Johnson & Johnson's (JNJ.US) Guselkumab has been approved in China for the treatment of Crohn's disease.

Johnson & Johnson (JNJ.US) announced that its new application for the approval of Guselkumab Injection (IV) and Guselkumab Injection for the treatment of adult patients with moderate to severe active Crohn's disease has been approved by the National Medical Products Administration (NMPA) of China. Guselkumab had previously been approved in China for the treatment of psoriasis. According to Johnson & Johnson's press release, as a dual mechanism of action IL-23 inhibitor, this is the first global approval of Guselkumab for the treatment of moderate to severe active adult Crohn's disease. Crohn's disease is a chronic systemic disease characterized by inflammation of the gastrointestinal tract or digestive tract, which can cause persistent diarrhea, abdominal pain, and rectal bleeding. It is a progressive disease that worsens over time. Guselkumab had previously been approved in the United States for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and moderate to severe active ulcerative colitis, and its new application for the treatment of moderate to severe active Crohn's disease was also accepted by the FDA in June 2024. According to Johnson & Johnson's press release, this approval was based on clinical data from two key Phase 3 studies (GALAXI2 and GALAXI3) in the GALAXI project. In the trial, both doses of Guselkumab successfully achieved the co-primary endpoint, achieving statistically significant and clinically meaningful clinical and endoscopic results compared to placebo, and demonstrating superiority to the comparator drug in the multiple controlled endoscopic endpoints based on the pooled results of the two studies.