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中베이진, BTK 저해제 美FDA에 첫 NDA.."우선심사 지정" - 바이오스펙테이터

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中베이진, BTK 저해제 美FDA에 첫 NDA.."우선심사 지정"

입력 2019-08-26 13:26 수정 2019-08-28 15:35

바이오스펙테이터 봉나은 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
FDA, 재발성/불응성 외투세포림프종(MCL) 치료제로 BTK 저해제 ‘자누브루티닙’에 대한 NDA 심사 승인, 우선심사 대상으로 지정

미국 나스닥, 홍콩증권거래소(HKEX)에 상장한 중국 바이오제약사 베이진(BeiGene)은 미국 식품의약국(FDA)이 이전에 1회 이상 치료받은 경험이 있는 재발성/불응성 외투세포림프종(Mantle cell lymphoma, MCL) 환자의 치료제로 BTK 저해제 ‘자누브루티닙(Zanubrutinib, 프로그램명: BGB-3111)’에 대한 신약허가신청(NDA) 심사를 승인했다고 지난 21일 밝혔다. 베이진이 FDA에 신약허가를 신청한 첫번째 치료제다.

FDA는 자누브루티닙을 우선심사 대상으로 지정해 ‘처방의약품 신청자 수수료법(PDUFA)’에 따라 최종 심사결과를 2020년 2월 27일까지 발표할 예정이다.

베이진은 셀진과 중국 내 판권계약을 통해 아브락산(Abraxane, 성분명: nanoparticle albumin–bound paclitaxel), 레블리미드(Revlimid, 성분명: lenalidomide), 비다자(Vidaza, 성분명: azacitidine) 등을 판매하고 있는 기업이다.

자누브루티닙은 베이진이 개발한 BTK(Bruton’s tyrosine kinase) 저해제로, 다양한 B세포 악성종양 치료를 위한 임상에서 단일 또는 병용요법으로 투여되고 있다. BTK는 신호전달에 관여하는 B세포 수용체(BCR)의 주요 요소 중 하나로, B세포 악성종양에서 세포의 증식과 생존에 중요한 역할을 하는 것으로 알려졌다....

'프리미엄 뉴스서비스 BioS+'는 독자들에게 가치(value)있는 기사를 제공합니다.
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