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2026. 05. 11

[PR] GCCL Supports Clinical Trial Analysis for CuroCell’s CAR-T Therapy "RIMQARTO®"

GCCL Supports Clinical Trial Analysis for CuroCell’s CAR-T Therapy "RIMQARTO®" Product ApprovalGlobal clinical trial sample analysis organization 'GCCL' announced on May 8 that it contributed to the development of advanced biopharmaceuticals in Korea by providing integrated bioanalysis and central laboratory services for the key clinical trials underpinning the Ministry of Food and Drug Safety’s approval process for the CAR-T therapy "RIMQARTO® (Anvalcaptagene Autoleucel)" developed by CuroCell.RIMQARTO® is the first CAR-T therapy developed in Korea and has been designated as an orphan drug for adult patients with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) who have relapsed or are refractory after two or more prior systemic treatments. The product approval is significant as it marks the entry of a domestically developed CAR-T therapy into the commercial stage, and is considered a major achievement that demonstrates Korea’s capabilities in cell and gene therapy development. In particular, by establishing a domestic production and supply base for CAR-T therapies—a field previously reliant on imported products—it is expected to improve treatment accessibility for patients with difficult-to-treat blood cancers.GCCL participated in Rimqarto's pivotal clinical trial, "CRC01-01," providing integrated bioanalysis and central laboratory services. From method development and validation to clinical sample analysis, sample logistics, and project management, GCCL managed the entire process, reliably generating and administering clinical analysis data used to evaluate the safety and efficacy of the therapy. This contributed to enhancing the quality and completeness of the pivotal clinical trials that formed the basis for product approval.Clinical trials for CAR-T therapies require comprehensive evaluation of immune responses, cellular immunity, pharmacodynamic effects, persistence at the genetic level, and safety indicators, demanding a high degree of analytical sensitivity, reproducibility, and quality control. Leveraging a variety of analytical platforms and its experience in immunoassays, GCCL supported immune response and biomarker assessments, thereby demonstrating its capabilities in clinical development of CAR-T therapies. Notably, clinical trials for cell and gene therapies often involve more complex interconnections among sample types, analytical parameters, processing conditions, and requirements for transport and storage compared to traditional anticancer drug trials, making robust sample management expertise as important as analytical proficiency. As a central laboratory, GCCL systematically managed the entire process from collection, transport, and storage to preprocessing and analysis linkage of clinical samples gathered from multiple institutions nationwide, ensuring the stable acquisition of reliable clinical analysis data even in complex multi-center clinical trial environments.Building on its prior experience supporting pivotal clinical trial analyses for major domestic vaccine development projects, GCCL once again demonstrated its capabilities as a clinical analysis partner supporting advanced biopharmaceutical development by providing integrated bioanalysis and central laboratory services for this CAR-T therapy approval trial. Additionally, GCCL is expanding its experience in supporting clinical development of CAR-T therapies by continuing to provide analytical services for follow-up trials of the same drug targeting adult B-cell acute lymphoblastic leukemia (ALL).Kwan Goo Cho, CEO of GCCL, stated, "It is deeply meaningful to participate as a clinical trial analysis partner in the milestone of obtaining Korea's first CAR-T therapy product approval," adding, "We will continue to actively support new drug development in cell and gene therapies, anticancer agents, and biopharmaceuticals by leveraging our global-level analytical infrastructure and quality management systems."

2026. 04. 06

[PR] GCCL signs vaccine research partnership with VisMederi at World Vaccine Congress 2026

GCCL said Friday it has signed a memorandum of understanding (MOU) with Italian pharmaceutical firm VisMederi to collaborate on vaccine development research at the World Vaccine Congress 2026 in Washington, D.C.The two companies agreed to explore joint projects across multiple stages of development, including research on vaccine candidates targeting high-risk pathogens. They will also cooperate in areas such as joint marketing and operational support, GCCL said.The partnership will expand support for global vaccine development projects, including responses to infectious diseases and pandemics, leveraging the companies’ biosafety level 2 and 3 (BL2–3) research facilities and analytical capabilities.Alessandro Manenti, Chief Development Officer (CDO) of VisMederi, said the agreement marks “an important milestone” in strengthening collaboration in the global vaccine market, based on the companies’ combined expertise and networks.“We anticipate new collaborative opportunities across various markets with GCCL and are committed to expanding our joint efforts to support vaccine development projects,” he said.GCCL CEO Cho Kwan-gu said vaccine development requires a strong understanding of regional regulations and operational environments, as well as reliable analytical support.“This agreement strengthens our foundation for global cooperation in responding to emerging variants and future pandemics,” Cho said. “We will continue leveraging both companies’ expertise and networks to provide systematic and reliable services to vaccine development partners worldwide.”출처 : KBR(https://www.koreabiomed.com)

2026. 03. 25

[PR] GCCL Showcases RSV FRNT Research and Integrated Bioanalytical Capabilities at WVC

GCCL Showcases RSV FRNT Research and Integrated Bioanalytical Capabilities at World Vaccine Congress 2026GCCL Co., Ltd. (GCCL), a global clinical trial laboratory services provider, announced that it will attend World Vaccine Congress 2026 (WVC 2026), taking place from March 30 to April 2 in Washington, D.C., where it will operate an exhibition booth and present a poster featuring its latest research findings.At the event, GCCL will present a poster on the development and optimization of a Focus Reduction Neutralization Test (FRNT) assay for evaluating neutralizing antibody titers against Respiratory Syncytial Virus (RSV).According to GCCL's research team led by Dr. Jaewook Hyeon, GCCL established an automated FRNT analytical platform to address limitations of conventional neutralizing antibody assays by enabling automated, instrument-based detection of infection signals and quantitative interpretation of results. The assay performance was evaluated using the WHO International Standard and the licensed monoclonal antibody therapy palivizumab (Synagis®). GCCL expects the platform to support key stages of RSV vaccine and therapeutic development, including candidate screening, efficacy evaluation, and clinical immunogenicity assessment.By establishing an FRNT-based analytical platform in an area where commercial testing infrastructure remains limited and reliance on a limited number of specialized global CROs remains high, GCCL aims to broaden access to high-quality neutralizing antibody testing for vaccine and therapeutic developers worldwide. The company expects this capability to help clients secure more reliable immunogenicity assessment data and support development timelines with greater flexibility.During WVC 2026, GCCL will also operate a dedicated exhibition booth to showcase its integrated clinical trial sample analysis and assay development capabilities for vaccine and therapeutic development. The company plans to actively explore business collaboration opportunities through meetings with global vaccine and pharmaceutical companies attending the event.Commenting on the company's participation, Kwan Goo Cho, CEO of GCCL, said, "Leveraging the analytical capabilities required throughout vaccine and therapeutic development, GCCL will continue expanding discussions with global partners on joint projects and service collaborations, with the goal of translating these opportunities into tangible business outcomes. Through our exhibition booth and poster presentation, we will further refine our ability to address the analytical needs of global clients and strengthen the foundation for long-term partnerships as as trusted lab partner for vaccine and therapeutic development worldwide."

2026. 03. 13

[PR] GCCL Signs Strategic MOU with KBIOHealth New Drug Development Center

GCCL Signs Strategic MOU with KBIOHealth New Drug Development Center to Strengthen Linkages Across the Drug Development Ecosystem▶ The two organizations will collaborate on joint national R&D projects, research initiatives, and network infrastructure supportGCCL Co., Ltd. (GCCL), a global clinical trial laboratory services provider, announced on the 13th that it signed a memorandum of understanding (MOU) with the New Drug Development Center of the Osong Medical Innovation Foundation (hereinafter “KBIOHealth”) on March 12 to contribute to the advancement of clinical research and the pharmaceutical industry.The signing ceremony was held at GCCL headquarters and attended by key representatives from both organizations, including Hye Jung Han, Center Director of the KBIOHealth New Drug Development Center, and Kwan Goo Cho, CEO of GCCL. During the ceremony, the two parties reaffirmed their commitment to collaboration and discussed ways to establish a practical linkage structure between drug development R&D and the clinical trial sample analysis industry, enabling research outcomes generated through public research infrastructure to be seamlessly advanced into the clinical stage.Through this MOU, the two organizations plan to cooperate in various areas, including: ▲ strengthening linkages between Korea’s clinical trial sample analysis industry and the drug development ecosystem, ▲ collaboration on national R&D projects and joint research initiatives, ▲ exchange of technologies, academic expertise, and professional talent through the co-planning and operation of educational programs, ▲ joint marketing activities such as exhibitions, seminars, and promotional initiatives, and ▲ sharing and utilizing domestic and global networks, infrastructure, and resources.In particular, this agreement goes beyond a simple institutional partnership and focuses on enhancing the practical competitiveness of Korea’s drug development ecosystem by combining public research infrastructure with industrial execution capabilities in analysis services. By integrating the KBIOHealth New Drug Development Center’s public research infrastructure with GCCL’s expertise in clinical trial sample analysis and project execution, the two organizations aim to establish an organically connected, step-by-step support framework that ensures technologies accumulated in the R&D stage can be reliably implemented in clinical trials.Hyejung Han, Center Director of the KBIOHealth New Drug Development Center, said, “This agreement will serve as a meaningful opportunity to promote the practical application of domestic research outcomes and strengthen industrial competitiveness by linking drug development support infrastructure with specialized clinical trial analysis capabilities. We will continue to expand cooperation with a wide range of industry partners to help revitalize Korea’s new drug development ecosystem.”Kwan Goo Cho, CEO of GCCL, said, “Clinical trial sample analysis should go beyond simply performing tests and serve as a strategic partner throughout the drug development process. Collaboration with a public drug development support institution presents an important opportunity to further strengthen the research foundation of Korea’s pharmaceutical and biotech industry. Through our partnership with the KBIOHealth New Drug Development Center, GCCL will support domestic R&D achievements in gaining global clinical competitiveness.”Meanwhile, the KBIOHealth New Drug Development Center is a public institution under the Ministry of Health and Welfare that supports the development of biopharmaceutical innovations by industry, academia, research institutes, and hospitals through world-class infrastructure. In particular, it focuses on providing early-stage development support for antibody therapeutics, recombinant protein therapeutics, cell and gene therapies, and vaccines.GCCL, a subsidiary of the GC Group, is a leading total solution provider for clinical trial sample analysis, offering an integrated "one-stop lab solution" with central, bioanalysis, and BSL-3 labs under a single system. With tailored solutions, GCCL delivers precise and efficient analytical services across all phases of clinical trials, solidifying its position as a trusted partner in new drug development. Leveraging advanced platforms and LIMS, the company supports partners across APAC and beyond with customized and compliant solutions. In recognition of its leadership, GCCL recently received Frost & Sullivan's 2025 Best Practices Customer Value Leadership Award in the Asia-Pacific clinical sample analysis services industry.

2026. 02. 25

[PR] GCCL Signs MOU with KIMCo Foundation to Support Clinical Research for Bio Ventures

GCCL Signs MOU with KIMCo Foundation to Support Clinical Research for Bio VenturesGCCL Co., Ltd. (GCCL), a global clinical trial laboratory services provider, announced on the 25th that it signed a memorandum of understanding (MOU) with the Korea Innovative Medicines Consortium (hereinafter “KIMCo Foundation") on the 24th to support clinical research and regulatory readiness for early-stage biotech ventures.This agreement was established to strengthen the research competitiveness of Korea’s pharmaceutical and biotech industry and support tangible drug development outcomes by linking GCCL’s clinical trial sample analysis and research support capabilities with KIMCo Foundation’s initiatives to build a collaborative ecosystem for innovative drug development and to advance its K-Bio company builder program.Through this MOU, the two organizations plan to collaborate in a wide range of areas, including: ▲ cooperation for company building of bio ventures invested in and fostered by KIMCo, ▲ collaboration on national R&D projects and joint research initiatives, ▲ exchange of technology, academic expertise, and professional talent through the joint planning and operation of educational programs, ▲ joint marketing activities such as exhibitions, seminars, and promotional initiatives, and ▲ cooperation in sharing and utilizing domestic and global networks, infrastructure, and resources.This agreement is especially meaningful in that it presents a collaborative model capable of organically linking the clinical research and analytical infrastructure needed across the entire drug development lifecycle, from early-stage bio ventures to the clinical stage. In particular, for early-stage bio ventures invested in and supported by KIMCo Foundation, the two organizations plan to establish a collaborative support model that provides professional assistance necessary for clinical entry and research execution, including joint biomarker discovery, customized assay development, and clinical design consulting, thereby helping generate outcomes with global competitiveness. In addition, they plan to provide regulatory consulting support aimed at improving IND success rates for biotech companies preparing clinical trials for regulatory approval.Kyung Hwa Huh, CEO of KIMCo Foundation, said, “This agreement is significant in that it establishes a foundation through which bio ventures pursuing innovative drug development can receive practical support at the clinical research stage, including biomarker discovery and assay development. Through our collaboration with GCCL, we will continue to expand effective partnership models that connect research sites with industry.”Kwan Goo Cho, CEO of GCCL, said, “This agreement with KIMCo Foundation marks an important starting point for cooperation to support the innovative growth of Korea’s pharmaceutical and biotech industry. Based on GCCL’s accumulated expertise and global execution experience in clinical trial sample analysis, we will contribute to increasing the likelihood of successful drug development for domestic bio ventures and pharmaceutical companies.”Meanwhile, KIMCo Foundation is an industry-led open innovation platform established in 2020 through the joint contribution of 59 domestic pharmaceutical companies and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. By bringing together the industry’s capabilities and resources, the foundation is driving innovative growth. Through company-building programs that include investment and technical support for promising bio startups, mentoring and consulting by pharmaceutical and biotech experts, and support for global commercialization, KIMCo Foundation is contributing to strengthening the competitiveness of Korea’s bio industry.GCCL, a subsidiary of the GC Group, is a leading total solution provider for clinical trial sample analysis, offering an integrated "one-stop lab solution" with central, bioanalysis, and BSL-3 labs under a single system. With tailored solutions, GCCL delivers precise and efficient analytical services across all phases of clinical trials, solidifying its position as a trusted partner in new drug development. Leveraging advanced platforms and LIMS, the company supports partners across APAC and beyond with customized and compliant solutions. In recognition of its leadership, GCCL recently received Frost & Sullivan's 2025 Best Practices Customer Value Leadership Award in the Asia-Pacific clinical sample analysis services industry.

2026. 02. 10

GCCL and Medicover Integrated Clinical Services Announce Strategic Collaboration

GCCL and Medicover Integrated Clinical Services Announce Strategic Collaboration to Strengthen Multinational Clinical Trial Services[February 10, 2026] GCCL Co., Ltd. (GCCL), a data-driven clinical trial services provider, and Medicover Integrated Clinical Services (MICS), part of Medicover, an international healthcare and diagnostic services company, have signed a Memorandum of Understanding (MOU) to collaborate on multinational clinical trial services.Through this MOU, the two companies aim to establish a collaborative framework covering Europe, the United States, and the Asia-Pacific (APAC) region. By leveraging their respective experience in clinical trial operations and client communications across key regions, the partnership seeks to enhance cross-regional communication efficiency and improve operational stability in global clinical trial projects.Key areas of collaboration under the MOU include clinical trial operations and sample analysis collaboration across regions; project management support and coordinated client communication by region; joint marketing collaboration; joint client development and market expansion; and the enhancement of service competitiveness through test item alignment and improved analytical efficiency.By combining MICS’s extensive experience and network in Europe and the U.S. with GCCL’s specialized analytical capabilities and project management expertise in the APAC region, the two companies expect to offer a more seamlessly connected and optimized environment for multinational clinical trial operations and analysis.“This agreement represents an important opportunity to effectively combine the expertise and customer bases of both organizations and further strengthen the global clinical trial ecosystem,” said Łukasz Hubisz, General Manager of MICS. “Through our collaboration with GCCL, we aim to strengthen communication with clients in Asia and support the smoother execution of global clinical trial projects.”Kwan Goo Cho, CEO of GCCL, added, “This partnership marks an important first step in reinforcing clinical collaboration between Europe and Asia. Through our strategic cooperation with MICS, we aim to set new standards for global clinical trial execution and deliver meaningful analytical outcomes for our clients.”About GCCLGCCL, a subsidiary of the GC Group, is a leading total solution provider for clinical trial sample analysis, offering an integrated “one-stop lab solution” with central, bioanalysis, and BSL-3 labs under a single system. With tailored solutions, GCCL delivers precise and efficient analytical services across all phases of clinical trials, solidifying its position as a trusted partner in new drug development. Leveraging advanced platforms and LIMS, the company supports partners across Asia and beyond with customized and compliant solutions. In recognition of its leadership, GCCL recently received Frost & Sullivan’s 2025 Best Practices Customer Value Leadership Award in the Asia-Pacific clinical sample analysis services industry. For more details, visit: www.eng.gccl.co.kr.About Medicover Integrated Clinical Services (MICS)Medicover Integrated Clinical Services (MICS) is a strategic business organization of Medicover Diagnostic Services that supports the development and commercialization of innovative therapies and medicines. MICS focuses on clinical applications and clients from pharmaceuticals, diagnostics, biopharma, biotech, medtech and contract research organizations (CROs). MICS’ activities are organized along discrete service lines: Central Laboratory Services, Site Management Organization, Precision Medicine. MICS has been providing bespoke services to clients and their patients for over 20 years, making strategic use of Medicover assets, including laboratories with state-of-the-art diagnostic equipment, medical clinics and hospitals, as well as the vast expertise and enthusiasm of a global workforce. For more details, visit:: Medicover MICS.*The full press release was distributed via PR Newswire and is available at the link below: https://www.prnewswire.com/news-releases/gccl-and-medicover-integrated-clinical-services-announce-strategic-collaboration-to-strengthen-multinational-clinical-trial-services-302683542.html

2026. 01. 15

GCCL and OPIS Announce Strategic Collaboration to Advance Global Clinical Trial Capabilities

GCCL and OPIS Announce Strategic Collaboration to Advance Global Clinical Trial Capabilities[January 14, 2026] GCCL, a leading South Korea-based provider of clinical trial sample analysis, and OPIS, a global full-service contract research organization (CRO), have signed a Memorandum of Understanding (MOU) on the sidelines of the 44th Annual J.P. Morgan Healthcare Conference 2026 in San Francisco, USA, to expand their collaboration and strengthen their position in the global clinical trial market.With the rising proportion of multinational clinical trials, sponsors face varying regulatory requirements, clinical environments, and data demands across regions, driving growing demand for tailored CRO services. GCCL and OPIS will address these needs by combining their expertise to deliver integrated solutions that optimize clinical trial planning, sample analysis, and data management, offering comprehensive and customized services for biopharmaceutical companies in Europe and Asia.At the signing ceremony, representatives from both companies discussed establishing a collaborative framework across multiple areas, including joint global clinical trial services, conducting joint projects, development of new business opportunities, and additional initiatives.Through this collaboration, GCCL aims to expand strategic partnerships with global CROs and research organizations, strengthen its capability to deliver fully integrated clinical trial solutions across Asia, Europe, and the Americas, and extend tailored services to a broader range of biopharmaceutical companies.Commenting on the partnership, Giovanni Trolese, Vice President at OPIS, said, “This collaboration combines OPIS’s Europe-focused global network with GCCL’s clinical trial analysis expertise, creating a significant opportunity to deliver integrated and efficient clinical trial services to clients. We look forward to further expanding the global clinical trial network and continuously enhancing client-focused, innovative solutions through our close collaboration with GCCL.”KwanGoo Cho, CEO of GCCL, added, “This MOU represents more than a partnership; it is a strategic collaboration to deliver optimized clinical trial solutions for global biopharmaceutical companies. By leveraging our close cooperation, we aim to maximize operational efficiency and provide tailored solutions to a diverse range of sponsors, generating tangible business synergies.”About GCCLGCCL, a subsidiary of the GC Group, is a leading clinical trial sample analysis provider offering an integrated “one-stop lab solution” with central, bioanalysis, and BSL-3 labs under one system. With tailored solutions, GCCL delivers precise and efficient analytical services across all phases of clinical trials, solidifying its position as a trusted partner in new drug development. Leveraging advanced platforms and LIMS, the company supports partners across Asia and beyond with customized and compliant solutions. In recognition of its leadership, GCCL recently received Frost & Sullivan’s 2025 Best Practices Customer Value Leadership Award in the Asia-Pacific clinical sample analysis services industry. For more details, visit: www.eng.gccl.co.kr.About OPISOPIS was founded in 1998 by medical doctors from the Pharma Industry and is a global clinical CRO with 26 years of experience in a wide range of therapeutic areas. OPIS provides full-service, 360° clinical trial support from study concept creation and protocol development to full project execution, study data handling, and up to study closure, analysis, and reporting. OPIS manages Phase I-IV, interventional, non-interventional, and medical device studies on an international level. OPIS is committed to continuous growth and expansion, and currently has affiliates in 18 countries around the world. For more details, visit: www.opisresearch.com

2025. 12. 19

GCCL: An Integrated All-in-One Lab Partner for Multinational Clinical Trials

*Life Sciences Review / December 18, 2025 - https://cro-apac.lifesciencesreviewapac.com/vp/-gccl/gccl:_an_integrated_all-in-one_lab_partner_for_multinational_clinical_trialsGCCL: An Integrated All-in-One Lab Partner for Multinational Clinical TrialsAs global clinical pipelines continue to expand in complexity, biopharmaceutical companies face rising demands for reliable, high-quality, and scientifically aligned clinical sample analysis across multiple regions. Many sponsors now seek central lab partners capable of unifying workflows that traditionally operate in silos, from kit production to bioanalysis and data reporting. GCCL, strategically based in Korea, has emerged as a preferred Asia-Pacific (APAC) hub for multinational trials by offering a fully integrated approach to clinical sample analysis that connects central lab operations, bioanalysis, R&D-driven method development, and controlled logistics within a single unified system.With experience supporting more than 1,200 clinical projects since 2019 and managing over 34,000 vials each month, GCCL has become a trusted analytical partner for global drug development programs seeking consistency, scientific depth, and operational reliability.Integrated Lab Operations Built for Global TrialsGCCL’s all-in-one model is designed to consolidate functions that are often divided across multiple vendors in multinational studies. The central laboratory supports full clinical safety testing and sample management for all clinical phases, offering comprehensive diagnostic coverage for global trials. The bioanalytical laboratory specializes in PK/PD, ADA, NAb, and biomarker analysis, utilizing advanced platforms such as LBA, LC-MS/MS, and ddPCR. GCCL also operates a BSL-3 facility that enables high-risk infectious disease studies, including PRNT/FRNT and specialized virology assays.All of these services function within a coordinated system, ensuring that sample handling, analysis, and reporting adhere to consistent standard operating procedures (SOPs) across all study regions. This unified framework enables sponsors to minimize variability, shorten timelines, and maintain a single source of truth for trial data across the APAC, North America, and Europe.R&D-Backed Scientific Expertise for Next-Generation ModalitiesGCCL’s R&D Lab strengthens its service model by providing targeted, study-specific scientific support. Lab experts develop and validate customized assays that reflect the biology of each therapeutic modality, from CNS biomarkers to oncology endpoints and metabolic disease markers. Recent collaborations include CNS biomarker method development for neurodegenerative disease programs, highlighting GCCL’s capacity to support emerging therapeutic areas with targeted scientific rigor.Unlike laboratories that provide standardized menus, GCCL emphasizes tailored scientific consultation. Lab experts work directly with sponsors from early-stage planning through database lock, helping refine assay design, sample requirements, technology selection, and biomarker strategy aligned with regulatory expectations. This close and continuous scientific involvement is often cited by sponsors as a key differentiator from large, compartmentalized global labs.Recent R&D achievements include CNS biomarker method development for neurodegenerative disease programs and analytical advances supporting biosimilar, infectious disease, and gene-therapy-related studies.Controlled Kit Production and Bio-Logistics That Protect Sample IntegrityPre-analytical variation is one of the biggest risks in multinational clinical trials. To address this, GCCL manages its own kit production based on protocol-specific requirements and oversees outbound and inbound logistics using validated bio-logistics processes. This includes a nationwide cold-chain network with dedicated drivers and partnership with verified global shipping vendors.These capabilities decrease variability in sample collection and transportation, ensuring that the biological integrity is maintained from the collection site to the laboratory. The system is further enhanced by G-HUB, GCCL’s integrated IT platform for study setup, kit tracking, sample status visibility, and laboratory data review. With real-time sample tracking and centralized oversight, sponsors gain transparency throughout the entire workflow. This level of control reduces delays, minimizes sample loss, and ensures consistency across all participating regions.Consistent Quality Aligned With International StandardsGCCL’s operations are built on globally recognized clinical quality frameworks. Its GCLP-certified laboratories maintain strict quality control, traceability, and audit-ready documentation that meet FDA, EMA, and ICH M10 expectations. The combination of validated platforms, unified workflows, and cross-functional alignment ensures that analytical outputs remain consistent across study phases, endpoints, and regions.With more than 200 method validation and analysis cases across PK/PD, ADA, and NAb studies, GCCL has demonstrated proficiency in delivering compliant, regulator-ready data for both early-phase programs and late-phase global trials.Analytical Expertise Across Therapeutic AreasGCCL offers specialized analytical support across a variety of therapeutic areas, including oncology, central nervous system (CNS) diseases, infectious diseases, metabolic disorders such as metabolic dysfunction-associated steatohepatitis (MASH) and obesity, biosimilars, antibody-drug conjugates (ADCs), as well as cell and gene therapies. For each indication, GCCL utilizes appropriate analytical techniques and develops customized methods supported by advanced technology and clinical trial experience. GCCL also has a strong capability in infectious diseases, backed by a BSL-3 facility and advanced molecular platforms that enable it to meet global demands for virology and pathogen analysis.This extensive expertise allows sponsors to consolidate multiple analytical endpoints with a single partner, thereby reducing operational complexity and accelerating decision-making.A Strategic APAC Hub Built for Speed and ConnectivityStrategically located near Seoul, Korea, GCCL benefits from the region’s strong clinical research ecosystem, rapid patient recruitment environment, and proximity to CROs, hospitals, and pharmaceutical hubs. With streamlined logistics through major international airports, GCCL ensures fast and reliable sample transport across borders.This environment has made Korea a preferred destination for global sponsors using Dual-Region Trial Setups, where early-phase studies are conducted in the US or Europe and patient enrollment and cost-efficient bioanalysis are executed in Korea. Through this model, GCCL helps sponsors accelerate timelines, optimize budgets, and maintain scientific and operational consistency across regions.Leveraging integrated operations, deep laboratory expertise, and experience managing thousands of sample shipments each month, GCCL provides sponsors with the reliability and scalability required for high-quality, multi-region clinical execution.Advancing Global Clinical Research With Integrated Lab SolutionsAs modern drug development increasingly depends on harmonized analytical systems capable of supporting complex modalities, GCCL continues to strengthen its position as a global clinical sample analysis CRO. Its unified central lab, bioanalytical capabilities, R&D-driven method development, controlled kit production, and validated logistics create a complete infrastructure designed to minimize variability and maximize scientific reliability.With proven execution across more than 1,200 studies and a commitment to providing tailored, regulator-aligned analytical solutions, GCCL offers global sponsors the consistency, speed, and scientific depth required to advance innovative therapeutics across North America, Europe, and APAC.

2025. 10. 30

GCCL Highlights the Rise of “K-Lab,” Sets Its Sights Beyond Korea to the Global Stage

GCCL Highlights the Rise of “K-Lab,” Sets Its Sights Beyond Korea to the Global Stage| Interview | Choi Yu-hwa, Head of Business Operations, GCCLKorea’s No.1 Clinical Sample Analysis Provider Joins KoNECT Korean Delegation“More Efficiently Positioned Than Singapore… Aiming to Become Asia’s Leading Lab”[Berlin | ESMO 2025 – Reported by Byung-woo Hwang] GCCL, a leading Korean clinical sample analysis company, showcased its competitiveness on the global stage at the European Society for Medical Oncology (ESMO 2025).Participating as part of the Korean delegation organized by the Korea National Enterprise for Clinical Trials (KoNECT), GCCL is actively expanding its presence beyond the domestic market and into international territories.“One of the most memorable reactions we heard at ESMO 2025 was, ‘We didn’t know there was such a high-level analytical lab in Korea,’” said Choi Yu-hwa, Head of Business Operations at GCCL, in an interview with DailyPharm. “We wanted to demonstrate that global clinical sample analysis can be performed not only in Singapore or Europe, but also in Korea.”“Korea’s Leading Clinical Sample Analysis Lab Begins Its Global Challenge”▲ Choi Yu-hwa, Head of Business Operations, GCCLGCCL is a specialized clinical sample analysis company under the Green Cross Holdings group and currently holds the No.1 market share in Korea’s clinical sample analysis sector.The company provides PK (pharmacokinetics), PD (pharmacodynamics), ADA, biomarker analysis, and central laboratory services across all phases of clinical trials, from Phase 1 through Phase 4.In particular, GCCL operates a dedicated bioanalytical laboratory, supporting early-phase trials with drug concentration and metabolism data, and late-phase trials with large-scale quantitative and qualitative patient data management. All analytical outputs are delivered in compliance with global regulatory standards.“Within Korea, GCCL is unquestionably the leading lab CRO in terms of technology, infrastructure, and talent,” Choi said. “Now, our goal is to expand into overseas sample analysis and establish GCCL as a central player in global clinical trials.”The company has already been building global awareness through continuous participation in major international conferences, including BIO Europe, ASCO, and BIO USA.“Earlier this year, we often heard people ask, ‘Why did you come all the way from Korea?’” Choi noted. “Now, as we meet the same industry professionals repeatedly at different events, more people recognize GCCL and are familiar with our capabilities.”Choi identified GCCL’s core strengths as technical expertise, geopolitical positioning, and experience gained during the COVID-19 pandemic.“Korea is known for its highly skilled technicians and exceptional technical precision,” she explained. “In clinical sample analysis, this level of craftsmanship directly translates into quality. During the COVID-19 pandemic, GCCL handled more than 30% of the sample analysis for government- and industry-led vaccine and therapeutic development projects, which significantly strengthened our R&D-driven analytical capabilities.”She also highlighted Korea’s strategic geographic location as a key advantage.“Korea is even more efficient than Singapore in terms of logistics,” Choi said. “It is ideally positioned as a hub connecting samples from Europe and North America to Asia.”Looking ahead, Choi emphasized GCCL’s long-term vision. “Our immediate goal is to establish ourselves as Asia’s representative lab CRO, and in the long run, to expand into the U.S. and European markets,” she said. “We will continue to prove that Korea is home to world-class clinical sample analysis laboratories.”Source: DailyPharm, reported by Byung-woo Hwang (https://www.dailypharm.com/Users/News/NewsView.html?ID=327934&REFERER=NP)*This article is a direct translation of an original Korean-language article prepared by GCCL.

2025. 10. 23

GCCL Targets Global Expansion, Differentiates Through Advanced Clinical Sample Analysis

GCCL Targets Global Expansion, Differentiates Through Advanced Clinical Sample Analysis[On-site Interview] Choi Yu-hwa, Head of Business Operations: “Developing Demand-Driven Assays for CNS and Beyond”GCCL, a clinical trial sample analysis company under the GC Group, is accelerating its global CRO strategy by leveraging its strong R&D capabilities in assay development. While reinforcing its position in the Asia market—traditionally centered around Singapore—the company is also stepping up efforts to expand into Western markets.The Bell met with Choi Yoo-hwa, Head of Business Operations at GCCL, to discuss the company’s global expansion strategy and recent achievements in analytical method development. Choi also serves as a member of the R&D Expert Committee under Korea’s Food and Drug Safety Regulatory Science Innovation Committee, an advisory body to the Ministry of Food and Drug Safety (MFDS).◇ IR Pitching and Networking Events Target Potential ClientsGCCL participated in BioPlus-Interphex Korea (BIX 2025) with a dedicated exhibition booth, introducing visitors to its differentiated central laboratory services and R&D-driven analytical capabilities.BIX 2025, hosted by the Korea Biotechnology Industry Organization (KoreaBIO) and organized by RX Korea, was held at COEX in Seoul from October 15 to 17. The event featured exhibitions, conferences, and partnering meetings designed to promote collaboration among domestic and international biotech companies.At this year’s event, GCCL placed a strong focus on engaging potential clients. In addition to operating its booth, the company hosted separate IR pitching and networking sessions for professionals from the pharmaceutical and investment communities. The goal was not only to promote GCCL’s services, but also to contribute to the broader growth of the biotech ecosystem.“We wanted to create an opportunity for biotech startups facing funding challenges to connect with potential investors,” Choi explained. “Despite the difficult industry environment, we were able to organize this event thanks to the strong support of the GC Group.”Founded in 2019, GCCL was established as a spin-off of the clinical trial analysis division of the Green Cross Medical Foundation. GC LabCell initially held a stake in the company, and following its merger into GC Cell in 2021, GCCL became a subsidiary of GC Cell. More than 20 years of accumulated sample analysis expertise from the Green Cross Medical Foundation now form the foundation of GCCL’s competitiveness.GC Cell currently holds a 65.45% stake in GCCL as the largest shareholder, followed by C&R Research with 25.57%. The Green Cross Medical Foundation also retains a 4.35% stake.Among CROs, GCCL places particular emphasis on its role as a central laboratory. In multicenter clinical trials, central labs integrate and analyze samples collected from multiple hospitals, ensuring consistency and reliability in analytical results and ultimately improving the credibility of clinical trial outcomes.◇ Differentiation Through R&D Lab Services: CNS and Cell Therapy Assay DevelopmentGCCL’s core competitive strength lies in its R&D laboratory services. While many central labs focus primarily on routine chemistry and hematology tests, GCCL has expanded its scope to include biomarker discovery, assay development, and validation. The company supports pharmaceutical sponsors across the entire development continuum—from biomarker identification in early research to late-stage clinical trials.“Traditionally, central labs paid limited attention to R&D,” Choi noted. “However, during the COVID-19 pandemic, central lab functions became essential for vaccine and therapeutic development. That period allowed us to accumulate significant R&D experience.”GCCL places particular emphasis on customized assay development in close collaboration with clients. In the first half of 2025, the company completed the development of analytical methods for cell therapies and CNS disease biomarkers. A representative example is the joint development of a biomarker assay with Curebus, a Korean biotech company developing novel treatments for Alzheimer’s disease.GCCL has also entered into a collaboration agreement with a major domestic pharmaceutical company to support a late-stage immuno-oncology clinical trial using a proprietary neutralizing antibody assay developed in-house.“Developing biomarker assays for Alzheimer’s disease and Parkinson’s disease is highly challenging,” Choi said. “By co-developing CNS biomarker assays with our clients, we successfully completed method development and published joint academic papers. More recently, we signed an MOU with Seoul National University’s Center for Neuropsychiatric Disease Evaluation, expanding our research scope from clinical to non-clinical stages.”Currently holding the No. 1 market share in Korea’s central lab CRO sector, GCCL’s next objective is global expansion. The company aims to firmly establish itself as a leading player in Asia while steadily extending its footprint into Western markets.Historically, Singapore has served as the hub of the Asian central lab market. However, GCCL believes that Korea’s precision technologies and analytical expertise are fully competitive on a global level, and is positioning itself to help reshape the regional market landscape.One remaining challenge is expanding experience in multinational clinical trials. While GCCL has extensive experience in domestic sample analysis, its exposure to multi-country trials remains relatively limited. To address this, the company plans to establish strategic partnerships with overseas CROs, laboratories, and clinical trial partners, positioning itself as a coordinating hub that provides integrated services across regions.“This year, we were recognized by Frost & Sullivan as a key provider of bioanalytical services in the Asia-Pacific region,” Choi said. “This recognition signifies that GCCL has entered the top tier in APAC. While Singapore has long been considered the center of the Asian central lab market, we want to demonstrate that GCCL can represent Asia as a leading central laboratory.”Source: The Bell, reported by Kim Chan-hyuk - https://www.thebell.co.kr/free/content/ArticleView.asp?key=202510161121309160108581 *This article is a direct translation of an original Korean-language article prepared by GCCL.

2025. 09. 24

[PR] GCCL and Frontage Laboratories Announce Strategic Collaboration

GCCL and Frontage Laboratories Announce Strategic Collaboration to Strengthen Global Clinical Trial Capabilities[September 24, 2025] GCCL (Global Clinical Central Lab), a South Korea-based leading provider of clinical trial sample analysis, and Frontage Laboratories, Inc., a USA based full-service contract research organization (CRO), announced on September 23 that they had signed a strategic Memorandum of Understanding (MOU) pursuant to which they intend to explore ways to strengthen their presence in the global clinical trial market.In signing the MOU, GCCL and Frontage intend to consider opportunities to leverage the complementary services and networks of both companies to enhance competitiveness, particularly in the United States and Asia-Pacific (APAC) regions, while driving mutual growth. In particular, during the signing ceremony, the two companies reaffirmed their commitment to collaboration and discussed opportunities for cooperation including joint clinical trial services in the U.S.A. and APAC regions, co-marketing and project support initiatives, development of new business opportunities, and additional initiatives.In addition, GCCL and Frontage will combine their respective regional expertise and global networks to collaborate in executing clinical trial projects while increasing efficiency and differentiation of services for clients worldwide. In doing so, GCCL would expect to further strengthen its global capabilities, while Frontage would look to bolster its clinical trial support system in the APAC region.“Through this MOU, Frontage is hoping to develop a relationship with GCCL with the goal of reinforcing its presence in the APAC market and work closely with GCCL to providing faster and more efficient support for global clinical trials,” said Dr. Nan Zhang, MD. PhD., Senior Vice President of Frontage. “By finding paths to collaborate and leverage the expertise and client networks of both companies, we would hope to further enhance the global clinical trial ecosystem and deliver high-quality, trusted services to our customers.” KwanGoo Cho, CEO of GCCL, added, “We are hoping to develop a strategic relationship with Frontage focused on a spirit of collaboration. By working together, GCCL’s bioanalytical and central lab expertise in APAC and Frontage’s global capabilities may create new growth opportunities in the global clinical trial market for both companies. As always, we continue to aim to set a new standard in clinical trial execution and deliver meaningful analytical outcomes to our clients.”About GCCL (Global Clinical Central Lab)GCCL, a subsidiary of the GC Group, is a leading clinical trial sample analysis provider offering an integrated “one-stop lab solution” with central, bioanalysis, and BSL-3 labs under one system. With tailored solutions, GCCL delivers precise and efficient analytical services across all phases of clinical trials, solidifying its position as a trusted partner in new drug development. Leveraging advanced platforms and LIMS, the company supports partners across Asia and beyond with customized and compliant solutions. In recognition of its leadership, GCCL recently received Frost & Sullivan’s 2025 Best Practices Customer Value Leadership Award in the Asia-Pacific clinical sample analysis services industry. For more details, visit: www.eng.gccl.co.kr.About Frontage Laboratories, Inc.Frontage Holdings Corp (1521.HK), together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions. For more details, visit: www.frontagelab.com.

2025. 09. 22

[PR] GCCL Signs MOU with Seoul National University’s Research Center (CLEVERcns)

GCCL Signs MOU with Seoul National University’s Research Center for Neuro-Psychiatric Disorder to Strengthen Collaboration in Clinical Research▶ Strategic partnership to advance clinical research in neuropsychiatric disorders, expand domestic and international infrastructure, and enhance global competitivenessGlobal clinical trial sample analysis organization GCCL (Global Clinical Central Lab, CEO KwanGoo Cho) announced on September 22 that it signed a Memorandum of Understanding (MOU) on September 19 with the Research Center for Neuro-Psychiatric Disorder of Seoul National University (CLEVERcns, Director Ki-Jeong Cheon) to promote mutual collaboration in clinical research on neuropsychiatric disorders and contribute to the development of the pharmaceutical industry.The MOU signing ceremony was attended by key representatives from both organizations, including CEO Kwan-Gu Cho of GCCL and Director Ki-Jeong Cheon of CLEVERcns. The parties reaffirmed their commitment to enhancing the quality of domestic neuropsychiatric clinical trials, expanding infrastructure for CNS clinical trial sample analysis, and strengthening global competitiveness.Key areas of collaboration outlined in the MOU include: ▲ Strengthening preclinical-to-clinical linkages in brain disease research, ▲ Joint development of CNS disease biomarkers and analytical methods, ▲ Collaborative operation of educational programs and exchange of technical and academic information, ▲ Joint promotion and support for “end-to-end CNS projects” and cooperation in global expansion, ▲ Sharing and utilization of domestic and international networks, infrastructure, and resources, ▲ Other areas of mutual interest as needed.CLEVERcns, a Seoul National University Hospital-affiliated center, leverages the hospital’s and university’s facilities and research infrastructure to support new drug development in neuropsychiatric disorders, providing clinical consultation and efficacy evaluation services. GCCL provides comprehensive clinical trial sample analysis services for the field and is a leader in developing CNS disease biomarkers and analytical methods.Through this collaboration, GCCL and CLEVERcns aim to generate more precise and reliable research data while providing end-to-end support from preclinical to clinical research for brain and CNS disorder studies.Director Ki-Jeong Cheon of CLEVERcns stated, “Research in neuropsychiatric disorders is highly complex and challenging, and obtaining high-quality clinical trial data is critical to the success of drug development. Through this MOU, domestic pharmaceutical and biotech companies, as well as researchers, will be able to utilize a world-class CNS clinical research environment more efficiently, contributing to the global recognition of Korea’s CNS research capabilities.”CEO KwanGoo Cho of GCCL added, “GCCL supports clinical trial success for domestic and international pharmaceutical and biotech companies by providing state-of-the-art analytical platforms and high-quality analytical services in CNS research. Our strategic collaboration with CLEVERcns represents an important step in strengthening the overall CNS research ecosystem. We will continue to prioritize data reliability and analytical quality while offering differentiated clinical trial sample analysis services in the global market.”GCCL is a fully GCLP-certified (Good Clinical Laboratory Practice) clinical trial sample analysis organization in Korea, providing tailored clinical analysis services that meet global standards across all phases of clinical trials, from Phase 1 to Phase 4. With advanced analytical platforms, including ddPCR instruments, and specialized sample analysis and method development services, GCCL supports domestic pharmaceutical and biotech companies as well as partners throughout Asia and worldwide.

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