On August 27, 2026, Johnson & Johnson announced that its interleukin-23 (IL-23) receptor antagonist icotrokinra (艾特雅®, 盐酸伊可白滞素片) has been officially approved by China's National Medical Products Administration (NMPA) for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as pediatric patients aged 12 years and older weighing at least 40 kg. Icotrokinra is the first and currently only targeted oral peptide drug that precisely blocks the IL-23 receptor. The Center for Drug Evaluation of the NMPA granted it priority review qualification in November 2025.
In four Phase III clinical studies enrolling a total of 2,500 patients, icotrokinra met all primary efficacy endpoints and demonstrated a favorable safety profile. In the head-to-head superiority study, approximately 70% of patients achieved complete or almost complete skin clearance (IGA 0/1) at Week 16, and 55% achieved a Psoriasis Area and Severity Index improvement of ≥90% (PASI 90) response, significantly superior to both placebo and deucravacitinib. In the ICONIC-LEAD study, 85.1% of Chinese enrolled patients achieved IGA 0/1 at Week 16, and 71.6% achieved PASI 90 response; at Week 24, approximately 70% of Chinese enrolled patients achieved complete skin clearance (IGA 0). The difference in adverse event rates between the icotrokinra treatment group and the placebo group did not exceed 1.1% through Week 16, and no new safety signals were identified through Week 52.
Psoriasis affects more than 8.4 million patients in China, with nearly one-quarter of plaque psoriasis patients classified as moderate-to-severe cases. Icotrokinra was co-discovered and developed by Protagonist Therapeutics and Johnson & Johnson under a licensing and collaboration agreement, with Johnson & Johnson retaining exclusive worldwide rights for Phase II and subsequent clinical development. As a "biologic in a pill," icotrokinra is administered orally once daily, breaking the long-standing dependence on injectable agents for the IL-23 target. Industry analysts predict its annual sales could exceed $5 billion, profoundly transforming the psoriasis treatment landscape.
Source: Xi'an Janssen / Johnson & Johnson | https://www.xian-janssen.com.cn/news/6550