Execution Of Agreements Regarding The Joint Development Of Biosimilars For Specified Products

Alfresa Holdings Corporation (head office: Chiyoda-ku, Tokyo; Representative Director & President: Ryuji Arakawa; hereinafter “Alfresa Holdings”); Kidswell Bio Corporation (head office: Chuo-ku, Tokyo; President & CEO: Shinya Kurebayashi; hereinafter “Kidswell”); and Chiome Bioscience Inc. (head office: Shibuya-ku, Tokyo; President & CEO: Masamichi Koike; hereinafter “Chiome”) have entered into agreements regarding the joint development of biosimilars^*1 for specified products (hereinafter referred to as the “Agreement”).

Biosimilars, while offering the same quality, safety, and efficacy as reference biologics^*2, are priced lower under the National Health Insurance (NHI) drug pricing system, which means their widespread use will help expand treatment options for patients, reduce the burden of medical expenses, and optimize medical costs. In recent years, the Ministry of Health, Labour and Welfare (MHLW) has been actively promoting measures to encourage the use of biosimilars, and in this context, the MHLW has introduced the “Subsidy Program for the Development of Domestic Manufacturing Facilities for Biosimilars” (hereinafter the “Subsidy Program”), which aims to establish a stable domestic supply system for biosimilars. Furthermore, in December 2023, the MHLW set a numerical target of ensuring that, by the end of fiscal year 2029, biosimilars account for more than 80% of total prescriptions for at least 60% of all eligible active ingredients^*3. Accordingly, biosimilars are anticipated to achieve significant market penetration in the years ahead.

In May, 2025, Alfresa Holdings, Kidswell, and Chiome were selected for the MHLW’s Subsidy Program. And together with Mycenax Biotech Inc. (hereinafter “Mycenax”), a Taiwan-based company with a proven track record as a contract development and manufacturing organization (CDMO)^*4 for biosimilars and other biopharmaceuticals, the three companies are currently working to establish a domestic manufacturing facility for biosimilars.

Furthermore, with the conclusion of the agreements for the joint development of biosimilars, Alfresa 1 Holdings, Kidswell, and Chiome will leverage their respective expertise - Alfresa Group’s nationwide pharmaceutical distribution network and manufacturing capabilities, Kidswell’s experience in the development and stable supply of multiple biosimilars, and Chiome’s long-standing expertise in antibody drug research and development—to advance collaboration toward the development of new biosimilars. The manufacturing processes for the newly developed biosimilars are expected to be transferred to the domestic manufacturing facility established under the MHLW’s Subsidy Program for commercial production, thereby building a track record of manufacturing and contributing to the stable operation of the facility.

This Agreement further strengthens our initiative to build Japan’s comprehensive value chain for biosimilars—from new development through manufacturing and distribution. It is intended to promote the stable operation of domestic manufacturing facilities, establish a reliable domestic supply system for biosimilars, enable the export of domestically manufactured biosimilar drug substances and formulations, and foster the development of skilled professionals in the field of biologics, thereby contributing to the advancement of Japan’s biopharmaceutical industry.

About Alfresa Holdings
Alfresa Holdings is the holding company for the Alfresa Group, which operates businesses ranging from the development, manufacture, and distribution of pharmaceuticals to the operation of dispensing pharmacies and is the top corporate group in Japan in terms of ethical pharmaceuticals wholesaling, with consolidated net sales exceeding ¥2.9 trillion in the fiscal year ended March 31, 2 2025. Guided by its corporate philosophy, “we create and deliver a fresh life for all,” the entire Group supports supply chains for pharmaceuticals and other products, a form of social infrastructure underpinning Japanese healthcare, contributing to a wide range of medical needs. The company will continue to evolve and expand its total supply chain services to provide integrated services across the Group, from the introduction, development, and manufacture of pharmaceuticals and other products through to their distribution, sale, and post-marketing surveillance, as well as lastmile operations. For more information, visit https://www.alfresa.com/eng/

About Kidswell
Kidswell upholds a corporate philosophy of “biotech striving for value creation—for a comprehensive healthcare system for children, families, and society.” Under this philosophy, it promotes its biosimilars business, a stable earnings base that has already launched four biosimilar pharmaceuticals, and a cell therapy (regenerative medicine) business, which has one potential product in the clinical development stage and is expected to become a foundation for considerable growth in the future. The company engages in R&D activities every day, striving to provide patients suffering from illness with innovative medicines and treatments and thereby help realize a society in which people can live brighter and happier lives. For more information, visit https://www.kidswellbio.com/en/

About Chiome
Chiome is a biotech company dedicated to the discovery and development of antibody drug candidates to treat diseases with high unmet medical needs with its proprietary technologies, such as the ADLib system and Tribody, its polyspecific antibody production technology. In addition to its drug discovery and development business, which handles in-house drug discovery, and its drug discovery support business, which provides high-quality technical services to pharmaceutical manufacturers and other organizations, the company promotes collaboration with pharmaceutical manufacturers and start-ups as a form of integrated drug discovery (IDD), aimed at contributing toward biosimilar-related business and promoting movement in the Japan’s drug discovery ecosystem. For more information, visit https://www.chiome.co.jp/?id=en

About Mycenax
Mycenax is a pioneer in the biopharmaceutical CDMO industry in Taiwan, with a value chain that covers a full range of processes, from cell line construction, production, analytical methods, and formulation development to commercial production and aseptic filling. Out of its development and manufacturing base in Taiwan, the company has integrated the upstream and downstream areas of the biopharmaceutical field and provides CDMO services to customers around the world. For more information, visit https://www.mycenax.com/about.php?id=28&lang=en.

^{Note 1}: An equivalent product of the equivalent quality of a reference (original) biologic that has already been approved and sold in Japan that is sold by a different pharmaceutical manufacturer following the patent expiration and reexamination period of the original biologic

^{Note 2}: Reference biologics refer to biopharmaceuticals that serve as the standard for biosimilars and have already been approved and marketed in Japan. Biopharmaceuticals are complex medicines whose active ingredients are proteins and other substances produced using recombinant DNA technology and cell culture techniques. They are expected to be effective in treating diseases that have been difficult to address with conventional chemically synthesized pharmaceuticals.

^{Note 3}: “Policy for Promoting the Use of Biosimilars,” Ministry of Health, Labour and Welfare (Japanese only) https://www.mhlw.go.jp/content/10807000/001310038.pdf

^{Note 4}: CDMO (Contract Development and Manufacturing Organization):, an organization that undertakes the process from the development of manufacturing process through clinical trial materials to commercial production of pharmaceuticals.