Previously, the drug's marketing applications in the U.S. and EU included data from four pivotal Phase III studies: ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2.

ICONIC-ADVANCE 1 and 2 are randomized controlled Phase III clinical trials designed to evaluate the efficacy and safety of Icotrokinra compared with Deucravacitinib (the world's first approved TYK-2 allosteric inhibitor) and placebo in patients with moderate to severe plaque psoriasis. The co-primary endpoints are the proportion of participants achievingPASI 90(90% improvement in Psoriasis Area and Severity Index) andIGA Score: 0/1(Skin symptoms eliminated or nearly eliminated), with at least a 2-grade improvement.

In these two studies,Icotrokinra achieved two co-primary endpoints at week 16 compared to placebo.The incidence of adverse events was similar., and at the time point, it demonstrated superior efficacy and safety compared to deucravacitinib.

• Compared with placebo (Week 16) and deucravacitinib (Week 16 and Week 24),Icotrokinra Shows Superior Skin Clearance Rate。
  

• The incidence of adverse events (AE) with Icotrokinra was similar to placebo, with no new safety signals identified. As of Week 24, the AE rate for Icotrokinra was numerically lower than that of deucravacitinib.

In all studies, the pooled safety data showed,IcotrokinraThe proportion of patients experiencing adverse events (AE) was similar between the treatment group (49.1%) and the placebo group (51.9%), with no new safety signals identified.

In addition, Johnson & Johnson has launched the Phase III ICONIC-ASCEND study, the first trial designed to demonstrate the superiority of the oral drug Icotrokinra over injectable biologics.Head-to-Head Study of Ustekinumab。

In terms of long-term data, in the ICONIC-LEAD study,Icotrokinra Demonstrates Sustained Skin Clearance and Favorable Safety in Adult and Adolescent Patients at Week 52。

• At week 52, adult patients who achieved PASI 90 and were re-randomized to the icotrokinra group at week 24 had a higher PASI 90 maintenance rate compared to those re-randomized to the placebo group (84% vs 21%; p<0.001).

• At week 52, 86% of adolescents treated with icotrokinra for 52 weeks achieved PASI 90, while 77% of those who switched from placebo to icotrokinra at week 16 achieved PASI 90.

According to Frost & Sullivan statistics, the total number of patients with autoimmune diseases worldwide has exceeded 500 million, and nearly 40 million people in China are suffering from major autoimmune diseases.It is estimated that by 2030, the global market size for autoimmune disease drugs will soar to 176 billion US dollars., with a compound annual growth rate of 3.6% from 2022 to 2030. The market size in China is expected to achieve an astonishing leap, reaching nearly 25 billion USD by 2030, which is 10 times the amount in 2020, becoming an important growth pole in the global autoimmune drug market.

Unlike the currently marketed IL-23 products, which are all monoclonal antibody injections,Oral Administration of IcotrokinraUndoubtedly provides patients with a more convenient treatment option.

Previously approved investigational drugs targeting IL-23 are mainly used for the treatment of moderate to severe active ulcerative colitis, including Johnson & Johnson's guselkumab, Eli Lilly's Omvoh (mirikizumab), AbbVie's risankizumab, and PharmaCore's tildrakizumab, all of which are injectables.

In addition, there are multiple IL-23 p19 drugs under research and development.。

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