cm to px

cm to px - 2024년 실시간 업데이트

건선 치료제 바이오시밀러는 美에 임상 3상 계획 신청

셀트리온
[연합뉴스TV 캡처.재판매 및 DB 금지]

(서울=연합뉴스) 김현수 기자 = 셀트리온은 자가면역질환 치료제 '스텔라라'의 바이오시밀러(바이오의약품 복제약) '스테키마'(성분명 우스테키누맙)가 유럽 의약품청(EMA) 산하 약물 사용 자문위원회(CHMP)로부터 '승인 권고' 의견을 받았다고 1일 밝혔다.

CHMP는 의약품의 과학적 평가 결과를 바탕으로 허가 여부를 논의해 EMA에 의견을 제시하는 기관이다.이 같은 허가 권고는 유럽연합 집행위원회(EC)의 최종 승인에 결정적인 역할을 한다고 회사는 설명했다.

스테키마의 오리지널약 스텔라라는 판상형 건선,건선성 관절염,크론병,cm to px궤양성 대장염 등 자가면역질환 치료제로 쓰이는 글로벌 제약사 얀센의 제품이다.

이번에 스테키마가 승인 권고를 받은 질환은 판상형 건선,건선성 관절염,크론병 등이다.

스테키마는 지난 달 식품의약품안전처로부터 스텔라라로 치료할 수 있도록 허가받은 모든 적응증에 대해 품목 허가를 받은 바 있다.

한편,셀트리온은 미국 식품의약청(FDA)에 건선 치료제 '코센틱스'(성분명 세쿠키누맙)의 바이오시밀러 'CT-P55'의 임상 3상 시험 계획(IND)을 신청했다고 이날 공시했다.

세계적 제약사 노바티스가 개발한 코센틱스는 인터루킨(IL)-17A 억제제로 건선성 관절염,cm to px강직성 척추염,중등증·중증 판상 건선 등에 사용된다.

셀트리온은 CT-P55를 활용해 중등도에서 중증 판상형 건선 환자 375명을 대상으로 글로벌 임상 3상을 진행할 계획이다.

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The 100% privacy-safe noise & occupancy solution

cm to px - 최고의 온라인 슬롯사이트

Know what’s happening between check-in and check-out, without compromising guest privacy.

Full Property Coverage, Outdoors and In

Indoor monitoring, plus the industry’s only weatherproof outdoor noise sensor, to protect your whole property 24/7.

Automated Guest Messaging for Faster Resolution

Automatically resolve noise issues any time of day or night, while you and your team #resteasy.

Elevated-Occupancy Detection to Prevent Crowds and Parties

Noise issues and excessive occupancy often go hand-in-hand. Find out when a crowd is gathering, and stop parties before they happen.

Partnering With Communities To Support Fair Regulation

We partner with cities, counties and vacation rental alliances, to incentivize good renting practices and support renting freedoms.

Chosen by more U.S. cities than any other product to protect neighborhoods and communities from noise and nuisance.

Trusted by companies all over the world.

Be there without being there.

Prevent what you can’t predict. From anywhere, at any time.

easy to use

24/7monitoring

prevent costlydamage

simpleautomatedresolution

elevatedoccupancydetection

Built for rentalbusinesses of all sizes.

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monitoring

prevent costly
damage

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automated
resolution

elevated
occupancy
detection

Built for rental
businesses of all sizes.