By Fineline Cube 
US giant Johnson & Johnson (J&J, NYSE: JNJ) announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its Tremfya (guselkumab) intravenous infusion (IV) and Tremfya (guselkumab) injection. The drug is now approved for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients who have had an insufficient response, lost response, or are intolerant to traditional treatments or biologics.
Tremfya’s Previous Approvals
Tremfya, a monoclonal antibody against interleukin-23, was previously approved in China for the treatment of moderate to severe plaque psoriasis and moderate to severe active Crohn’s disease (CD).
Clinical Trial Results
The approval is based on results from the Phase IIb/III QUASAR study. The study demonstrated that patients treated with guselkumab experienced significant symptom improvement as early as Week 1 compared to placebo, with the therapeutic effect progressively strengthening over 12 weeks. Notably, 50% of patients in the 200mg Q4W dose group and 45% in the 100mg Q8W dose group achieved the primary endpoint of clinical remission at week 44, both significantly higher than the placebo group at 19%. The endoscopic remission rate of the guselkumab group was also significantly higher than that of the placebo group (p<0.001).-Fineline Info & Tech