Sumitomo Pharma and RACTHERA have submitted an application to Japan’s Ministry of Health for market authorization of its stem cell-derived therapy for Parkinson’s, Raguneprocel.
What’s Raguneprocel, and how’s it being used?
Raguneprocel consists of induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cells (neural progenitors are immature cells that have not yet become dopamine-producing neurons). Dopamine is a key neurotransmitter in motor control, and the lack thereof is a hallmark of Parkinson’s disease, hence the shaking/inability to control movement.
Sumitomo Pharma, amongst many others, is hoping that transplanting its stem cell therapy can regenerate those dopamine-producing neurons.
Raguneprocel has through safety/efficacy Phase 1/2 trials at Kyoto University Hospital, which showed good safety and efficacy; you can read the published results in Nature here.
If approved, the product will be marketed by Sumitomo Pharma and produced by its CDMO, S-RACMO (a joint venture between Sumitomo Chemical and Sumitomo Pharma).
The therapy has been granted priority review status under Japan’s SAKIGAKE Designation System, which is designed to accelerate the development and review of innovative medical products.
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