百利天恒(688506.SH)：iza-bren（EGFR×HER3 双抗ADC）用于治疗晚期 EGFR 突变的非小细胞肺癌获得美国 FDA 突破性疗法认定

Core Insights - SystImmune, Inc., a wholly-owned subsidiary of Baillie Gifford (688506.SH), has received Breakthrough Therapy Designation from the FDA for izalontamabbrengitecan (iza-bren) for treating locally advanced or metastatic non-small cell lung cancer with specific mutations after prior treatments [1][2] Group 1 - The Breakthrough Therapy Designation is based on clinical research data from studies BL-B01D1-101, BL-B01D1-203, and BL-B01D1-LUNG-101, demonstrating the reliability of existing data [2] - The designation highlights the significant unmet clinical needs faced by patients after EGFR TKI and platinum-based chemotherapy, as most patients experience disease progression approximately 18 months after first-line treatment [2] - The FDA's Breakthrough Therapy Designation aims to expedite the development and review process for drugs that may significantly outperform existing standard therapies [2]