June 3, 2024

Practical Application of Pharmaceuticals Using iPS Cells is Within Reach

Qualips, a rising star from Osaka University, has made a significant stride in the race for iPS cell technology. They are on the verge of submitting a regulatory application to the Ministry of Health, Labour and Welfare for iPS cell-derived cardiac muscle sheets. This pivotal move, when Japanese companies are striving to keep pace with their international counterparts in the commercial development of iPS cells, underscores the global competition in this field and the potential game-changing impact of Qualips's product.

The journey of iPS cells, a testament to human ingenuity, began in 2006 with the groundbreaking work of Shinya Yamanaka, a renowned professor at Kyoto University. He achieved a feat that was once thought impossible, becoming the first person in the world to generate iPS cells from mice successfully. His pioneering work continued in 2007, when he replicated this success with human iPS cells, marking a significant milestone in regenerative medicine and inspiring a new era of possibilities.

Research and development began in earnest in 2014 with the enactment of the "Law for Ensuring the Safety of Regenerative Medicine, etc." (New Law for Regenerative Medicine). In the same year, Masayo Takahashi, the project leader at the Institute of Physical and Chemical Research and current president of Vision Care Inc., and her team performed the world's first transplant for retinal disease.

On the other hand, the Ministry of Health, Labour and Welfare has been cautious in developing practical uses, considering safety, including cancer risk. In Japan, research is primarily conducted by universities. Some criticism has come from pharmaceutical companies and clinicians, questioning the focus on research and the need for more perspective on manufacturing technology or practical application hubs.

The development of company-led projects is shifting to international locations. Cynata Therapeutics, based in Australia and partially owned by Fujifilm, and Fate Therapeutics in the US, along with others, are progressing with corporate clinical trials. Blue Rock Therapeutics, a company owned by German-based Bayer and located in the US, has initiated the development of a treatment for Parkinson's disease.

In Japan, clinical trials for Parkinson's disease are being conducted by Kyoto University and Sumitomo Pharma. Additionally, a start-up company from Keio University has also begun clinical trials. However, practical application will take some time. If Qualips's product is approved, it will significantly advance regenerative medicine in Japan.