Johnson & Johnson's Tremfya and Tremfya D Achieve Global First Approval in China for Crohn's Disease

On February 25, 2025, Johnson & Johnson announced that Tremfya Duo (Guselkumab Injection (Intravenous Infusion)) and Tremfya (Guselkumab Injection) have been approved in China for the treatment of adult patients with moderate to severe active Crohn's disease who have had an inadequate response, lost response, or were intolerant to conventional therapies or biologics. This accelerated approval was granted due to the National Medical Products Administration’s designation of the product as a breakthrough therapy and priority review, marking the world’s first approval of Guselkumab for the Crohn's disease indication. Notably, as the only interleukin-23 inhibitor with a dual mechanism of action, Guselkumab is the only IL-23 inhibitor that demonstrated superiority over Stelara (Ustekinumab) across multiple endoscopic endpoints in the double-blind head-to-head registration clinical trial (GALAXI).

This approval is based on clinical data from two pivotal Phase III studies (GALAXI 2 and GALAXI 3) within the GALAXI program. GALAXI 2 and GALAXI 3 are double-blind head-to-head registration clinical trials that demonstrated the superiority of guselkumab over Stelara (ustekinumab) in the treatment of Crohn’s disease. In the trials, both dosing regimens of guselkumab successfully achieved the co-primary endpoints, showing statistically significant and clinically meaningful clinical and endoscopic outcomes compared to placebo. Additionally, based on pooled results from the two studies, guselkumab demonstrated superiority over Stelara (ustekinumab) at multiplicity-controlled endoscopic endpoints. The two dosing regimens in the trials were: 200 mg intravenous induction (at weeks 0, 4, and 8) followed by either 100 mg subcutaneous maintenance every 8 weeks or 200 mg subcutaneous maintenance every 4 weeks.

"Patients are always at the core of everything we do. This accelerated approval is an important testament to our unwavering commitment to patients in China, continuously bringing innovative medicines to help patients achieve longer-lasting disease remission and return to healthy lives. Tremfya (Ternogas) has become the first IL-23 inhibitor approved in China for Crohn's disease, marking another milestone in the treatment of this condition," said Cherry Huang, President of Innovative Pharmaceuticals, Johnson & Johnson China. "This ‘global first launch’ is also strong evidence of Johnson & Johnson’s 18 years of pioneering innovation in the immunology field in China. We will continue to focus on the research and development of the IL-23 pathway, committed to meeting the full-course treatment needs of patients with inflammatory bowel disease."

Crohn's disease is one of the two main subtypes of Inflammatory Bowel Disease (IBD), severely affecting the health of millions of people worldwide. Over the past few decades, the incidence of Crohn's disease in China has continued to rise, with an annual incidence rate of approximately 0.51-1.09 per 100,000 people, and the peak age of onset is concentrated between 20 and 30 years old. As the first and only fully human, dual-mechanism inhibitor that selectively neutralizes interleukin-23, Guselkumab has significantly improved clinical remission and deep remission rates in the treatment of Crohn's disease, raising the therapeutic effects to a new standard.