CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of sugemalimab in combination with chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC). Sugemalimab is CStone’s proprietary programmed death-ligand 1 (PD-L1) targeted antibody.
The positive CHMP opinion is based on the results of the Phase III GEMSTONE-302 study, which demonstrated the efficacy and safety of sugemalimab in treating NSCLC. With this recommendation, sugemalimab is poised to become the first anti-PD-L1 monoclonal antibody (mAb) approved in Europe for both squamous and non-squamous NSCLC, irrespective of PD-L1 expression levels. This milestone also positions CStone to be the first Chinese biopharmaceutical company to potentially launch a domestic anti-PD-L1 mAb in markets outside of China. In China, sugemalimab has already been approved for five indications, including stage III and IV NSCLC, extranodal NK/T-cell lymphoma, esophageal squamous cell carcinoma, and gastric cancer.- Flcube.com
