Fujirebio and Sysmex Begin Sales Collaboration for Dementia Testing

Fujirebio Holdings, Inc. (HQ: Minato-ku, Tokyo; President & CEO: Goki Ishikawa; “Fujirebio”), a consolidated subsidiary of H.U. Group Holdings, Inc. (HQ: Minato-ku, Tokyo; Chairman, President and Group CEO: Shigekazu Takeuchi) and Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano, “Sysmex”) have agreed on a sales collaboration for dementia testing. This agreement follows continued discussions based on the Basic Agreement on Business Collaboration in the Field of Immunoassay concluded in October 2023.¹ Sysmex will exclusively sell Fujirebio's fully automated Lumipulse^® immunoassay systems and dementia-related reagents ("the Products") in regions and countries mutually agreed upon by both companies. Going forward, Fujirebio and Sysmex will collaborate to meet the growing testing needs accompanying the wider adoption of therapeutic drugs and will gradually expand the countries where the Products are sold.

Since entering into the Basic Agreement on Business Collaboration in October 2023, the two companies have engaged in ongoing discussions aimed at accelerating the development of immunoassays and their global expansion. In November 2023, they concluded a Contract Development and Manufacturing Organization (CDMO) agreement² for reagents in the field of neurodegenerative diseases, including Alzheimer's disease. Furthermore, in December 2023, they signed a basic agreement for the supply of reagent raw materials owned by each company,³ and have promoted specific initiatives to accelerate the mutual development of new reagents.

With the aging of the global population, the number of patients with neurodegenerative diseases is rapidly increasing. In particular, Alzheimer's disease⁴ is a serious medical and social issue. In recent years, new therapeutic drugs to slow the progression of Alzheimer's disease have emerged, leading to a growing demand for wider access to the testing necessary for their effective use.

Fujirebio has strong reagent development and manufacturing capabilities, while Sysmex has a global sales and service network as well as extensive experience in regulatory applications. By combining these respective strengths, Fujirebio and Sysmex will commence sales of the Products in Brazil, and plan to progressively expand into Central and South America, the Middle East, Asia, and other regions. By leveraging the strengths of Fujirebio’s Products together with Sysmex’s fully automated immunoassay systems, the HISCL™ Series, the two companies will contribute to the early adoption of testing in the field of dementia.

* Lumipulse^® is a registered trademark of Fujirebio Inc. All rights reserved.
* HISCL™ is a trademark of Sysmex Corporation.

References

1		October 10, 2023 news release: “Fujirebio and Sysmex Enter into Basic Agreement on Business Collaboration in the Field of Immunoassay”
		https://www.fujirebio.com/en/news-events/fujirebio-and-sysmex-enter-into-basic-agreement-on-business-collaboration-in-the-field
2		November 30, 2023 news release: “Fujirebio and Sysmex Expand CDMO Partnership into the Field of Neurodegenerative Diseases under Their Immunoassay Collaboration”
		https://www.fujirebio.com/en/news-events/fujirebio-and-sysmex-expand-cdmo-partnership-into-the-field-of-neurodegenerative
3		December 14, 2023 news release: “Fujirebio and Sysmex Sign Agreement for the Supply of Reagent Raw Materials in the Field of Immunoassay”
		https://www.fujirebio.com/en/news-events/fujirebio-and-sysmex-sign-agreement-for-the-supply-of-reagent-raw-materials-in-the
4		According to the World Health Organization (WHO), it is estimated that more than 55 million people worldwide are currently living with dementia, and the number is expected to reach 130 million in 2050. Alzheimer’s disease may contribute to 60–70%.
		Source: Global status report on the public health response to dementia executive summary (Sep. 2, 2021, World Health Organization)
		https://apps.who.int/iris/bitstream/handle/10665/344707/9789240034624-eng.pdf

About Fujirebio

Fujirebio is a diagnostics company with over 75 years of experience delivering innovative solutions to healthcare providers, pharmaceutical companies, and IVD partners worldwide. Leveraging world-class expertise in neurology, oncology, infectious diseases, and beyond, and assays available on the robust Lumipulse^® platform, Fujirebio’s open business model accelerates access to breakthrough diagnostics through strategic partnerships across the life science industry. Part of H.U. Group, Fujirebio combines strong R&D capabilities, regulatory expertise, and scalable manufacturing to deliver high-impact diagnostic solutions. Fujirebio’s flexible CDMO model helps its diagnostic partners bring validated solutions to the market faster— driving better decisions, treatments, and patient outcomes.

For more information about Fujirebio, please visit www.fujirebio.com.

About Sysmex Corporation

Sysmex Corporation, headquartered in Kobe, Japan, is a global leader in in vitro diagnostics. Since its foundation in 1968, Sysmex has focused on diagnostics as the core of its business, and today, it supports the health of people in over 190 countries and regions worldwide. Sysmex continues to innovate in diagnostics, and to collaboratively create unique values in the areas of personalized medicine and novel treatments, under its long-term vision of "Together for a better healthcare journey." Through its unique technology, solutions, and co-creation with various partners, Sysmex delivers new value and addresses the universal desire of people to live longer and healthier lives.

*"Healthcare journey" is a trademark of Sysmex Corporation, registered in Japan.

For more information about Sysmex, please visit www.sysmex.co.jp/en/.

The purpose of this news release is to communicate our business activities to our stakeholders. It may or may not include information about Sysmex's products or their research and development, but this is not intended for promotion, advertising, or medical advice. The information contained in this press release is current as of the date of the announcement but may be subject to change without prior notice.

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