CStone Announces MHRA Approval of Sugemalimab for First-Line Treatment of Non-Small Cell Lung Cancer in the UK

CStone China

This approval marks the second international marketing authorization for sugemalimab outside of China, following its recent approval by the European Commission.The approval is based on results from the Phase 3 GEMSTONE-302 clinical trial, which demonstrated that sugemalimab in combination with chemotherapy significantly prolonged progression-free survival (PFS) and overall survival (OS) in treatment-naive patients with metastatic NSCLC.Long-term survival data from the GEMSTONE-302 study were presented at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting.CStone is actively communicating with regulatory authorities, including the European Medicines Agency (EMA) for marketing authorization applications for additional indications of sugemalimab.CStone has entered into a strategic commercialization partnership with Ewopharma for sugemalimab in Central & Eastern Europe and Switzerland, with further collaborations expected soon in regions including Western Europe, Latin America, the Middle East, and Southeast Asia.View original content:https://www.prnewswire.co.uk/news-releases/cstone-announces-mhra-approval-of-sugemalimab-for-first-line-treatment-of-non-small-cell-lung-cancer-nsclc-in-the-uk-302292575.html