Since Japan introduced its "Sakigake" pioneering therapy review and approval scheme on a pilot basis in 2015, a total of 27 products have been admitted, with 11 moving through to their first approval globally, including several innovative new treatments for oncology and rare diseases.
Big In Japan: Assessing Seven Years Of Sakigake
11 Global-First Approvals
Japan’s fast-track approval system for innovative drug candidates has marked its seventh year since launch, during which it has accepted 27 candidates with 13 of these moving to approval. But in recent years the system has faced a decreasing number of admitted candidates, this original infographic analysis shows.

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