百利天恒(688506)：IZA-BREN首次获FDA授予突破性疗法资格 “重磅炸弹”药物初具雏形

Group 1 - The core point of the news is that SysImmune's Iza-Bren (BL-B01D1) has received breakthrough therapy designation from the FDA for treating advanced or metastatic NSCLC patients with specific EGFR mutations who have previously undergone EGFR-TKI and platinum-based chemotherapy [1] - The breakthrough therapy designation is based on clinical trial data from studies BL-B01D1-101, BL-B01D1-203, and BL-B01D1-LUNG-101, which indicate improved efficacy and manageable safety in patients with EGFRmt NSCLC after prior treatments [1] - The company has initiated over 40 clinical studies for Iza-Bren, with significant upcoming data releases expected at the WCLC and ESMO conferences in September-October 2025 [2] Group 2 - The company aims to become a multinational corporation (MNC) with global capabilities, having established key pillars in early research, clinical development, and production supply [3] - The revenue forecasts for the company are projected at 2.018 billion, 2.035 billion, and 2.541 billion yuan for the years 2025, 2026, and 2027 respectively, maintaining a "buy" rating for the stock [3]