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Initiated In-house Production of HISCL™ TARC Assay Kit and HISCL™ ANP Assay Kit

- Succession of Manufacturing and Marketing Approval from Shionogi to Accelerate Global Expansion and Business Growth in the Immunochemistry Field -

Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) announced that as of February 22, 2024, the Company has succeeded manufacturing and marketing approval for the HISCL TARC Assay Kit and the HISCL ANP Assay Kit from Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter, "Shionogi"), and has initiated in-house production.

Sysmex and Shionogi co-developed the HISCL TARC Assay Kit and the HISCL ANP Assay Kit in 2014 and have been promoting business expansion in the Japanese market for a long time, with Shionogi as the legal manufacturer and Sysmex as the seller.

Sysmex has responded flexibly to diversified medical needs in cooperation with Shionogi to reduce the burden on patients and improve the quality of testing, such as obtaining insurance coverage for the unique item HISCL TARC Assay Kit in April 2014 as an aid to determine the severity of atopic dermatitis, followed by additional indications as an aid for assessment of COVID-19 aggravation risk in June 2021 and an aid to diagnose drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (DIHS/DRESS) in July 2023.

As part of its long-term corporate strategy, Sysmex strives to expand its business domain by strengthening existing businesses and creating new ones. In the existing field of immunochemistry, Sysmex is promoting early expansion of reagent parameters and global market penetration. In order to successfully accommodate the rapidly changing market environment, it is essential to make timely business decisions, ensure stable supplies, and establish an effective service and support system. To strengthen these structures, Sysmex and Shionogi have reached an agreement for the transfer of manufacturing and marketing approval to Sysmex and to proceed with the transfer of reagent manufacturing. Going forward, Sysmex-manufactured reagents will be gradually introduced into the market.

Sysmex has a solid foundation established in global R&D, production, logistics, sales, and service & support, cultivated through businesses such as hematology and hemostasis. Furthermore, by leveraging our unique parameters, such as dementia-related and liver fibrosis-related reagents, together with the HISCL TARC Assay Kit, which offers unique value, we will steadily promote activities to further accelerate global market penetration and business expansion while enhancing customer satisfaction.

Sysmex remains committed to delivering anshin (peace of mind) to its customers through the continued expansion of high-value testing parameters that contribute to reducing patient burden and improve the quality of testing, as well as proactive global expansion.
 
Reference
April 21, 2014 news release: Sysmex to Launch the HISCL™ TARC Assay Kit for Atopic Dermatitis - Allows for Automated Testing in Only 17 Minutes -
https://www.sysmex.co.jp/en/news/2014/140421.html
Product Overview
Generic name (JMDN)
Th2 chemokine/TARC kit
Product name HISCL™ TARC Assay Kit
in vitro diagnostics approval number in Japan 225AAAMX00132000
Intended use
Measuring the amount of human TARC in serum (to assist in determining the severity of atopic dermatitis and assist in the diagnosis of drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (DIHS/DRESS); and to aid in determining the exacerbation risks of SARS-CoV-2-positive patients).
Manufacturer and seller Sysmex Corporation
Target market Japan
(To be expanded gradually outside Japan)
Launch Gradually on or after February 22, 2024

Generic name (JMDN)
Atrial natriuretic peptide kit
Product name HISCL™ ANP Assay Kit
in vitro diagnostics approval number in Japan 225AAAMX00145000
Intended use
For measuring the amount of human atrial natriuretic peptide (ANP) in plasma.
Manufacturer and seller Sysmex Corporation
Target market Japan
(To be expanded gradually outside Japan)
Launch Gradually on or after February 22, 2024

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/.

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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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