Origin of Company Name
It was believed that bio-venture companies, especially who aim drug development, was typically high risk and high return for the investment. In fact, the cost for the drug development tends to be more than hundreds million US dollars in major advanced countries and therefore, quite numbers of Japanese bio-venture companies discontinued their developments by failure in the clinical trials as phase II (evaluation of efficacy with small numbers of patients) or phase III (pivotal study with larger numbers of patients). According to this feature, which means extensive investment are required for the drug development, in case of a company with multiple pipelines, it would be reasonable that the investors regard such company as high risk.
However, now the situation will be changed in Japan, especially in the field of regeneration medicine. “Bills on Safety Assurance of Regenerative Medicine” and “Law for Partial Revision of the Pharmaceutical Affairs Law” will become effective at 25th November this year and they are to become strong driving forces to boost up the field of regenerative medicine. In this circumstance, the risk of the development of regeneration medical products will become drastically mitigated by obtaining seeds, whose clinical data are already filed in clinical researches performed in i.e., universities. Moreover, the regeneration medical products could be launched much earlier by utilizing the temporal approval system, compared with other conventional drugs. In this system, MHLW (Ministry of Health, Labour and Welfare) is able to temporally approve the regeneration medicine products whose clinical data represent safety and suggestive efficacy. After launching the products, further clinical trials will be continued to accumulate the efficacy and safety data for the authorization of the definitive approval. Furthermore, manufacturing of the regeneration medical products derived from human cells are definitively categorized in this new law and allowed to be outsourced as medical service. All together, bio-venture companies could minimize the risk of the development of the regeneration medical product and maximize the return by implementing several pipelines in low costs. Regience seeks to be the leading company in this field of regeneration medicine.