<p><em>- 拉丁美洲首次獲得監管批准標誌着區域市場擴展的戰略里程碑</em> <em>- 世界首個無抗生素製造工藝確保了卓越的安全性</em></p>
<p>, /PRNewswire/ -- GC Biopharma(006280.KS)，韓國領先的生物製藥產品供應商，今天宣佈其水痘疫苗 BARYCELA Inj. 已獲得危地馬拉公共衞生與社會援助部（Ministerio de Salud Pública y Asistencia Social）的市場授權。這一批准標誌着 BARYCELA Inj. 在拉丁美洲地區獲得的首個監管許可，為鄰近市場提供高質量免疫接種鋪平了道路。</p>
<p>BARYCELA Inj. 是一種活疫苗，採用 GC Biopharma 的專有 MAV/06 菌株開發。與傳統疫苗不同，BARYCELA Inj. 是全球首個通過完全無抗生素工藝製造的水痘疫苗。通過在生產過程中消除使用抗生素（如卡那黴素、新黴素和紅黴素），該疫苗從根本上防止了與抗生素殘留相關的潛在不良反應，確保了兒童羣體的安全性。</p>
<p>此外，BARYCELA Inj. 最近被納入世界衞生組織（WHO）立場文件，正式被認可為與基於 Oka 菌株的現有疫苗具有可互換性。這一官方認可顯著拓寬了 BARYCELA Inj. 在全球市場的臨牀應用，使其能夠無縫融入多樣化的國家免疫接種計劃。憑藉其經過驗證的產品特性，GC Biopharma 打算加速進入國際採購機構和個體私營市場。</p>
<p>&#34;在拉丁美洲獲得首個市場授權是我們疫苗技術全球競爭力的證明，&#34; GC Biopharma 監管科學與產品開發負責人 Jae Woo Lee 表示。&#34;我們致力於通過提供差異化和更安全的預防解決方案來加強我們在全球市場的地位。&#34;</p>
<p><strong>關於 GC Biopharma</strong></p>
<p>GC Biopharma（前稱綠十字公司）是一家總部位於韓國龍仁的生物製藥公司。該公司在血漿衍生物和疫苗的開發與製造方面擁有超過半個世紀的經驗，並通過成功進入美國市場的 Alyglo®（靜脈免疫球蛋白 G）於 2024 年擴大其全球影響力。為了滿足未來醫療的需求，GC Biopharma 繼續通過利用其在蛋白質、mRNA 和脂質納米顆粒（LNP）藥物遞送平台的核心研發能力推動創新，開發針對罕見疾病以及免疫學與炎症（I&amp;I）領域的治療方案。欲瞭解更多信息，請訪問 https://www.gcbiopharma.com/eng/</p>
<p><em>本新聞稿可能包含</em> 生物製藥 <em>的前瞻性聲明，表達了 GC Biopharma 管理層當前的信念和期望。這些聲明並不代表 GC Biopharma 或其管理層對未來表現的任何保證，並涉及已知和未知的風險、不確定性及其他因素。除法律或證券交易所規則要求外，GC Biopharma 不承擔更新或修訂本新聞稿中包含的任何前瞻性聲明或其可能做出的任何其他前瞻性聲明的義務。</em></p>
<p><strong>GC Biopharma 媒體聯繫人</strong></p>
<p>金素希</p>
<p>[email protected]</p>
<p>尹藝琳</p>
<p>[email protected]</p>
<p>南允宰</p>
<p>[email protected]</p>
<p>來源 GC Biopharma</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzI2Jk5ld3NJdGVtSWQ9Q04xOTk4NCZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMjYwMjIzUFJfTkVXU19VU1BSX19fX19DTjE5OTg0?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzI2Jk5ld3NJdGVtSWQ9Q04xOTk4NCZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMjYwMjIzUFJfTkVXU19VU1BSX19fX19DTjE5OTg0"/></p>

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<p>GC Biopharma 已獲得危地馬拉公共衞生部對其水痘疫苗 BARYCELA Inj. 的市場授權。這標誌着該疫苗在拉丁美洲獲得的首個監管批准，增強了該地區的免疫接種可及性。BARYCELA Inj. 的一個顯著特點是採用無抗生素的生產工藝，確保了更高的安全性。該疫苗還獲得了世界衞生組織的認可，確認其與現有疫苗的可互換性，便於其納入國家免疫接種計劃。GC Biopharma 旨在通過這一批准擴大其市場影響力</p>

<p><em>- First regulatory clearance in Latin America marks a strategic milestone for regional market expansion</em> <em>- World's first antibiotic-free manufacturing process ensures superior safety profile</em></p>
<div class="lb-trans"><p><em>- 拉丁美洲首次獲得監管批准標誌着區域市場擴展的戰略里程碑</em> <em>- 世界首個無抗生素製造工藝確保了卓越的安全性</em></p>
</div><p>, /PRNewswire/ -- GC Biopharma(006280.KS), a leading provider of biopharmaceutical products in South Korea, announced today that its varicella vaccine, BARYCELA Inj., has been granted marketing authorization from the Ministry of Public Health and Social Assistance (Ministerio de Salud Pública y Asistencia Social) of Guatemala. This approval marks a significant milestone as the first regulatory clearance for BARYCELA Inj. in the Latin American region, paving the way for expanded access to high-quality immunization across neighboring markets.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- GC Biopharma(006280.KS)，韓國領先的生物製藥產品供應商，今天宣佈其水痘疫苗 BARYCELA Inj. 已獲得危地馬拉公共衞生與社會援助部（Ministerio de Salud Pública y Asistencia Social）的市場授權。這一批准標誌着 BARYCELA Inj. 在拉丁美洲地區獲得的首個監管許可，為鄰近市場提供高質量免疫接種鋪平了道路。</p>
</div><p>BARYCELA Inj. is a live attenuated vaccine developed using GC Biopharma's proprietary MAV/06 strain. Distinguishing itself from conventional vaccines, BARYCELA Inj. is the world's first varicella vaccine manufactured through an entirely antibiotic-free process. By eliminating the use of antibiotics—such as kanamycin, neomycin, and erythromycin—during production, the vaccine fundamentally prevents potential adverse reactions associated with antibiotic residues, ensuring an enhanced safety profile for pediatric populations.</p>
<div class="lb-trans"><p>BARYCELA Inj. 是一種活疫苗，採用 GC Biopharma 的專有 MAV/06 菌株開發。與傳統疫苗不同，BARYCELA Inj. 是全球首個通過完全無抗生素工藝製造的水痘疫苗。通過在生產過程中消除使用抗生素（如卡那黴素、新黴素和紅黴素），該疫苗從根本上防止了與抗生素殘留相關的潛在不良反應，確保了兒童羣體的安全性。</p>
</div><p>Furthermore, with its recent inclusion in the World Health Organization (WHO) position paper, BARYCELA inj. has been officially recognized for its interchangeability with existing vaccines based on the Oka strain. This official endorsement significantly broadens the clinical utility of BARYCELA Inj. in global markets, allowing for seamless integration into diverse national immunization programs. Leveraging its validated product profile, GC Biopharma intends to accelerate its penetration into both international procurement agencies and individual private markets.</p>
<div class="lb-trans"><p>此外，BARYCELA Inj. 最近被納入世界衞生組織（WHO）立場文件，正式被認可為與基於 Oka 菌株的現有疫苗具有可互換性。這一官方認可顯著拓寬了 BARYCELA Inj. 在全球市場的臨牀應用，使其能夠無縫融入多樣化的國家免疫接種計劃。憑藉其經過驗證的產品特性，GC Biopharma 打算加速進入國際採購機構和個體私營市場。</p>
</div><p>&#34;Securing this first marketing authorization in Latin America is a testament to the global competitiveness of our vaccine technology,&#34; Jae Woo Lee, Head of the Regulatory Science &amp; Product Development at GC Biopharma. &#34;We are committed to strengthening our position in the global market by providing a differentiated and safer preventive solution to healthcare systems worldwide.&#34;</p>
<div class="lb-trans"><p>&#34;在拉丁美洲獲得首個市場授權是我們疫苗技術全球競爭力的證明，&#34; GC Biopharma 監管科學與產品開發負責人 Jae Woo Lee 表示。&#34;我們致力於通過提供差異化和更安全的預防解決方案來加強我們在全球市場的地位。&#34;</p>
</div><p><strong>About GC Biopharma</strong></p>
<div class="lb-trans"><p><strong>關於 GC Biopharma</strong></p>
</div><p>GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo®(intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&amp;D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&amp;I (Immunology &amp; Inflammation). To learn more about the company, visit https://www.gcbiopharma.com/eng/</p>
<div class="lb-trans"><p>GC Biopharma（前稱綠十字公司）是一家總部位於韓國龍仁的生物製藥公司。該公司在血漿衍生物和疫苗的開發與製造方面擁有超過半個世紀的經驗，並通過成功進入美國市場的 Alyglo®（靜脈免疫球蛋白 G）於 2024 年擴大其全球影響力。為了滿足未來醫療的需求，GC Biopharma 繼續通過利用其在蛋白質、mRNA 和脂質納米顆粒（LNP）藥物遞送平台的核心研發能力推動創新，開發針對罕見疾病以及免疫學與炎症（I&amp;I）領域的治療方案。欲瞭解更多信息，請訪問 https://www.gcbiopharma.com/eng/</p>
</div><p><em>This press release may contain</em> biopharmaceuticals <em>in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule.</em></p>
<div class="lb-trans"><p><em>本新聞稿可能包含</em> 生物製藥 <em>的前瞻性聲明，表達了 GC Biopharma 管理層當前的信念和期望。這些聲明並不代表 GC Biopharma 或其管理層對未來表現的任何保證，並涉及已知和未知的風險、不確定性及其他因素。除法律或證券交易所規則要求外，GC Biopharma 不承擔更新或修訂本新聞稿中包含的任何前瞻性聲明或其可能做出的任何其他前瞻性聲明的義務。</em></p>
</div><p><strong>GC Biopharma Contacts (Media)</strong></p>
<div class="lb-trans"><p><strong>GC Biopharma 媒體聯繫人</strong></p>
</div><p>Sohee Kim</p>
<div class="lb-trans"><p>金素希</p>
</div><p>[email protected]</p>
<div class="lb-trans"><p>[email protected]</p>
</div><p>Yelin Jun</p>
<div class="lb-trans"><p>尹藝琳</p>
</div><p>[email protected]</p>
<div class="lb-trans"><p>[email protected]</p>
</div><p>Yoonjae Na</p>
<div class="lb-trans"><p>南允宰</p>
</div><p>[email protected]</p>
<div class="lb-trans"><p>[email protected]</p>
</div><p>SOURCE GC Biopharma</p>
<div class="lb-trans"><p>來源 GC Biopharma</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzI2Jk5ld3NJdGVtSWQ9Q04xOTk4NCZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMjYwMjIzUFJfTkVXU19VU1BSX19fX19DTjE5OTg0" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=CN19984&amp;Transmission_Id=202603260223PR_NEWS_USPR_____CN19984&amp;DateId=20260326"/></p>

02:23 ETGC Biopharma Receives Marketing Authorization for Varicella Vaccine 'BARYCELA Inj.' in Guatemala

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ETGC Biopharma 在危地馬拉獲得了水痘疫苗'BARYCELA Inj.'的銷售授權