Johnson & Johnson (JNJ.US) "Gus-etched Mab" New Domestic Indications Approved

On May 9th, Johnson & Johnson (JNJ.US) received approval in China for the use of Stelara (ustekinumab injection, intravenous infusion) and Stelara (ustekinumab injection) in the treatment of adult patients with moderate to severe active ulcerative colitis who have had an inadequate response to traditional treatments or biologics, or who are non-responsive or intolerant. Ustekinumab is the first approved fully human interleukin 23 inhibitor with a dual mechanism of action, which not only directly binds to interleukin 23, but also targets CD64+ inflammatory cells that are major producers of interleukin 23. This approval for ulcerative colitis is based on data from the pivotal Phase IIb/III QUASAR study, which assessed the efficacy and safety of ustekinumab in adult patients with moderate to severe active ulcerative colitis who have had an inadequate response or intolerance to traditional treatments, other biologics, and/or JAK inhibitors. The results showed that patients treated with ustekinumab demonstrated significant symptom improvement as early as week 1 compared to placebo, and this improvement continued to strengthen over 12 weeks.