Japan’s Healios Eyes First Approvals As It Progresses Regenerative Therapies
Healios, a Japanese regenerative medicine bioventure, expects to continue benefiting from a supportive regulatory environment in Japan as it progresses three clinical assets toward approval in the next few years, says CEO Dr. Hardy Kagimoto in an exclusive interview.
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While the environment for cell and regenerative medicines in Japan is ‘exciting’ and positive, ongoing dialog with policy makers and regulators is needed to ensure a reflection of industry and patient concerns, one CEO says.
Japan has formally enacted new legislation governing the development, approval and use of regenerative medicines, including induced pluripotent stem (iPS) cells, in a move welcomed by companies both inside and outside the country.
While it was not as affected as some other countries, Japan still had the pandemic to deal with and regulators responded while managing to keep up regular product review work, including several world-first approvals. Coronavirus vaccine roll-outs and the first general annual reimbursement price cut are on the cards for this year.