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글로벌제약산업정보

임상정보

국내 바이오의약품 임상 현황 (2022/1/3 ~ 2022/1/7)

국내 바이오의약품 임상 현황 (2022/1/3 ~ 2022/1/7) : 작성자, 작성일, 조회수, 출처,원문, 정보 제공
작성자	관리자
작성일	2022-01-12	조회수	900
국가정보	아시아>대한민국
출처	식품의약품안전처
원문	https://nedrug.mfds.go.kr/searchDrug?sort=&sortOrder=false&searchYn=true&ExcelRowdata=&page=1&searchDivision=detail&itemName=&entpName=&ingrName1=&ingrName2=&ingrName3=&itemSeq=&stdrCodeName=&atcCodeN

국내 바이오의약품 임상시험 현황입니다.

○기간: 2022.1.3. ~ 2022.1.7.

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

의뢰자	제품명	임상시험제목	임상시험 단계	개발지역	승인일
노보노디스크제약(주)	Icosema	일일 기저 인슐린으로 적절하게 조절되지 않는 제2형 당뇨병이 있는 시험대상자에서, 경구용 항당뇨약을 병용하거나 병용하지 않았을 때, 주 1 회 아이코세마 및 주 1 회 인슐린 아이코덱의 유효성 및 안전성을 비교하는 52 주 임상시험	3a상	국외개발	2022-01-06
아이엔씨리서치사우쓰코리아 유한회사	나비시시주맙(Navicixizumab)	백금 저항성 상피성 난소암, 원발성 복막암 또는 나팔관암 환자에서 파클리탁셀 단독요법 대비 나비시시주맙 + 파클리탁셀 병용요법 및 나비시시주맙 단독요법에 대한 제3상, 다기관, 공개, 무작위배정 임상시험	3상	국외개발	2022-01-05
한국로슈	Ranibizumab PDS (Port Delivery System)	혈관신생 나이 관련 황반변성 환자를 대상으로 라니비주맙(RANIBIZUMAB) 트 전달 시스템의 장기 안전성과 내약성을 평가하기 위한 다기관, 라벨 공개 연장 임상시험(PORTAL)	3상	국외개발	2022-01-04

이전글 해외 바이오의약품 임상 현황 (2022/1/3 ~ 2022/1/9)
다음글 국내 바이오의약품 임상 현황 (2021/12/20 ~ 2021/12/24)

<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-decoration-color: initial; 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;" 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-decoration-color: initial; 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;">
 
 
<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-decoration-color: initial; 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;" 255,="" rgb(255,="" 13px;="" nanum="">○기간: 2022.1.3. ~ 2022.1.7.
<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-decoration-color: initial; 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;" 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-decoration-color: initial; 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;"> 
<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-decoration-color: initial; 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;">
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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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노보노디스크제약(주)</td>
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Icosema</td>
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일일 기저 인슐린으로 적절하게 조절되지 않는 제2형 당뇨병이 있는 시험대상자에서, 경구용 항당뇨약을 병용하거나 병용하지 않았을 때, 주 1 회 아이코세마 및 주 1 회 인슐린 아이코덱의 유효성 및 안전성을 비교하는 52 주 임상시험</td>
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3a상</td>
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국외개발</td>
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2022-01-06</td>
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아이엔씨리서치사우쓰코리아 유한회사</td>
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나비시시주맙(Navicixizumab)</td>
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백금 저항성 상피성 난소암, 원발성 복막암 또는 나팔관암 환자에서 파클리탁셀 단독요법 대비 나비시시주맙 + 파클리탁셀 병용요법 및 나비시시주맙 단독요법에 대한 제3상, 다기관, 공개, 무작위배정 임상시험</td>
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3상</td>
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국외개발</td>
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2022-01-05</td>
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한국로슈</td>
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Ranibizumab PDS (Port Delivery System)</td>
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혈관신생 나이 관련 황반변성 환자를 대상으로 라니비주맙(RANIBIZUMAB) 트 전달 시스템의 장기 안전성과 내약성을 평가하기 위한 다기관, 라벨 공개 연장 임상시험(PORTAL)</td>
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3상</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: 71.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;">
2022-01-04</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-decoration-color: initial; 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;" 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-decoration-color: initial; 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;"> <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-decoration-color: initial; 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;" 255,="" rgb(255,="" 13px;="" nanum="">○기간: 2022.1.3. ~ 2022.1.7. <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-decoration-color: initial; 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;" 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-decoration-color: initial; 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;"> <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-decoration-color: initial; 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;"> <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: 84.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 노보노디스크제약(주)</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 71.72pt; height: 84.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> Icosema</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 255.02pt; height: 84.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 일일 기저 인슐린으로 적절하게 조절되지 않는 제2형 당뇨병이 있는 시험대상자에서, 경구용 항당뇨약을 병용하거나 병용하지 않았을 때, 주 1 회 아이코세마 및 주 1 회 인슐린 아이코덱의 유효성 및 안전성을 비교하는 52 주 임상시험</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 68pt; height: 84.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 3a상</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 51.17pt; height: 84.63pt; 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: 84.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 2022-01-06</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: 84.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 아이엔씨리서치사우쓰코리아 유한회사</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 71.72pt; height: 84.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 나비시시주맙(Navicixizumab)</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 255.02pt; height: 84.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 백금 저항성 상피성 난소암, 원발성 복막암 또는 나팔관암 환자에서 파클리탁셀 단독요법 대비 나비시시주맙 + 파클리탁셀 병용요법 및 나비시시주맙 단독요법에 대한 제3상, 다기관, 공개, 무작위배정 임상시험</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 68pt; height: 84.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 3상</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 51.17pt; height: 84.63pt; 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: 84.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 2022-01-05</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: 71.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 한국로슈</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 71.72pt; height: 71.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> Ranibizumab PDS (Port Delivery System)</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 255.02pt; height: 71.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 혈관신생 나이 관련 황반변성 환자를 대상으로 라니비주맙(RANIBIZUMAB) 트 전달 시스템의 장기 안전성과 내약성을 평가하기 위한 다기관, 라벨 공개 연장 임상시험(PORTAL)</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 68pt; height: 71.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 3상</td> <td valign="middle" style="margin: 0px; padding: 0px; border: 1px solid rgb(166, 166, 166); border-image: none; width: 51.17pt; height: 71.63pt; 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: 71.63pt; color: rgb(125, 125, 125); line-height: 1.6; font-family: 'Nanum Gothic'; font-size: 13px; box-sizing: inherit; text-size-adjust: none;"> 2022-01-04</td> </tr> </tbody> </table> 
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