Celltrion said it presented a long-term post-analysis result from a global phase 3 study of Zymfentra, its subcutaneous formulation of infliximab, during the 2025 Crohn’s & Colitis Congress (CCC)

CCC is an IBD-focused conference held in the U.S., gathering global experts in gastroenterology to discuss the latest research, clinical advancements, and treatment developments. This year’s event is being held in San Francisco, Calif., from Thursday to Saturday.

Celltrion's study at the congress focused on the results of a long-term 102-week follow-up analysis from its global phase 3 trial of Zymfentra. The research was shared through a poster presentation following an oral presentation of the study results at the 2024 United European Gastroenterology Week (UEGW) last October.

The clinical trial included 192 patients with Crohn’s disease (CD) and 237 patients with ulcerative colitis (UC). It examined the efficacy, immunogenicity, and safety of an increased dosage regimen of CT-P13 SC, comparing patients who received an escalated dose (from 120mg to 240mg) with those who remained on the standard dosage.

Results showed that patients requiring dose escalation after 22 weeks exhibited significant improvements in clinical remission, clinical response, and endoscopic response by week 102.

Moreover, most of those who received the increased dosage demonstrated enhanced efficacy within eight weeks of dose adjustment. The safety profile remained consistent with that of the standard dosage group, and no new safety concerns were identified.

Based on these findings, Celltrion secured a label extension from the European Commission (EC) last July, allowing for increased maintenance dosing of Zymfentra (marketed as Remsima SC in Europe) for Crohn’s disease patients.

Celltrion expects that these latest study results will reinforce treatment options for IBD patients and further increase U.S. physicians' preference for prescribing Zymfentra.

“Our research continues to validate Zymfentra’s therapeutic efficacy and safety through numerous prestigious international conferences, generating strong interest and positive feedback from the medical community,” a Celltrion official said. “We are committed to enhancing our product’s competitiveness and accessibility, ensuring greater market penetration and improved patient treatment options.”