Johnson & Johnson (JNJ.US) has applied for its first-in-class new drug to be marketed domestically in China, and the Center for Drug Evaluation (CDE) has included it in the list for priority review.

On November 19th, the official website of China's National Medical Products Administration (CDE) announced that Johnson & Johnson (JNJ.US) had submitted an application for the listing of a new drug, Icotrokinra hydrochloride tablets, which is suitable for treating moderate to severe plaque psoriasis in adults and children aged 12 and older who are suitable for systemic treatment or phototherapy. On the same day, the Icotrokinra hydrochloride tablets were also included in the priority review process by CDE, marking a key step in its approval process in China. Icotrokinra hydrochloride tablets (Icotrokinra) is a first-in-class oral peptide drug (IL-23R antagonist) acquired by Johnson & Johnson from Protagonist for nearly $1 billion. The drug was filed for approval in the United States in July and in Europe in September of this year. It is worth mentioning that Icotrokinra is currently the world's first and only IL-23R targeting drug that has been filed for approval. Johnson & Johnson has high hopes for the drug, with estimated peak sales expected to exceed $5 billion annually. The drug's approval applications in the United States and the European Union included data from four key Phase III studies, including ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2. ICONIC-ADVANCE 1 and 2 are randomized controlled Phase III clinical trials aimed at evaluating the efficacy and safety of Icotrokinra compared to Deucravacitinib (the world's first approved TYK-2 inhibitor) and placebo in patients with moderate to severe plaque psoriasis. The primary endpoints were the percentage of subjects reaching PASI 90 (90% improvement in the Psoriasis Area and Severity Index) and an IGA score of 0/1 (elimination or near elimination of skin symptoms), with at least a 2-grade improvement. In these two studies, Icotrokinra achieved both primary endpoints compared to placebo by week 16, with a similar rate of adverse events, and showed superior efficacy and safety compared to Deucravacitinib at various time points. Compared to placebo (at week 16) and Deucravacitinib (at weeks 16 and 24), Icotrokinra demonstrated a higher rate of skin clearance. The incidence of adverse events with Icotrokinra was similar to placebo, with no new safety signals identified. By week 24, the incidence of adverse events with Icotrokinra was numerically lower than with Deucravacitinib. In all studies, the proportion of patients experiencing adverse events was similar between the Icotrokinra group (49.1%) and the placebo group (51.9%), with no new safety signals identified. Additionally, Johnson & Johnson has initiated the Phase III ICONIC-ASCEND study, which is the first head-to-head study to demonstrate that the oral drug Icotrokinra is superior to the injectable biologic Ustekinumab. In terms of long-term data, the ICONIC-LEAD study showed sustained skin clearance rates and good safety in adult and adolescent patients at week 52. Icotrokinra hydrochloride tablets were jointly developed by Johnson & Johnson and Protagonist Therapeutics. According to their collaboration agreement, Johnson & Johnson obtained exclusive rights to develop and commercialize the drug globally from the Phase II clinical trial stage of Icotrokinra. The decision by CDE to include the drug in the priority review process was based on its outstanding efficacy and safety characteristics demonstrated in multiple international multicenter clinical trials, providing strong evidence for the treatment of patients with moderate to severe psoriasis, particularly in the pediatric population.