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h81텔DBzone24^%맘카페DB??

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작성자 호철 댓글 0건 조회 8회 작성일 25-04-26 15:18

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h81텔DBzone24^%맘카페DB?? [이데일리 신민준 기자] 할로자임이 알테오젠 기술을 활용해 키트루다 피하주사(SC) 제형을 개발하고 있는 글로벌 제약사 머크를 상대로 특허 침해 소송을 제기했다.(이미지=각 사.)26일 외신과 한국바이오협회에 따르면에 할로자임은 지난 24일(현지시간) 뉴저지 연방 법원에 머크의 항암제 키트루다 피하주사 제형이 자사의 15개 특허를 침해했다는 내용의 소송을 제기했다고 밝혔다. 해당 소송은 할로자임이 2011년 출원한 재조합 인간 히알루로니다아제 ‘MDASE’와 관련된 특허에 대해 다루고 있다. 인간 히알루로니다아제 단백질은 정맥주사(IV)로 주입되는 약물의 피하 투여를 가능하게 한다.할로자임은 머크가 계획하고 있는 키트루다 피하주사 제형의 상업화를 막기 위한 금지 명령을 요구했다. 키트루다 피하주사 제형은 오는 9월 23일 이전에 미국 식품의약국(FDA)의 품목 허가 결정이 내려질 것으로 예상된다. 할로자임은 금전적 구제 이외에 머크의 침해가 고의적이라며 가중적 손해배상(Enhancement of Damages) 요구하고 있다. 미국 특허법은 고의 침해가 인정는 경우 합리적 실시료를 가중해 배상을 명할 수 있다. 이번 소송은 할로자임이 잠재적인 라이선스 계약을 위해 머크에 연락하고 양측이 합의에 도달하지 못할 경우 소송이 뒤따를 수 있다고 공개적으로 경고한 후 제기됐다.머크는 기존 키트루다IV의 2028년 특허 만료에 대비하기 위해 알테오젠(196170)의 히알루로니다아제 ‘ATL-B4’를 활용해 키트루다 피하주사 제형을 개발하고 있다. ALT-B4는 영국 아스트라제네카와 일본 다이이치산쿄도 각각 암 치료제의 피하주사를 개발하기 위해 계약하는 등 글로벌 시장에서 관심을 받고 있다. 할로자임은 재조합 인간 히알루로니다제 PH20 효소를 기반으로 하는 Enhanze 피하 전달 기술로 알려졌다. 할로자임은 PH20을 연구하면서 과학자들은 변형된 아미노산 사슬을 가진 6700개 이상의 추가 단백질 라이브러리를 만들었다. 이 라이브러리와 추가 연구를 통해 할로자임은 2016년부터 MDASE 특허 포트폴리오를 구축했다. 머크는 ALT-B4가 알테오젠에 의해

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