AKESO(09926) 智通财经网·2025-04-22 23:54Core Insights - The article discusses the positive results of a Phase III clinical trial (AK112-306/HARMONi-6) for the dual-specific antibody drug Iwosimab (PD-1/VEGF) in treating advanced squamous non-small cell lung cancer (sq-NSCLC) [1][2] - The trial demonstrated a statistically significant improvement in progression-free survival (PFS) compared to the control group, indicating a major clinical benefit [1][2] - Iwosimab is positioned to become a new standard treatment option in the NSCLC field, enhancing the clinical benefits of immunotherapy [2] Group 1: Clinical Trial Results - The HARMONi-6 trial included 532 participants, with approximately 63% having central squamous cell carcinoma, aligning with real-world patient distribution [1][2] - In the intention-to-treat population, the Iwosimab plus chemotherapy group showed a decisive positive result in PFS compared to the control group [1] - The safety profile of Iwosimab was favorable, with no new safety signals identified, and the incidence of treatment-related severe adverse events was similar to the control group [1] Group 2: Drug Development and Market Position - Iwosimab is the first PD-1/VEGF dual-specific tumor immunotherapy drug developed by the company, expected to receive NMPA approval for use in advanced EGFR-mutant NSCLC by May 2024 [3] - The drug is currently involved in 12 ongoing Phase III clinical trials, including three international multi-center studies [3] - Iwosimab is being tested for a total of 18 indications, covering various cancers such as lung cancer, biliary cancer, head and neck squamous cancer, triple-negative breast cancer, colorectal cancer, pancreatic cancer, and hepatocellular carcinoma [3]