History of CMIC

April 1992

​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.

September 1994

​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.

June 1996

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.

1996

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).

April 1997

​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.

August 2000

​​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.

September 2001​

​Ventured into the Chinese market with CRO services

June 2002

​​Started the pharmacovigilance business

July 2004

​​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.

August 2005

​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.

December 2007

​​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.

January 2011

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.

January 2012

​​Became a holding company, CMIC Holdings Co., Ltd, upon divestiture

May 2012

​​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.

December 2012

​​Launched RENISCHIEM L-FABP® for in vivo diagnostic use in Europe

January 2013

​​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.

August 2013

​​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.

July 2014

​​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.

May 2015​

​​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.

February 2016

​​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.

June 2017

​​Established a joint venture focused on analytical research in China

​This joint venture with Shanghai Fosun Pharmaceutical Development Co., Ltd. was established to provide analytical laboratory services for generic pharmaceuticals.

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