Business Alliance between ArkMS Inc. and M-With Co., Ltd. to Expand CRO Business

ArkMS Inc. (Headquarters: Toshima-ku, Tokyo; President: Hitoshi Mizuo; hereinafter 'ArkMS'), a subsidiary of our company, has entered into a basic agreement for a business alliance with M-With Co., Ltd. (Headquarters: Osaka-shi, Osaka; President: Shunichi Sugimoto; hereinafter 'M-With') regarding safety-related support services and sales activities for pharmaceuticals and medical devices. Details are as follows.

1. Background and Purpose A notification issued by the Ministry of Health, Labour and Welfare in July 2024 states that if no specific issues requiring evaluation arise during the approval review process or post-marketing, post-marketing effectiveness can be evaluated through methods such as literature analysis rather than post-marketing surveillance (PMS). However, when the number of clinical trial cases is limited, PMS is highly important, and continuous safety evaluation and the promotion of proper use are essential. In addition, with the sophistication of post-marketing safety support, there is a growing need for planning and consulting beyond routine post-marketing surveys, as well as the creation of RMP-related materials and medical writing.

The Alfresa Group positions 'Total Supply Chain Service (TSCS)'—which provides integrated support from drug introduction/development and manufacturing to logistics, sales, PMS, and last-mile delivery—as a pillar of its business strategy. We provide the 'PATH-Solution' platform to comprehensively support the entry of overseas emerging biopharmaceutical companies into the Japanese market. As a CRO within the TSCS, ArkMS provides comprehensive, high-quality solutions in the fields of pharmaceuticals, medical devices, and regenerative medicine, ranging from clinical trials and investigator-initiated trials to post-marketing surveillance.

Through this alliance, we will bring together experts from both companies with practical experience in pharmaceutical companies to further strengthen our systems in PMS, PV, and medical writing in the GVP and GPSP domains, where M-With excels. By sharing sales networks, we aim to expand opportunities for proposals to existing clients and create new business opportunities. Through these efforts, we will further expand ArkMS's CRO business and TSCS functions.