마크 슬롯머신 - krslotID=2024-10-31%2Fswaaqk.html

마크 슬롯머신 - 2024년 실시간 업데이트

자가면역질환 치료제 '스테키마' 신청 1년만에 식약처 허가

셀트리온
[연합뉴스TV 캡처.재판매 및 DB 금지]

(서울=연합뉴스) 김현수 기자 = 셀트리온은 자가면역질환 치료제 '스텔라라'의 바이오시밀러(바이오의약품 복제약) '스테키마'(성분명 우스테키누맙·프로젝트명 CT-P43)가 식품의약품안전처로부터 품목 허가를 획득했다고 12일 공시했다.

셀트리온에 따르면 CT-P43에 대해 품목 허가가 내려진 것은 한국이 처음이다.셀트리온은 이를 시작으로 이미 허가 신청을 마친 미국,마크 슬롯머신유럽 등 글로벌 주요국에서도 허가를 획득해 본격적인 글로벌 우스테키누맙 시장 공략에 나선다는 방침이다.

CT-P43의 오리지널 의약품인 스텔라라는 판상형 건선,마크 슬롯머신건선성 관절염,마크 슬롯머신크론병,궤양성 대장염 등 자가면역질환 치료제로 얀센이 개발했다.

셀트리온은 이번 스테키마 품목 허가가 판상형 건선,마크 슬롯머신소아 판상 건선,마크 슬롯머신크론병 등 국내에서 스텔라라로 치료할 수 있도록 허가받은 모든 적응증을 대상으로 이뤄졌다고 설명했다.

앞서 셀트리온은 지난해 6월 식약처에 CT-P43의 품목 허가를 신청했다.

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