CStone Pharmaceuticals-B (02616) announced that the European Commission (EC) has approved a new indication for sugemalimab: as a monotherapy for adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose tumor cells express PD-L1 ≥1%, lack EGFR-sensitive mutations or ALK/ROS1 genomic alterations, and have not progressed after platinum-based chemoradiotherapy (CRT).
Dr. Jianxin Yang, CEO, R&D President, and Executive Director of CStone Pharmaceuticals, stated: "Following the EC’s initial approval in 2024 for sugemalimab as a first-line treatment for metastatic squamous and non-squamous NSCLC, this new approval—achieved within just one year—marks sugemalimab’s full coverage from Stage III to IV NSCLC in Europe, offering a new therapeutic option for a broader patient population. CStone remains committed to enhancing global accessibility to sugemalimab, fulfilling our long-term promise to patients."
Dr. Qingmei Shi, Chief Medical Officer of CStone, emphasized: "This approval makes sugemalimab the second PD-(L)1 antibody in Europe for Stage III NSCLC, addressing a critical unmet need in this disease area. We are proud of our clinical development and regulatory team’s outstanding performance, whose efficiency ensured a swift and smooth approval under the European Medicines Agency (EMA) review pathway. We will continue strengthening our global capabilities to deliver innovative therapies to patients worldwide."
The EC has now approved two indications for sugemalimab: 1. In combination with platinum-based chemotherapy as a first-line treatment for metastatic NSCLC without EGFR-sensitive mutations or ALK/ROS1/RET genomic alterations (this indication has also been approved by the UK’s MHRA). 2. As a monotherapy for unresectable Stage III NSCLC patients with PD-L1 ≥1%, no EGFR/ALK/ROS1 alterations, and no disease progression post platinum-based CRT.
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