Celltrion

<!DOCTYPE html> <html lang="en" class="en"> <head> <meta charset="utf-8"> <meta http-equiv="X-UA-Compatible" content="IE=edge, chrome=1"> <meta name="viewport" content="width=device-width, initial-scale=1.0, minimum-scale=1.0, maximum-scale=1.0, user-scalable=no, minimal-ui"> <meta name="format-detection" content="telephone=no"> <meta name="title" content="셀트리온 Celltrion" /> <meta name="author" content="Celltrion" /> <meta name="description" content="" /> <meta name="keywords" content=""> <title>Celltrion</title> <meta property="og:title" content="셀트리온 Celltrion"> <meta property="og:description" content=""> <meta property="og:url" content=""> <meta property="og:images" content=""> <meta property="og:type" content="website"> <link rel="shortcut icon" type="image/x-icon" href="/front/assets/common/images/common/favicon.ico"> <meta name="csrf_name" content="_csrf" /> <meta name="csrf_token" content="58a54a96-0bde-48b5-8c4b-e09c88356acb" /> <link href="/front/assets/common/js/lib/jquery-ui.min.css" rel="stylesheet"> <link href="/front/assets/common/js/lib/selectric.css" rel="stylesheet"> <link href="/front/assets/common/js/lib/swiper-bundle.min.css" rel="stylesheet"> <link href="/front/assets/common/js/lib/aos.css" rel="stylesheet"> <link href="/front/assets/common/css/ui.common.min.css" rel="stylesheet"> <script async src=https://www.googletagmanager.com/gtag/js?id=UA-146344575-1></script> <script> window.dataLayer = window.dataLayer || []; function gtag() { dataLayer.push(arguments); } gtag('js', new Date()); gtag('config', 'UA-146344575-1'); </script> </head> <body> <div class="cpnt_dialogWrap active" data-popup-close="24h"> <div class="wrapList"> <div class="cpnt_dialog_pop" data-name="popLeft"> <div class="cpntWrap" data-popup-no="251"> <div class="cpntHeader"> <strong>Notice to Shareholders</strong> </div> <div class="cpntBody"> <div class="ty_editor"><p><span style="font-family:"Arial",sans-serif;font-size:11.5pt;"><span lang="EN-US" dir="ltr"><strong>[UPDATE - Company's Position and Response Strategy Regarding the U.S. Trump Administration's Tariff Policy(2)]</strong></span></span></p><p> </p><p><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr">Recently, U.S. President Trump signed an executive order imposing reciprocal tariff on all countries, leading to inquiries from some shareholders regarding whether tariffs will be applied to pharmaceuticals.</span></span></p><p> </p><p><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr">On January 30th, we informed shareholders of the company's response strategies under consideration via the notice [Response Strategy to the U.S. Trump Administration’s Tariff Policy on Pharmaceuticals].</span></span></p><p> </p><p><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr">Given our shareholders' concerns, we provide the following update on our review:</span></span></p><p> </p><p><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr"><strong>1. Outlook on the Trump Administration's Drug Tariff Policy </strong></span></span></p><p> </p><ul><li><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr">President Trump briefly mentioned imposing tariffs on foreign-produced pharmaceuticals, along with semiconductors and steel, during his inauguration speech last month. On February 13 (local time), he decided on reciprocal tariffs, which impose duties on foreign goods equivalent to the tariffs those countries apply to U.S. products. This has heightened market interest in the potential implementation of pharmaceutical tariffs.</span></span></li><li><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr">As previously mentioned, pharmaceutical tariffs that could lead to drug price increases are showing a policy direction that directly contradicts President Trump's earlier stance, which showed notable institutional efforts to lower drug prices. In addition, on the 12th of this month, Mike Johnson, the Speaker of the House of Representatives, said in an interview with Reuters that some items including pharmaceuticals could be excluded from the reciprocal tariffs, so whether drug tariffs will actually be implemented still requires careful observation. </span></span></li></ul><p style="margin-left:36.0pt;"> </p><p><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr"><strong>2. Company’s Response Strategy and Preparedness </strong></span></span></p><p> </p><p style="margin-left:20.0pt;"><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr">As explained in our initial notice last month, we have already established a response system for various scenarios regarding potential U.S. drug tariffs. This system can be summarized as follows:</span></span></p><p style="margin-left:20.0pt;"> </p><p style="margin-left:18.0pt;"><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr"><strong>Short-Term Response: Minimizing Tariff Impact for 2025 </strong></span></span></p><p style="margin-left:18.0pt;"> </p><ul><li><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr">We have already completed pre-emptive measures to minimize the impact of potential tariffs for 2025. As of the end of January, we have transferred approximately nine months' worth of inventory for our products scheduled for U.S. sale in 2025. This ensures minimal impact on this year's U.S. sales, regardless of whether drug tariffs are imposed.</span></span></li><li><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr">Production through Contract Manufacturing Organization (CMO) is a common practice in the pharmaceutical industry. We have been producing finished Drug Products (DP) through local CMOs even before the emergence of tariff risks. Through negotiations with these manufacturers, we have already secured additional production capacity. This completes our response to minimize the impact of potential drug tariffs for 2025.</span></span></li></ul><p> </p><p style="margin-left:18.0pt;"><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr"><strong>Mid- to Long-Term Response: Focus on Drug Substance Exports and Consideration of Local Production Facilities </strong></span></span></p><p style="margin-left:18.0pt;"> </p><ul><li><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr">We are already focusing on exporting Drug Substance (DS), which are subject to significantly lower tariffs than finished DPs in the event that tariffs are implemented. Additionally, we are in discussions with local CMOs with sufficient manufacturing capabilities to explore product production cooperation. </span></span></li><li><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr">These efforts will allow us to respond to changing circumstances by expanding local finished DP manufacturing beyond current levels if necessary, depending on pharmaceutical tariff trends.</span></span></li><li><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr">Therefore, we have already established strategies to minimize the impact of tariffs even beyond 2026. However, we have been reviewing in detail the acquisition of a pharmaceutical raw material production facility in the United States since last year, and we plan to finalize the investment decision within the first half of this year. This will allow us to promptly develop more fundamental and sustainable countermeasures against protectionist trade risks.</span></span></li></ul><p> </p><p><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr">We will respond swiftly and effectively to all situations to ensure that our shareholders do not have concerns regarding the direction of the Trump administration's tariff policies. We will continuously share updates on related progress, striving to maintain our shareholders' trust and support for the company. </span></span></p><p> </p><p><span style="font-family:"Arial",sans-serif;"><span lang="EN-US" dir="ltr">Thank you.</span></span></p></div> <a href="https://www.celltrion.com/en-us/company/notice/3689" target="_self" class="btn_detail">Read more</a> </div> <div class="cpntFooter"> <span class="check"> <input type="checkbox" id="checkPopup251"> <label for="checkPopup251">Do not display for 24 hours</label> </span> <button name="btnPopupClose" type="button" class="btn_close">Close</button> </div> </div> </div> </div> </div> <header id="header"> <section class="innerWrap"> <h1 class="logo"><a href="/en-us" title="Celltrion"><span class="blind">Celltrion</span></a></h1> <article id="gnbWrap"> <ul class="gnb"> <li> <a href="javascript:void(0);" title="ABOUT US">ABOUT US</a> <dl> <dd> <a href="/en-us/company/celltrion" title="About Celltrion">About Celltrion</a> 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class="section-header"> <h2 class="title"> <span>Daring to Go Beyond</span> </h2> </div> <div class="videos"> <video poster="/front/assets/common/images/mainNew/main_visual_bg2.webp" loop muted playsinline > <source src="/front/assets/common/images/mainNew/main_visual_bg2.mov" type="video/mp4; codecs=hvc1" /> <source src="/front/assets/common/images/mainNew/main_visual_bg2.webm" type="video/webm" /> </video> </div> </div> <div class="sticky"> <div class="inwrap"> <div class="cell-visual-1"></div> </div> </div> </section> <section class="business"> <div class="bg-wrap"> <div class="bg research-bg"></div> <div class="bg production-bg"></div> <div class="bg distribution-bg"></div> </div> <div class="cell-visual-1"></div> <div class="section-header"> <h3 class="title">One-Stop <br>Solution <br>Provider</h3> <p class="text"> Celltrion provides one-stop solutions for the entire process of biopharmaceutical business from R&D to clinical trials, regulatory affairs, production and distribution. </p> <a href="/en-us/business/rnd/capabilities" class="btn btn-more"> Read more<span class="icon"></span> </a> </div> <article class="subsection research"> <div class="sticky"> <div class="cell-visual-1"></div> <div class="deco"></div> <div class="inwrap"> <div class="subsection-header"> <div class="title-wrap"> <span class="num">01</span> <h5 class="title">R&D</h5> </div> <div class="text-wrap"> <p class="text"> Celltrion, as a global biopharmaceutical company with outstanding R&D know-hows, will continue to pursue its goal in promoting health and well-being of patients. </p> <a href="/en-us/business/rnd" class="btn btn-more"> Read more<span class="icon"></span> </a> </div> </div> <div class="slider"> <div class="swiper"> <div class="swiper-wrapper"> <div class="swiper-slide"> <a href="/en-us/business/rnd" class="content"> <div class="category"> <strong>R&D</strong> </div> <div class="description"> <span class="num">01</span> <p class="text"> Operates Korea's largest Global R&D Center capable of biologics and small molecules research </p> </div> <div class="image"> <img src="/front/assets/common/images/mainNew/main_business_research_01.webp" alt=""> </div> </a> </div> <div class="swiper-slide"> <a href="/en-us/business/rnd" class="content"> <div class="category"> <strong>Clinical Trials</strong> </div> <div class="description"> <span class="num">02</span> <p class="text"> Successfully accumulated global clinical trial experiences on mAb biopharmaceuticals </p> </div> <div class="image"> <img src="/front/assets/common/images/mainNew/main_business_research_02.webp" alt=""> </div> </a> </div> <div class="swiper-slide"> <a href="/en-us/business/rnd" class="content"> <div class="category"> <strong>Regulatory Affairs</strong> </div> <div class="description"> <span class="num">03</span> <p class="text"> Outstanding capacity dedicated to regulatory approvals and sales of biopharmaceuticals </p> </div> <div class="image"> <img src="/front/assets/common/images/mainNew/main_business_research_03.webp" alt=""> </div> </a> </div> </div> <div class="slide-nav"> <button type="button" class="swiper-button-prev"></button> <button type="button" class="swiper-button-next"></button> </div> </div> </div> </div> </div> </article> <article class="subsection production"> <div class="sticky"> <div class="cell-visual-1"></div> <div class="deco"></div> <div class="inwrap"> <div class="subsection-header"> <div class="title-wrap"> <span class="num">02</span> <h5 class="title">Production</h5> </div> <div class="text-wrap"> <p class="text"> Celltrion was the first in Asia to operate US FDA cGMP certified animal cell culture facilities. It operates animal cell culture and downstream process facilities designated as "National Core Technology". </p> <a href="/en-us/business/production" class="btn btn-more"> Read more<span class="icon"></span> </a> </div> </div> <div class="slider"> <div class="swiper"> <div class="swiper-wrapper"> <div class="swiper-slide"> <a href="/en-us/business/production" class="content"> <div class="description"> <span class="num">01</span> <p class="text"> Operates US FDA and Europe EMA cGMP certified production facilities </p> </div> <div class="image"> <img src="/front/assets/common/images/mainNew/main_business_production_01.webp" alt=""> </div> </a> </div> <div class="swiper-slide"> <a href="/en-us/business/production" class="content"> <div class="description"> <span class="num">02</span> <p class="text"> Operates large-scale, in-house manufacturing facilities with a production capacity of 250,000L </p> </div> <div class="image"> <img src="/front/assets/common/images/mainNew/main_business_production_02.webp" alt=""> </div> </a> </div> <div class="swiper-slide"> <a href="/en-us/business/production" class="content"> <div class="description"> <span class="num">03</span> <p class="text"> World class production capabilities and quality control system </p> </div> <div class="image"> <img src="/front/assets/common/images/mainNew/main_business_production_03.webp" alt=""> </div> </a> </div> </div> <div class="slide-nav"> <button type="button" class="swiper-button-prev"></button> <button type="button" class="swiper-button-next"></button> </div> </div> </div> </div> </div> </article> <article class="subsection distribution"> <div class="sticky"> <div class="cell-visual-1"></div> <div class="deco"></div> <div class="inwrap"> <div class="subsection-header"> <div class="title-wrap"> <span class="num">03</span> <h5 class="title">Distribution</h5> </div> <div class="text-wrap"> <p class="text"> Celltrion established and expanded direct sales network across major global markets including the US and Europe. It is the largest manufacturer and exporter of biosimilars in Korea. </p> <a href="/en-us/business/distribution" class="btn btn-more"> Read more<span class="icon"></span> </a> </div> </div> <div class="slider"> <div class="swiper"> <div class="swiper-wrapper"> <div class="swiper-slide"> <a href="/en-us/business/distribution" class="content"> <div class="description"> <span class="num">01</span> <p class="text"> Establishment and expansion of direct global sales network </p> </div> <div class="image"> <img src="/front/assets/common/images/mainNew/main_business_distribution_01.webp" alt=""> </div> </a> </div> <div class="swiper-slide"> <a href="/en-us/business/distribution" class="content"> <div class="description"> <span class="num">02</span> <p class="text"> Distributes multiple antibody products in approximately 100 countries </p> </div> <div class="image"> <img src="/front/assets/common/images/mainNew/main_business_distribution_02.webp" alt=""> </div> </a> </div> <div class="swiper-slide"> <a href="/en-us/business/distribution" class="content"> <div class="description"> <span class="num">03</span> <p class="text"> No. 1 manufacturer and exporter of biosimilars in Korea </p> </div> <div class="image"> <img src="/front/assets/common/images/mainNew/main_business_distribution_03.webp" alt=""> </div> </a> </div> </div> <div class="slide-nav"> <button type="button" class="swiper-button-prev"></button> <button type="button" class="swiper-button-next"></button> </div> </div> </div> </div> </div> </article> </section> <section class="products"> <div class="sticky"> <div class="inwrap"> <div class="cell-visual-1"></div> <div class="section-header"> <h3 class="title"> Our Biopharmaceutical <br>Products & Pipeline </h3> </div> <div class="contents"> <div class="slide-tab"> <ul> <li><button type="button" data-slide="approval" class="btn active">Products <span class="num"></span></button></li> <li><button type="button" data-slide="pipeline" class="btn">Pipeline <span class="num"></span></button></li> </ul> </div> <div class="slider"> <div class="slide-approval"> <div class="stack"> <div class="stack-wrapper"> <div class="stack-slide"> <a href="/en-us/products/approved/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>Remsima®</strong> <figure> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232717101221-aee6d979-4351-44ea-bd06-03cd795a187a.png" alt="Remsima®"> </figure> <span>Rheumatoid arthritis, IBD</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/approved/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>Truxima®</strong> <figure> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232717081243-541e7171-85c0-4eb8-8dd5-a7611e3078ad.png" alt="Truxima®"> </figure> <span>Non-Hodgkin’s lymphoma</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/approved/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>Herzuma®</strong> <figure> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232717061252-6dfb4ce2-9535-44c1-bb86-baeb17865027.png" alt="Herzuma®"> </figure> <span>Metastatic breast cancer</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/approved/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>Remsima® SC</strong> <figure> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232717041254-8c30afd4-284e-40a9-8025-bad293809b9f.png" alt="Remsima® SC"> </figure> <span>Rheumatoid arthritis, IBD</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/approved/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>Yuflyma®</strong> <figure> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232717001256-843e240a-25af-40f1-b1e4-05483ad9e599.png" alt="Yuflyma®"> </figure> <span>Rheumatoid arthritis, IBD</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/approved/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>Vegzelma®</strong> <figure> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232716591205-bea088a2-0857-4098-bc2b-b663cecc9a94.png" alt="Vegzelma®"> </figure> <span>Metastatic colorectal cancer</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/approved/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>Eydenzelt®</strong> <figure> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/241808300729-b92c74ee-29ee-4b22-a9e0-9133528eda48.jpg" alt="Eydenzelt®"> </figure> <span>Diabetic macular edema, osteoporosi</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/approved/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>Steqeyma®</strong> <figure> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/241808300737-768b7be5-0dea-496b-aa2b-5f477ee40c10.jpg" alt="Steqeyma®"> </figure> <span>Psoriasis, inflammatory bowel disea</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/approved/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>Stoboclo®/Osenvelt®</strong> <figure> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/250714460131-9bdf340d-a750-4e11-9877-0b1085daa0f6.png" alt="Stoboclo®/Osenvelt®"> </figure> <span>Osteoporosis</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/approved/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>Avtozma®</strong> <figure> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/250714440140-4fbf354d-37f0-470a-8a4c-cea43a92aee2.png" alt="Avtozma®"> </figure> <span>Rheumatoid arthritis</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/approved/biologics?activeTab=ANTIBODY_NEW_DRUG"> <div class="content"> <strong>Zymfentra™</strong> <figure> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232716571251-4bc044ff-eb24-4ba8-b049-39146b979e3e.png" alt="Zymfentra™"> </figure> <span>Inflammatory bowel disease</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/approved/biologics?activeTab=ANTIBODY_NEW_DRUG"> <div class="content"> <strong>Regkirona™</strong> <figure> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232716571204-3e53b7bd-7ed6-45f5-9212-47cc9ce4cab8.png" alt="Regkirona™"> </figure> <span>COVID-19</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> </div> </div> <div class="stack-rail"> <ul class="stack-pagination"> </ul> </div> <div class="stack-navigation"></div> </div> <div class="slide-pipeline"> <div class="stack"> <div class="stack-wrapper"> <div class="stack-slide"> <a href="/en-us/products/pipelines/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>CT-P39</strong> <figure> <img src="/front/assets/common/images/main/img_product_02_01.png" alt="CT-P39"> </figure> <span>Asthma, urticaria</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/pipelines/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>CT-P44</strong> <figure> <img src="/front/assets/common/images/main/img_product_02_02.png" alt="CT-P44"> </figure> <span>multiple myeloma</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/pipelines/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>CT-P51</strong> <figure> <img src="/front/assets/common/images/main/img_product_02_03.png" alt="CT-P51"> </figure> <span> Melanoma, lung cancer</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/pipelines/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>CT-P53</strong> <figure> <img src="/front/assets/common/images/main/img_product_02_04.png" alt="CT-P53"> </figure> <span>Multiple sclerosis</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="stack-slide"> <a href="/en-us/products/pipelines/biologics?activeTab=ANTIBODY_BIOSIMILAR"> <div class="content"> <strong>CT-P55</strong> <figure> <img src="/front/assets/common/images/main/img_product_02_05.png" alt="CT-P55"> </figure> <span>Psoriasis</span> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> </div> </div> <div class="stack-rail"> <ul class="stack-pagination"></ul> </div> <div class="stack-navigation"></div> </div> </div> </div> </div> </div> </section> <section class="global"> <div class="sticky"> <div class="bg"></div> <div class="inwrap"> <div class="section-header"> <h3 class="title"> Advanced and affordable, <br> globally accessible </h3> <p class="text"> We established a global distribution network <br> in over 100 countries <br> 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href="/en-us/company/media-center/magazine" class="btn btn-more"> Read more<span class="icon"></span> </a> </div> <div class="cards"> <div class="card" ,> <a href="javascript:void(0);" title="★Vol018 Two Primary Pathways of Biologics Administration_Web_eng.pdf" encData="MMPXhmkZUeIyItDVowmO1nLimys4XCLNfe+7i8X2ZfQ=" onclick="commUtil.fnViewPdfFile(this.getAttribute('encData'));"> <div class="images"> <img src="https://cellhomeblob.blob.core.windows.net/files/board/magazine/252314590144-9a4349ea-9bd7-4672-8f0b-2be1afcb6754.jpg" alt="Two Primary Pathways of Biologics Administration: Subcutaneous and Intravenous Routes"> </div> <div class="texts"> <strong>Two Primary Pathways of Biologics Administration: Subcutaneous and Intravenous Routes</strong> <p>When deciding the most appropriate formulation of medication to administer to the human body, medication’s physical and chemical properties, ingredients, intended use, and therapeutic objectives are considered. There are approximately 190 formulation types, including pills (tablets), powders, and liquids. While injection is the most common method of administering biologics, continuous efforts are being made to develop various formulations for these therapies.</p> </div> </a> </div> <div class="card" ,> <a href="javascript:void(0);" title="★Vol017 Autoimmune diseases Causes and Treatment Options_web_Eng.pdf" encData="9EKLveB2yr8Zurz4X47ehrQWMwjB6EKiu6BRkuQtPnA=" onclick="commUtil.fnViewPdfFile(this.getAttribute('encData'));"> <div class="images"> <img src="https://cellhomeblob.blob.core.windows.net/files/board/magazine/240508431140-a43ed5b5-0420-46ab-95c9-0ecd3b31d8bd.jpg" alt="Autoimmune diseases: Causes and treatment options"> </div> <div class="texts"> <strong>Autoimmune diseases: Causes and treatment options</strong> <p>Humans have various defensive mechanisms, including leukocytes, for responding to harmful external antigens like bacteria and viruses. These defensive mechanisms are referred to as the “immune system,” which is designed to discriminate between “self” and “non-self” and protect normal cells within the body instead of attacking them.</p> </div> </a> </div> <div class="card" ,> <a href="javascript:void(0);" title="★Vol016 Microbiome treatments Infinite possibilities of microbiota in human body_web_eng.pdf" encData="Kb2Bvv0I92ClXe7UbtW98ORf5Runa1DRALUe6t/pH48=" onclick="commUtil.fnViewPdfFile(this.getAttribute('encData'));"> <div class="images"> <img src="https://cellhomeblob.blob.core.windows.net/files/board/magazine/241908220735-b387bdac-45c9-4bf3-83a5-8799cb7b7b44.jpg" alt="Microbiome treatments : Infinite possibilities of microbiota in human body"> </div> <div class="texts"> <strong>Microbiome treatments : Infinite possibilities of microbiota in human body</strong> <p>The term “microbiome” combines “microbiota,” meaning microorganisms, and “genome,” referring to biological genetic information. It describes the microbial community residing in the human body. Microbiome treatments are therapeutics developed using these microbiota and/or their derived substances found in the human body.</p> </div> </a> </div> </div> </div> </div> </section> <section class="news"> <div class="inwrap"> <div class="section-header"> <h3 class="title">News</h3> </div> <div class="slide-btns"> <div class="slide-tab"> <ul> <li><button type="button" data-slide="press" class="btn active">Press Releases</button></li> <li><button type="button" data-slide="notice" class="btn">Notice</button></li> </ul> </div> </div> <div class="slider"> <div class="slide-press"> <div class="slide-nav"> <button type="button" class="swiper-button-prev"></button> <button type="button" class="swiper-button-next"></button> </div> <div class="swiper"> <div class="swiper-wrapper"> <div class="swiper-slide"> <a href="/en-us/company/media-center/press-release/3691"> <div class="bg"></div> <div class="content"> <strong>Celltrion Expands Biosimilar Portfolio in the European Union Following European Commission Approval of Two Biosimilars</strong> <p>Celltrion gains simultaneous regulatory approval of two monoclonal antibody biosimilars across three treatments – Eydenzelt® (aflibercept), Stoboclo® and Osenvelt® (denosumab) in the EU marketEuropean Commission approval based on totality of evidence including extensive comparative analytical, pharmacokinetic and clinical dataThe company expands its biosimilar portfolio to 11 in 2025 as planned, further strengthening its commitment to a portfolio of 22 drugs by 2030 February 18, 2025 09:57 PM Eastern Standard Time INCHEON, South Korea--Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars: Eydenzelt® (CT-P42, aflibercept), a biosimilar to Eylea® to treat multiple retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV); and Stoboclo® and Osenvelt® (CT-P41, denosumab), biosimilars referencing Prolia® and Xgeva® used for all indications of the reference products. The EC approval expands Celltrion’s diverse biosimilars portfolio across multiple therapeutic areas such as skeletal-related disorders and ophthalmology. “Celltrion is committed to expanding access to high-quality monoclonal antibody treatments for patients across Europe,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “Securing regulatory approval for three biosimilar products on the same day highlights our commitment to providing healthcare professionals with reliable, effective, and accessible treatment options for their patients. With a portfolio of 11 biosimilar brands and a fully integrated approach—from research and development to manufacturing and direct supply—Celltrion is increasing treatment options, improving patient access to biologics, and strengthening its role as a trusted partner for healthcare professionals in Europe, all while supporting the sustainability of healthcare systems.” Data showed that Eydenzelt® (40 mg/mL solution for injection in vial and pre-filled syringe), Stoboclo® (60 mg solution for injection in pre-filled syringe) and Osenvelt® (120 mg solution for injection in vial) have comparable quality, safety and efficacy when compared to their respective reference products, Eylea® (aflibercept) and Prolia® and Xgeva® (denosumab), respectively. 1,2,3 “The European Commission approval of Eydenzelt®, Stoboclo® and Osenvelt® are a significant milestone and a welcome addition to our portfolio of medicines to address a significant unmet need in therapeutic areas including skeletal-related disorders and ophthalmology,” said Min Kyoung Jeon, Vice President and Head of Regulatory Affairs Division at Celltrion. “The approval highlights Celltrion’s continuous commitment to expanding the availability, access and uptake of these important treatment options to patients with unmet needs.” The company’s therapeutics include a total of 11 biosimilar products: 4 immunology products, including Remsima®/Inflectra® (US), Remsima® SC, Yuflyma®, and SteQeyma®; 3 oncology products, including Truxima®, Herzuma®, and Vegzelma®; and other therapeutic areas, including Omlyclo®, Eydenzelt®, Stoboclo® and Osenvelt®. About CT-P41 Phase III Clinical TrialThe Phase III study randomised 479 patients to receive 60 mg of CT-P41 or reference product every six months (Weeks 0 and 26; treatment period [TP] I). Results of the study showed that CT-P41 had equivalent efficacy and pharmacodynamics to reference denosumab, with similar pharmacokinetic and comparable safety and immunogenicity profiles.3 About CT-P42 Phase III Clinical TrialIn a randomised, double-masked, parallel-group, multi-centre Phase III study of Eydenzelt® (CT-P42), the efficacy, safety, pharmacokinetics, usability and immunogenicity of Eydenzelt® was compared to Eylea® (aflibercept) in patients with diabetic macular edema (DME). Results of the study showed that Eydenzelt® met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed trends similar to Eylea®.1,2 About Stoboclo® (CT-P41, biosimilar denosumab)Stoboclo® (denosumab), a receptor activator of NF-κb ligand (RANKL) inhibitor, is a treatment developed as a biosimilar to reference product Prolia® (denosumab). In Europe, Stoboclo® has been approved to treat osteoporosis in postmenopausal women and in men at increased risk of fractures, bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.4 Stoboclo® was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA). About Osenvelt® (CT-P41, biosimilar denosumab)Osenvelt® (denosumab) is a receptor activator of NF-κb ligand (RANKL) inhibitor developed as a biosimilar referencing Xgeva® (denosumab). Osenvelt® has been approved in Europe to prevent skeletal-related events in adults with advanced malignancies involving bone, and to treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.5 Osenvelt® was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA). About Eydenzelt® (CT-P42, biosimilar aflibercept)Eydenzelt® (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor referencing Eylea®. Based on comprehensive data from a Phase III clinical trial confirming therapeutic equivalence to Eylea®3, Eydenzelt® is approved to treat neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV).6 Eydenzelt® was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA). About CelltrionCelltrion is a leading biopharmaceutical company that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business, and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. These statements may be identified by words such as “prepares,” “hopes to,” “upcoming,” ”plans to,” “aims to,” “to be launched,” “is preparing,” “once gained,” “could,” “with the aim of,” “may,” “once identified,” “will,” “working towards,” “is due,” “become available,” “has potential to,” the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. Trademarks Stoboclo® and Osenvelt® are registered trademarks of Celltrion Inc.Prolia® and Xgeva® are registered trademarks of Amgen Inc. Eydenzelt® is a registered trademark of Celltrion Inc.Eylea® is a registered trademark of Bayer AG. References_____________________________________1 Sebastian Wolf et al., Long-term efficacy and Safety of CT-P42 compared to Reference Aflibercept in Diabetic Macular Edema: 52-Week Results from the Phase 3 CT-P42 3.1. [EURETINA 2024, Abstract #CA24-2257-8397]. Available at: https://abstracts.euretina.org/2024/ca24-2257-8397/r/recxUD7DqYfFfjC7s [Last accessed February 2025].2 Sebastian Wolf et al., Biosimilar Candidate CT-P42 in Diabetic Macular Edema: 24-Week Results from a Randomized, Active-Controlled, Phase III Study. Available at: https://www.sciencedirect.com/science/article/pii/S2468653024003063 [Last accessed February 2025].3 Reginster JY et al. Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis. Osteoporos Int. 2024 Nov;35(11):1919-1930. doi: 10.1007/s00198-024-07161-x. Epub 2024 Jul 23. PMID: 39042292; PMCID: PMC11499533. Available at: https://pubmed.ncbi.nlm.nih.gov/39042292/ [Last accessed February 2025].4 European Medicines Agency Summary of Product Characteristics (SmPC), Stoboclo. [Last accessed February 2025].5 European Medicines Agency Summary of Product Characteristics (SmPC), Osenvelt. [Last accessed February 2025].6 European Medicines Agency Summary of Product Characteristics (SmPC), Eydenzelt. [Last accessed February 2025].</p> </div> <div class="date"> <span>2025<br>02</span> <strong>19</strong> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="swiper-slide"> <a href="/en-us/company/media-center/press-release/3668"> <div class="bg"></div> <div class="content"> <strong>U.S. FDA approves Celltrion's AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA®</strong> <p>The intravenous (IV) formulation of AVTOZMA® (tocilizumab-anoh) is expected to be available in the U.S. in August 2025Approval was received for multiple indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and COVID-19[1]AVTOZMA® becomes Celltrion's fifth immunology biologic and seventh biosimilar approved by the FDA JERSEY CITY, N.J., Jan. 30, 2025 -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved AVTOZMA® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to ACTEMRA®. AVTOZMA is indicated for the treatment of multiple diseases including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and coronavirus disease (COVID-19).[1] "Introducing both IV and SC formulations of AVTOZMA provides flexibility and a wider range of treatment options," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "This approval represents a strategic addition to our immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and healthcare providers. Our goal is to provide safe and effective alternatives and ensure appropriate access so plan sponsors can address unique population needs." The FDA's decision is based on a comprehensive data package and the totality of evidence, including the results from a phase III study demonstrating biosimilarity between AVTOZMA and reference tocilizumab in patients with moderate to severe active RA. The primary endpoint was met in terms of change from baseline in disease activity score using 28 joints (DAS28)-ESR at Week 24, and the final 1-year results supported comparability in secondary efficacy, pharmacokinetic (PK), safety and immunogenicity results between AVTOZMA and reference tocilizumab. The clinical results demonstrated that AVTOZMA and its reference tocilizumab are highly similar and have no clinically meaningful differences in terms of efficacy, safety, pharmacokinetics (PK) and immunogenicity.[2] In accordance with the patent settlement agreement with Genentech, the intravenous (IV) formulation of AVTOZMA® (tocilizumab-anoh) is expected to be available in the U.S. in August 2025. Celltrion has a license to market the subcutaneous formulation in the U.S. commencing on the license date, which remains confidential. AVTOZMA is Celltrion's seventh biosimilar granted marketing authorization in the U.S. About AVTOZMA® (tocilizumab-anoh)[1] AVTOZMA® (tocilizumab-anoh), containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial designed to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of CT-P47 compared to reference tocilizumab, AVTOZMA was filed for regulatory approval with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in January and February 2024, respectively. INDICATION AVTOZMA® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).Giant Cell Arteritis (GCA): Adult patients with GCA.Polyarticular Juvenile Idiopathic Arthritis (pJIA): Patients 2+ years-old with active pJIA.Systemic Juvenile Idiopathic Arthritis (sJIA): Patients 2+ years-old with active sJIA.COVID-19: Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS INFECTIONS AVTOZMA® and other tocilizumab products may increase the risk of serious infections, potentially leading to hospitalization or death, especially in patients using concurrent immunosuppressants. If a serious infection develops, interrupt AVTOZMA until the infection is controlled. Reported infections include:Active tuberculosis (TB) which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during treatment (except in COVID-19 patients) and treat latent infections before starting AVTOZMA.Invasive fungal infections: Such as candidiasis, aspergillosis, and pneumocystis, may present as disseminated rather than localized disease.Opportunistic infections, including bacterial, viral and other opportunistic pathogens. Monitor patients for signs of infection, including TB, during and after AVTOZMA treatment.Contraindications: Known hypersensitivity to tocilizumab products.Serious Infections. Serious and sometimes fatal infections have been reported with AVTOZMA. Do not use during active infections, including localized infections. Discontinue AVTOZMA if a serious infection occurs and resume only once controlled.Gastrointestinal (GI) Perforation. Gastrointestinal perforations, often linked to diverticulitis, have been reported with tocilizumab. Use AVTOZMA cautiously in high-risk patients and promptly evaluate new abdominal symptoms for early detection and management.Hepatoxicity. Monitor for hepatic injury signs. Avoid AVTOZMA if ALT/ AST >1.5x ULN (RA/GCA) or >10x ULN (COVID-19); discontinue if ALT/AST >5x ULN or symptoms of liver disease develop.Changes in Laboratory Parameters. Monitor neutrophils, platelets, liver enzymes, and lipids due to potential treatment-related changes; avoid initiating AVTOZMA in patients with critically low ANC or platelet counts.Immunosuppression. The impact of AVTOZMA on malignancy development is unknown, but it may increase risk as an immunosuppressant.Hypersensitivity Reactions, including anaphylaxis, and death, have occurred; administer IV infusions with anaphylaxis management support, discontinue permanently if reactions occur, and avoid use in patients with known hypersensitivity.Demyelinating Disorders. The impact of tocilizumab on demyelinating disorders is unknown, but rare cases were reported; monitor symptoms and use caution with preexisting or recent disorders.Active Hepatic Disease and Hepatic Impairment. Treatment with AVTOZMA is not recommended.Live Vaccines. Avoid concurrent use with AVTOZMA.Adverse Reactions (≥5%) include upper respiratory tract infections, nasopharyngitis, headache, hypertension, elevated ALT, and injection site reactions. For more information, see Full Prescribing Information. About CelltrionCelltrion is a leading biopharmaceutical company based in Incheon, South Korea that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 countries. Celltrion has seven biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), STEQEYMA® (ustekinumab-stba), and AVTOZMA® (tocilizumab-anoh), as well as novel biologic ZYMFENTRA® (infliximab-dyyb). For more information, please visit https://www.celltrion.com/en-us. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares," "hopes to," "upcoming," "plans to," "aims to," "to be launched," "is preparing," "once gained," "could," "with the aim of," "may," "once identified," "will," "working towards," "is due," "become available," "has potential to," the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. TrademarksAVTOZMA® is a registered trademark of Celltrion Inc.ACTEMRA® is a registered trademark of Chugai Pharmaceutical Co., Ltd. References[1] AVTOZMA U.S. prescribing information (2024)[2] Gerd Burmester et al., Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study. Poster Presentation (abstract no. 0502). Presented at ACR 2024. Available at: https://acrabstracts.org/abstract/similar-efficacy-pk-safety-and-immunogenicity-of-tocilizumab-biosimilar-ct-p47-and-reference-tocilizumab-in-patients-with-moderate-to-severe-active-rheumatoid-arthritis-week-52-results-from-the/ [Last accessed December 2024]</p> </div> <div class="date"> <span>2025<br>01</span> <strong>31</strong> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="swiper-slide"> <a href="/en-us/company/media-center/press-release/3659"> <div class="bg"></div> <div class="content"> <strong>Celltrion unveils strategic vision for advancing its innovative drug pipeline at the 43rd Annual J.P. Morgan Healthcare Conference</strong> <p>Celltrion unveils strategic roadmap for the first time outlining its innovative drug development strategy and its plan to submit 13 Investigational New Drug (IND) application by 2028Company reinforces its commitment to a two-pillar growth strategy focusing on its groundbreaking new drug developments including next-generation antibody drug conjugates (ADCs) and multispecific antibodies INCHEON, South Korea, Jan. 14, 2025 /PRNewswire/ -- Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, today announced its innovative drug development strategy in the rigorous and cutting-edge field of novel drug therapeutics at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, California. Celltrion's presentation, titled 'Unveiling our strategy for advancing innovative drug pipelines' took place at the main track. Celltrion's Chairman Jung-Jin Seo and Chief Executive Officer Jin-Seok Seo outlined new drug developments including its next-generation antibody drug conjugate (ADC) platform, with two biobetter ADC candidates CT-P70 and CT-P71. CT-P70 and CT-P71 are ADCs designed to target solid cancers; with CT-P70 focusing on non-small cell lung cancer (NSCLC) and CT-P71 aiming to treat bladder cancer. These therapeutics leverage the new payload 'PBX-7016,' which demonstrated low toxicity and high tumor growth inhibition (TGI) effects during its development, positioning it as a platform capable of delivering 'best-in-class' therapeutics within the same mechanism of action. In addition, the company announced its plan to develop dual-payload ADCs that incorporate two distinct payloads with complementary mechanisms of action, aiming to deliver a more potent cytotoxic response to cancer cells. The company also plans to focus on developing multispecific antibodies that selectively target cancer cells or are activated only under specific conditions. CT-P72 is a tumor-selective multispecific antibody which has demonstrated improved on-target off-tumor toxicity through cytotoxic research results showing clear differences between normal tissue cells and cancer cells. The next-generation multispecific antibody therapeutics in development will focus on enhancing safety enhancing tumor selectivity by conditional activation with 'conditionally-active multispecific antibodies (MsAb)' and maximizing therapeutic potential of tumor killing immune cells with 'immuno-oncology multispecific antibodies (MsAb).' "Celltrion redefined biologics and demonstrated our development capabilities in monoclonal antibodies (mAbs), a groundbreaking class of therapeutic agents by achieving the vision of having a portfolio of 11 drugs by 2025," said Jin-Seok Seo. "We plan to leverage our diverse experience and expertise accumulated in antibody drug development as we accelerate the development of next-generation new drugs, highlighting antibody-drug conjugates (ADCs) and multispecific antibody drugs as the dual driving forces for the company's future growth." Mr. Seo outlined IND submission timelines of its novel drug pipeline with plans to develop 13 new drugs by 2028, including 9 ADCs and 4 multispecific antibodies. Jin-Seok Seo added, ''Just two years after the full-scale launch of next-generation drug development, four new drug candidates are set to enter clinical trials sequentially, with new drug projects expected to follow every year. Our lead candidates have showcased remarkable progress and outcomes from their preclinical stage, bringing us closer to achieving our vision of becoming a global leader in the new drugs and breakthrough treatments." About CelltrionCelltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.These statements may be also identified by words such as "prepares," "hopes to," "upcoming," "plans to," "aims to," "to be launched," "is preparing," "once gained," "could," "with the aim of," "may," "once identified," "will," "working towards," "is due," "become available," "has potential to," the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws.</p> </div> <div class="date"> <span>2025<br>01</span> <strong>15</strong> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="swiper-slide"> <a href="/en-us/company/media-center/press-release/3629"> <div class="bg"></div> <div class="content"> <strong>U.S. FDA approves Celltrion's STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab)</strong> <p>STEQEYMA (CT-P43) is approved for both adult and pediatric patients with plaque psoriasis (PsO) and active psoriatic arthritis (PsA) as well as adults with Crohn's disease (CD) and ulcerative colitis (UC)STEQEYMA is a strategic addition to Celltrion's portfolio, expanding the portfolio and building on Celltrion's expertise in immunologySTEQEYMA is expected to be marketed in the U.S. in February 2025 JERSEY CITY, N.J., Dec. 17, 2024 -- Celltrion announced today that the U.S. Food and Drug Administration (FDA) has approved STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis.[1] The FDA approval of STEQEYMA was based on the totality of evidence, including the results from a phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that STEQEYMA and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of safety and efficacy. "The approval of STEQEYMA reflects Celltrion's continued investment in providing treatment options to patients diagnosed with ulcerative colitis, Crohn's disease, psoriasis, and psoriatic arthritis," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "STEQEYMA is now the latest biologic in our immunology portfolio, joining ZYMFENTRA® (infliximab-dyyb). Our portfolio, supported by our fully integrated platform, establishes Celltrion USA as an important player in the U.S. immunology market." "Plaque psoriasis and psoriatic arthritis are both autoimmune disorders that affect the skin and present differently in all patients," said Mark G. Lebwohl*, MD, Icahn School of Medicine at Mount Sinai, New York. "The approval of new treatment option is welcome news for people living with certain chronic inflammatory conditions, such as psoriasis, which affect more than 3% of the US adult population." Ustekinumab is a fully human monoclonal antibody that selectively inhibits both interleukin (IL)-12 and IL-23, two cytokines that play an important role in inflammatory and immune responses. Celltrion Inc. had reached a settlement and license agreement with the manufacturer of the reference biologic, Johnson & Johnson, granting a license entry date for STEQEYMA in the United States in February 2025. Notes to Editors:*Dr. Mark Lebwohl is a paid consultant for Celltrion. About STEQEYMA® (ustekinumab-stba)STEQEYMA®, formerly known as CT-P43, is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases. It encompasses all indications approved for the STELARA® reference product, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn's disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. STEQEYMA is available in both subcutaneous and intravenous formulations. The subcutaneous injection comes in two strengths: 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial. INDICATIONSSTEQEYMA® (ustekinumab-stba) is indicated for the treatment of:Plaque Psoriasis (PsO) in adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.Psoriatic Arthritis (PsA) in adults and pediatric patients 6 years of age and older with active psoriatic arthritis.Crohn's Disease (CD) in adult patients with moderately to severely active Crohn's disease.Ulcerative Colitis (UC) in adult patients with moderately to severely active ulcerative colitis. IMPORTANT SAFETY INFORMATIONSTEQEYMA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STEQEYMASerious infections have occurred. Avoid starting STEQEYMA during any clinically important active infection. If a serious or clinically significant infection develop, discontinue STEQEYMA until the infection resolves.Serious infections from mycobacteria, salmonella, and BCG vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances.Evaluate patients for TB prior to starting STEQEYMA. Initiate treatment of latent TB before administering STEQEYMA.Ustekinumab products may increase risk of malignancy. The safety of ustekinumab products in patients with a history of or a known malignancy has not been evaluated. Monitor all patients receiving STEQEYMA for signs of malignancies.If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STEQEYMA.If Posterior Reversible Encephalopathy Syndrome (PRES) is suspected, treat promptly, and discontinue STEQEYMA.Avoid use of live vaccines in patients during treatment with STEQEYMA. Non-live vaccinations received during STEQEYMA treatment may not elicit enough immune response to prevent disease.If diagnosis of noninfectious pneumonia is confirmed, discontinue STEQEYMA and institute appropriate treatment.The most common adverse reactions (≥3%) reported in patients receiving ustekinumab were:Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue.CD: vomiting, nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis.UC: nasopharyngitis, nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. For more information, see Full Prescribing Information. About ZYMFENTRA® (infliximab-dyyb)ZYMFENTRA® is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), moderately to severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body.ZYMFENTRA (infliximab-dyyb) was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040. ZYMFENTRA (infliximab-dyyb) U.S. Use and Important Safety InformationZYMFENTRA is a prescription medicine indicated in adults for maintenance treatment of:moderately to severely active Crohn's disease following treatment with an infliximab product administered intravenously.moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. It is not known if ZYMFENTRA is safe and effective in children under 18 years of age. What is the most important information I should know about ZYMFENTRA? SERIOUS INFECTIONSPatients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. Reported infections include:Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with ZYMFENTRA. Treatment for latent infection should be initiated prior to treatment with ZYMFENTRA.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection. MALIGNANCIESMalignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants. Post-marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis, and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with ZYMFENTRA, especially in these patient types. In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls and the expected rate in the general population. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. As the potential role of TNF blocker therapy in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy.Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. CONTRAINDICATIONSZYMFENTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients of ZYMFENTRA or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness). HEPATITIS B VIRUS REACTIVATIONTNF blockers, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating ZYMFENTRA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing ZYMFENTRA for patients identified as carriers of HBV, and monitor closely for active HBV infection during and following termination of therapy with ZYMFENTRA. Discontinue ZYMFENTRA in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of ZYMFENTRA, and monitor patients closely. HEPATOTOXICITYHepatobiliary disorders, including acute liver failure, jaundice abnormal hepatic function, hepatic steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia, and non-alcoholic fatty liver, have been reported in patients receiving infliximab products post-marketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, ZYMFENTRA should be discontinued, and a thorough investigation of the abnormality should be undertaken. CONGESTIVE HEART FAILURECases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Some cases had a fatal outcome. In several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality. ZYMFENTRA has not been studied in patients with a history of CHF and ZYMFENTRA should be used with caution in patients with CHF. HEMATOLOGIC REACTIONCases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to infliximab-product therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of ZYMFENTRA in patients who develop significant hematologic abnormalities. HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONSIn post-marketing experience, serious systemic hypersensitivity reactions (including anaphylaxis, hypotension, and serum sickness) have been reported following administration of infliximab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. INJECTION SITE REACTIONSIn clinical studies, localized injection-site reactions were reported following administration of ZYMFENTRA. If a clinically significant injection-site reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. NEUROLOGIC REACTIONSAgents that inhibit TNF have been associated with central nervous system (CNS) manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering ZYMFENTRA in patients with these disorders and consider discontinuation if these disorders develop. RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER BIOLOGICS PRODUCTSSerious infections and neutropenia have been reported with concurrent use of ZYMFENTRA with other immunosuppressive biological products. The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended. RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR BIOLOGICAL PRODUCTSConsider the half-life and mode of action of prior biological products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA. AUTOIMMUNITYTreatment with TNF blockers may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue ZYMFENTRA treatment if symptoms of a lupus-like syndrome develop. VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTSPrior to initiating ZYMFENTRA, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA due to the possibility of clinical infections, including disseminated infections. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to ZYMFENTRA. ADVERSE REACTIONSIn clinical trials with ZYMFENTRA, the most common adverse reactions occurring in ≥3% of ZYMFENTRA-treated patients included site reactions, COVID-19, anemia, arthralgia, infection site reaction, increased alanine aminotransferase and abdominal pain for UC, and COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia for CD. This is the most important information to know about ZYMFENTRA. For more information, talk to your HCP. Please click for Full U.S. Prescribing Information.Globally, prescribing information varies; refer to the individual country product label for complete information. About Celltrion USACelltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 countries. For more information, please visit: www.celltrionusa.com. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion that may constitute forward-looking statements, under pertinent securities laws. These statements may be identified by words such as "prepares," "hopes to," "upcoming," "plans to," "aims to," "to be launched," "is preparing," "once gained," "could," "with the aim of," "may," "once identified," "will," "working towards," "is due," "become available," "has potential to," the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion's management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions with respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. Such risks and uncertainties may include, among other things, uncertainties regarding the launch timing and commercial success of Celltrion in the United States; the uncertainties inherent in supply chain, manufacturing, research and development, and the possibility of unfavorable new clinical data and further analyses of existing clinical data as they relate to Celltrion products; intellectual property and/or litigation/settlement implications; decisions by the FDA impacting labeling, manufacturing processes, safety, promotion, and/or other matters that could affect the availability or commercial potential of Celltrion products; and uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to competitive products; and competitive developments. A further description of risks and uncertainties can be found in Celltrion's Annual Report. Although forward-looking statements contained in this presentation are based upon what management of Celltrion believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements. TrademarksSTELARA® is a registered trademark of Johnson & Johnson.STEQEYMA® is a registered trademark of Celltrion, Inc., used under license.References[1] STEQEYMA U.S. prescribing information (2024)</p> </div> <div class="date"> <span>2024<br>12</span> <strong>18</strong> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="swiper-slide"> <a href="/en-us/company/media-center/press-release/3620"> <div class="bg"></div> <div class="content"> <strong>Celltrion Receives Positive CHMP Opinion for Three Biosimilars in the European Union</strong> <p>The Committee for Medicinal Products for Human Use (CHMP) adopts positive opinions for Celltrion’s three biosimilar candidates – Eydenzelt® (aflibercept), Stoboclo® and Osenvelt® (denosumab), and Avtozma® (tocilizumab)Celltrion is committed to expanding access to biologic treatments in skeletal-related disorders, ophthalmology, and immunology December 16, 2024 08:33 AM Japan Standard Time INCHEON, South Korea -- Celltrion today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions and recommended marketing authorisations for three biosimilar candidates: Eydenzelt® (CT-P42, aflibercept), Stoboclo® and Osenvelt® (CT-P41, denosumab), and Avtozma® (CT-P47, tocilizumab). This significant milestone reflects the company’s leadership in biosimilar innovation and commitment to expanding access to biologic treatments across Europe. Eydenzelt (40 mg/mL solution for injection in vial and pre-filled syringe), a biosimilar to Eylea® (aflibercept), is recommended for approval to treat multiple retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV). In a Phase III study of Eydenzelt, the efficacy, safety, pharmacokinetics and immunogenicity of Eydenzelt was compared to Eylea in patients with diabetic macular edema (DME), demonstrating therapeutic equivalence to Eylea by meeting the predefined equivalence criteria.1 If marketing authorisation is granted by the European Commission (EC), Eydenzelt would be one of the first-wave aflibercept biosimilars in Europe. Stoboclo (60 mg solution for injection in pre-filled syringe) and Osenvelt (120 mg solution for injection in vial) have been recommended for approval for all indications of the reference products Prolia® and Xgeva®, respectively. The positive CHMP opinion was based on the totality of evidence including results from a Phase III clinical trial in postmenopausal osteoporosis (PMO), and the results showed that CT-P41 had equivalent efficacy and pharmacodynamics (PD) to reference denosumab, with similar pharmacokinetics (PK) and comparable safety and immunogenicity profiles.2 Avtozma, a biosimilar referencing RoActemra® (tocilizumab), has been recommended for all indications of its reference product, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA) and giant cell arteritis (GCA). The positive CHMP opinion for Avtozma was supported by a comprehensive data package and totality of evidence demonstrating Avtozma’s biosimilarity to RoActemra, with no clinically meaningful differences in efficacy, PK equivalence, safety or immunogenicity.3,4 “With CHMP approvals for Eydenzelt, Avtozma, and Prolia/Xgeva biosimilars, Celltrion solidifies its leadership in the European biosimilar market, offering one of the most extensive antibody biosimilar portfolios. Our vertically integrated model ensures supply chain stability while addressing the specific challenges faced by European healthcare professionals and patients. These approvals underscore our commitment to supporting European healthcare systems by improving access to high-quality, affordable treatments,” said Taehun Ha, Vice President and Head of Europe. “Our focus remains on empowering clinicians with the tools and solutions they need, as we aim to transition from a pioneer to a frontier leader in European healthcare.” The CHMP’s recommendations will now be referred to the EC, which will decide whether to grant a marketing authorisation for Eydenzelt, Stoboclo and Osenvelt, and Avtozma. If marketing authorisations are granted, the three biosimilars will be made available across EU member states, furthering Celltrion’s commitment to delivering innovative and accessible healthcare solutions. About CT-P41 Phase III Clinical TrialThe Phase III study randomised 479 patients to receive 60 mg of CT-P41 or reference product every six months (Weeks 0 and 26; treatment period [TP] I). Before dosing at Week 52, patients initially assigned to reference product in TP I were re-randomised in a 1:1 ratio to continue with the reference product or switch to CT-P41 in TP. All patients initially randomly assigned to CT-P41 in TP I continued their treatment with CT-P41 in TP II. In TP II, 422 patients were randomised in Week 52 (CT-P41 maintenance group: 221, reference product maintenance group: 100, switched to CT-P41 group: 101). The primary efficacy endpoint was met in terms of percent change from baseline in bone mineral density (BMD) for lumbar spine (L1-L4) by dual-energy X-ray absorptiometry (DXA) at Week 52, and the primary pharmacodynamics (PD) endpoint was met in terms of area under the effect curve (AUEC) of serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX) over the initial six months. Results of the study showed that CT-P41 had equivalent efficacy and PD to reference denosumab, with similar PK and comparable safety and immunogenicity profiles.2 About CT-P42 Phase III Clinical TrialIn a randomised, double-masked, parallel-group, multi-centre Phase III study of Eydenzelt® (CT-P42), the efficacy, safety, pharmacokinetics, usability and immunogenicity of Eydenzelt was compared to Eylea® (aflibercept) in patients with diabetic macular edema (DME). The primary endpoint was the change from baseline in best corrected visual acuity (BCVA) measured at Week 8, comparing Eydenzelt and Eylea. Results of the study showed that Eydenzelt met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed trends similar to Eylea.1,5 About CT-P47 Phase III Clinical TrialThis was a Phase III, randomised, active-controlled, double-blind trial to compare the efficacy and safety of Avtozma® (CT-P47) and RoAtemra® (tocilizumab) in patients with moderate to severely active rheumatoid arthritis (RA). The Phase III study randomised 479 patients to receive 8mg/kg of CT-P47 or reference tocilizumab every 4 weeks (Week 0 and 24; treatment period [TP] I). Before dosing at Week 24, patients initially assigned to tocilizumab in TP I were re-randomised in a 1:1 ratio to continue with tocilizumab or switch to CT-P47 in TP II up to Week 52. In TP II, 444 patients were randomised in Week 24 (CT-P47 maintenance group: 225, tocilizumab maintenance group: 109, switched to CT-P47 group: 110). The primary endpoint was mean change from baseline in Disease Activity score in 28 joints (DAS28; erythrocyte sedimentation rate [ESR]) at week 12. Efficacy equivalence was determined if confidence intervals (CIs) for the treatment difference was within the predefined equivalence margin: (95% CI: -0.6, +0.6 (analysis of covariance [ANCOVA]) at week 12). Therapeutic equivalence of CT-P47 and reference tocilizumab in treating RA was demonstrated and supported by comparable and sustained efficacy results up to Week 52. CT-P47 was also well tolerated with a safety profile comparable to reference tocilizumab, and no notable safety issue was identified following the single transition from reference tocilizumab to CT-P47 compared with maintenance groups up to Week 52. 3,4 About Stoboclo® (CT-P41, biosimilar candidate of denosumab)Stoboclo® (denosumab), a receptor activator of NF-κb ligand (RANKL) inhibitor, is a treatment developed as a biosimilar to reference product Prolia® (denosumab). In Europe, Stoboclo has been recommended for approval to treat osteoporosis in postmenopausal women and in men at increased risk of fractures, bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. About Osenvelt® (CT-P41, biosimilar candidate of denosumab)Osenvelt® (denosumab) is a receptor activator of NF-κb ligand (RANKL) inhibitor developed as a biosimilar referencing Xgeva® (denosumab). Osenvelt has been recommended for approval in Europe to prevent skeletal-related events in adults with advanced malignancies involving bone, and to treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. About Eydenzelt® (CT-P42, biosimilar candidate of aflibercept)Eydenzelt® (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor referencing Eylea®. Based on comprehensive data from a Phase III clinical trial confirming therapeutic equivalence to Eylea1, Eydenzelt was filed for regulatory approval with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in June and November 2023, respectively. About Avtozma® (CT-P47, biosimilar candidate of tocilizumab)CT-P47, containing the active ingredient tocilizumab, is a recombinant humanised monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial, designed to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of CT-P47 compared to the reference product RoActemra®4, CT-P47 was filed for regulatory approval with the U.S. FDA and EMA in January and February 2024, respectively. About CelltrionCelltrion is a leading biopharmaceutical company based in Incheon, South Korea that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. The company’s solutions include world-class monoclonal antibody biosimilars such as Remsima®, Truxima® and Herzuma®, providing broader patient access globally. Celltrion has also received U.S. FDA and EC approval for Vegzelma® and Yuflyma®, FDA approval for Zymfentra®, and EC approval for Remsima® SC, Omlyclo®, SteQeyma®. To learn more, please visit www.celltrion.com/en-us. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business, and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.These statements may be identified by words such as “prepares,” “hopes to,” “upcoming,” ”plans to,” “aims to,” “to be launched,” “is preparing,” “once gained,” “could,” “with the aim of,” “may,” “once identified,” “will,” “working towards,” “is due,” “become available,” “has potential to,” the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. TrademarkStoboclo® and Osenvelt® are registered trademarks of Celltrion Inc. Prolia® and Xgeva® are registered trademarks of Amgen Inc.Eydenzelt® is a registered trademark of Celltrion Inc. Eylea® is a registered trademark of Bayer AG.Avtozma® is a registered trademark of Celltrion, Inc., used under license. RoActemra® is a registered trademark of Chugai Pharmaceutical Co., Ltd. References1 Sebastian Wolf et al., Long-term efficacy and Safety of CT-P42 compared to Reference Aflibercept in Diabetic Macular Edema: 52-Week Results from the Phase 3 CT-P42 3.1. [EURETINA 2024, Abstract #CA24-2257-8397]. Available at: https://abstracts.euretina.org/2024/ca24-2257-8397/r/recxUD7DqYfFfjC7s [Last accessed December 2024]. 2 Reginster JY et al. Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis. Osteoporos Int. 2024 Nov;35(11):1919-1930. doi: 10.1007/s00198-024-07161-x. Epub 2024 Jul 23. PMID: 39042292; PMCID: PMC11499533. Available at: https://pubmed.ncbi.nlm.nih.gov/39042292/ [Last accessed December 2024]. 3 Smolen JS et al., Efficacy and safety of CT-P47 versus reference tocilizumab: 32-week results of a randomised, active-controlled, double-blind, phase III study in patients with rheumatoid arthritis, including 8 weeks of switching data from reference tocilizumab to CT-P47. RMD Open. 2024;10(4), e004514. Available at: https://rmdopen.bmj.com/content/10/4/e004514.abstract [Last accessed December 2024]. 4 Gerd Burmester et al., Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study. Poster Presentation (abstract no. 0502). Presented at ACR 2024. Available at: https://acrabstracts.org/abstract/similar-efficacy-pk-safety-and-immunogenicity-of-tocilizumab-biosimilar-ct-p47-and-reference-tocilizumab-in-patients-with-moderate-to-severe-active-rheumatoid-arthritis-week-52-results-from-the/ [Last accessed December 2024]. 5 Sebastian Wolf et al., Biosimilar Candidate CT-P42 in Diabetic Macular Edema: 24-Week Results from a Randomized, Active-Controlled, Phase III Study. Available at: https://www.sciencedirect.com/science/article/pii/S2468653024003063 [Last accessed December 2024].</p> </div> <div class="date"> <span>2024<br>12</span> <strong>16</strong> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> </div> </div> </div> <div class="slide-notice"> <div class="slide-nav"> <button type="button" class="swiper-button-prev"></button> <button type="button" class="swiper-button-next"></button> </div> <div class="swiper"> <div class="swiper-wrapper"> <div class="swiper-slide"> <a href="/en-us/company/notice/3689"> <div class="bg"></div> <div class="content"> <strong>Notice to Shareholders [UPDATE - Company's Position and Response Strategy Regarding the U.S. Trump Administration's Tariff Policy(2)]</strong> <p>Recently, U.S. President Trump signed an executive order imposing reciprocal tariff on all countries, leading to inquiries from some shareholders regarding whether tariffs will be applied to pharmaceuticals. On January 30th, we informed shareholders of the company's response strategies under consideration via the notice [Response Strategy to the U.S. Trump Administration’s Tariff Policy on Pharmaceuticals]. Given our shareholders' concerns, we provide the following update on our review: 1. Outlook on the Trump Administration's Drug Tariff Policy President Trump briefly mentioned imposing tariffs on foreign-produced pharmaceuticals, along with semiconductors and steel, during his inauguration speech last month. On February 13 (local time), he decided on reciprocal tariffs, which impose duties on foreign goods equivalent to the tariffs those countries apply to U.S. products. This has heightened market interest in the potential implementation of pharmaceutical tariffs.As previously mentioned, pharmaceutical tariffs that could lead to drug price increases are showing a policy direction that directly contradicts President Trump's earlier stance, which showed notable institutional efforts to lower drug prices. In addition, on the 12th of this month, Mike Johnson, the Speaker of the House of Representatives, said in an interview with Reuters that some items including pharmaceuticals could be excluded from the reciprocal tariffs, so whether drug tariffs will actually be implemented still requires careful observation. 2. Company’s Response Strategy and Preparedness As explained in our initial notice last month, we have already established a response system for various scenarios regarding potential U.S. drug tariffs. This system can be summarized as follows: Short-Term Response: Minimizing Tariff Impact for 2025 We have already completed pre-emptive measures to minimize the impact of potential tariffs for 2025. As of the end of January, we have transferred approximately nine months' worth of inventory for our products scheduled for U.S. sale in 2025. This ensures minimal impact on this year's U.S. sales, regardless of whether drug tariffs are imposed.Production through Contract Manufacturing Organization (CMO) is a common practice in the pharmaceutical industry. We have been producing finished Drug Products (DP) through local CMOs even before the emergence of tariff risks. Through negotiations with these manufacturers, we have already secured additional production capacity. This completes our response to minimize the impact of potential drug tariffs for 2025. Mid- to Long-Term Response: Focus on Drug Substance Exports and Consideration of Local Production Facilities We are already focusing on exporting Drug Substance (DS), which are subject to significantly lower tariffs than finished DPs in the event that tariffs are implemented. Additionally, we are in discussions with local CMOs with sufficient manufacturing capabilities to explore product production cooperation. These efforts will allow us to respond to changing circumstances by expanding local finished DP manufacturing beyond current levels if necessary, depending on pharmaceutical tariff trends.Therefore, we have already established strategies to minimize the impact of tariffs even beyond 2026. However, we have been reviewing in detail the acquisition of a pharmaceutical raw material production facility in the United States since last year, and we plan to finalize the investment decision within the first half of this year. This will allow us to promptly develop more fundamental and sustainable countermeasures against protectionist trade risks. We will respond swiftly and effectively to all situations to ensure that our shareholders do not have concerns regarding the direction of the Trump administration's tariff policies. We will continuously share updates on related progress, striving to maintain our shareholders' trust and support for the company. Thank you.</p> </div> <div class="date"> <span>2025<br>02</span> <strong>19</strong> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="swiper-slide"> <a href="/en-us/company/notice/3666"> <div class="bg"></div> <div class="content"> <strong>Notice to Shareholders [Response Strategy to the U.S. Trump Administration’s Tariff Policy on Pharmaceuticals]</strong> <p>Dear Shareholders, In a recent speech shortly after his inauguration, U.S. President Donald Trump briefly mentioned that, along with semiconductors and steel, foreign-produced pharmaceuticals would also be subject to tariffs. Given that some of our shareholders have expressed concerns regarding this statement, we would like to provide a brief overview of our current response strategy. 1. Outlook on the Trump Administration's Drug Tariff Policy To date, President Trump has not presented specific policy proposals regarding drug tariffs, and the actual implementation is still uncertain, requiring further review and policy observation.Tariffs on drugs could lead to rising drug prices in the U.S., imposing significant burdens on consumers and the healthcare system. Therefore, it is unclear whether President Trump will actually enforce such measures.Notably, during his first term, President Trump consistently pushed for lower drug prices, and this tariff policy would directly contradict his previous stance on drug pricing. 2. Company’s Response Strategy and Preparedness Since the election of President Trump, we have closely analyzed various scenarios regarding the possibility of tariffs and have already in place a system capable of responding immediately, regardless of how the policy is implemented. Short-Term Response: Securing Sufficient Inventory in the U.S. We currently have sufficient inventory of our products in the U.S. to meet demand until at least the third quarter of 2025, without the need for additional imports.For products that are expected to be depleted sooner, we have the capability to produce finished pharmaceuticals (DP) from active pharmaceutical ingredients (API) already imported to the U.S. Mid-Term Response: Shift to a DS-centric Supply Strategy If tariffs are sustained in the long term, we plan to focus on exporting drug substances (DS), which are subject to lower tariffs, rather than finished drug products (DP) that face higher tariffs, and adjust our strategy to produce finished drug products at local manufacturing sites.We are already exploring cooperation with local companies that have sufficient manufacturing capacity to produce our products. Long-Term Response: Evaluating Establishment of Local Manufacturing Facilities in the U.S. We are considering the acquisition or establishment of local manufacturing facilities in the U.S. capable of producing both finished drug products and drug substances.This would help us create a stable supply chain that is less affected by political and social changes in the U.S., while also expanding our market share in the U.S. 3. Exchange Rate Environment and Positive Outlook for Exporting Companies As mentioned earlier, if the Trump administration imposes tariffs, it is likely to increase the prices of consumer goods and raw materials in the U.S., leading to inflation.If inflation worsens, there is a higher possibility that the U.S. Federal Reserve will continue its tight monetary policy, which could result in sustained high exchange rates.A high exchange rate environment can be beneficial for global export companies like us, enhancing our competitiveness in the U.S. market and improving profitability. In conclusion, we will continue to monitor the Trump administration's tariff policy direction and are fully prepared to respond immediately if the policy is enacted. Moreover, in light of the changes in the global economic environment, we will leverage exchange rate fluctuations to maintain a stable profit structure and actively pursue long-term growth strategies. Additionally, we will strive to minimize supply and sales risks and maximize shareholder value through sustainable growth. We thank our shareholders for their continued trust and support, and we promise to share updates on our response efforts promptly and transparently. Thank you.</p> </div> <div class="date"> <span>2025<br>01</span> <strong>30</strong> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="swiper-slide"> <a href="/en-us/company/notice/3587"> <div class="bg"></div> <div class="content"> <strong>Notice to Shareholders Regarding Updates on Our Business Progress</strong> <p>Dear shareholders, Despite the ongoing domestic and international uncertainties, Celltrion's business operations are progressing smoothly. We would also like to reaffirm our unwavering commitment to implementing management practices that enhance shareholder value.The business initiatives presented to domestic and international shareholders and investors during the Hong Kong Investor Day are progressing smoothly. The planned share cancellation within the year was promptly executed, as confirmed by the "Decision on Share Cancellation" disclosure on December 4. The remaining initiatives discussed during the Investor Day will proceed without any setbacks, and we will do our utmost to fulfill our commitments to shareholders and investors. The impact of increased financial market volatility, which has recently raised concerns among our shareholders, is expected to be limited. Recent domestic uncertainties may lead to short-term volatility in the financial market. However, as more than 90% of Celltrion's revenue is generated overseas, primarily in USD or EUR, depreciation of the Korean won against the US dollar is expected to have little to no negative impact on our business. Amid external uncertainties, we remain steadfast in carrying out our duties and strengthening our core capabilities, striving to translate our efforts into tangible results.Additionally, we will keep you posted on any information that needs to be shared throughout this process. We would like to reaffirm that enhancing shareholder value remains our top priority. The executive leadership and all employees remain fully committed to repaying the trust our esteemed shareholders have placed in Celltrion. Lastly, we sincerely thank our shareholders for your unwavering interest and support for Celltrion.</p> </div> <div class="date"> <span>2024<br>12</span> <strong>04</strong> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="swiper-slide"> <a href="/en-us/company/notice/3556"> <div class="bg"></div> <div class="content"> <strong>Details on Accessing the Hong Kong Investor Day Session </strong> <p>We are providing detailed information regarding the Hong Kong Investor Day session announced on our website on November 22, 2024. Please find the details for accessing the session below:1. Date: Wednesday, November 27, 2024, at 4:00 PM KST 2. Target Audience: Domestic and Global investors 3. Format: On-site event and online streaming 4. AgendaThe session, hosted by our top management, will include a presentation on key management topics such as biosimilar market outlook, expansion of our product portfolio, progress in new drug development, CDMO business plan etc. 5. Joining InstructionsThe session will be live streamed via YouTube at the following link: (https://url.kr/gfl5o6) or the QR code below. The broadcast will begin promptly at the scheduled time. [Additional Information]As this is an international IR event, the presentation and Q&A session will be conducted in Korean, with English interpretation provided.Presentation materials in both Korean and English will be accessible on our website prior to the event. </p> </div> <div class="date"> <span>2024<br>11</span> <strong>26</strong> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> <div class="swiper-slide"> <a href="/en-us/company/notice/3531"> <div class="bg"></div> <div class="content"> <strong>Notice to Shareholders (Regarding the latest business progress and outlook)</strong> <p>Dear Shareholders,In recent times, the uncertainty in both domestic and international financial markets has led to increased volatility in the stock market. Despite this, we would like to inform you that Celltrion's business operations and growth strategy are proceeding as planned, without disruption. In this regard, we would like to provide an update on some of the key aspects of our business. 1. Our current revenue guidance is expected to be met without difficulty. As announced on September 9, Celltrion has set revenue targets of 3.5 trillion KRW for 2024 and 5 trillion KRW for 2025. As of the third quarter of this year, we have already achieved a cumulative revenue of 2.4936 trillion KRW, and we anticipate no challenges in surpassing our 3.5 trillion KRW target for 2024. Given this growth momentum, we are confident that our 2025 revenue target of 5 trillion KRW will also be achievable. Globally, we are witnessing robust growth in bid wins and prescription performance across our established products, such as Remsima, as well as new offerings, Steqeyma(Stelara biosimilar) and Omlyclo(Xolair biosimilar). Notably, as of the fourth quarter, all foundational efforts to drive U.S. sales growth for Zymfentra have been successfully completed. This sets the stage for a significant acceleration in revenue growth, and we remain optimistic about our performance in the coming quarters Regarding the potential impact of the U.S. presidential election results on market stability, as previously mentioned, the anticipated policies of the newly inaugurated Trump 2.0 administration are expected to continue and build upon the previous Trump administration’s initiatives, such as drug price reduction measures and the America First Healthcare Plan. This policy direction is likely to create a favorable environment for the expansion of biosimilar prescriptions, which is a key area of focus for Celltrion’s business. Furthermore, the projected strengthening of the U.S. dollar, influenced by the administration’s "America First" policy, is expected to benefit Celltrion, given our strong reliance on export-driven revenue. Additionally, since our pharmaceutical products are exempt from tariffs under WTO regulations, we will not be impacted by potential tariff increases. As a result, if the Trump 2.0 administration takes office, we foresee a unique opportunity to focus on expanding our operations and improving performance, particularly in comparison to industries that may be more affected by policy shifts. 2. The groundwork for the CDMO business, poised to be a key growth driver, is advancing as planned. After announcing our plans for expanding our CDMO (Contract Development and Manufacturing Organization) business in September, we have been making rapid progress. We plan to establish a new CDMO subsidiary, fully owned by Celltrion, by the end of this year. The selection of sites and the scale and configuration of facilities are also progressing quickly. The project is advancing well, with the materialized business plan currently in its final review stage, and from next year, we will begin the design and construction of the plants and sales activities to lay the foundation for the CDMO business. 3. We will focus on engaging with both domestic and international investors, beginning with the financial markets in Asia. From November 20th to the end of this year, Chairman Jung Jin Seo and other top management of Celltrion will visit key financial markets, such as Singapore and Hong Kong, to hold investor events. These events will be attended by global investors, and we will provide detailed explanations about our growth outlook, the potential of our CDMO business with detailed execution plans, our ongoing and upcoming innovative drug pipelines as our future growth drivers, and more. In January next year, we will participate in the JP Morgan Healthcare Conference, the largest healthcare conference in the world, where we will present a more detailed roadmap of our innovative drug pipelines including two ADC candidates, CT-P70 and CT-P71, which have recently shown positive outcomes. Additionally, Celltrion plans to unveil an expanded lineup of innovative drugs at the conference, featuring a cocktail antibody drug combined with Celltrion’s immunology agent, as well as an orally administered antibody treatment aimed at IBD. Celltrion will continue to actively engage in IR activities to ensure that the value of the company is well recognized by investors. 4. We are committed to prioritizing and enhancing shareholder value. As part of our shareholder value enhancement policy, Celltrion has been actively buying back its own shares. We have completed three share buyback programs this year, and with the ongoing fourth buyback, we will repurchase approximately 1.82 million shares, worth about 335.1 billion KRW in total, by the end of this year. In light of the recent escalation in domestic financial market uncertainty and to prevent excessive declines in our stock price, we are actively reviewing plans for additional share buybacks and are considering conducting share buybacks periodically until market conditions stabilize. In addition to these efforts, we will continue to explore various shareholder-friendly policies to further enhance shareholder value and ensure that our management practices are aligned with the best interests of our shareholders. We assure you that we will continue to make every effort to maintain open communication with our shareholders. Lastly, we would like to make one request to our valued shareholders. We kindly ask shareholders who have entered into securities lending agreements regarding Celltrion shares to terminate these agreements. Despite the ban on short selling, the current short position in Celltrion shares is approximately 300 billion KRW, and the securities lending balance remains high at approximately 1.268 trillion KRW. While this figure has decreased somewhat, it remains at a high level. An excessively high level of loaned shares poses the risk of being exploited against the company, especially during periods of stock price volatility. By terminating these securities lending agreements, shareholders will directly contribute to the long-term growth and value enhancement of the company.We deeply appreciate the continued support and interest of our shareholders. </p> </div> <div class="date"> <span>2024<br>11</span> <strong>16</strong> </div> <span class="btn-point"> <span></span> <span></span> </span> </a> </div> </div> </div> </div> </div> </div> </section> <footer id="footer"> <section class="innerWrap"> <div class="footerTopBtn"> <button type="button" class="iconGoToTop" title="Top scroll"><span class="blind">Top button</span></button> </div> <article id="footerWrap"> <ul class="menu"> <li> <dl> <dt> <a href="javascript:void(0);" title="ABOUT US">ABOUT US</a> </dt> <dd> <a href="/en-us/company/celltrion" title="About Celltrion">About Celltrion</a> </dd> <dd> <a href="/en-us/company/notice" title="Notice">Notice</a> </dd> <dd> <a href="/en-us/company/media-center" title="Media Center">Media Center</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="BUSINESS">BUSINESS</a> </dt> <dd> <a href="/en-us/business/overview" title="Business Areas">Business Areas</a> </dd> <dd> <a href="/en-us/business/rnd" title="R&D">R&D</a> </dd> <dd> <a href="/en-us/business/production" title="Production">Production</a> </dd> <dd> <a href="/en-us/business/distribution" title="Distribution">Distribution</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="PRODUCTS">PRODUCTS</a> </dt> <dd> <a href="/en-us/products/approved" title="Products">Products</a> </dd> <dd> <a href="/en-us/products/pipelines" title="Pipeline">Pipeline</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="ESG">ESG</a> </dt> <dd> <a href="/en-us/esg/environment" title="Environmental">Environmental</a> </dd> <dd> <a href="/en-us/esg/society" title="Social">Social</a> </dd> <dd> <a href="/en-us/esg/governance" title="Governance">Governance</a> </dd> <dd> <a href="/en-us/esg/data-room" title="ESG Archive">ESG Archive</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="IR">IR</a> </dt> <dd> <a href="/en-us/investment/financial" title="Financial Information">Financial Information</a> </dd> <dd> <a href="/en-us/investment/stock-info" title="Stock Summary">Stock Summary</a> </dd> <dd> <a href="/en-us/investment/notice" title="Public Disclosures">Public Disclosures</a> </dd> <dd> <a href="/en-us/investment/ir" title="IR Archive">IR Archive</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="CAREERS">CAREERS</a> </dt> <dd> <a href="/en-us/careers/talent" title="Our Values">Our Values</a> </dd> <dd> <a href="/en-us/careers/recruit" title="How to Apply">How to Apply</a> </dd> <dd class="outlink"> <a href="https://recruit.celltrion.com/CELLTRION.html" title="Jobs" target="_blank">Jobs</a> </dd> </dl> </li> </ul> <div class="familySite"> <div class="inputSelect dark"> <select id="familySiteSelector" class="selector"> <option>Family Site</option> <option value="https://www.celltrionph.com/en-us/home/index">Celltrion Pharm</option> <option value="https://www.celltrionbeauty.com">Celltrion Skincure</option> <option value="https://www.celltrionwelfare.com">Celltrion Welfare</option> <option value="https://celltrionenter.com">Celltrion Ent.</option> </select> </div> </div> <div class="logo"><span class="blind">Celltrion</span></div> <ul class="sideMenu"> <li><a href="/en-us/terms/privacy-policy" title="Privacy Policy">Privacy Policy</a></li> <li><a href="/en-us/terms/legal-notice" title="Legal Notice">Legal Notice</a></li> <li><a href="/en-us/terms/import-export-policy" title="Export and Import Management Policy">Export and Import Management Policy</a></li> <li><a href="/en-us/contact/inquiry" title="Contact Us">Contact Us</a></li> <li><a href="/en-us/contact/directions" title="Directions">Directions</a></li> </ul> <address>23, Academy-ro, Yeonsu-gu, Incheon, Republic of Korea<span>+82-32-850-5000</span><p>© CELLTRION INC. 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