China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced the completion of a market approval filing with the National Medical Products Administration (NMPA) in China for its programmed-death 1 (PD-1) monoclonal antibody (mAb), Enlangsubai. The targeted indication is recurrent or metastatic cervical cancer with positive PD-L1 expression that has failed at least first-line platinum-containing chemotherapy.
Phase III Study Initiation
In addition to the market approval filing, Enlangsubai has also initiated a Phase III confirmatory study in first-line cervical cancer. This study aims to further validate the drug’s efficacy and safety in treating cervical cancer at an earlier stage, potentially expanding its therapeutic applications.
Significance of the Development
The completion of the market approval filing and the initiation of the Phase III study mark significant milestones for CSPC Pharmaceutical. These developments highlight the company’s commitment to advancing innovative cancer treatments and improving patient outcomes for cervical cancer patients with unmet medical needs.-Fineline Info & Tech
