Enlonstobart Injection.

‌Enlonstobart Injection is a fully human, high-affinity anti-PD-1 IgG4 monoclonal antibody designed to treat patients with recurrent or metastatic cervical cancer who are PD-L1 positive. ‌

Enlonstobart Injection was developed by CSPC Pharmaceuticals and is indicated for patients with recurrent or metastatic cervical cancer who are PD-L1 positive (CPS ≥ 1) and have failed previous platinum-based chemotherapy. The mechanism of action of this drug is to reverse the inhibitory immune response mediated by the PD-1 pathway and activate the body’s anti-tumor immune response by blocking the interaction of PD-1 with PD-L1 and PD-L2.

Clinical study results of Enlonstobart Injection showed that the drug has a good effect on patients with PD-L1 positive recurrent or metastatic cervical cancer. A Phase II study called SYSA1802-CSP-004 was conducted in 47 institutions in China, and a total of 107 patients with PD-L1 positive, recurrent or metastatic cervical cancer were included. The primary endpoint of the study was the objective response rate (ORR) assessed by an independent review committee according to RECIST version 1.1. In addition, the safety of Enlangsubaimab has also been verified, providing a new treatment option for patients with recurrent or metastatic cervical cancer.

In addition, Enlangsubaimab injection (SG001) is a recombinant anti-PD-1 fully human monoclonal antibody developed by Shijiazhuang Pharmaceutical Group, which is an IgG4 type monoclonal antibody drug. The Phase 3 clinical trial of this drug is a randomized, double-blind Phase 3 clinical trial conducted in China, which aims to evaluate the efficacy and safety of this drug plus platinum-containing chemotherapy with or without bevacizumab for the first-line treatment of patients with PD-L1-positive recurrent or metastatic cervical cancer.

In summary, Enlangsubaimab, as a new type of therapeutic drug, provides new treatment hope for patients with recurrent or metastatic cervical cancer, especially in the case of limited treatment options for recurrent or metastatic cervical cancer after first-line treatment. Its efficacy and safety have been preliminarily verified, and further clinical studies are underway to confirm its efficacy and safety‌1