On February 8, according to the official website of NMPA, the fenolimab injection (trade name: Anyouping) submitted by Sinocell Engineering Co., Ltd. was approved for marketing. Indications: This product is used in combination with platinum-containing chemotherapy for the first-line treatment of recurrent and/or metastatic head and neck squamous cell carcinoma.
Fenolimab is a recombinant humanized anti-PD-1 IgG4 monoclonal antibody injection independently developed by Sinocell. It can block the binding of PD-1 to its ligand, increase the supply of T cells and inflammatory cytokines in the tumor site, reduce the proportion of regulatory T cells and myeloid-derived suppressor cells in the tumor microenvironment, change the tumor microenvironment, restore and enhance the immune killing function of T cells, and thus inhibit tumor growth.

According to Yaozhi data, as of now, 12 PD-1 monoclonal antibodies have been approved for marketing in China, including 2 imported drugs and 10 domestic drugs.
In terms of the indication of head and neck squamous cell carcinoma, previously only Merck's K drug and BMS's O drug were approved in China. Sinocell's fenolimab is the first domestically produced PD-1 monoclonal antibody approved for the treatment of head and neck squamous cell carcinoma.
In addition to head and neck squamous cell carcinoma, Sinocell has also submitted a new indication application for fenolimab combined with bevacizumab for the first-line treatment of hepatocellular carcinoma (acceptance number: CXSS2400009). Yaozhi Data predicts that it is expected to be approved in the near future.

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