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Japan fast-tracks cell and gene therapies
Japan's regenerative law
Shinya Yamanaka won the Nobel Prize in 2012 for his work creating a new, simple way to generate stem cells. A regenerative medicine law followed that fast-tracks cell and gene therapies. A wave of innovative startups was born from this movement, and some of them already manufacture their own cell therapies.
How the US compares
The US is fairly conservative on these therapies, though the FDA shows growing intent to fast-track cell and gene therapies. South Korea and Japan are among the countries that move faster, and Japan pairs the speed with high-quality medical care.
Why build there
Japan also has one of the longest lifespans in the world and a massively aging population. The mix of regulation, science, and demand is one reason a longevity company chose to build there, with customers that include one of the largest life science conglomerates in the country.
How did Yamanaka turn skin cells into stem cells?
In 2006, Shinya Yamanaka's lab showed that adding four genes, Oct4, Sox2, Klf4, and c-Myc, to mouse skin cells reprogrammed them into cells that act like embryonic stem cells. His team repeated this in human cells in 2007. The resulting cells are called induced pluripotent stem cells. Yamanaka shared the 2012 Nobel Prize in Physiology or Medicine with John Gurdon.
How does Japan's conditional approval work?
Changes to Japan's drug law in 2014 created a path for regenerative medicine products. A product can win conditional, time-limited approval based on safety and probable efficacy. The maker must then confirm efficacy within a set period, up to seven years. If it fails to do so, the approval can be withdrawn.
Why do cell therapies need special rules?
Cell therapies are living products that vary by donor and cannot be sterilized like a pill. The patient groups they treat are often small, which makes large trials hard to run. Regulators have therefore built separate pathways for them. The first CAR-T therapy to win US approval was Kymriah in 2017.
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