Junshi gets a ‘breakthrough’
Shanghai’s Junshi Biosciences achieved another milestone last week when the Food and Drug Administration granted a breakthrough therapy designation for toripalimab for the treatment of nasopharyngeal carcinoma. The announcement makes toripalimab the first China-made PD-1 drug to receive a breakthrough therapy designation. The therapy received an orphan drug designation from the U.S. regulators earlier in May.
China watchers will remember that toripalimab, marketed as Tuoyi, became the first homegrown PD-1 drug to be approved by China in December 2018.
The breakthrough therapy designation “recognizes the significant clinical benefits toripalimab has shown for the treatment of nasopharyngeal carcinoma” and will allow the company to work closer with the FDA, Junshi’s CEO Ning Li said in a statement.
Last week, the company also announced the formation of a joint venture with Beijing Eirene Biotech to co-develop a drug that targets CD39, an enzyme upregulated in various cancers that is responsible for immune suppression in tumor microenvironments.
China watchers will remember that toripalimab, marketed as Tuoyi, became the first homegrown PD-1 drug to be approved by China in December 2018.
The breakthrough therapy designation “recognizes the significant clinical benefits toripalimab has shown for the treatment of nasopharyngeal carcinoma” and will allow the company to work closer with the FDA, Junshi’s CEO Ning Li said in a statement.
Last week, the company also announced the formation of a joint venture with Beijing Eirene Biotech to co-develop a drug that targets CD39, an enzyme upregulated in various cancers that is responsible for immune suppression in tumor microenvironments.
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