Johnson & Johnson Announces China Approval of Tremfya and Tremfya D for Ulcerative Colitis Treatment

On May 9, 2025, Johnson & Johnson announced that Tremfya Plus (Guselkumab Injection (Intravenous Infusion)) and Tremfya (Guselkumab Injection) have been approved in China for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to conventional therapy or biologics. In February this year, Guselkumab received its first global approval for Crohn's disease in China. This approval marks it as the first interleukin-23 inhibitor in China for the treatment of ulcerative colitis.
Guselkumab is the first approved fully human, dual-mechanism interleukin-23 inhibitor, which not only directly binds to interleukin-23 but also targets CD64+ inflammatory cells, the primary producers of interleukin-23. Interleukin-23 is a cytokine secreted by activated monocytes/macrophages and dendritic cells, and it is known to be a driving factor in immune-mediated diseases, including ulcerative colitis.
The approval for ulcerative colitis was based on data from the pivotal 2b/3 phase QUASAR study, which evaluated the efficacy and safety of guselkumab in adult patients with moderate to severe active ulcerative colitis who had an inadequate response to or were intolerant to conventional therapies, other biologics, and/or JAK inhibitors, including:

Compared with the placebo, patients receiving Guselkumab showed significant symptom improvement as early as Week 1, and this improvement continued to enhance over 12 weeks.

Among patients receiving maintenance treatment with 200mg of guselkumab subcutaneous injection every four weeks, 50% achieved the primary endpoint of clinical remission at week 44, while 45% of patients receiving maintenance treatment with 100mg of guselkumab subcutaneous injection every eight weeks achieved the same clinical remission; in contrast, only 19% of patients receiving placebo treatment reached clinical remission (p<0.001).

Among patients receiving maintenance treatment with subcutaneous guselkumab, 34% (200mg) and 35% (100mg) achieved endoscopic remission (normalization, MES=0) within one year, demonstrating significant healing of the intestinal mucosa; in contrast, only 15% of patients receiving placebo achieved endoscopic remission (p<0.001).
Ulcerative colitis is a type of inflammatory bowel disease (IBD) that causes chronic inflammation in the intestines and damages the colonic mucosa. Currently, there are approximately 600,000 ulcerative colitis patients in China. The condition typically follows a chronic course with repeated relapses, and its incidence rate is continuously rising, severely affecting an increasing number of patients. At present, there is no cure for ulcerative colitis.
"There remains a significant unmet clinical need in the treatment of ulcerative colitis," said Cherry Huang, President of Johnson & Johnson Innovative Medicine China. "This approval once again demonstrates Johnson & Johnson’s commitment to improving the quality of life for patients with inflammatory bowel disease through innovation. With 40 years of innovative progress in China, we hope to set new standards for efficacy and healthy living for more Chinese patients."