CSTONE PHARMA-B(02616): Sugelizumab Recommended Again in ESMO Guidelines [I, A] - Used for Consolidation Treatment of Stage III Non-Small Cell Lung Cancer

CSTONE PHARMA-B (02616) announced that its core commercialized product Sugli Single Antibody has received a Grade I, A recommendation from the European Society for Medical Oncology (ESMO). This time, Sugli Single Antibody has been included in the "Early and Locally Advanced Non-Small-Cell Lung Cancer Living Guideline" for use in consolidation therapy for stage III non-small cell lung cancer (NSCLC) patients after synchronous or sequential radiation and chemotherapy. This recommendation will significantly help Sugli Single Antibody's access process in the EU and other markets, benefiting a broader range of patients and providing solid support for its global commercial expansion. In February 2025, Sugli Single Antibody in combination with chemotherapy received a Grade I, A recommendation from ESMO for use as first-line treatment for both squamous and non-squamous stage IV NSCLC dual indications in the "Non-Driving Gene Positive Metastatic Non-Small-Cell Lung Cancer Living Guideline". With this, Sugli Single Antibody's two approved lung cancer indications in the EU and UK have been included in the ESMO guidelines, fully demonstrating its clinical value. According to the latest ESMO guidelines: Patients with stage III NSCLC who are wild-type EGFR, without ALK or ROS1 gene mutations, and have not experienced disease progression after synchronous or sequential radiation and chemotherapy, can receive consolidation therapy with Sugli Single Antibody for a period not exceeding 24 months. This recommendation is applicable to patients with tumor cell (TC) PD-L1 expression levels 1% [ESMO - Magnitude of Clinical Benefit Scale (MCBS) v2.0 score: 3 points; already approved by the European Medicines Agency (EMA)], with evidence grade of I, A. The treatment recommendations in the guidelines are based on the results of the pivotal phase III clinical trial GEMSTONE-301, which demonstrated that Sugli Single Antibody as consolidation therapy for stage III NSCLC can statistically significantly improve progression-free survival (PFS) and clinically meaningful overall survival (OS) extension for patients. As of now, Sugli Single Antibody has established commercial partnerships in Europe, the Middle East and Africa, Latin America, with a commercial network expanding to over sixty countries and regions globally. Market access applications have been approved or are in the review stage in over ten countries, and overseas commercialization plans are steadily and efficiently progressing.