Celltrion, Inc.

Celltrion's Phase 3 Study Validates Yuflyma's Interchangeability with Humira for Psoriasis Treatment

3 months ago

• A Phase 3 trial involving 367 Estonian patients demonstrated pharmacokinetic equivalence between Yuflyma and Humira in treating moderate to severe plaque psoriasis, with comparable efficacy and safety profiles. • Celltrion has submitted a supplemental application to the FDA in January 2024 seeking interchangeability status for Yuflyma, which could streamline the prescription switching process. • As the world's first high-concentration Humira biosimilar, Yuflyma offers advantages including reduced injection volume and citrate-free formulation, targeting a market where Humira generated $14.4 billion in global sales in 2024.

Celltrion Advances Novel ADC Cancer Drug CT-P70 with FDA IND Filing

4 months ago

• Celltrion has submitted an IND application to the FDA for CT-P70, a novel antibody-drug conjugate targeting cMET in multiple solid tumors including NSCLC, colorectal, and gastric cancers. • Preclinical studies demonstrate CT-P70's superior efficacy in cMET low-expression tumors compared to competing ADCs, suggesting potential benefits for a broader patient population. • The development represents Celltrion's first step in its ambitious strategy to develop 13 new drug candidates by 2028, with global Phase 1 trials planned to begin in mid-2025.