Johnson & Johnson (JNJ.US) first-in-class new drug declared for listing in China CDE included it in the proposed priority review

The Zhitong Finance App learned that on November 19, the CDE official website revealed that Johnson & Johnson (JNJ.US) declared the launch of the new Class 1 drug, eicobucin hydrochloride tablets, which are suitable for the treatment of adult patients with moderate to severe plaque psoriasis suitable for systematic treatment or phototherapy and children aged 12 and over. On the same day, icobacin hydrochloride tablets were also included by the CDE in the proposed priority review, marking a key step in its marketing process in China.

Icotrokinra hydrochloride tablets (Icotrokinra) are first-in-class oral polypeptide drugs (IL-23R antagonists) introduced by Johnson & Johnson at a cost of nearly 1 billion US dollars from Nutriist. The drug was declared for sale in the US in July of this year, and declared for sale in Europe in September. It is worth mentioning that Icotrokinra is currently the first and only IL-23R targeted drug to be marketed in the world. Johnson & Johnson has high hopes for this, and it is expected that the peak annual sales volume will reach more than 5 billion US dollars.

Previously, the drug's US and EU marketing applications included data from four key Phase III studies, including ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2.

ICONIC-ADVANCE1 and 2 are randomized controlled phase III clinical trials to evaluate the efficacy and safety of Icostrokinra compared to deuterocloxitinib (the world's first approved TYK-2 allosteric inhibitor) and placebo in patients with moderate to severe plaque psoriasis. Common primary endpoints were that subjects achieved a PASI 90 (90% improvement in psoriatic area and severity index) and an IGA score of 0/1 (elimination or almost elimination of skin symptoms), and an improvement of at least 2 levels.

In both studies, compared to placebo, Icotrokinra reached two common primary endpoints at week 16, had similar adverse event rates, and showed superior efficacy and safety over deuterium clexitinib at the time point in time.

Compared to placebo (week 16) and deuterocloxitinib (weeks 16 and 24), Icotrokinra showed better skin clearance. The incidence of adverse events (AEs) with Icotrokinra was similar to that of placebo, and no new safety signals were found. As of week 24, the AE incidence of Icotrokinra was numerically lower than deuteroclecitinib.

In all studies, pooled safety data showed a similar proportion of patients experiencing adverse events (AEs) between the Icotrokinra group (49.1%) and the placebo group (51.9%), and no new safety signals were found.

Additionally, Johnson & Johnson has initiated the Phase III ICONIC-ASCEND study, the first head-to-head study aimed at proving that the oral drug Icosorkinra is superior to injectable biologic ursinumab. In terms of long-term data, in the ICONIC-LEAD study, Icotrokinra showed sustained skin clearance and good safety in adult and adolescent patients at week 52.

According to reports, icobacin hydrochloride tablets were jointly developed by Johnson & Johnson and Nutriist Therapeutics. According to the cooperation agreement between the two parties, Johnson & Johnson has obtained exclusive rights to develop and commercialize the drug worldwide since Icotrokinra entered phase II clinical trials. The decision to include CDE in the priority review is mainly based on the drug's excellent efficacy and good safety characteristics in multiple international multi-center clinical trials. The clinical data provided strong evidence-based medical evidence for patients with moderate to severe psoriasis, especially pediatric patients.