CStone Pharmaceuticals Monday has submitted a Type II variation application to the European Medicines Agency - EMA for sugemalimab, seeking approval for treating unresectable stage III non-small cell lung cancer - NSCLC in patients who have not progressed after platinum-based chemoradiotherapy.
If approved, sugemalimab would become an alternative in a space where only one PD-L1 antibody is currently authorized in Europe, potentially strengthening its position as a key immunotherapy for lung cancer.
The submission is backed by data from the GEMSTONE-301 Phase III trial, which showed a 36% reduction in disease progression or death, a 56% reduction in the risk of death, and a favorable safety profile. Sugemalimab is already approved in Europe for metastatic NSCLC.
Sugemalimab has multiple approvals in China, including for metastatic NSCLC, unresectable stage III NSCLC, extranodal NK/T-cell lymphoma, and certain gastrointestinal cancers. It has also received European and UK approvals for use with chemotherapy in metastatic NSCLC patients without specific genomic mutations.
For comments and feedback contact: editorial@rttnews.com
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.