Ligand Pharmaceuticals Incorporated announced that its partner CStone Pharmaceuticals has received approval from China’s National Medical Products Administration (NMPA) for sugemalimab (Cejemly®), an OmniAb-derived anti-PD-L1 monoclonal antibody, for the first-line treatment of metastatic (stage IV) non-small cell lung cancer (NSCLC) in combination with chemotherapy. Sugemalimab is an anti-PD-L1 antibody in development to treat various cancers. Positive results from the planned interim analysis of the Phase 3 study in stage IV NSCLC (GEMSTONE 302) were reported in August 2020 and updated data were presented in a late-breaking oral presentation at the IASLC 2021 World Conference on Lung Cancer, showing that sugemalimab plus chemotherapy continued to demonstrate improvement in progression-free survival (PFS) than seen in the interim analysis. CStone reported in May 2021 that the Phase 3 study evaluating sugemalimab in stage III NSCLC (GEMSTONE-301) met its primary endpoint of prolonged PFS in a planned interim analysis. On September 2, CStone announced that the NMPA accepted the NDA of sugemalimab for consolidation therapy in patients with unresectable stage III NSCLC who have not progressed after concurrent or sequential radiotherapy and chemotherapy. In addition to NSCLC, sugemalimab is being investigated in a Phase 2 registrational study for relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) and in Phase 3 registrational studies for gastric cancer and esophageal cancer. Sugemalimab has received breakthrough therapy designation from both the U.S. Food and Drug Administration and Center for Drug Evaluation (CDE) of China’s NMPA for the treatment of adult patients with R/R ENKTL.