기가뱃 - 플뱅

기가뱃 - 2024년 실시간 업데이트

코센틱스 지난해 6조원 상당 매출…"CT-P55 등 파이프라인 차질없이 진행할 것"셀트리온은 미국식품의약국(FDA)으로부터 자사의 바이오시밀러 'CT-P55'에 대한 임상 3상 시험계획서(IND)를 승인받았다고 14일 밝혔다.CT-P55의 오리지널 의약품은 '코센틱스(성분명: 세쿠키누맙)'다.

이번 임상은 판상형 건선 환자 총 375명을 대상으로,오리지널 의약품과 CT-P55 간의 유효성과 안전성,기가뱃동등성 입증을 위한 비교연구를 진행할 예정이다.

[사진=셀트리온]

코센틱스는 인터루킨(IL)-17A 억제제다.강직성 척추염,기가뱃건선성 관절염,기가뱃중등증·중증 판상 건선 등 자가면역질환에 사용되는 치료제다.지난해 기준 코센틱스의 글로벌 시장 매출은 약 49억8000만달러(한화 약 6조4740억원)에 달한다.물질 특허는 미국에서 오는 2029년 1월 만료되고,유럽에서는 2030년 7월 만료될 예정이다.

CT-P55는 셀트리온의 자가면역질환 바이오시밀러 파이프라인 중 하나다.지난해 12월에는 일본 의약품의료기기종합기구(PMDA)로부터 임상 1상 IND 승인을 획득해 순조롭게 임상을 진행하고 있다.

셀트리온은 자가면역질환 분야에서 종양괴사인자 알파(TNF-α) 억제제부터 인터루킨 억제제까지 제품 포트폴리오를 지속적으로 확대해 시장 경쟁력을 강화한다는 계획이다.

셀트리온 관계자는 "CT-P55를 비롯한 파이프라인의 임상 3상 절차를 차질없이 진행해 바이오시밀러 사업 부문에서 성장 가도를 달려나가겠다"고 말했다.

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기가뱃 - 플뱅

The 100% privacy-safe noise & occupancy solution

기가뱃 - 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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24/7
monitoring

prevent costly
damage

simple
automated
resolution

elevated
occupancy
detection

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businesses of all sizes.