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Global new Drug R&D express: Janssen Pharma's guselkumab,AstraZeneca's ravulizumab,SMT112


1 First Phase 3 TREMFYA® (guselkumab) Data in Inflammatory Bowel Disease Show Positive Induction Results Among Patients with Moderately to Severely Active Ulcerative Colitis

Janssen Pharma announced the results from the Phase 3 QUASAR Induction Study (NCT04033445) of guselkumab for the treatment of adults with moderately to severely active ulcerative colitis. The data showed statistically significant and clinically meaningful remission (22.6% vs. 7.9%, p <0.001) of guselkumab compared to placebo at Week 12, meeting its primary endpoint. Besides, a greater proportion of guselkumab group at Week 12 achieved with clinical response (61.5% vs. 27.9%, p<0.001), endoscopic improvement (26.8% vs. 11.1%, p<0.001) and histo-endoscopic mucosal improvement (23.5% vs. 7.5%, p<0.001). The TEAEs in guselkumab group were generally comparable to placebo group.

2 Ultomiris approved in the EU for adults with neuromyelitis optica spectrum disorder (NMOSD)

AstraZeneca announced the European Union approved of Ultomiris (ravulizumab) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-AQP4 antibody-positive neuromyelitis optica spectrum disorder (NMOSD). The approval was based on the phase 3 CHAMPION-NMOSD (NCT04201262) Study, which showed Ultomiris had a median treatment duration of 73 weeks (relapse risk reduction: 98.6%, hazard ratio (95% CI): 0.014 (0.000, 0.103), p<0.0001) and continuing through a median duration of 90 weeks.

3 Summit Therapeutics Announces First Patient Treated in Phase III HARMONi Clinical Trial Evaluating Ivonescimab (SMT112)

Summit Therapeutics announced that the first United States-based patient has been enrolled in the Phase III HARMONi study. HARMONi is a Phase III multiregional, randomized, double-blinded study, enrolled patients from the US, Canada, Europe, and China. The study will evaluate the efficacy and safety of ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd-generation EGFR TKI such as osimertinib.


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