Japan will use for the first time a stem cell treatment owned by Mesoblast Pharmaceutical. The product will be launched on the market by JCR Pharmaceutical, a local partner.
The treatment will be used for the so-called graft versus host disease (GVHD), which is a side effect of bone marrow or umbilical cord blood transplant surgery.
Around 1200 people in Japan develop acute GVHD every year, according to the Japan Society of Hematopoietic Cell Transplantation.
Broker Bell Potter estimated this could be a $59 million-a-year market and, if the number of transplants will grow, this should see a rise in demand for the treatment. If approved, this would be the first allogeneic stem cell product to be launched in Japan, according to the international press.
JCR could obtain approval within a year from filing to launch the treatment, which would rank it as one of the first of Mesoblast’s products to be launched.
Instead of phased clinical trials, the law changes enable regenerative medicines to demonstrate efficacy in pilot studies of as few as 10 patients if the change is dramatic enough, or a few hundred with more marginal treatments.