CStone nabs fifth Chinese approval for anti-PD-L1 drug

Chinese biopharma CStone Pharmaceuticals (HKEX: 2616) has won a fifth approval for Cejemly (sugemalimab) in China.

The National Medical Products Administration (NMPA) has approved the supplemental biologics license application (sBLA) for Cejemly alongside fluoropyrimidine and platinum-containing chemotherapy as a first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression.

"We are working closely with the US Food and Drug Administration and European Medicines Agency and other global regulatory bodies to explore registration pathways"Cejemly becomes the world’s first PD-L1 monoclonal antibody approved for this indication.