CSPC Pharma (01093.HK) announced that its newly developed Class 1 biological product, En Shuxing (trade name: Enshu Xing@), used for treatment, has been conditionally approved for listing by the China National Drug Administration.

The product is a recombinant anti-PD-1 fully human monoclonal antibody of the IgG4 type targeting human programmatic cell death protein-1 (PD-1), which reverses the inhibitory immune response mediated by the PD-1 pathway, and thereby activates the body's anti-tumor immune response. The product is approved for the treatment of recurrent or metastatic cervical cancer patients with positive PD-L1 expression (CPS≥1) who have failed previous platinum-based chemotherapy. This approval was primarily based on a crucial phase II clinical trial that included patients with recurrent or metastatic cervical cancer who previously failed at least one platinum-based chemotherapy regimen with positive PD-L1 expression (of which 36.5% had previously received ≥2 lines of systemic treatment). The results showed that the product significantly improved objective response rate (ORR) of advanced cervical cancer, with an ORR evaluated by an independent imaging evaluation committee of 29%, including 2 complete remission and 29 partial remission cases, with a median duration of response of 16.6 months. At the same time, the safety of the product is excellent.

This is the first indication for which this product has received marketing approval. Currently, a phase III clinical trial evaluating the combination of En Shuxing with platinum-containing chemotherapy with/without pembrolizumab for frontline treatment of recurrent or metastatic cervical cancer patients with PD-L1 positivity (CPS≥1) is underway. In addition, multiple clinical trials on different solid tumors using combination therapies involving nanomedicines, antibody drugs/conjugates, small molecule drugs, etc. developed by Allied Group are also underway.