<p><em>- 拉丁美洲首次获得监管批准标志着区域市场扩展的战略里程碑</em> <em>- 世界首个无抗生素制造工艺确保了卓越的安全性</em></p>
<p>, /PRNewswire/ -- GC Biopharma(006280.KS)，韩国领先的生物制药产品供应商，今天宣布其水痘疫苗 BARYCELA Inj. 已获得危地马拉公共卫生与社会援助部（Ministerio de Salud Pública y Asistencia Social）的市场授权。这一批准标志着 BARYCELA Inj. 在拉丁美洲地区获得的首个监管许可，为邻近市场提供高质量免疫接种铺平了道路。</p>
<p>BARYCELA Inj. 是一种活疫苗，采用 GC Biopharma 的专有 MAV/06 菌株开发。与传统疫苗不同，BARYCELA Inj. 是全球首个通过完全无抗生素工艺制造的水痘疫苗。通过在生产过程中消除使用抗生素（如卡那霉素、新霉素和红霉素），该疫苗从根本上防止了与抗生素残留相关的潜在不良反应，确保了儿童群体的安全性。</p>
<p>此外，BARYCELA Inj. 最近被纳入世界卫生组织（WHO）立场文件，正式被认可为与基于 Oka 菌株的现有疫苗具有可互换性。这一官方认可显著拓宽了 BARYCELA Inj. 在全球市场的临床应用，使其能够无缝融入多样化的国家免疫接种计划。凭借其经过验证的产品特性，GC Biopharma 打算加速进入国际采购机构和个体私营市场。</p>
<p>&#34;在拉丁美洲获得首个市场授权是我们疫苗技术全球竞争力的证明，&#34; GC Biopharma 监管科学与产品开发负责人 Jae Woo Lee 表示。&#34;我们致力于通过提供差异化和更安全的预防解决方案来加强我们在全球市场的地位。&#34;</p>
<p><strong>关于 GC Biopharma</strong></p>
<p>GC Biopharma（前称绿十字公司）是一家总部位于韩国龙仁的生物制药公司。该公司在血浆衍生物和疫苗的开发与制造方面拥有超过半个世纪的经验，并通过成功进入美国市场的 Alyglo®（静脉免疫球蛋白 G）于 2024 年扩大其全球影响力。为了满足未来医疗的需求，GC Biopharma 继续通过利用其在蛋白质、mRNA 和脂质纳米颗粒（LNP）药物递送平台的核心研发能力推动创新，开发针对罕见疾病以及免疫学与炎症（I&amp;I）领域的治疗方案。欲了解更多信息，请访问 https://www.gcbiopharma.com/eng/</p>
<p><em>本新闻稿可能包含</em> 生物制药 <em>的前瞻性声明，表达了 GC Biopharma 管理层当前的信念和期望。这些声明并不代表 GC Biopharma 或其管理层对未来表现的任何保证，并涉及已知和未知的风险、不确定性及其他因素。除法律或证券交易所规则要求外，GC Biopharma 不承担更新或修订本新闻稿中包含的任何前瞻性声明或其可能做出的任何其他前瞻性声明的义务。</em></p>
<p><strong>GC Biopharma 媒体联系人</strong></p>
<p>金素希</p>
<p>[email protected]</p>
<p>尹艺琳</p>
<p>[email protected]</p>
<p>南允宰</p>
<p>[email protected]</p>
<p>来源 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>

标普生物技术 3 倍做多 - Direxion

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<p>GC Biopharma 已获得危地马拉公共卫生部对其水痘疫苗 BARYCELA Inj. 的市场授权。这标志着该疫苗在拉丁美洲获得的首个监管批准，增强了该地区的免疫接种可及性。BARYCELA Inj. 的一个显著特点是采用无抗生素的生产工艺，确保了更高的安全性。该疫苗还获得了世界卫生组织的认可，确认其与现有疫苗的可互换性，便于其纳入国家免疫接种计划。GC Biopharma 旨在通过这一批准扩大其市场影响力</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>- 拉丁美洲首次获得监管批准标志着区域市场扩展的战略里程碑</em> <em>- 世界首个无抗生素制造工艺确保了卓越的安全性</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)，韩国领先的生物制药产品供应商，今天宣布其水痘疫苗 BARYCELA Inj. 已获得危地马拉公共卫生与社会援助部（Ministerio de Salud Pública y Asistencia Social）的市场授权。这一批准标志着 BARYCELA Inj. 在拉丁美洲地区获得的首个监管许可，为邻近市场提供高质量免疫接种铺平了道路。</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. 是一种活疫苗，采用 GC Biopharma 的专有 MAV/06 菌株开发。与传统疫苗不同，BARYCELA Inj. 是全球首个通过完全无抗生素工艺制造的水痘疫苗。通过在生产过程中消除使用抗生素（如卡那霉素、新霉素和红霉素），该疫苗从根本上防止了与抗生素残留相关的潜在不良反应，确保了儿童群体的安全性。</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. 最近被纳入世界卫生组织（WHO）立场文件，正式被认可为与基于 Oka 菌株的现有疫苗具有可互换性。这一官方认可显著拓宽了 BARYCELA Inj. 在全球市场的临床应用，使其能够无缝融入多样化的国家免疫接种计划。凭借其经过验证的产品特性，GC Biopharma 打算加速进入国际采购机构和个体私营市场。</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;在拉丁美洲获得首个市场授权是我们疫苗技术全球竞争力的证明，&#34; GC Biopharma 监管科学与产品开发负责人 Jae Woo Lee 表示。&#34;我们致力于通过提供差异化和更安全的预防解决方案来加强我们在全球市场的地位。&#34;</p>
</div><p><strong>About GC Biopharma</strong></p>
<div class="lb-trans"><p><strong>关于 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（前称绿十字公司）是一家总部位于韩国龙仁的生物制药公司。该公司在血浆衍生物和疫苗的开发与制造方面拥有超过半个世纪的经验，并通过成功进入美国市场的 Alyglo®（静脉免疫球蛋白 G）于 2024 年扩大其全球影响力。为了满足未来医疗的需求，GC Biopharma 继续通过利用其在蛋白质、mRNA 和脂质纳米颗粒（LNP）药物递送平台的核心研发能力推动创新，开发针对罕见疾病以及免疫学与炎症（I&amp;I）领域的治疗方案。欲了解更多信息，请访问 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>本新闻稿可能包含</em> 生物制药 <em>的前瞻性声明，表达了 GC Biopharma 管理层当前的信念和期望。这些声明并不代表 GC Biopharma 或其管理层对未来表现的任何保证，并涉及已知和未知的风险、不确定性及其他因素。除法律或证券交易所规则要求外，GC Biopharma 不承担更新或修订本新闻稿中包含的任何前瞻性声明或其可能做出的任何其他前瞻性声明的义务。</em></p>
</div><p><strong>GC Biopharma Contacts (Media)</strong></p>
<div class="lb-trans"><p><strong>GC Biopharma 媒体联系人</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>尹艺琳</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>来源 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 在危地马拉获得了水痘疫苗'BARYCELA Inj.'的销售授权