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Hsinchu, Taiwan – August 25, 2026

GBC, a precision medicine company (TWSE: 4117), today announced that its GBC CL i120 Fully Automated Chemiluminescence Immunoassay System has recently obtained European Union In Vitro Diagnostic Medical Devices Regulation (IVDR) certification, making it the first CLIA system in GBC’s portfolio to complete the relevant EU IVDR registration process. GBC stated that the IVDR certification of the GBC CL i120 marks important progress in the regulatory readiness, product quality, and international market expansion of its next-generation automated immunoassay platform. It also establishes a solid foundation for the overseas expansion of related CLIA instruments and reagents, supporting future business growth and operational momentum.

GBC noted that the CL i120 Fully Automated Chemiluminescence Immunoassay System is one of the Group’s key platforms for developing its next-generation IVD portfolio. Designed to address the demand for automation, efficiency, and consistent testing quality among small- and medium-sized healthcare facilities, laboratories, and regional medical institutions, the platform is supported by a comprehensive range of instruments and chemiluminescence reagents covering tumor markers, thyroid function, hormones, infectious diseases, and other immunoassay applications. To date, 13 CLIA reagents have obtained medical device approvals from Taiwan’s TFDA, highlighting GBC’s continued progress in the development of its CLIA instruments and reagents, as well as its regulatory strategy. As additional reagent products receive regulatory approvals, the broader menu is expected to expand the platform’s application scope and strengthen reagent utilization following instrument placement.

According to the latest report from market research firm MMR Statistics, the global IVD market is projected to grow from US$87.2 billion in 2025 to US$135.59 billion by 2032, representing a compound annual growth rate (CAGR) of 6.51%. Growth is driven by the increasing burden of chronic and infectious diseases, rising demand for early and precise testing, the expansion of preventive healthcare programs, and growing adoption of molecular diagnostics, point-of-care testing, automation, and AI-assisted diagnostic technologies.

GBC stated that it sees continued growth opportunities in the global IVD market as testing increasingly moves toward automation, precision, and real-time results. Healthcare institutions and laboratories are placing greater emphasis on testing efficiency, result consistency, and comprehensive test menus. With high sensitivity, a high degree of automation, and strong scalability across test applications, chemiluminescence immunoassay (CLIA) technology has become an important platform for immunoassay testing. By combining its CLIA platform with comprehensive reagent development capabilities, GBC aims to strengthen its product competitiveness in the IVD market, while increasing the visibility of its GBC brand and creating further opportunities for international business expansion.

GBC continues to steadily expand its precision medicine business, with its CLIA chemiluminescence immunoassay systems regarded as one of the key growth drivers. Approximately 11 CLIA systems have been placed at healthcare institutions and laboratories in Taiwan to date. Through instrument placements, reagent adoption, and customer feedback, GBC is gradually building its application experience and market service capabilities. GBC emphasized that its CLIA strategy goes beyond the sales of individual instruments. By integrating platform instruments, testing reagents and consumables, after-sales services, and application support, the company aims to establish long-term partnerships and drive the gradual expansion of reagent utilization.

Following the CL i120’s EU IVDR certification, GBC expects to further strengthen the confidence of overseas distributors and healthcare channels in the product’s regulatory compliance and quality consistency, creating additional opportunities for market entry. The company is also actively exploring opportunities in the Middle East and Southeast Asia. Based on the regulatory requirements and testing needs of individual markets, GBC will gradually introduce its instruments, reagents, and consumables, expanding the commercialization opportunities of its CLIA platform overseas and supporting future business growth.

Media Contacts

GBC
Frank Lin, General Manager
Tel: +886-3-577-9221
frank.lin@gbc.com.tw

IR Trust
Sandy Cheng, Vice President
Tel: +886-2-2585-5701 / +886-931-914-467
sandy@ir-trust.tw

About GBC

GBC (TWSE: 4117), founded in June 1984, has established an integrated value chain covering research, development, manufacturing, sales, and testing services. For more than 40 years, GBC has remained committed to creating better and more affordable in vitro diagnostic (IVD) products that are accessible to everyone. Its product portfolio covers infectious diseases, respiratory infections, blood virology, fertility and sexual health, oncology, human genetics, and emerging infectious diseases. GBC’s IVD products and instruments have become trusted solutions for healthcare professionals, laboratory technicians, blood banks, and consumers, with products sold in more than 40 countries worldwide.

Building on its expertise in testing, GBC is expanding toward precision medicine, preventive healthcare, and broader health applications by integrating testing technologies with complementary approaches. Its businesses span precision IVD reagents, Digital Medical Laboratory (DML) services, and the commercialization of antimicrobial peptide (AMP) pharmaceutical and healthcare products, supporting the company’s long-term development in the broader healthcare market.

Official Website: GBC Official Website

Forward-Looking Statements

This document and the related information released concurrently contain forward-looking statements. Except for statements concerning facts that have already occurred, all statements regarding GBC’s future business operations, potential events, and prospects—including, but not limited to, forecasts, targets, estimates, and operating plans—are forward-looking statements. Such statements are subject to various factors and uncertainties that may cause actual results to differ materially from those expressed or implied. These factors include, but are not limited to, price fluctuations, actual demand, exchange rate movements, market share, market competition, changes in legal, financial, and regulatory frameworks, international economic and financial market conditions, political risks, cost estimates, and other risks and variables beyond GBC’s control. These forward-looking statements are based on current expectations and assessments, and GBC assumes no obligation to update them in the future.

Three Core Technology Platforms and Global Expansion to Drive Long-Term Growth

Hsinchu, Taiwan — June 17, 2026

General Biologicals Corporation (GBC; TWSE: 4117), a precision healthcare and diagnostic solutions provider, held its 2026 Annual General Meeting of Shareholders, chaired by Chairman Tsung-Ching Lin. Shareholders approved the Company’s 2025 business report, financial statements, earnings distribution proposal, and other agenda items.

GBC stated that 2025 was a pivotal year for the Group as it advanced its business transformation, optimized its asset structure, and strengthened its core technology platforms. Although revenue from its core operations remained in a stage of product portfolio optimization and commercialization of new businesses, improvements in asset allocation and investment gains significantly enhanced full-year profitability. Earnings per share (EPS) after tax reached a record high, laying an important foundation for the subsequent resumption of trading on the Taipei Exchange’s Emerging Stock Market and the Company’s medium- to long-term development.

GBC reported consolidated revenue of NT$216 million for 2025, down 14.36% year on year. The decline was primarily attributable to the Company’s product portfolio optimization strategy, which focused resources on precision healthcare, technology platforms, and higher-value-added products. As a result, gross margin increased significantly to 27.63%.

In addition, GBC’s subsidiaries, GB Holdings Limited (GBH) and Gene Research Laboratories Co., Ltd., participated in a share-swap investment with Leo International Precision Health Aktiengesellschaft (LIPH), a company listed on the Main Standard of the Frankfurt Stock Exchange. The transaction not only supported the Group’s international market expansion, but also improved capital efficiency and financial stability through asset allocation adjustments and operational structure optimization. Benefiting from gains on the disposal and revaluation of investments by its subsidiaries, GBC recorded full-year net income after tax of NT$465 million and EPS of NT$7.46, both representing record highs. Net book value per share also increased to NT$12.29.

GBC’s shares resumed trading at securities firms’ business premises on June 12. The Company noted that the resumption of trading marks the gradual return of normal capital market operations following the completion of relevant procedures and strengthened information disclosure. Going forward, GBC will continue to enhance corporate governance and financial transparency. Building on the improved financial structure, higher net book value per share, and progress in commercializing its core technology platforms in 2025, the Company is strengthening its foundation and confidence for medium- to long-term transformation and growth.

Looking ahead, GBC will continue to focus on “technology platforms, commercial applications, and market validation” across three key areas: precision healthcare and liquid biopsy technologies; diagnostic instruments and testing systems; and cyclic peptide and protein technology platforms. The Company will continue developing Circulating Tumor Cell (CTC) liquid biopsy, CLIA Chemiluminescence Immunoassay Systems, AIO Fully Automated Nucleic Acid Testing and Analysis Systems, and applications based on cyclic peptide and protein technologies. These platforms will serve as important foundations for future medical testing, new product development, and international collaboration.

Among these platforms, the CLIA Chemiluminescence System and AIO Molecular Testing System represent key areas for the future commercialization of GBC’s precision healthcare products. CLIA products can be applied to tumor markers, thyroid function, infectious diseases, hormones, and specialized testing applications. The AIO System is designed for a range of settings, including regional hospitals, clinics, and laboratories. Its instrument placement model is expected to drive continued reagent usage, supporting a dual-track approach focused on “product portfolio diversification” and “growth in recurring revenue.”

At the same time, GBC is continuing to integrate CTC liquid biopsy with AI-powered image analysis. Through digital scanning, cloud-based pathology, and AI analysis services, the Company aims to expand applications in cancer risk assessment, treatment monitoring, and precision testing.

In addition, GBC’s subsidiary Gene Research Laboratories Co., Ltd. continues to develop its proprietary “oh care” brand, with antimicrobial peptide P113 as its core technology. The product portfolio covers three major categories: oral care, skincare, and antimicrobial cleaning products. The brand has entered more than 500 physical retail outlets across Taiwan and more than 30 major e-commerce platforms worldwide, including the well-known U.S. e-commerce platform Amazon. These efforts are expected to increase product penetration and brand recognition while establishing a stable and sustainable revenue stream for the Group.

GBC stated that the Group is committed to moving from its transformation stage toward scaled and international growth. With clear long-term trends in global precision healthcare, smart healthcare, and regenerative medicine, GBC is actively advancing its CLIA and AIO systems, CTC testing technologies, oh care brand, and international market expansion.

The Company is also actively developing markets across North America, the Middle East, Europe, and Southeast Asia. By deepening its technology platforms, accelerating product commercialization, and expanding international partnerships, GBC expects to create new momentum for future business growth.

GBC (4117) held its 2026 Annual General Meeting of Shareholders, during which shareholders approved the Company’s 2025 business report, financial statements, earnings distribution proposal, and other agenda items. Chairman Tsung-Ching Lin is pictured second from right, and General Manager M. D. Lin is pictured at far right.

Media Contacts

General Biologicals Corporation (GBC)
M. D. Lin, General Manager
Tel: +886-3-577-9221
frank.lin@gbc.com.tw

IR Trust
Sandy Cheng, Vice President
Tel: +886-2-2585-5701 / +886-931-914-467
sandy@ir-trust.tw

About GBC

General Biologicals Corporation (GBC; TWSE: 4117) was founded in 1984 and is a Taiwan-based precision diagnostics and healthcare technology company with an integrated value chain spanning research and development, manufacturing, sales, and testing services. Its products and services are marketed in more than 40 countries worldwide.

GBC focuses on three major areas: precision diagnostics, liquid biopsy, and smart healthcare. Its core businesses include in-vitro diagnostics (IVD), clinical laboratory testing services, and healthcare technology applications. Its IVD portfolio covers chemiluminescence immunoassay (CLIA), molecular testing, blood screening, and automated testing systems. By integrating AI-powered analysis and digital healthcare technologies, GBC supports healthcare institutions in improving disease detection, cancer monitoring, and clinical decision-making efficiency, while continuing to expand its presence in precision cancer testing and smart healthcare.

Guided by its philosophy of “From Detection to Decision,” GBC continues to advance testing technology innovation and international market expansion. The Company is committed to transforming testing data into actionable insights for clinical decision-making and developing healthcare solutions that are more precise, timely, and clinically valuable.

GBC Official Website:
https://www.gbc.com.tw/tw/home/

Disclaimer

This document and the related information released concurrently contain forward-looking statements. Except for statements relating to facts that have already occurred, all statements concerning GBC’s future business operations, potential events, and prospects, including but not limited to forecasts, targets, estimates, and operating plans, constitute forward-looking statements.

Forward-looking statements are subject to various factors and uncertainties that may cause actual results to differ materially from those expressed or implied herein. These factors include, but are not limited to, price fluctuations, actual demand, exchange-rate movements, market share, market competition, changes in legal, financial, and regulatory frameworks, international economic and financial market conditions, political risks, cost estimates, and other risks and variables beyond the Company’s control.

These forward-looking statements are based on current expectations and assessments. The Company assumes no obligation to update or revise such statements in the future.