Li Ning (Junshi)
A 'breakthrough' PD-1? From China? FDA says why not for rare cancer
PD-(L)1 inhibitors may be the standard of care and the cornerstone therapy for a number of cancers, but in other niches, the FDA is still happy to consider them a breakthrough.
Late Thursday — and early Friday in China — regulators granted the breakthrough designation to Junshi Biosciences. It’s a first for an anti-PD-1 from China, said the Shanghai-based, Hong Kong-listed biotech, which also won the domestic race by nabbing the first Chinese checkpoint OK back in December 2018.
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