Icotrokinra (Oral IL-23R Antagonist) Files for Market Approval in China Following Global Submissions and Positive Phase 3 Data
Xian Janssen
Pharmaceutical R&D and Manufacturer
Johnson & Johnson
Medical Device R&D and Manufacturer
PSORIASIS NEWS
On November 19, 2025, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) showed that Xian Janssen (the applicant) submitted a marketing application for Icotrokinra Hydrochloride Tablets, a Class 1 new drug.This medication is suitable for adult patients with moderate to severe plaque psoriasis who are receiving systemic treatment or phototherapy, as well as pediatric patients aged 12 years and above.。SameDay，The drugAlsoByCDEN/AIncluded in the proposed priority review.
Screenshot of CDE Official Website
Icotrokinra Hydrochloride Tablets (Icotrokinra) is a first-in-class oral peptide drug (IL-23R antagonist) that Johnson & Johnson has heavily invested in to acquire from Protagonist.The drug was submitted for market approval in the U.S. in July and in Europe in September this year, and an application for market approval was filed in China in November.
According to a Phase III clinical study published in The New England Journal of Medicine on November 5, 2025 [1], the study included 684 patients aged 12 years and older with moderate to severe plaque psoriasis, of whom 456 were in the medication group (Icotrokinra) and 228 in the placebo group.
At week 16, 65% of subjects in the Icotrokinra group achieved an IGA 0/1 response, compared to 8% in the placebo group; the proportions achieving a PASI 90 response were 50% and 4%, respectively. By week 16, the proportion of subjects experiencing at least one adverse event was 49% in both groups; the most common adverse events in both groups were nasopharyngitis and upper respiratory tract infections.
The inclusion of icotrokinra in the priority review process in China is expected to accelerate the product's approval and market launch, providing more psoriasis patients with a new treatment option at an earlier date. This progress also highlights China's strong support for innovative drugs and its determination to align with global advancements in autoimmune disease treatments, setting a positive example for the development and market entry of similar drugs in the future.。
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