CStone Announces European Medicine Agency CHMP Recommends Approval of Cejemly® as First-Line Treatment for NSCLC

CStone Pharmaceuticals China Europe

EMA CHMP recommendation is based on the results of a Phase 3 clinical trial (GEMSTONE-302) demonstrating significant progression-free survival (PFS) and overall survival (OS) benefits of sugemalimab in combination with chemotherapy as a first-line treatment for non-small cell lung cancer (NSCLC).Sugemalimab is expected to become the first anti-PD-L1 monoclonal antibody (mAb) in the world approved in Europe for both first-line squamous and non-squamous NSCLC, regardless of PD-L1 expression, potentially also the first domestic anti-PD-L1 mAb marketed in ex-China regions.In addition to the recent partnership with Ewopharma in Central Eastern Europe and Switzerland, multiple potential partners in other countries or regions are in deep conversations with CStone for sugemalimab.View original content:https://www.prnewswire.co.uk/news-releases/cstone-announces-european-medicine-agency-chmp-recommends-approval-of-cejemly-sugemalimab-anti-pd-l1-as-first-line-treatment-for-nsclc-302161134.html