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On September 3, the CDE official website showed that Dongyang Sunshine’s 3.
3-type recombinant anti-PD-1 fully human monoclonal antibody injection was declared for clinical use
.
This is the second domestically reported PD-1 biosimilar drug, and it is presumed to be a nivolumab biosimilar drug
Shandong Boan Biology was the first to declare PD-1 biosimilars in China
.
The nivolumab-like drug LY01015 was first submitted for clinical application in February 2021 and was approved for clinical use on May 6, and clinical trials have not yet started
The internal volume of PD-1 is continuously increasing.
According to the Insight database, in addition to the approved products, there are still 32 models under development; dual antibodies are the new hotspot in research and development.
Domestic PD-1 pattern (Clinical Phase III project)
From: Insight database