Johnson & Johnson's Guselkumab has been approved for treating Crohn's disease in China.

Johnson & Johnson (JNJ.US) announced that the application for approval of the infliximab injection (intravenous infusion) and infliximab injection for a new indication has been approved by the National Medical Products Administration (NMPA) in China for the treatment of moderate to severe active Crohn's disease in adult patients. Previously, infliximab had been approved in China for the treatment of psoriasis. According to the Johnson & Johnson press release, as a interleukin-23 inhibitor with a dual mechanism of action, this is the first global approval of infliximab for the treatment of moderate to severe active adult Crohn's disease. Crohn's disease is a chronic systemic disease characterized by inflammation in the gastrointestinal or digestive tract, which can cause persistent diarrhea, abdominal pain, and rectal bleeding during flare-ups. It is a progressive disease that worsens over time. Infliximab has 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. In addition, its new indication for the treatment of moderate to severe active Crohn's disease was accepted by the FDA in June 2024. According to the Johnson & Johnson press release, this approval was based on clinical data from two key phase 3 studies (GALAXI 2 and GALAXI 3) in the GALAXI project. In the trials, both dose groups of infliximab successfully met the co-primary endpoints, demonstrating statistically significant and clinically meaningful clinical and endoscopic results compared to placebo, and superiority over the control drug based on the pooled results of the two studies on multiple controlled endoscopic endpoints.