On May 9, Johnson & Johnson announced that the Guselkumab Injection (including subcutaneous and intravenous infusion) had receivedNMPAApproved for the treatment of adult patients with moderate to severe active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapies or biologics.Guselkumab, developed by Johnson & Johnson, is a fully human monoclonal antibody and an IL-23 inhibitor. By selectively binding to the p19 subunit of IL-23, it blocks the interaction with its receptor, thereby inhibiting inflammatory responses. Compared with similar drugs (such as ustekinumab), its fully human nature reduces immunogenicity and minimizes the risk of allergic reactions.
This approval marks Guselizumab Injection as the first interleukin-23 inhibitor in China for the treatment of ulcerative colitis. In an earlier February, Guselizumab received its global first approval in China for Crohn's disease.Development Stage of Guselkumab'%20fill='%23FFFFFF'%3E%3Crect%20x='249'%20y='126'%20width='1'%20height='1'%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
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About Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory bowel disease (IBD), primarily affecting the colon and rectum. It is characterized by continuous inflammation and ulcer formation in the intestinal mucosa, accompanied by symptoms of rectal irritation such as abdominal pain, mucus-filled bloody stools, and frequent bowel movements. Currently, there are approximately 600,000 ulcerative colitis patients in China.
Regarding Clinical Research
The approval for ulcerative colitis was based on data from the pivotal Phase IIb/III QUASAR study, which showed:
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 those receiving maintenance treatment with 100mg of guselkumab subcutaneous injection every eight weeks achieved the same clinical remission; in contrast, only 19% in the placebo group reached clinical remission.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 reached endoscopic remission (p<0.001).In terms of safety, the incidence of adverse events (AE) in the Guselkumab group was comparable to that of the placebo group. The incidence of serious AEs was 2.9% in the Guselkumab group and 7.1% in the placebo group. The incidence of discontinuation due to AEs was 1.7% in the Guselkumab group and 3.9% in the placebo group.
Guselkumab provides an efficient and safe treatment option for various immune-mediated diseases by precisely targeting the IL-23 pathway. BesidesIBDGuselkumab was also approved in China in 2019 for the treatment of moderate to severe plaque psoriasis. According to the PharmaDATA database, global sales of guselkumab reached $3.67 billion in 2024.Sales Changes of Guselkumab![]()
1. Johnson & Johnson Official Website
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