July 26, 2016
CMIC HOLDINGS Co., Ltd.
MEDINET Co., Ltd.

CMIC HOLDINGS Co., Ltd. (“CMIC”) and MEDINET Co., Ltd. (“MEDINET”) announced that they have signed Business Alliance Agreement for health and medical care fields of regenerative medicine and cell therapy.

 

Details and Background of the Business Alliance

The Act on the Safety of Regenerative Medicine and the Act on Pharmaceuticals and Medical Devices were enacted in November 2014.  It led to establishment of practice criteria for clinical trials and the expedited approval system for regenerative medicine.  It is believed that this legislation will lead to increase clinical trial activities in Japan. To make gineered cell become a “Regenerative Medical Product ”, it is important to establish systems for transportation, quality management, and the manufacturing process taking into consideration the unique characteristics of the cells and tissues. It requires comprehensive support from the process of development, clinical trials, application for approval, commercial manufacturing, sales, to post-marketing surveillance.
CMIC and MEDINET will fully utilize their techniques and experiences to expand business by providing new solutions to support various services for production and distribution of specified cell products, investigational products, and regenerative medical products. This will contribute to develop of the regenerative medicine and cell therapy.

Our Approaches of Regenerative Medicine Fields

CMIC is encouraging the spread of regenerative medicine quickly and safely by establishing a specialized consulting team for regenerative medicine in May 2015 and
build new facility in July 2016, which is prepared for safe biological studies that are needed for development of regenerative medicine.
In May 2015, MEDINET obtained a license for manufacturing specified cell products at Shinagawa Cell Processing Facility (Shinagawa CPF) adjacent National Strategic Economic Zone.  MEDINET utilizes Shinagawa CPF to focus on contract development and manufacturing of specified cell products, investigational products, and regenerative medical products. This is designed for future contracted development and manufacturing of various manufactured cells such as immune cell, somatic-cell, stem-cell, iPS-cell and etc.

Our Services by the Business Alliance

Through the business alliance, CMIC and MEDINET plan to provide “One -Stop Service” from pre-clinical research through to development, manufacturing, and commercial launch. These services will include formulation comprehensive development strategies, execution of clinical trials, consulting application for approval, quality examination and
stable supply of specified cell products, investigational products and regenerative medical products after launch, and post-marketing surveillance for domestic and foreign customers who are considering development and launch of regenerative medical products in Japan.
CMIC and MEDINET will organize product launch plans in Japan combined with CMIC’S extensive experience as In Country Clinical Care-taker (ICCC)*1 in the pharmaceutical and medical device industries and MEDINET’s most experienced cell-processing expertise as Contract Development and Manufacturing Organization (CDMO)*2 which includes
solutions such as process development and productions of investigational and commercial products. The plan is to provide services so that customers need not establish a local business department and manufacturing plants in Japan.

【CMIC HOLDINGS Co., Ltd.】

CMIC Group started business in 1992 as the first CRO in Japan, and the company today provides comprehensive support services for development, manufacturing, sales, and marketing of pharmaceutical products. Also, the company operates to respond to diversifying needs by managing the Healthcare Business sector and developing and selling diagnostic pharmaceuticals and orphan drugs. CMIC Group has developed a unique business model that we call “Pharmaceutical Value Creator (PVC)” based on our abundant accumulated experience and knowledge as a CRO pioneer.  CMIC utilize PVC to create new value in the healthcare field.

For more information, visit our website: https://www.cmicgroup.com/e/

【MEDINET Co., Ltd.】

MEDINET has provided a comprehensive service, which includes technical know-how, facilities, systems, materials, professional cell-engineers, and other requirements to conduct immuno-cell therapy, to medical institutions as Immuno-Cell Therapy Total Support Service since 1999. With our experience and knowledge in over 160,000 cases with no sever accident, MEDINET offers a range of solutions for the regenerative medicine and cell therapy industries, from pre-clinical research through to development and clinical trial manufacturing, and commercial launch in Japan.

For more information, visit our website:  https://www.medinet-inc.co.jp/english/
*1:It performs the procedures necessary for sponsoring the trial on behalf of the sponsor if the sponsor is not domiciled within Japan.
*2: This business provides lifecycle-spanning services for drugs, medical devices or regenerative medical products from development, investigational products manufacturing, through commercial production.

Contact Us

CMIC HOLDINGS Co., Ltd.

Corporate Communication Division PR Group

Tel : +81-3-6779-8200 /  E-mail: irpr@cmic.co.jp

MEDINET Co., Ltd.

Corporate Strategy Department

Tel : +81-45-478-0041  /  E-mail:  info-cmo@medinet-inc.co.jp