On the evening of February 11th, China Securities Network reported that Shenzhou Cell announced that its holding subsidiary Shenzhou Cell Engineering Co., Ltd. (hereinafter referred to as "Shenzhou Cell Engineering") had recently received approval from the National Medical Products Administration for the issuance of Finolizumab Injection (trade name: Anyuping) ®） The Drug Registration Certificate is used for the treatment of head and neck squamous cell carcinoma.

Finolizumab is a recombinant humanized anti-PD-1 IgG4 monoclonal antibody injection independently developed by the company (project code: SCT-I10A）， This is approved for the treatment of head and neck squamous cell carcinoma. Finolizumab is a functional monoclonal antibody against PD-1, which can increase the supply of T cells and inflammatory cytokines at the tumor site by blocking the binding of PD-1 to its ligand, reduce the proportion of regulatory T cells and myeloid derived suppressor cells in the tumor microenvironment, alter the tumor microenvironment, restore and enhance the immune killing function of T cells, and thus inhibit tumor growth.

As of February 11th, globally, only pembrolizumab has been approved as a first-line treatment for head and neck squamous cell carcinoma, and pembrolizumab is only approved as a monotherapy for PD-L1 positive individuals in China. There are currently no PD-1/L1 inhibitors approved as first-line treatment for the entire population of head and neck squamous cell carcinoma in China. According to the comparison of phase III clinical research results between fenokinumab and pembrolizumab, the combination of fenokinumab and chemotherapy has significant competitive advantages in various indicators such as objective response rate, complete response rate, median progression free survival, and median overall survival. After being approved for market, Finolizumab is expected to fill the gap in the lack of officially approved immunotherapy drugs for the entire population of first-line head and neck squamous cell carcinoma in China, providing a new treatment option for the first-line treatment of advanced head and neck squamous cell carcinoma. (Zhao Wanying)