Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 352

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 352

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 352

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 352

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 352

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 352

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 352

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 352

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 352

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 350

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 352

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 534

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 534

Warning: mysql_fetch_array() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 535
삼성바이오에피스, '솔리리스 시밀러' 中 3상 승인 - 바이오스펙테이터

본문 바로가기

바이오스펙테이터

기사본문

삼성바이오에피스, '솔리리스 시밀러' 中 3상 승인

입력 2020-01-10 08:57 수정 2020-01-10 08:57

바이오스펙테이터 장종원 기자

허셉틴 바이오시밀러 이어 두번째 임상 승인..상반기 첫 환자 등록 목표

삼성바이오에피스가 희귀질환 치료제 솔리리스 바이오시밀러 'SB12(성분명 에쿨리주맙)'의 중국 임상 3상에 돌입한다.

삼성바이오에피스는 최근 중국의약품관리국(NMPA: National Medical Products Administration)으로부터 SB12의 3상 임상시험 신청서(CTA: Clinical Trial Application)를 승인 받았다고 10일 밝혔다.

작년 12월 유방암 치료제 SB3(성분명 트라스트주맙, 허셉틴 바이오시밀러)에 이어 중국에서 두 번째 제품의 임상 3상 승인이다.

삼성바이오에피스가 개발 중인 SB12는 미국 알렉시온(Alexion)이 개발한 `솔리리스(Soliris)`의 바이오시밀러이다. 솔리리스는 희귀난치성 질환 `발작성 야간 혈색소뇨증(PNH)' 치료제로서 연간 글로벌 매출이 약 4조원 규모이고, 환자 1인당 연간 치료 비용이 수억원대에 달하는 대표적인 고가 의약품으로 알려져 있다.

삼성바이오에피스는 작년 8월 SB12의 글로벌 임상 3상을 개시했으며 총 50명의 PNH 환자를 대상으로 SB12와 오리지널 의약품과의 유효성, 안전성, 면역원성 등을 비교하는 연구를 진행하고 있다. 이번 임상 승인을 통해 글로벌 임상을 중국으로 확대할 수 있게 됐으며 중국에서는 상반기 첫 환자 방문을 목표로 임상 시험이 진행될 계획이다.

삼성바이오에피스 관계자는 “SB12의 성공적인 개발을 통해 중국 시장에서도 고가 바이오의약품에 대한 환자들의 접근성을 확대할 수 있도록 노력하겠다”고 밝혔다.

한편, 삼성바이오에피스는 중국 헬스케어 벤처펀드 운용사 'CBC그룹(전 C-브릿지 캐피탈)'과의 파트너십 계약을 통해 CBC그룹의 자회사 '에퍼메드 테라퓨틱스(Affamed Therapeutics)'와 함께 SB12의 중국 내 인허가 및 상업화를 추진할 계획이다.

삼성바이오에피스는 '에퍼메드 테라퓨틱스'와 현재 SB3의 중국 내 임상3상을 진행하고 있으며, 향후 안과질환 치료제 SB11(성분명: 라니비주맙, 루센티스 바이오시밀러)과 SB15 (성분명: 애플리버셉트, 아일리아 바이오시밀러)에 대한 중국 내 임상, 인허가 및 상업화도 협업할 계획이다.

카카오스토리로 기사 공유하기