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ENERGI-F703DFU is currently in Phase III clinical development in both Taiwan and the US.
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Under the agreement, Daiichi Sankyo handles development and supply, while Innovent Biologics leads commercialisation in China.
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The approval means mFlusiva becomes the first mRNA-based vaccine to be authorised on the US market for flu prevention.
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Alongside Alkeus, several companies like Belite Bio, Ocugen and Nanoscope are aiming to secure a place on the Stargardt market where there are no approved therapies.
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The biotech will now focus on the two other BiTEs in its pipeline, CTIM-76 and CT-202.
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