CSPC Pharma's subsidiary, Giant Stone Bio-Pharmaceutical Co., Ltd. (referred to as "Giant Stone Bio"), which developed Enlang Subei monoclonal antibody injection (trade name: Enshuxi), recently obtained conditional approval from the National Medical Products Administration for its listing application.
Enlang Subei monoclonal antibody injection is a recombinant anti-PD-1 fully human monoclonal antibody, which is an IgG4 monoclonal antibody drug. It targets human programmed cell death protein-1 (PD-1) to reverse the inhibition of immune response mediated by the PD-1 pathway, thereby activating the body's anti-tumor immune response. The indication approved for this product is for the treatment of relapsed or metastatic cervical cancer patients with a history of failure to platinum-containing chemotherapy and PD-L1 expression ≥1. This approval is mainly based on a key phase II clinical trial, where the study subjects were relapsed or metastatic cervical cancer patients with PD-L1 expression positive that had failed platinum-containing first-line treatment (of which 36.5% had received ≥2 systemic treatments). The results showed that this product significantly improved the objective response rate (ORR) of advanced cervical cancer, with an ORR evaluated by an independent imaging evaluation committee of 29%, including 2 complete remissions and 29 partial remissions, and a median duration of response of 16.6 months. At the same time, the safety of the product is good.