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글로벌제약산업정보

임상정보

국내 바이오의약품 임상 현황 (2022/1/17 ~ 2022/1/21)

국내 바이오의약품 임상 현황 (2022/1/17 ~ 2022/1/21) : 작성자, 작성일, 조회수, 출처,원문, 정보 제공
작성자	관리자
작성일	2022-01-26	조회수	1,056
국가정보	아시아>대한민국
출처	식품의약품안전처
원문	https://nedrug.mfds.go.kr/searchClinic

국내 바이오의약품 임상시험 현황입니다.

○기간: 2022.1.17. ~ 2022.1.21.

○출처: 의약품안전나라(의약품통합정보시스템) > 의약품등 정보 > 임상시험정보 > 임상시험정보공개 (링크 바로가기)

의뢰자	제품명	임상시험제목	임상시험 단계	개발지역	승인일
피피디디벨럽먼트피티이엘티디	Astegolimab	만성 폐쇄성 폐질환 환자에서 아스테골리맙의 유효성과 안전성을 평가하기 위한 제2b상, 무작위 배정, 이중 눈가림, 위약 대조, 다기관 임상시험	2b상	국외개발	2022-01-20
(주)종근당바이오	CKDB-501A	중등증 또는 중증의 미간주름 개선에 있어 CKDB-501A의 안전성과 유효성을 평가하기 위한 무작위 배정, 이중 눈가림, 활성 대조, 단일기관 1상 임상시험	1상	국내개발	2022-01-18
(주)대웅제약	DWP708	상피성장인자 수용체 억제제 관련 피부 부작용 치료에 대한 DWP708의 유효성 탐색 및 안전성 평가를 위한 다기관, 무작위배정, 이중눈가림, 위약대조, 치료적 탐색, 제 2상 임상시험	2상	국내개발	2022-01-17
한국애브비(주)	ABBV-011 및 Budigalimab(ABBV-181)	재발성 또는 불응성 소세포폐암 시험대상자에서 ABBV-011을 단일제제로, 부디갈리맙(ABBV-181)과 병용한 1상 연구	1상	국외개발	2022-01-17

이전글 2021 임상시험 관련 자주 묻는 질의응답(의약품)
다음글 해외 바이오의약품 임상 현황 (2022/1/17 ~ 2022/1/23)

<p align="left" style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum="">국내 바이오의약품 임상시험 현황입니다.<span style="color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 10pt; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">
 
 
<p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum="">○기간: 2022.1.17. ~ 2022.1.21.
<p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum="">○출처: 의약품안전나라(의약품통합정보시스템) > 의약품등 정보 > 임상시험정보 > 임상시험정보공개 (<a style="border: 0px currentColor; border-image: none; color: rgb(125, 125, 125); text-decoration: none; box-sizing: inherit; text-size-adjust: none;" href="https://nedrug.mfds.go.kr/searchClinic" target="_self">링크 바로가기</a>)
<p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;"> 
<table style="border: currentColor; border-image: none; color: rgb(125, 125, 125); text-transform: none; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; border-collapse: collapse; table-layout: fixed; box-sizing: inherit; border-spacing: 0px; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">
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의뢰자</td>
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제품명</td>
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임상시험제목</td>
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임상시험 단계</td>
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개발지역</td>
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승인일</td>
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피피디디벨럽먼트피티이엘티디</td>
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Astegolimab</td>
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만성 폐쇄성 폐질환 환자에서 아스테골리맙의 유효성과 안전성을 평가하기 위한 제2b상, 무작위 배정, 이중 눈가림, 위약 대조, 다기관 임상시험</td>
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2b상</td>
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국외개발</td>
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2022-01-20</td>
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(주)종근당바이오</td>
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CKDB-501A</td>
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중등증 또는 중증의 미간주름 개선에 있어 CKDB-501A의 안전성과 유효성을 평가하기 위한 무작위 배정, 이중 눈가림, 활성 대조, 단일기관 1상 임상시험</td>
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1상</td>
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국내개발</td>
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2022-01-18</td>
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(주)대웅제약</td>
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DWP708</td>
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상피성장인자 수용체 억제제 관련 피부 부작용 치료에 대한 DWP708의 유효성 탐색 및 안전성 평가를 위한 다기관, 무작위배정, 이중눈가림, 위약대조, 치료적 탐색, 제 2상 임상시험</td>
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2상</td>
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국내개발</td>
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2022-01-17</td>
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한국애브비(주)</td>
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ABBV-011 및 Budigalimab(ABBV-181)</td>
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재발성 또는 불응성 소세포폐암 시험대상자에서 ABBV-011을 단일제제로, 부디갈리맙(ABBV-181)과 병용한 1상 연구</td>
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1상</td>
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국외개발</td>
<td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 70.49pt; height: 47.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;">
2022-01-17</td>
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<p align="left" style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum="">국내 바이오의약품 임상시험 현황입니다.<span style="color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 10pt; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;"> <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum="">○기간: 2022.1.17. ~ 2022.1.21. <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum="">○출처: 의약품안전나라(의약품통합정보시스템) > 의약품등 정보 > 임상시험정보 > 임상시험정보공개 (<a style="border: 0px currentColor; border-image: none; color: rgb(125, 125, 125); text-decoration: none; box-sizing: inherit; text-size-adjust: none;" href="https://nedrug.mfds.go.kr/searchClinic" target="_self">링크 바로가기</a>) <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;"> <table style="border: currentColor; border-image: none; color: rgb(125, 125, 125); text-transform: none; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; border-collapse: collapse; table-layout: fixed; box-sizing: inherit; border-spacing: 0px; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;"> <tbody style="box-sizing: inherit; text-size-adjust: none;"> <tr style="box-sizing: inherit; text-size-adjust: none;"> <td valign="middle" style="background: rgb(242, 242, 242); margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 100.02pt; height: 34.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 의뢰자</td> <td valign="middle" style="background: rgb(242, 242, 242); margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 71.72pt; height: 34.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 제품명</td> <td valign="middle" style="background: rgb(242, 242, 242); margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 255.02pt; height: 34.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 임상시험제목</td> <td valign="middle" style="background: rgb(242, 242, 242); margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 68pt; height: 34.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 임상시험 단계</td> <td valign="middle" style="background: rgb(242, 242, 242); margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 51.17pt; height: 34.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 개발지역</td> <td valign="middle" style="background: rgb(242, 242, 242); margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 70.49pt; height: 34.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 승인일</td> </tr> <tr style="box-sizing: inherit; text-size-adjust: none;"> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 100.02pt; height: 47.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 피피디디벨럽먼트피티이엘티디</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 71.72pt; height: 47.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> Astegolimab</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 255.02pt; height: 47.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 만성 폐쇄성 폐질환 환자에서 아스테골리맙의 유효성과 안전성을 평가하기 위한 제2b상, 무작위 배정, 이중 눈가림, 위약 대조, 다기관 임상시험</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 68pt; height: 47.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 2b상</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 51.17pt; height: 47.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 국외개발</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 70.49pt; height: 47.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 2022-01-20</td> </tr> <tr style="box-sizing: inherit; text-size-adjust: none;"> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 100.02pt; height: 60.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> (주)종근당바이오</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 71.72pt; height: 60.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> CKDB-501A</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 255.02pt; height: 60.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 중등증 또는 중증의 미간주름 개선에 있어 CKDB-501A의 안전성과 유효성을 평가하기 위한 무작위 배정, 이중 눈가림, 활성 대조, 단일기관 1상 임상시험</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 68pt; height: 60.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 1상</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 51.17pt; height: 60.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 국내개발</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 70.49pt; height: 60.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 2022-01-18</td> </tr> <tr style="box-sizing: inherit; text-size-adjust: none;"> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 100.02pt; height: 60.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> (주)대웅제약</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 71.72pt; height: 60.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> DWP708</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 255.02pt; height: 60.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 상피성장인자 수용체 억제제 관련 피부 부작용 치료에 대한 DWP708의 유효성 탐색 및 안전성 평가를 위한 다기관, 무작위배정, 이중눈가림, 위약대조, 치료적 탐색, 제 2상 임상시험</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 68pt; height: 60.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 2상</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 51.17pt; height: 60.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 국내개발</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 70.49pt; height: 60.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 2022-01-17</td> </tr> <tr style="box-sizing: inherit; text-size-adjust: none;"> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 100.02pt; height: 47.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 한국애브비(주)</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 71.72pt; height: 47.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> ABBV-011 및 Budigalimab(ABBV-181)</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 255.02pt; height: 47.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 재발성 또는 불응성 소세포폐암 시험대상자에서 ABBV-011을 단일제제로, 부디갈리맙(ABBV-181)과 병용한 1상 연구</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 68pt; height: 47.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 1상</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 51.17pt; height: 47.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 국외개발</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 70.49pt; height: 47.31pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 2022-01-17</td> </tr> </tbody> </table> 
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