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SanBio's nerve cell therapy gets FDA regenerative medicine tag

The U.S. Food and Drug Administration granted the regenerative medicine advanced therapy designation to SanBio Group's SB623 to treat patients with chronic neurological motor deficits following a brain injury.

The SanBio Group, which consists of Japanese biotechnology company SanBio Co. Ltd. and Mountain View, Calif.-based SanBio Inc., said the status was backed by data which showed that patients receiving SB623 had improved motor functions compared to those that received sham surgery in a phase 2 trial.

The designation allows for expedited development of cell therapies, such as SB623, and the potential for a priority review and accelerated approval. The treatment works by triggering the brain's natural regenerative ability to recover lost motor functions.

SanBio said it is looking to work with the FDA on a potentially accelerated clinical development program.

SB623 has already secured an advanced therapy medicinal product designation in the EU and the Sakigake designation in Japan, which promotes the development of innovative medicines.