Biopharmaceutical company CStone Pharmaceuticals (HKEX:2616) on Friday announced European Commission approval of sugemalimab (Cejemly) in combination with platinum-based chemotherapy for first-line treatment of non-small cell lung cancer (NSCLC).
The drug becomes the first Chinese-developed anti-PD-L1 monoclonal antibody approved in Europe.
This approval was based on the GEMSTONE-302 Phase 3 trial, which demonstrated improved survival rates.
CStone has partnered with Swiss pharmaceutical company Ewopharma for commercialisation in Central and Eastern Europe and in Switzerland. The company is seeking further partnerships for Western Europe and other regions.
CStone plans to submit additional applications to the European Medicines Agency for indications in other cancer types.
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