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Junshi/Coherus Approved for US Launch of PD-1 without US Trials

publication date: Oct 30, 2023

Shanghai Junshi Bio and Coherus BioSciences announced the US FDA approved their partnered PD-1 drug, Loqtorzi™, to treat two relatively rare nasopharyngeal carcinoma indications without any US trials. In early 2022, the FDA refused to OK a PD-1 developed by Lilly and Suzhou Innovent because the IND’s trial data did not include any Caucasians. The rejection implied that China’s novel drugs could not be brought to the US based on China data. It seems the situation is more nuanced than previously thought, though the actual rules aren’t entirely clear. More details....

Stock Symbols: (HK: 1877; SHA: 688180) (NSDQ: CHRS)

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