Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its adebrelimab (SHR-1316), a programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb). The molecule is now approved for use in combination with chemotherapy to treat first-line extensive stage small-cell lung cancer (ES-SCLC), marking a significant advancement in the treatment options available for this aggressive form of cancer.
Clinical Trial and Efficacy
Adebrelimab was evaluated in the CAPSTONE-1 study as a treatment for ES-SCLC versus chemotherapy alone. The study enrolled 462 patients across various sites in China. Results showed a statistically significant improvement in overall survival (OS) with adebrelimab, achieving 15.3 months compared to 12.8 months for chemotherapy alone. This significant improvement highlights the potential of adebrelimab to enhance patient outcomes in the treatment of ES-SCLC.
Market Approval and Development Pipeline
The market approval filing for adebrelimab was submitted in January of this year. Hengrui is actively developing the molecule for various other solid tumor types, including non-small cell lung cancer, ovarian cancer, and hepatocellular carcinoma. This broad development strategy positions Hengrui to potentially expand the use of adebrelimab across multiple cancer indications, further solidifying its role in the oncology treatment landscape.-Fineline Info & Tech
