셀트리온, 램시마 피하주사제형 유럽 임상3상 Part 1 승인 만료

Celltrion announced on June 18, 2026, that the approval for the European Phase 3 Trial Part 1 of Rashima Subcutaneous (CT-P13 SC) has expired, citing strategic changes in its clinical development plan. The trial aimed to evaluate the efficacy and safety of CT-P13 subcutaneous injection in children with moderate-to-severe active Crohn's disease. The trial application was submitted on February 27, 2024, and approved on June 17, 2024, but under EU CTR regulations, failure to submit a Part 2 trial plan within two years of Part 1 approval results in expiration. Celltrion plans to finalize a new trial strategy after discussions with regulatory authorities. The company's stock closed at 173,600 won, down 0.57% from the previous day. As of its latest financial report, Celltrion reported total assets of 22.3349 trillion won, liabilities of 4.9824 trillion won, and equity of 17.3525 trillion won, with revenue of 4.1625 trillion won and net profit of 131.5 billion won. Listed on KOSPI since February 27, 1991, Celltrion is a foundational pharmaceutical materials manufacturer.