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한미 기술수출 바이오신약 '롤론티스' 美 허가신청 - 바이오스펙테이터

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한미 기술수출 바이오신약 '롤론티스' 美 허가신청

입력 2018-12-28 05:54 수정 2018-12-28 05:54

바이오스펙테이터 장종원 기자

스펙트럼, FDA에 생물의약품 허가신청 완료..랩스커버리 적용 첫 글로벌 신약 탄생 '9부능선'

한미약품의 플랫폼기술 '랩스커버리'로 개발된 바이오신약이 첫 미국 시판허가를 신청했다. 바이오의약품의 약효 주기를 획기적으로 늘려주는 한미약품의 독자 개발 플랫폼 기술이 드디어 상용화 단계에 도달했다.

한미약품 파트너사 스펙트럼 파마슈티컬스는 27일(현지시간) 미국 식품의약국(FDA)에 장기지속형 호중구감소증 치료제 ‘롤론티스(Rolontis)'의 생물의약품 허가신청(BLA)을 완료했다고 밝혔다.

롤론티스는 한미약품이 2012년 스펙트럼에 기술수출한 랩스커버리 적용 바이오신약으로 기존 호중구감소증 치료제의 약효 지속 시간을 늘린 약물이다. 한미약품은 롤론티스의 1상시험을 마치고 기술수출했고 스펙트럼은 2015년말부터 임상 3상에 돌입했다.

스펙트럼은 골수 억제성 화학치료요법에 의해 호중구감소증이 발현된 643명의 초기 유방암 환자를 대상으로 진행한 임상 3상 2건의 데이터(RECOVER와 ADVANCE 연구)를 토대로 이번 BLA를 신청했다.

두 연구 모두에서 경쟁약물인 페그필라스팀(제품명 뉴라스타) 대비 ‘호중구감소증 발현 기간 및 안전성’의 비열등성 및 우수한 상대적 위험 감소율 등이 확인됐다. 이 수치는 총 네번의 치료 사이클(cycle) 동안 유지됐다.

스펙트럼 대표이사 조 터전 사장은 “롤론티스는 스펙트럼의 성장을 책임질 핵심 품목으로, FDA 허가신청 단계까지 도달한 것을 기쁘게 생각한다”며 “이번 BLA는 의료진에게 15년만에 새로운 호중구감소증 치료 옵션을 제공하는데 한 발짝 더 다가선 것"이라고 말했다.

한미약품 대표이사 권세창 사장은 “랩스커버리로 개발된 글로벌 신약의 첫번째 FDA 시판허가 신청이라는 점에서 의미가 크다”고 말했다.

랩스커버리는 롤론티스 외에도 현재 사노피와 얀센에 각각 기술수출된 에페글레나타이드(당뇨), HM12525A(비만·당뇨) 등에도 적용돼 글로벌 개발이 활발히 진행 중이다. 한미약품은 최근 랩스커버리를 통해 비알코올성 지방간염 및 희귀질환 치료 영역으로도 파이프라인을 확장해 나가고 있다.

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