CMIC Group was the first company to provide CRO (contract research organization) services in Japan. Relevant laws and rules had not been established when the group was first established. The CRO Study Group (which later became the Japan CRO Association) was formed by Mr. Kazuo Nakamura, the current CEO of CMIC Group, and others to conduct promotion and public relations activities and to negotiate with the authorities for the establishment of CROs in Japan.
Later, when the new Good Clinical Practice (GCP) regulations came into force in 1997, CROs gained legal ground for the first time, and since then demands for CRO services have rapidly increased. We believe that CMIC’s history directly reflects the history of CROs in Japan.
Acquisition of an inactive company, and Kazuo Nakamura was appointed CEO of the new company
This first contract research organization (CRO) in Japan was founded without existing legislation and operated out of a one-room flat. The history of CMIC directly reflects the history of CROs in Japan.
Founding of the Japan CRO Association with three other companies working in the field at that time
Kazuo Nakamura served as secretariat for 5 years from establishment, and then as a chairman for 13 years (1999-2012), contributing greatly to the development of the association and the industry as a whole. The Japanese CRO market expanded to an estimated worth of 133,000 million yen during this period.
Started clinical research coordination (CRC) services for the first time in Japan (later became the Site Support Institute)
CMIC became the first company to provide CRC/SMO (Site Management Organization) services that are essential for conducting clinical trials in Japan today. The business supports medical institutions in every aspect of conducting clinical studies.
Established the first South Korean CRO as a joint venture
Taking the first step into the larger Asian market (As of 2017, there are 12 sites across Asia, including Singapore and China, as well as sites in the USA).
Enforcement of the new Good Clinical Practice (GCP) guidelines and legislation of CROs
This was followed by rapid development of CROs and expansion within Japan.
Started a contract sales organization (CSO) (later became known as CMIC Ashfield)
The business faced some challenges due to late market entry, but after merging with Ashfield, it came to hold the third largest market share in Japan, providing multi-channel solutions to clients’ diverse needs
Ventured into the Chinese market with CRO services
Started the pharmacovigilance business
Launched services that support quality assurance and bioanalysis of pharmaceuticals(later became known as CMIC Pharma Science Co. Ltd.)
The business entered the non-clinical field by acquiring an analytical laboratory.
Launched a contract development manufacturing organization (CDMO) (later known as CMIC CMO)
Pharmaceutical manufacturing plants were purchased first in South Korea, and then in Japan. (Currently, we have 3 plants in Japan, 1 in the USA, and 1 in South Korea.) The company also entered the challenging field of establishing manufacturing methods for next-generation medicines.
Started CDMO business in the USA (CMIC CMO USA Corporation)
CMIC took its first stride in USA. Bioanalysis services were commenced in Chicago in March 2015.
Launched the RENAPRO® L-FABP test, an in vivo diagnostic for urinary
liver-type fatty acid-binding protein (L-FABP), which has been attracting worldwide attention as a new biomarker of renal disorders RENAPRO® L-FABP test is the world’s first highly sensitive test for L-FABP in urine samples, developed by us at CMIC. Research was conducted at laboratories outside the company due to the nonavailability of necessary facilities in-house.
Became a holding company, CMIC HOLDINGS Co., Ltd, upon divestiture
Established OrphanPacific, Inc., a joint venture for the manufacture and sales of pharmaceuticals, mostly orphan drugs.
This new company utilizes domestic and overseas networks to provide a stable supply of established drugs, introduce drugs for treatment of rare diseases, and assist foreign companies without a Japanese base to enter the Japanese market.
Launched RENISCHIEM L-FABP® for in vivo diagnostic use in Europe
Launched Buphenyl® for the treatment of urea cycle disorders
Urea cycle disorders affect approximately 200 individuals, with an estimated incidence of 1 in 46,000 births in Japan. Buphenyl® had been approved as a standard therapy overseas but not in Japan, and therefore Japanese patients were left with the option of having to import Buphenyl® by themselves. CMIC develops and sells drugs for the treatment of rare diseases for which development has been postponed despite high clinical demand.
Launched Normosang® for the treatment of acute porphyria
Porphyria is a group of inherited disorders caused by mutation of genes associated with enzymes involved in heme biosysthesis, affecting an estimated 1 in 100,000 individuals in Japan (accurate statistics unavailable). Normosang® was included in the list of products designated as drugs for rare diseases in September 2011. It was approved as the first-line drug for acute porphyria in 1985 in Europe, and its approval in Japan is anticipated.
Commenced development of production process of next-generation antibodies
A joint venture was established with JSR Corporation to promote projects to discover and manufacture next-generation antibodies, aimed at providing global support services for development and manufacturing, and supplying processing materials based on the knowledge gained through the project.
Established a consulting team focusing on regenerative medicines
A consulting team specialized in regenerative medicines was also established in response to increasing demands, ahead of others in the industry
Established a joint venture focusing on new pharmaceutical development in the field of oncology
Highly specialized and experienced staff with a wealth of knowledge in oncology were intensively recruited to reinforce the business relating to new pharmaceutical development in the field of oncology.
Capital and business alliance in the CDMO business
Capital and business alliance in the CDMO business with Development Bank of Japan Inc.