EPS Holdings, Inc.
Suzuken Co., Ltd.
Bushu Pharmaceuticals Ltd.
News Release

EPS Holdings, Suzuken Group, and Bushu Pharmaceuticals Sign Partnership
Agreement to Support the Introduction of Unapproved Drugs (Drug LossProducts) into the Japanese Market

2024/5/9, EPS Holdings, Inc., News Release --- EPS Holdings, Inc. (headquarters: Shinjuku Ward, Tokyo,Representative Director: Hao Yan; hereinafter, “EPS Group”) announces that it has entered into a partnershipagreement with Suzuken Co., Ltd. (headquarters: Nagoya City, President and CEO: Shigeru Asano; hereinafter,“Suzuken”), Suzuken’s consolidated subsidiary, Sanwa Kagaku Kenkyusho Co., Ltd. (headquarters: Nagoya
City, President and CEO: Shusaku Isono; hereinafter, “SKK”), and Bushu Pharmaceuticals Ltd. (headquarters:Kawagoe City, Saitama Prefecture, President and CEO: Tadao Takano; hereinafter, “Bushu Pharma”) for a
joint business to support the launch of drug loss products in Japan.
1. The Situation of Drug Loss in Japan
In recent years, Japan has faced a growing issue with drug loss, which refers to drugs that have been approvedin other countries but remain unapproved in Japan. Reports have in fact shown that about 70% of the new drugs
approved in Europe and the U.S. in the past five years are products that have not been approved in Japan*1.
Furthermore, about half of the unapproved drugs in Japan have been granted orphan drug designation by either
the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA)*2, highlighting thefact that clinically important drugs have either not been developed in Japan or are experiencing delays indevelopment.
While various factors are involved in the cause of drug losses in a complicated manner, one factor is thought
to be the shift in the development and marketing of new drugs in Europe and the U.S. from large pharmaceuticalcompanies to emerging pharmaceutical companies that do not have Japanese subsidiaries*3. Many of theseemerging pharmaceutical companies are established in the U.S., and it is speculated that their priority is todevelop and market their products in the U.S. and Europe, and their priority to enter the Japanese market isrelatively low. This is due to the financial aspects, lack of understanding of the Japanese market and its
regulations, language barriers, and other factors. On the other hand, numerous emerging pharmaceuticalcompanies are considering the possibility of future expansion into Japan and are hesitant to out-license theirdevelopment and marketing rights in Japan prematurely, as this might limit their future options.
*1: Quoted from the Office of Pharmaceutical Industry Research, Policy Research News No. 63, July 2021,‘Drug Lag: The Situation and Characteristics of Unapproved Drugs in Japan’*2: Quoted from the Office of Pharmaceutical Industry Research, Policy Research News No. 66, July 2022,‘Drug Lag: Can Unapproved Drugs Meet Japan’s Unmet Medical Needs?’*3: Quoted from ‘Pharmaceutical Industry Vision 2021’

(Please note that the references listed above are available only in Japanese, and the titles have beentranslated solely for the purpose of this document’s publication.)
2. Outline of the Business Model
This business model is a one-stop service that provides the roles necessary to enter the Japanese market, fromdevelopment, application for approval of manufacturing and marketing, manufacturing, sales and marketing,and distribution, through the cooperation of the three group companies, Suzuken Group, EPS Group, andBushu Pharma. (Reference: Business Model Diagram)
Although approval of new drugs requires an application for approval by the marketing authorization holder inJapan, it is possible to use the foreign exceptional approval system under the Pharmaceutical and Medical
Device (PMD) Act. By appointing a Japanese marketing authorization holder, even if the company is not basedin Japan, the foreign licensing company can obtain approval using its own company name. In this businessmodel, SKK will serve as the Designated Marketing Authorization Holder (DMAH), and the three groupcompanies will collaborate to develop, apply for manufacturing and marketing approval, and commercialize
unapproved drugs in Japan.
Reference: Business Model Diagram

3. Characteristics of the Business Model(1) Providing one-stop support for entering the Japanese market
Traditionally, licensing companies seeking to enter the Japanese market had to individually conduct
activities aimed at development and commercialization within Japan themselves. This business modelallows SKK to serve as the point of contact, combining the CDMO*4 functions of Bushu Pharma, theCRO*5 and CSO*6 functions of EPS Group, and the pharmaceutical manufacturing capability of SKK
along with the manufacturer distribution and wholesale distribution capabilities of the Suzuken Group, toprovide a comprehensive one-stop service.
(2) Assisting in obtaining approvals under the name of the licensing company
This business model allows for obtaining approval under the licensing company's name without having toestablish a Japanese subsidiary or securing personnel for entry into the Japanese market, by utilizing theforeign exceptional approval system. This will contribute to increasing the recognition and branding of
the licensing company in the Japanese market. In addition, on behalf of the licensing companies, the threegroup companies, which have extensive experience in their respective fields in Japan, will collaborate toprovide high-quality services, including manufacturing of drugs, the roles required as the marketing
authorization holder, and stable supply of pharmaceuticals.
(3) Offering a business model that requires no initial investment
In accordance with the financial circumstances of licensing companies, such as emerging pharmaceuticalcompanies, SKK and EPS Group will bear the costs associated with development in Japan. Following themarket launch, we will provide a pay-for-performance service that recoups development costs from futuresales. This enables the licensing companies with financial constraints to enter the Japanese market withoutrisk.
*4: CDMO: Contract Development and Manufacturing Organization*5: CRO: Contract Research Organization*6: CSO: Contract Sales Organization
4. Roles of Each Company(1) EPS Group
Support for development and contact center operations, etc.
(2) Suzuken Group
Liaison with licensing companies, development and regulatory authority correspondence, general affairs
related to manufacturing and marketing business as a designated marketing authorization holder, sales andmarketing operations, and post-marketing distribution of specialty drugs, etc.
(3) Bushu Pharma
Production of drugs for clinical trials and commercial purpose, and secondary packaging services incompliance with the Japanese regulations (including final packaging and labeling), etc.
5. Future Outlook
The three group companies will work together to actively engage with foreign emerging pharmaceuticalcompanies in order to secure early agreements for this business model and to expedite the launch of drugs
not yet approved in Japan. By doing so, we aim to deliver highly anticipated new drugs to patients.

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About Suzuken (https://www.suzuken.co.jp/en/)
The Suzuken Group has defined health creation as its primary business domain and is engaged not onlyin its core business of ethical drug distribution but also in the comprehensive development of medical andhealth-related businesses. These activities include the research, development, and manufacturing of newdrugs, support services for pharmaceutical manufacturers, as well as the operations of pharmacy andnursing care businesses. Furthermore, the Suzuken Group is the only pharmaceutical wholesaler thatboasts a comprehensive distribution function, which we refer to as the healthcare distribution platform,
ranging from pharmaceutical manufacturers to wholesalers, and extending further to medical institutions
and pharmacies. This enables us to address the diversifying and increasingly sophisticated demands of
medical distribution from the perspectives of manufacturers, medical institutions, pharmacies, and evenpatients, offering a one-stop solution.

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About Sanwa Kagaku Kenkyusho (https://www.skk-net.com/en/)
SKK is a subsidiary of Suzuken, one of Japan's leading pharmaceutical wholesalers, and is headquarteredin Nagoya City, Aichi Prefecture. SKK is a pharmaceutical company that is capable of handling the entire
process from R&D to the sales and marketing of pharmaceuticals, providing ethical drugs and diagnostic
agents mainly in the fields of diabetes and kidney diseases. Embracing the corporate philosophy of Patientfriendly medicines for people worldwide”, SKK considers its mission as developing and delivering
pharmaceuticals that contribute to improving the quality of life (QOL) of patients.

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About EPS Holdings (https://www.eps-holdings.co.jp/en/)
Since its establishment as a CRO pioneer in 1991, EPS Holdings has provided solutions regarding drug
development, post-marketing development, marketing and sales, as well as consultation. In addition, it has
been a healthcare solution provider offering new value to pharmaceutical companies, medical devicecompanies, hospitals, clinics and academia through big data & AI, and regenerative medicine initiatives.
In 2021, we established a drug discovery business to support the clinical development of drug candidates
originating in academia as well as in domestic and foreign bio-ventures, and started a business providing
marketing support in Japan and other countries.

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About Bushu Pharmaceuticals (https://www.bushu-pharma.com/en/)
As one of the leading contract manufacturers of pharmaceutical products in Japan, Bushu Pharma offersa broad range of optimal solutions for technology transfer, pharmaceutical production, packaging, andlogistic services based on 25 years of experience and expertise as a CDMO in all phases of development,from R&D projects for pharmaceuticals such as solid dosage formulations, primary packaging of solid
dosage forms, production of injectable solutions, and more, to marketing approval of new drugs.

<Contact Information>
Suzuken Co., Ltd.
Corporate Communication Department
8 Higashikataha-machi, Higashi-ku, Nagoya City,Aichi, 461-8701, Japan
TEL: 052-950-6307

FAX: 052-961-4071

Sanwa Kagaku Kenkyusho Co., Ltd.
Management Strategy Department CSR Public Relations Group35 Higashi Sotobori-cho, Higashi-ku, Nagoya City,
Aichi, 461-8631, Japan
TEL: 052-951-8130

FAX: 052-950-1361

EPS Holdings, Inc.
Corporate Communication Office
Tsukudo Terrace, 2-1 Tsukudohachimancho,
Shinjuku-ku, Tokyo, 162-0815, Japan
E-mail: pr@eps.co.jp
Bushu Pharmaceuticals Ltd.
Marketing Department
1 Takeno, Kawagoe, Saitama, 350-0801, Japan
TEL: 049-273-6386

FAX: 049-233-4655

This is an English translation of a statement written initially in Japanese and is provided for reference purposes only.
The Japanese original shall prevail in the event of any discrepancy between this document and the original.