CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) of China has approved its market approval filing for enronsubaimab, a programmed-death 1 (PD-1) monoclonal antibody (mAb). The drug is indicated for the treatment of recurrent or metastatic cervical cancer in patients with positive PD-L1 expression who have failed at least first-line platinum-containing chemotherapy.
The regulatory approval was granted based on data from a pivotal Phase II study, which demonstrated that enronsubaimab significantly improved the objective response rate (ORR) in advanced cervical cancer. The Independent Imaging Review Committee reported an ORR of 29%, including two complete responses and 29 partial responses, along with a median duration of response of 16.6 months. The drug also showed a favorable overall safety profile.
The Category 1 biologic, enronsubaimab, is currently undergoing a Phase III clinical study in combination with chemotherapy, with or without bevacizumab, for first-line treatment of PD-L1 positive recurrent or metastatic cervical cancer.- Flcube.com
