Group 1 - The European Commission (EC) has approved a new indication for Sugli monoclonal antibody for the treatment of adult patients with unresectable stage III non-small cell lung cancer (NSCLC) who have PD-L1 expression ≥1%, no EGFR sensitive mutations, or ALK, ROS1 genomic alterations, and have not shown disease progression after platinum-based chemoradiotherapy (CRT) [1][2] - This approval marks Sugli as the second PD-(L)1 antibody approved for stage III NSCLC in Europe, addressing a critical treatment need in this disease area [1][2] - The approval comes just one year after the EC's initial approval of Sugli for first-line treatment of metastatic squamous and non-squamous NSCLC, indicating a rapid progression in the drug's availability for a broader patient population [1] Group 2 - The company emphasizes its commitment to enhancing global access to Sugli, ensuring that innovative treatments reach patients worldwide [1] - The clinical development and registration team of the company is recognized for their efficient execution, which facilitated the swift approval of Sugli under the European Medicines Agency (EMA) review pathway [1]
基石药业-B：舒格利单抗获欧盟委员会批准用于治疗Ⅲ期非小细胞肺癌