News

Dec. 21, 2023Press Release

Sysmex Makes Megakaryon Corporation into a Subsidiary, Aiming at Accelerating Efforts in the Field of Regenerative and Cellular Medicine

- Towards the Early Commercialization of Human iPS Cell-Derived Platelet Preparations -

Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) announces that on December 20, 2023, it acquired additional shares in Megakaryon Corporation (HQ: Shimogyo-ku, Kyoto, Japan; CEO, President: Kenichi Akamatsu), making the company a consolidated subsidiary. Megakaryon has fundamental technology for producing platelets from human iPS cells.¹ By strengthening the synergy between Megakaryon and the Sysmex Group, we aim to accelerate the commercialization of high-quality and highly safe platelet preparations derived from human iPS cells. In addition, we will explore the application of Megakaryon's technology as a raw material for the standard substances used in the quality control of our testing instruments, among other potential applications.

In its long-term corporate strategy announced in May 2023, Sysmex has outlined the development of new businesses in domains that straddle the boundaries of diagnostics and treatment, such as regenerative and cellular medicine, as part of its commitment to providing innovative healthcare.

Blood transfusions, including those using platelet and other blood preparations, are a fundamental treatment method in medical care.² However, all the blood needed for creating these preparations is currently sourced entirely from blood donations. The demand for platelet transfusions is high, and about 80% of patients who receive them, such as those with hematopoietic tumors like acute leukemia, or thrombocytopenia caused by aplastic anemia, undergo repeated transfusions as part of their treatment.³

However, when patients receive repeated transfusions, some may produce antibodies against antigens (HLA)⁴ that are different from their own bodies, and as a result, they may develop "platelet transfusion refractoriness," a condition where the effectiveness of the transfusion is lost. Furthermore, with platelet preparations derived from donated blood, there may be serious complications such as infections due to bacterial contamination at the time of blood donation, or allergic reactions caused by the plasma in the platelet preparation.

Megakaryon has world’s first fundamental technology for producing high quality platelet preparations from iPS cells, which do not express HLA or contain plasma. Thus, the commercialization of platelet preparations derived from human iPS cells could potentially enable safer transfusion therapy, free from these concerns or adverse reactions.

In December 2017, Sysmex invested in Megakaryon, aiming to contribute to the commercialization of human iPS cell-derived platelet preparations by leveraging platelet analysis technologies it has cultivated in the field of hematology. As part of this initiative, Sysmex has developed a testing method for the quality control of platelets derived from human iPS cells.

To strengthen synergies between Megakaryon and the Sysmex Group and accelerate efforts in regenerative and cellular medicine through the early commercialization of human iPS cell-derived platelet preparations, Sysmex conducted an additional acquisition of Megakaryon’s shares as of December 20, 2023, making it a consolidated subsidiary. Sysmex will closely collaborate with Megakaryon to apply the technology we have cultivated in the testing and diagnostic field, promoting the development of an automated manufacturing system for platelet preparations derived from human iPS cells, which includes quality control testing. Furthermore, Sysmex will also explore the potential application of Megakaryon's technology as a new manufacturing method for the standard substances indispensable for the quality control of its testing instruments.

Going forward, aiming to contribute to safe platelet transfusion therapy, Sysmex and Megakaryon, together with the entire Sysmex Group, will work closely in accelerating efforts toward the early commercialization of high-quality, highly safe human iPS cell-derived platelet preparations.

Overview of Megakaryon Corporation

Company name	Megakaryon Corporation
Location	Kyoto Research Park, 134 Minamimachi, Chudoji, Shimogyo-ku, Kyoto, Japan
Established	September 2011
Capital	100 million yen
Investment rate	80.9%
Representative	Kenichi Akamatsu (CEO, President)
No. of employees	10
Line of business	Commercialization of iPS cell-derived platelet preparations

Reference

December 25, 2017 news release: “Sysmex Invests in Megakaryon Corporation to Contribute to the Practical Realization of Platelet Preparations Derived from iPS Cells”

https://www.sysmex.co.jp/en/news/2017/171225.html

Terminology

1	Induced pluripotent stem cells (iPS cells): iPS cells produced from human skin or other cells through transfection of several factors are capable of differentiation into many types of cells of tissues and organs. iPS cells were discovered by a Kyoto University research group led by Dr. Shinya Yamanaka. Theoretically, these cells can be differentiated into any tissues or organs that constitute the human body. Attention is being focused on these cells for their potential in realizing regenerative medicine.
2	Blood preparations used in transfusions comprise whole blood preparations, red blood cell preparations, plasma preparations and platelet preparations. In the past, transfusions mainly used whole blood taken from donors, containing all of its constituents. However, it is now common to transfuse only blood components the patient requires - using red blood cell preparations, plasma preparations or platelet preparations.
3	Source: Megakaryon estimate based on Tokyo Metropolitan Government 2021 Blood Transfusion Survey
4	Human Leukocyte Antigen (HLA): The HLA is present in almost all cells and body fluids. It has been found to act as a histocompatibility antigen (important molecule involved in the human immune system recognizing self and non-self). The body recognizes and attacks anything transplanted which expresses a different type of HLA. Ensuring HLA compatibility is therefore an important factor in hematopoietic stem cell transplants, organ transplants and regenerative medicine.

About Sysmex Corporation

Sysmex Corporation, headquartered in Kobe, Japan, is a global leader in in vitro diagnostics. Since its establishment 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." To realize this vision, Sysmex identifies and verifies prioritized Sustainable Development Goals (SDGs) and materiality (priority issues), thereby maintaining its growth as a company that generates both social and economic value. 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. For more information about Sysmex Corporation, please visit www.sysmex.co.jp/en/.

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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 news release is current as of the date of the announcement but may be subject to change without prior notice.

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