智通财经网·2026-02-15 22:42Core Viewpoint - China National Pharmaceutical Group's innovative drug Bemosituzumab (brand name: Andevate®) has received approval from the National Medical Products Administration (NMPA) for a new indication in treating unresectable stage III non-small cell lung cancer (NSCLC) patients who have not experienced disease progression after platinum-based chemoradiotherapy [1] Group 1 - The approval is based on positive results from the R-ALPS study, which was presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] - The study included patients with locally advanced or unresectable stage III NSCLC who received either Bemosituzumab or a placebo as consolidation treatment until disease progression, with the primary endpoint being progression-free survival (PFS) assessed by blinded independent central review (BICR) [1] Group 2 - The median follow-up time was 19.4 months, with a median PFS of 9.69 months for the Bemosituzumab group compared to 4.17 months for the placebo group (HR=0.53, 95% CI 0.39-0.72, p<0.0001), indicating a 47% reduction in the risk of disease progression or death [2] - Subgroup analyses showed consistent benefit trends across various groups, demonstrating the broad applicability of this treatment [2] - Overall survival (OS) data is not yet mature, with median OS not reached, but a trend towards OS benefit was observed (HR=0.76, 95% CI 0.50-1.14) [2] Group 3 - The incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 29.4% in the Bemosituzumab group compared to 19.7% in the placebo group [2] - Bemosituzumab is the third PD-L1 inhibitor approved in China for consolidation treatment after radical chemoradiotherapy for locally advanced or unresectable NSCLC [2] - The company aims to continue focusing on innovation in lung cancer treatment, developing a pipeline that covers multiple molecular subtypes and treatment scenarios to enhance patient survival benefits [2]