<div id="readability-page-1"><div> <div> - First regulatory clearance in Latin America marks a strategic milestone for regional market expansion - World's first antibiotic-free manufacturing process ensures superior safety profile , /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. 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. 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. &#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; About GC Biopharma 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/ This press release may contain biopharmaceuticals 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. GC Biopharma Contacts (Media) Sohee Kim [email protected] Yelin Jun [email protected] Yoonjae Na [email protected] SOURCE GC Biopharma <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" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzI2Jk5ld3NJdGVtSWQ9Q04xOTk4NCZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMjYwMjIzUFJfTkVXU19VU1BSX19fX19DTjE5OTg0"/></div> </div></div>

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GC Biopharma has received marketing authorization for its varicella vaccine, BARYCELA Inj., from the Guatemalan Ministry of Public Health. This marks the first regulatory clearance for the vaccine in Latin America, enhancing access to immunization in the region. BARYCELA Inj. is notable for being produced through an antibiotic-free process, ensuring a superior safety profile. The vaccine has also been recognized by the WHO for its interchangeability with existing vaccines, facilitating its integration into national immunization programs. GC Biopharma aims to expand its market presence with this approval.

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