CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has received marketing approval from the European Commission (EC) for its PD-L1 inhibitor, Cejemly (sugemalimab). The approval covers the drug’s use in combination with platinum-based chemotherapy as a first-line treatment for adults with metastatic non-small-cell lung cancer (NSCLC), excluding patients with sensitizing EGFR mutations, ALK, ROS1, or RET genomic tumor aberrations. This marks a historic moment as sugemalimab becomes the first home-grown PD-L1 inhibitor to gain approval outside of China, highlighting the company’s global expansion strategy.
The decision by the EC follows the positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is based on the Phase III GEMSTONE-302 study. This trial demonstrated that the combination of sugemalimab with chemotherapy significantly improved progression-free survival and overall survival rates compared to the placebo group in patients with metastatic NSCLC.
In addition to the EC approval, CStone has entered into a strategic partnership with Ewopharma, granting the European firm the rights to commercialize sugemalimab in Switzerland and 18 Central and Eastern European Countries (CEECs). This collaboration is expected to enhance the drug’s accessibility and further solidify CStone’s presence in the global oncology market.- Flcube.com
