Celltrion (068270.KS) said Thursday it unveiled Phase 3 clinical data from Japan for its autoimmune disease treatment CT-P13 SC (Remsima SC) for the first time at Digestive Disease Week (DDW) 2026, held in Chicago from Monday through Thursday local time. CT-P13 SC is sold in the U.S. under the brand name Zymfentra, with the active ingredient infliximab.
DDW is the largest international academic conference in the digestive disease field, drawing more than 13,000 leading experts in gastroenterology, hepatology and endoscopy annually to share the latest clinical research and therapeutic development trends. At this year's conference, Celltrion operated a standalone booth and carried out activities including two poster presentations, a symposium and product briefing sessions.
On the opening day of the conference, Celltrion unveiled for the first time the 44-week results of a Phase 3 trial of CT-P13 SC conducted in Japan in patients with Crohn's disease (CD). Patients who had reached clinical remission, with major symptoms significantly reduced, on the existing intravenous (IV) formulation continued to show favorable tolerability and safety after switching to the subcutaneous (SC) formulation.
The company also released 102-week post-hoc analysis results from a global Phase 3 trial in patients with Crohn's disease and ulcerative colitis (UC) through a poster. When patients who had received placebo for at least 16 weeks after discontinuing IV treatment were administered 240 mg of CT-P13 SC, rapid recovery of clinical response and sustained efficacy through 102 weeks were confirmed.
Celltrion expects such clinical and research findings to strengthen prescribing confidence in CT-P13 SC. Backed by accumulated clinical data, CT-P13 SC posted revenue of 839.4 billion won ($610 million) in the global market in 2025, up about 40% from 2024. The treatment delivered particularly notable results in the European and U.S. markets. In five European countries, its market share topped 30% for the first time as of the third quarter of last year, while in the U.S., Zymfentra recorded its highest-ever monthly prescription volume as of January this year, up about 213% from a year earlier. Given this growth trajectory, CT-P13 SC is projected to exceed 1 trillion won in annual revenue this year.
"At DDW, the world's most prestigious digestive disease conference, we once again demonstrated the superior therapeutic efficacy and safety of CT-P13 SC and felt firsthand the firm confidence of global medical professionals," a Celltrion official said. "We will continue to secure clinical data that reflects the needs of the medical field."
