Founding & Foundation (1995-2003): Building the Basic Framework and Anchoring Global Standards

In 1995, Acon Bio was founded in Hangzhou, Zhejiang Province by a group of overseas-educated doctors returning from the United States, marking the start of its exploration in China's rapid diagnostic field. From its inception, the company established a global development strategy, integrating international standards into all aspects of its operations. During this period, Acon foresaw the huge demand for blood glucose testing in the global chronic disease management market and initiated preliminary R&D work on blood glucose rapid testing technologies, laying the groundwork for its subsequent focus on the blood glucose field. In 1998, Acon Bio successfully obtained U.S. FDA factory registration, becoming one of the earliest Chinese diagnostic enterprises to enter the international market; in 1999, it smoothly passed China's GMP certification for pharmaceuticals, establishing a standardized quality management system. During this phase, the company initially built a rapid immunoassay technology platform, with key breakthroughs in the R&D of core raw materials for blood glucose testing, such as glucose oxidase and dehydrogenase. This not only laid a solid foundation for subsequent product R&D and industrialization but also gradually formed a quality-centric competitive advantage, solidifying the groundwork for entering the global blood glucose testing market.

Innovation & Rise (2004-2008): Upgrading Technology Platforms and Becoming an Industry Leader

In 2004, Acon Bio launched the "Acon" brand focusing on chronic disease testing, with blood glucose testing as its core business, marking the company's official dedication to the blood glucose segment. By integrating biotechnology (BT) and electronic information technology (IT), Acon embarked on a path of diversified product layout. During this period, the company increased R&D investment to comprehensively upgrade its technology platforms, successfully establishing four core technology platforms: rapid immunoassay, antigen-antibody, biosensor, and rapid gene diagnosis. Specifically in the blood glucose field, it independently developed a series of blood glucose testing systems and test strips, including the first-generation On Call blood glucose meter with automatic coding function, which filled multiple domestic technological gaps in blood glucose rapid testing. These products featured advantages such as high accuracy, easy operation, and fast results, gaining widespread recognition in the domestic market.

In terms of quality system construction, Acon achieved continuous breakthroughs: it passed the U.S. FDA on-site inspection for the first time in 2005, and in 2008, it passed the inspection again with an excellent result of "zero deficiencies". Its blood glucose testing products fully complied with multiple international authoritative certification standards, including China's SFDA, EU CE, and U.S. FDA 510K. Relying on independent innovation capabilities and strict quality control, Acon Bio quickly grew into an industry leader in the rapid diagnostics and medical device segments. Its blood glucose testing products accounted for a leading share in the domestic market and began to enter the Southeast Asian and European markets, laying the foundation for its global expansion in the blood glucose field.

Expansion & Leadership (2009-2019): Global Layout and Enriching Product Matrix

During this phase, Acon Bio accelerated its global industrial layout, leveraging R&D advantages in both China and the United States to continuously expand product boundaries, forming a rich product matrix covering three major industries: in vitro diagnostic reagents, medical devices, and medical electronics. In the blood glucose field, the company achieved leapfrog development: it launched a series of upgraded blood glucose meters, such as the On Call® series with ultra-fast testing (5 seconds for results) and minimal blood sample requirements (0.4μL), and developed high-precision blood glucose test strips compatible with a wide range of hematocrit (HCT) levels (10-70%). Additionally, the company successively launched dry biochemical analyzers, hemoglobin analyzers, lipid analyzers, and other medical devices and supporting test reagents. It also continued to make efforts in PCR test reagents, ELISA test reagents, colloidal gold test reagents, and other fields, launching more than 20 new products annually. Its products covered multiple medical testing fields such as endocrine diseases (with blood glucose as the core), infectious diseases, prenatal and postnatal care, and tumors.

In terms of production and supply chain construction, Acon Bio built an efficient and intelligent production management system, accelerated the completion of automated factories, and gradually moved towards Industry 4.0 standards. It established a dedicated automated production line for blood glucose test strips, with an annual output reaching hundreds of millions of pieces, ensuring stable supply for the global market. Meanwhile, the company built a global marketing and cooperation network, establishing sound sales channels in over 140 countries and regions worldwide. Its blood glucose testing products were widely used in hospitals at all levels, blood centers, CDC, independent laboratories, and home care scenarios. Every year, billions of reagent units and millions of instruments, including a large number of blood glucose meters and test strips, were delivered to global users through this network. In addition, the company actively carried out international technological exchanges, inviting dozens of foreign scientists to China for guidance every year and sending R&D backbones to the United States for further study, continuously enhancing its core technological competitiveness in the blood glucose testing field.

Responsibility & Leapfrog Development (2020-Present): Emergency Response to the Pandemic and Deepening Global Influence

After the outbreak of the COVID-19 pandemic in 2020, Acon Bio, relying on its years of accumulated R&D and production advantages, quickly responded to global epidemic prevention needs and urgently promoted the R&D of COVID-19 testing products. While tackling the pandemic, the company continued to strengthen its innovation in the blood glucose field. In 2021, it launched the On Call® Advance blood glucose testing system, which adopted advanced GDH enzyme technology to further improve testing accuracy and stability. In 2022, the company's COVID-19 antigen test kit successfully obtained approval from China's NMPA and subsequently gained certifications from multiple international authoritative institutions such as U.S. FDA EUA, EU CE, and Australia TGA. Among them, the Flowflex™ COVID-19 antigen test kit was popular worldwide for its excellent performance and user experience, providing key support for global epidemic prevention and control. During this period, the company's blood glucose testing products maintained steady growth in the global market, especially in emerging markets such as Latin America and Africa, where they became the preferred choice for many patients and medical institutions.

During this period, Acon Bio further improved its global R&D and manufacturing system, establishing multi-center industrial bases in China, the United States, and Mexico, and continuously deepening its strategic layout of "rooted in China, radiating the world". In the blood glucose field, it set up a dedicated global R&D center focusing on the development of intelligent blood glucose monitoring solutions, including continuous glucose monitoring (CGM) technologies, to meet the diverse needs of global users. In the field of social responsibility, the company actively fulfilled its corporate obligations, donating 280,000 antigen test kits to support Hong Kong's anti-epidemic efforts through the Zhejiang-Hong Kong Chamber of Commerce, and carrying out public welfare screening activities relying on its technological advantages, including free blood glucose testing for grassroots communities, to provide health protection for the public. Meanwhile, the company continued to promote technological innovation and talent training, establishing cooperative relations with many domestic universities and research institutions to jointly carry out basic research and product development in the blood glucose field, cultivating professional talents for the industry and boosting the high-quality development of China's IVD industry.

Key Milestones Overview

● 1995: Acon Bio was founded in Hangzhou, initiating exploration in the rapid diagnostic field and preliminary R&D in blood glucose testing technology.

● 1998: Obtained U.S. FDA factory registration, taking the first step towards globalization and laying the foundation for exporting blood glucose products.

● 1999: Passed China's GMP certification for pharmaceuticals, establishing a standardized quality management system to ensure the quality of blood glucose products.

● 2004: Launched the "Acon" brand focusing on chronic disease testing, with blood glucose testing as the core, and built four core technology platforms to support blood glucose product innovation.

● 2005: Passed the U.S. FDA on-site inspection for the first time, with blood glucose products meeting international quality standards.

● 2008: Passed the U.S. FDA on-site inspection with "zero deficiencies", and blood glucose testing products gained leading market share in China.

● 2021: Launched the On Call® Advance blood glucose testing system, adopting advanced GDH enzyme technology to improve testing accuracy.

● 2022: COVID-19 antigen test kit obtained multiple international certifications; blood glucose testing products achieved steady growth in global emerging markets.

● Present: Products cover over 140 countries and regions, becoming one of the world's largest industrial bases for diagnostic products, with a prominent position in the global blood glucose testing market.

Our Commitment: Mission, Vision & Core Values

Mission: To provide comprehensive solutions for the global healthcare sector (Acon is the unique solution for global healthcare), with a focus on delivering high-quality blood glucose diagnostic solutions to safeguard the health of patients with chronic diseases worldwide.

Vision: To become a global leading provider of products and services in the healthcare sector, with excellence in the blood glucose testing field.

Core Values: Innovation-driven, quality-first, global perspective, and social responsibility. We firmly believe that high-quality products and advanced technologies come from high-caliber talents. We always take user needs as the guide, continuously innovate in the blood glucose field to make precise diagnosis accessible to everyone, and contribute to the cause of human health.