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基石药业-B:舒格利单抗再获欧洲药品管理局人用药品委员会积极意见
Zhi Tong Cai Jing· 2025-10-17 04:20
Core Viewpoint - 基石药业's drug, Sugli monoclonal antibody, received a positive opinion from the European Medicines Agency (EMA) for the treatment of adult patients with unresectable stage III non-small cell lung cancer (NSCLC) who have PD-L1 expression ≥1% and have not progressed after platinum-based chemoradiotherapy [1] Group 1: Company Developments - The CEO of 基石药业, Dr. Yang Jianxin, expressed satisfaction with the rapid and positive progress of the EMA review for Sugli monoclonal antibody, marking the second positive recommendation from CHMP within a year [1] - If approved, Sugli monoclonal antibody will solidify its position as a core immunotherapy for lung cancer, significantly enhancing its market position and commercial potential [1] - The company aims to collaborate with partners to accelerate the comprehensive launch of Sugli monoclonal antibody in the European market, providing high-quality and affordable treatment options for more patients [1] Group 2: Clinical Research Insights - The positive opinion for the new indication of Sugli monoclonal antibody is based on the GEMSTONE-301 study, a multicenter, randomized, double-blind phase III clinical trial demonstrating dual benefits in progression-free survival and overall survival for stage III NSCLC patients [1] - If the new indication is approved, Sugli monoclonal antibody will become the second PD-(L)1 antibody approved for stage III NSCLC in Europe, addressing a critical need in this disease area and offering new hope for patients [1] - The efficient positive opinion from CHMP is seen as recognition of the clinical development and registration team's efforts at 基石药业, reinforcing the commitment to meet the urgent medical needs of patients in China and globally [1]