【콩두피크닉】- 룩셈부르크 gdp

콩두피크닉 - 2024년 실시간 업데이트

유럽류마티스학회(EULAR)서 임상 발표
"정맥·피하주사 모두 효능·안전성 확인"

[서울=뉴시스] 셀트리온 로고.(사진=뉴시스 DB) *재판매 및 DB 금지

[서울=뉴시스]송연주 기자 = 바이오 기업 셀트리온이 류마티스 관절염 치료제 악템라 바이오시밀러(바이오의약품 복제약) 'CT-P47' 임상 3상 시험에서 유효성과 안전성을 확인했다.

셀트리온은 '2024 유럽류마티스학회'(EULAR 2024)에서 'CT-P47'의 임상 결과 2건을 포스터로 공개했다고 14일 밝혔다.EULAR는 오스트리아 빈에서 12~15일 진행 중이다.

류마티스관절염 환자 471명을 대상으로 52주간 진행한 CT-P47 정맥주사 제형의 임상 3상 중 32주까지의 결과,콩두피크닉1차 유효성 평가지표에서 오리지널 의약품 대비 동등한 유효성이 나타났다고 했다.안전성,콩두피크닉약동학적 특성에서도 유사성을 확인했다.

오리지널 제품에서 CT-P47로 교체 투여한 집단에서도 8주간 각 제품의 유지군들 대비 유사한 유효성,콩두피크닉안전성,약동학적 특성이 나타났다.

CT-P47의 피하주사 제형 임상 결과도 별도의 포스터로 공개됐다.류마티스관절염 환자 대상 오토인젝터(AI) 사용성 평가 3상에서는 높은 사용성과 자가 주사 성공률,유효성,안전성이 나타났다.CT-P47의 프리필드시린지(사전 충전형 주사)와 오토인젝터 두 가지 디바이스를 비교한 국내 1상에서도 약동학적 동등성과 안전성에서의 유사성을 확인했다고 했다.

셀트리온은 이번 임상 결과를 바탕으로 올해 초 국내,미국,콩두피크닉유럽 등에 악템라가 보유한 전체 적응증에 대한 CT-P47의 품목허가를 신청했다.오리지널 의약품 악템라가 두 가지 제형으로 출시된 만큼,콩두피크닉CT-P47도 피하주사와 정맥주사 두 가지 제형으로 출시 준비 중이다.

악템라는 체내 염증 유발에 관여하는 인터루킨(IL)-6 단백질을 억제해 염증을 감소시키는 인터루킨 억제제다.지난해 글로벌 매출은 약 26억3000만 프랑(약 4조원)에 달한다．

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【콩두피크닉】- 룩셈부르크 gdp

The 100% privacy-safe noise & occupancy solution

콩두피크닉 - 2024년 실시간 업데이트

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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Owners | Hosts

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