Janssen Announces Launch of Tremfya® (Guselkumab IV) in China for Adults with Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis

China Finance Network, June 9th: Today, Johnson & Johnson announced the launch of TREMFYA® (Guselkumab Injection (Intravenous Infusion)) in China for the treatment of adult patients with moderately to severely active Crohn's disease and ulcerative colitis who have had an inadequate response, lost response, or were intolerant to conventional therapy or biologics.

Tremfya (Guselkumab Injection (Intravenous Infusion)) was approved in February this year for the induction treatment of moderate to severe active Crohn's disease, and in April it was approved for the induction treatment of ulcerative colitis. Tremfya (Guselkumab Injection) was approved in 2019 for the treatment of psoriasis, and in February this year, its use was expanded to include maintenance treatment for moderate to severe active Crohn's disease, with an additional expansion in April for maintenance treatment of ulcerative colitis.

The approval of Guselkumab was based on data from the GALAXI Phase 3 study and the QUASAR Phase 3 study. GALAXI 2 and GALAXI 3 studies are double-blind head-to-head registration clinical trials. Based on the pooled data from these two studies, Guselkumab demonstrated superior efficacy compared to Stelara (Ustekinumab) in treating Crohn's disease across multiple controlled endoscopic endpoints. The QUASAR Phase 3 study in ulcerative colitis met its primary endpoint and all key secondary endpoints, including higher rates of endoscopic remission. The study showed that 45%-50% of patients with ulcerative colitis achieved clinical remission within one year, while 34%-35% of patients achieved endoscopic remission.

In the past few decades, the incidence rates of Crohn's disease and ulcerative colitis in China have continued to rise, with the peak age of onset showing an earlier trend. "These diseases have profoundly impacted the life trajectories of patients, affecting their education, careers, and family lives. Patients suffering from these two chronic and currently incurable diseases are seeking treatments that can effectively address challenging symptoms and provide long-lasting relief," said a representative from Johnson & Johnson. For years, Johnson & Johnson has been committed to developing innovative therapies to meet the unmet needs of patients with inflammatory bowel disease. "Our treatment options in China have evolved from Remicade to Stelara, and now to Tremfya and Tremfya. The product lineup continues to advance. As the first and only fully human, dual-mechanism therapy that selectively neutralizes interleukin-23, Tremfya and Tremfya offer sustained deep remission in both Crohn’s disease and ulcerative colitis, making it possible for patients to achieve dual control over disease management and personal goals."

Cherry Huang, President of Johnson & Johnson Innovative Medicine China, stated that the simultaneous launch of Tremfya in Crohn's disease and ulcerative colitis has brought a new treatment standard for Chinese IBD patients. "We will closely collaborate with multiple partners to continuously improve drug accessibility and further expand our robust immunology pipeline portfolio, bringing hope to more patients."

Recently, Johnson & Johnson officially launched the "Change IBD" action plan in China, committing to comprehensively enhance the diagnosis, treatment, and living standards of patients with inflammatory bowel disease (IBD). This plan focuses on three core areas — strengthening disease education, helping improve IBD diagnosis and treatment capabilities, and promoting societal support for patients. Key initiatives include the "Dual Life" disease education program, which encourages patients to participate in "shared decision-making" to improve treatment outcomes and quality of life.