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Conditional Global-First Nod For SanBio's Cell Therapy for TBI

But Product Consistency Challenge Looms

 
• By Lisa Takagi

SanBio’s lead cell therapy asset has been on a bumpy journey to its global-first approval and while a nod has now come in Japan in a high-need indication, a commercial launch is conditional on additional data to establish product equivalence and manufacturing consistency. 

SanBio's Akuugo can be the global first pharmaceutical product approved for TBI treatment.
• Source: Shutterstock

Japan has cautiously granted a conditional, global-first approval to SanBio Co., Ltd’s autologous mesenchymal stem cell (MSC)-based therapy Akuugo (vandefitemcel; SB623) for traumatic brain injury (TBI), setting the stage for a market debut after development setbacks in other settings. 

But regulatory authorities have said the regenerative medicine cannot be marketed until product equivalency between manufacturing batches can be properly...

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