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Junshi and Coherus Upbeat Despite US Rejection of Partnered PD-1

publication date: May 2, 2022

Stressing the positive, Shanghai Junshi Biosciences and its US partner, Coherus Bio, were not daunted by a US rejection of the BLA for their partnered PD-1 to treat nasopharyngeal carcinoma (NPC). The companies said the US FDA asked for a quality process change that is “readily addressable,” and they hope to resubmit the NDA by mid-summer. The major difficulty is scheduling an onsite inspection, given China’s COVID restrictions. In 2021, Junshi out-licensed US/Canada rights for the PD-1 to Coherus in a $1.1 billion deal. More details....

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

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