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<p class="0" style="text-align: center;" align="center"><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-weight: bold; font-size: 10pt;">[</span><span style="font-family: "맑은 고딕"; font-weight: bold; font-size: 10pt;">온코닉테라퓨틱스</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-weight: bold; font-size: 10pt;">(</span><span style="font-family: "맑은 고딕"; font-weight: bold; font-size: 10pt;">주</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-weight: bold; font-size: 10pt;">)] </span><span style="font-family: "맑은 고딕"; font-weight: bold; font-size: 10pt;">자큐보정 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-weight: bold; font-size: 10pt;">20mg (JAQBO Tab. 20mg) / </span><span style="font-family: "맑은 고딕"; font-weight: bold; font-size: 10pt;">자큐보구강붕해정 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-weight: bold; font-size: 10pt;">20mg (JAQBO ODT. 20mg)</span></p><p class="0" style="mso-pagination:none;text-autospace:none;mso-padding-alt:0pt 0pt 0pt 0pt;font-weight:bold;"><span style="font-size: 10pt;"> </span><!--[if !supportEmptyParas]--><span style="font-size: 10pt;"> </span><!--[endif]--><span style="font-size: 10pt;"> </span><o:p></o:p></p><p class="0"><span style="font-family: "맑은 고딕"; font-size: 10pt;">허가 일자</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">: (</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">필름코팅정</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">) 2024</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">년 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">04</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">월 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">24</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">일</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">, (</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">구강붕해정</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">) 2025</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">년 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">10</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">월 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">30</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">일 </span></p><p class="0"><span style="font-family: "맑은 고딕"; font-size: 10pt;">홈페이지</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">: <a href="http://onconic.co.kr/products/info.php">http://onconic.co.kr/products/info.php</a> </span></p><p class="0"><span style="font-family: "맑은 고딕"; font-size: 10pt;">정보출처</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">: </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-weight: bold; font-size: 10pt;"><a href="https://www.health.kr/searchDrug/result_drug.asp?drug_cd=2024042500003">https://www.health.kr/searchDrug/result_drug.asp?drug_cd=2024042500003</a></span></p><p class="0" style="text-align: start;"><span style="font-family: "맑은 고딕"; font-size: 10pt; font-weight: bold; letter-spacing: 0pt; text-align: center;"> <a href="https://www.health.kr/searchDrug/result_drug.asp?drug_cd=2025103100002">https://www.health.kr/searchDrug/result_drug.asp?drug_cd=2025103100002</a></span></p><p class="0" style="line-height:200%;text-align:center;word-break:keep-all;mso-pagination:none;text-autospace:none;mso-padding-alt:0pt 0pt 0pt 0pt;"><span lang="EN-US" style="mso-fareast-font-family:맑은 고딕;font-family:맑은 고딕;mso-ascii-font-family:맑은 고딕;mso-font-width:100%;letter-spacing:0pt;mso-text-raise:0pt;font-weight:bold;"><br></span></p><p class="0"><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-weight: bold; font-size: 10pt;">[</span><span style="font-family: "맑은 고딕"; font-weight: bold; font-size: 10pt;">화학 구조</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-weight: bold; font-size: 10pt;">]</span></p><p class="0"><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-weight: bold; font-size: 10pt;"><img src="/admin/data/webedit/20260513130959693389994.png" title="image04.png" width="400" height="240" rwidth="400" rheight="240.66390041493779" style="border-color: rgb(0, 0, 0); width: 400px; height: 240.664px;"><br style="clear:both;"> </span></p><p class="0"><span style="font-size: 10pt;"> </span><!--[if !supportEmptyParas]--><span style="font-size: 10pt;"> </span><span style="font-size: 10pt;"> </span></p><p class="0"><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-weight: bold; font-size: 10pt;">[</span><span style="font-family: "맑은 고딕"; font-weight: bold; font-size: 10pt;">약리작용 및 기전</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-weight: bold; font-size: 10pt;">]</span></p><p class="0"><span style="font-family: "맑은 고딕"; font-size: 10pt;">이 약은 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">1</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">정</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(218.0mg)</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">당 자스타프라잔 시트르산염</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(zastaprazan citrate) 20mg</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">을 함유하는 급여 전문의약품이다</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">. </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">이 약은 위벽세포 벽세포</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(parietal cell) </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">내의 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">H</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; vertical-align: super; font-size: 10pt;">+</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">/K</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; vertical-align: super; font-size: 10pt;">+</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">-ATPase</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">를 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">K</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; vertical-align: super; font-size: 10pt;">+</span><span lang="EN-US" style="font-size: 10pt;"> </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">이온 의존적 그리고 가역적으로 제어함으로써 위산의 분비를 억제하는 작용기전을 가지고 있는 칼륨 경쟁적 위산분비억제제</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(potassium-competitive acid blocker, P-CAB)</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">이다</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">. </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">이 약은 산에 의한 활성을 거쳐 작용하는 기존 양성자펌프억제제</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(proton pump inhibitor, PPI)</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">와 달리 직접 양성자 펌프를 억제하여 신속한 약효 발현과 장시간 효능 유지</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">, </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">효과적인 야간 위산분비의 저해 효과를 나타낸다</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">. </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">임상시험에 관한 자료로서 미란성 위식도역류질환의 치료에 대한 안전성 및 유효성을입증하는 임상시험으로 치료적 탐색임상시험 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">1</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">편</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">, </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">치료적 확증임상시험 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">1</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">편이 제출되어 검토후 유효성과 내약성을 확보한 것으로 판단되어 허가 및 승인되었다</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">. </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">이 약은 미란성 위식도역류질환의 치료에 사용하며 성인 기준으로 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">1</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">일 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">1</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">회 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">20mg</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">을 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">4</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">주간 경구투여하고 치료되지 않는 경우 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">4</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">주 추가 투여를 권장한다</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">. </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">아타자나비르</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(Atazanavir), </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">넬피나비어</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(Nelfinavir), </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">또는 릴피비린</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(Rilpivirine) </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">함유제제와의 상호작용이 보고되었으며</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">, </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">구조상 유당을 함유하고 있기 때문에 임부 및 수유부 또는 갈락토오스 불내성</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(galactose intolerance), Lapp </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">유당분해효소 결핍증</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(Lapp lactase deficiency), </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">포도당</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">-</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">갈락토오스 흡수장애</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(glucose-galactose malabsorption) </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">등의 유전적인 문제가 있는 환자에서는 투여를 금지해야 한다</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">. </span></p><p class="0"><span style="font-size: 10pt;"> </span><!--[if !supportEmptyParas]--><span style="font-size: 10pt;"> </span><!--[endif]--><span style="font-size: 10pt;"> </span><o:p></o:p></p><p class="0"><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-weight: bold; font-size: 10pt;">[</span><span style="font-family: "맑은 고딕"; font-weight: bold; font-size: 10pt;">연구개발 과정 및 최종 결과</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-weight: bold; font-size: 10pt;">]</span></p><p class="0"><span style="font-family: "맑은 고딕"; font-size: 10pt;">자스타프라잔은 최초 제일약품</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">주</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">)</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">에서 개발되어 임상</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">2</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">상까지 진행하였고</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">, </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">이후 괸계사인 온코닉테라퓨틱스</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">주</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">)</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">가 개발권리를 이전받아 후기 단계의 개발을 진행하였다</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">. </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">자큐보정은 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">2024</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">년 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">4</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">월에 국내 제</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">37</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">호 신약으로 국내 식약처 허가를 받은 이후 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">2024</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">년 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">10</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">월부터 위식도역류질환 치료제로 급여 출시되어 국내 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">1</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">조 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">3,000</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">억원 규모의 소화성궤야용제 시장에 본격 진출하였다</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">. </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">이후 국내 대형병원 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">5</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">곳 및 전국 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">60</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">여개 종합병원에서 처방코드 오픈 및 약물심의위원회</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(D/C) </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">승인을 받아 약물처방되고 있다</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">. </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">온코닉테라퓨틱스는 이후 자큐보의 후속 적응증인 위궤양 임상</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">3</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">상을 마무리하여 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">2025</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">년 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">6</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">월 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">17</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">일 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">“</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">미란성 위식도역류질환의 치료</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">” </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">적응증 이외에 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">“</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">위궤양의 치료</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">” </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">신규 항목을 추가하여 의약품 품목변경허가를 받았으며</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">, </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">또한 환자의 복약 순응도를 높인 구강붕해정</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(ODT) </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">제형을 개발하여 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">2025</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">년 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">10</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">월 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">30</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">일 </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">허가 심사를 승인받아 자큐보구강붕해정 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">20mg</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">을 출시하였다</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">. </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">자큐보구강붕해정은 특히 목넘김에 어려움이 있는 고령층 환자 비중이 큰 역류성 위식도 질환 특성상 물 없이도 간편하게 복용할 수 있어 복약 편의성을 높였다</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">. </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">현재 비스테로이드성 소염진통제</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(NSAIDs) </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">유발 위궤양예방을 위한 적응증 확대 임상</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(3</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">상</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">)</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">을 진행 중이며 이를 통해 자큐보정의 치료 범위와 시장 내 경쟁력을 동시에 강화해 나갈 계획이라고 밝혔다</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">. </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">해외동향으로는 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">2024</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">년 중화권 소재 리브존파마슈티컬 그룹과 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">1</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">억</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">2750</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">만달러</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">약 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">1694</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">억원</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">) </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">규모로 라이선스아웃</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(L/O) </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">계약을 진행한 바 있으며</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">, </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">이후 같은해 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">12</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">월 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">23</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">일 중국 식약처에서 자큐보의 중국 임상 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">3</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">상을 허가함에 따라 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">300</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">만달러</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">약 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">43</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">억</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">6920</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">만원</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">)</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">의 마일스톤 기술료를 받을 수 있게 됐다</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">. </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">국내에는 동일성분 및 동일용량의 의약품으로 제일헬스사이언스</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">주</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">)</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">의 온캡정 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">20mg, </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">제일약품</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">주</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">)</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">의 큐제타스정 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">20mg/</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">큐제타스구강붕해정 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">20mg</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">이 있다</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">. </span></p><p class="0"><span style="font-size: 10pt;"> </span><!--[if !supportEmptyParas]--><span style="font-size: 10pt;"> </span><!--[endif]--><span style="font-size: 10pt;"> </span><o:p></o:p></p><p class="0"><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(</span><span style="font-family: "맑은 고딕"; font-size: 10pt;">출처</span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">: </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">메디포뉴스 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(<a href="https://www.medifonews.com/news/article.html?no=195308);">https://www.medifonews.com/news/article.html?no=195308);</a> </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">헬스조선 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(<a href="https://m.health.chosun.com/svc/news_view.html?contid=2024042500987);">https://m.health.chosun.com/svc/news_view.html?contid=2024042500987);</a> </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">바이오스펙테이터 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(<a href="https://www.biospectator.com/news/view/24097);">https://www.biospectator.com/news/view/24097);</a> </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">팜뉴스 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(<a href="https://www.pharmnews.com/news/articleView.html?idxno=261164);">https://www.pharmnews.com/news/articleView.html?idxno=261164);</a> </span><span style="font-family: "맑은 고딕"; font-size: 10pt;">메디파나뉴스 </span><span lang="EN-US" style="font-family: "맑은 고딕"; letter-spacing: 0pt; font-size: 10pt;">(<a href="https://www.medipana.com/news/articleView.html?idxno=337181))">https://www.medipana.com/news/articleView.html?idxno=337181))</a></span></p><p class="0" style="line-height:200%;text-align:center;word-break:keep-all;mso-pagination:none;text-autospace:none;mso-padding-alt:0pt 0pt 0pt 0pt;"><span lang="EN-US" style="mso-fareast-font-family:맑은 고딕;font-family:맑은 고딕;mso-ascii-font-family:맑은 고딕;mso-font-width:100%;letter-spacing:0pt;mso-text-raise:0pt;font-weight:bold;"></span></p><div id="hwpEditorBoardContent" class="hwp_editor_board_content" data-hjsonver="1.0" data-jsonlen="52570"><!--[data-hwpjson]{ "documentPr": { "di": "", "dp": { "dn": "test.hwp", "ta": 1, "d1": 5, "d2": 1, "dv": 0, "dr": 1, "do": 1, "vj": "1.1", "an": "Hancom Office Hangul", "av": "11, 0, 0, 8808", "ao": "WIN", "ab": "32", "ar": "LE", "as": "Windows_10" }, "dis": false, "ds": { "ti": "", "la": "ko", "cr": "", "su": "", "de": "", "cd": "2026-05-13T13:08:22.414Z", "md": "1601-01-01T09:00:00.000Z", "pd": 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"01DCE28E2564F900000000B7", "ch": [ { "cc": 2, "ci": 1936024420, "co": "01DCE28E2564D1F0000000A3" } , { "cc": 2, "ci": 1668246628, "co": "01DCE28E2564D1F0000000A4" } , { "t": "[화학 구조]" } ] } ] }, "01DCE28E2564D1F0000000A8": { "np": "01DCE28E2564D1F0000000A9", "id": -2147483648, "pp": "01DCE28E2564F900000000C0", "si": "01DCE28E2564F900000000C2", "bf": 0, "ru": [ { "cp": "01DCE28E2564F900000000B8", "ch": [ { "t": "" } ] } ] }, "01DCE28E2564D1F0000000A9": { "np": "01DCE28E2564D1F0000000AA", "id": -2147483648, "pp": "01DCE28E2564F900000000BF", "si": "01DCE28E2564F900000000C2", "bf": 0, "ru": [ { "cp": "01DCE28E2564F900000000B8", "ch": [ { "cc": 11, "ci": 1735618336, "co": "01DCE28E2564D1F0000000A5" } , { "t": "" } ] } ] }, "01DCE28E2564D1F0000000AA": { "np": "01DCE28E2564D1F0000000AB", "id": -2147483648, "pp": "01DCE28E2564F900000000BF", "si": "01DCE28E2564F900000000C2", "bf": 0, "ru": [ { "cp": "01DCE28E2564F900000000B8", "ch": [ { "t": "" } ] } ] }, "01DCE28E2564D1F0000000AB": { "np": "01DCE28E2564D1F0000000AC", "id": -2147483648, "pp": "01DCE28E2564F900000000BF", "si": "01DCE28E2564F900000000C2", "bf": 0, "ru": [ { "cp": "01DCE28E2564F900000000B7", "ch": [ { "t": "[약리작용 및 기전]" } ] } ] }, "01DCE28E2564D1F0000000AC": { "np": "01DCE28E2564D1F0000000AD", "id": -2147483648, "pp": "01DCE28E2564F900000000BF", "si": "01DCE28E2564F900000000C2", "bf": 0, "ru": [ { "cp": "01DCE28E2564F900000000B9", "ch": [ { "t": "이 약은 1정(218.0mg)당 자스타프라잔 시트르산염(zastaprazan citrate) 20mg을 함유하는 급여 전문의약품이다. 이 약은 위벽세포 벽세포(parietal cell) 내의 H" } ] } , { "cp": "01DCE28E2564F900000000BA", "ch": [ { "t": "+" } ] } , { "cp": "01DCE28E2564F900000000B9", "ch": [ { "t": "/K" } ] } , { "cp": "01DCE28E2564F900000000BA", "ch": [ { "t": "+" } ] } , { "cp": "01DCE28E2564F900000000B9", "ch": [ { "t": "-ATPase를 K" } ] } , { "cp": "01DCE28E2564F900000000BA", "ch": [ { "t": "+" } ] } , { "cp": "01DCE28E2564F900000000B9", "ch": [ { "t": " 이온 의존적 그리고 가역적으로 제어함으로써 위산의 분비를 억제하는 작용기전을 가지고 있는 칼륨 경쟁적 위산분비억제제(potassium-competitive acid blocker, P-CAB)이다. 이 약은 산에 의한 활성을 거쳐 작용하는 기존 양성자펌프억제제(proton pump inhibitor, PPI)와 달리 직접 양성자 펌프를 억제하여 신속한 약효 발현과 장시간 효능 유지, 효과적인 야간 위산분비의 저해 효과를 나타낸다. 임상시험에 관한 자료로서 미란성 위식도역류질환의 치료에 대한 안전성 및 유효성을입증하는 임상시험으로 치료적 탐색임상시험 1편, 치료적 확증임상시험 1편이 제출되어 검토후 유효성과 내약성을 확보한 것으로 판단되어 허가 및 승인되었다. 이 약은 미란성 위식도역류질환의 치료에 사용하며 성인 기준으로 1일 1회 20mg을 4주간 경구투여하고 치료되지 않는 경우 4주 추가 투여를 권장한다. 아타자나비르(Atazanavir), 넬피나비어(Nelfinavir), 또는 릴피비린(Rilpivirine) 함유제제와의 상호작용이 보고되었으며, 구조상 유당을 함유하고 있기 때문에 임부 및 수유부 또는 갈락토오스 불내성(galactose intolerance), Lapp 유당분해효소 결핍증(Lapp lactase deficiency), 포도당-갈락토오스 흡수장애(glucose-galactose malabsorption) 등의 유전적인 문제가 있는 환자에서는 투여를 금지해야 한다. " } ] } ] }, "01DCE28E2564D1F0000000AD": { "np": "01DCE28E2564D1F0000000AE", "id": -2147483648, "pp": "01DCE28E2564F900000000BF", "si": "01DCE28E2564F900000000C2", "bf": 0, "ru": [ { "cp": "01DCE28E2564F900000000B9", "ch": [ { "t": "" } ] } ] }, "01DCE28E2564D1F0000000AE": { "np": "01DCE28E2564D1F0000000AF", "id": -2147483648, "pp": "01DCE28E2564F900000000BF", "si": "01DCE28E2564F900000000C2", "bf": 0, "ru": [ { "cp": "01DCE28E2564F900000000B7", "ch": [ { "t": "[연구개발 과정 및 최종 결과]" } ] } ] }, "01DCE28E2564D1F0000000AF": { "np": "01DCE28E2564D1F0000000B0", "id": -2147483648, "pp": "01DCE28E2564F900000000C1", "si": "01DCE28E2564F900000000C2", "bf": 0, "ru": [ { "cp": "01DCE28E2564F900000000B9", "ch": [ { "t": "자스타프라잔은 최초 제일약품(주)에서 개발되어 임상2상까지 진행하였고, 이후 괸계사인 온코닉테라퓨틱스(주)가 개발권리를 이전받아 후기 단계의 개발을 진행하였다. 자큐보정은 2024년 4월에 국내 제37호 신약으로 국내 식약처 허가를 받은 이후 2024년 10월부터 위식도역류질환 치료제로 급여 출시되어 국내 1조 3,000억원 규모의 소화성궤야용제 시장에 본격 진출하였다. 이후 국내 대형병원 5곳 및 전국 60여개 종합병원에서 처방코드 오픈 및 약물심의위원회(D/C) 승인을 받아 약물처방되고 있다. 온코닉테라퓨틱스는 이후 자큐보의 후속 적응증인 위궤양 임상3상을 마무리하여 2025년 6월 17일 “미란성 위식도역류질환의 치료” 적응증 이외에 “위궤양의 치료” 신규 항목을 추가하여 의약품 품목변경허가를 받았으며, 또한 환자의 복약 순응도를 높인 구강붕해정(ODT) 제형을 개발하여 " } ] } , { "cp": "01DCE28E2564F900000000B8", "ch": [ { "t": "2025년 10월 30일 " } ] } , { "cp": "01DCE28E2564F900000000B9", "ch": [ { "t": "허가 심사를 승인받아 자큐보구강붕해정 20mg을 출시하였다. 자큐보구강붕해정은 특히 목넘김에 어려움이 있는 고령층 환자 비중이 큰 역류성 위식도 질환 특성상 물 없이도 간편하게 복용할 수 있어 복약 편의성을 높였다. 현재 비스테로이드성 소염진통제(NSAIDs) 유발 위궤양예방을 위한 적응증 확대 임상(3상)을 진행 중이며 이를 통해 자큐보정의 치료 범위와 시장 내 경쟁력을 동시에 강화해 나갈 계획이라고 밝혔다. 해외동향으로는 2024년 중화권 소재 리브존파마슈티컬 그룹과 1억2750만달러(약 1694억원) 규모로 라이선스아웃(L/O) 계약을 진행한 바 있으며, 이후 같은해 12월 23일 중국 식약처에서 자큐보의 중국 임상 3상을 허가함에 따라 300만달러(약 43억6920만원)의 마일스톤 기술료를 받을 수 있게 됐다. 국내에는 동일성분 및 동일용량의 의약품으로 제일헬스사이언스(주)의 온캡정 20mg, 제일약품(주)의 큐제타스정 20mg/큐제타스구강붕해정 20mg이 있다. " } ] } ] }, "01DCE28E2564D1F0000000B0": { "np": "01DCE28E2564D1F0000000B1", "id": -2147483648, "pp": "01DCE28E2564F900000000BF", "si": "01DCE28E2564F900000000C2", "bf": 0, "ru": [ { "cp": "01DCE28E2564F900000000B9", "ch": [ { "t": "" } ] } ] }, "01DCE28E2564D1F0000000B1": { "np": "01DCE28E2564D1F0000000B2", "id": -2147483648, "pp": "01DCE28E2564F900000000BF", "si": "01DCE28E2564F900000000C2", "bf": 0, "ru": [ { "cp": "01DCE28E2564F900000000B9", "ch": [ { "t": "(출처: 메디포뉴스 (https://www.medifonews.com/news/article.html?no=195308); 헬스조선 (https://m.health.chosun.com/svc/news_view.html?contid=2024042500987); 바이오스펙테이터 (https://www.biospectator.com/news/view/24097); 팜뉴스 (https://www.pharmnews.com/news/articleView.html?idxno=261164); 메디파나뉴스 (https://www.medipana.com/news/articleView.html?idxno=337181))" } ] } ] }, "01DCE28E2564D1F0000000B2": { "np": "", "id": -2147483648, "pp": "01DCE28E2564F900000000BE", "si": "01DCE28E2564F900000000C2", "bf": 0, "ru": [ { "cp": "01DCE28E2564F900000000B6", 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} }--></div><p class="0" style="mso-pagination:none;text-autospace:none;mso-padding-alt:0pt 0pt 0pt 0pt;"><br></p><p class="0" style="mso-pagination:none;text-autospace:none;mso-padding-alt:0pt 0pt 0pt 0pt;"><span style="font-size: 10pt;"> </span><!--[if !supportEmptyParas]--><span style="font-size: 10pt;"> </span><!--[endif]--> <o:p></o:p></p> ==================== 답 변 ====================
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