CStone Pharmaceuticals-B (02616) announced that its core commercial product, sugemalimab, has received a [I, A] grade recommendation in the European Society for Medical Oncology (ESMO) guidelines. Sugemalimab has been included in the "Early and Locally Advanced Non-Small-Cell Lung Cancer Living Guideline" for use as consolidation therapy in patients with stage III non-small-cell lung cancer (NSCLC) following concurrent or sequential chemoradiotherapy. This recommendation is expected to significantly support sugemalimab's market access process in the European Union and other regions, benefiting a broader patient population and providing solid support for its global commercial expansion.

In February 2025, sugemalimab in combination with chemotherapy received a [I, A] recommendation in the ESMO "Metastatic Non-Small-Cell Lung Cancer Living Guideline" for the first-line treatment of both squamous and non-squamous stage IV NSCLC. With this latest inclusion, both of sugemalimab's approved lung cancer indications in the EU and UK are now covered by ESMO guidelines, fully demonstrating its clinical value.

According to the latest ESMO guideline, patients with EGFR wild-type, ALK- or ROS1-negative stage III NSCLC who have not experienced disease progression after concurrent or sequential chemoradiotherapy may receive sugemalimab as consolidation therapy for up to 24 months. This recommendation applies to patients with tumor cell PD-L1 expression ≥1% [ESMO-Magnitude of Clinical Benefit Scale (MCBS) v2.0 score: 3; approved by the European Medicines Agency (EMA)], with an evidence level of [I, A].

The treatment recommendation is based on results from the pivotal phase III clinical trial GEMSTONE-301, which confirmed that sugemalimab, when used as consolidation therapy in stage III NSCLC, provides statistically significant improvement in progression-free survival (PFS) and clinically meaningful overall survival (OS) benefit.

To date, sugemalimab has established four commercial partnerships in Europe, the Middle East, Africa, and Latin America, with its commercial network extending to over 60 countries and regions worldwide. Market access applications have been approved or are under review in more than ten countries, indicating steady and efficient progress in its overseas commercialization strategy.