Vol.10 Issue 2 / Latest topics 1Expanding the Clinical Testing Business Based on Synergies between Analytical and Measuring Instruments and Culture Media/Reagents

Making Nissui Pharmaceutical a Wholly-Owned Subsidiary In November 2022, Shimadzu Corporation used the prerogative from a stock merger to make Nissui Pharmaceutical Co., Ltd. (with Head Office at Taito-ku, Tokyo, and President Tokuya Ono) a wholly-owned subsidiary.
Nissui Pharmaceutical Co., Ltd., has changed its trade name to Shimadzu Diagnostics Corporation (hereinafter “SDC”) since April 1, 2023.

Given that analytical and measuring instruments are Shimadzu’s strongest product segment, adding SDC, which has extensive sales channels in clinical markets and a wealth of technology and expertise related to reagents, as a wholly-owned subsidiary will increase the corporate value of Shimadzu Corporation by generating synergies in the following three business areas.

  • Clinical diagnostics: Offer solutions that combine SDC’s reagents with Shimadzu’s liquid chromatograph mass spectrometers (LCMS),PCR testing systems, and other products.
  • Clinical microbial testing: Newly enter the clinical microbial testing market by advancing product development with SDC’s commercial distribution and technological capabilities in the field.
  • Cellular analysis: Use SDC’s culture media and Shimadzu

Investing in Biotech Venture MiCAN Technologies:Expanding Clinical Business by Focusing on Cell-Related Business In April 2023, SDC invested approximately 50 million yen in MiCAN Technologies, Inc. (Head Office: Kyoto City, hereinafter “MiCAN”), a biotechnology venture specializing in regenerative medicine, in addition to approximately 20 million yen invested in MiCAN in 2019.

In 2019, MiCAN developed Mylc cells, the world’s first white blood cells from humans that can be grown in culture. Developed from blood or iPS cells, Mylc cells offer high sensitivity to stimuli (suited to drug response testing), a homogeneous cell population with identical genetic information,and low production costs.

Pyrogen testing is essential to regenerative medicine. The test determines whether pharmaceutical products and vaccines are free of contamination by fever-inducing substances (pyrogens) found in bacteria. Laws in many countries require pyrogen testing on every production batch before shipment.Pyrogen testing is currently performed by animal testing in rabbits,but this practice is expected to be replaced by a cell-based test (the monocyte activation test, hereinafter “MAT”) based on forthcoming pharmacopoeia revisions and other regulatory changes in Europe and Japan. In 2021, MiCAN developed a MAT procedure using Mylc cells (MylcMAT method). With this additional investment, MiCAN will establish a stable production system for Mylc cells. SDC and MiCAN will commercialize a simple MylcMAT kit consisting of Mylc cells, test reagents, and cell culture media. They will jointly market this kit in Japan and Europe.

Shimadzu Group will continue to focus on cell-related business and work with MiCAN to expand global sales of test kits based on Mylc cell technology.In the clinical diagnostics business, Shimadzu Group is also exploring working with MiCAN to develop infectious disease test reagents.
These are used in PCR testing systems and liquid chromatograph mass spectrometers.