Core Viewpoint - The approval of the new indication for the bispecific antibody Iwosimab (PD-1/VEGF) for first-line treatment of PD-L1 positive non-small cell lung cancer (NSCLC) marks a significant advancement in cancer therapy in China, allowing patients to access a leading global treatment option [1][2]. Group 1: Drug Approval and Clinical Results - Iwosimab has received approval from the National Medical Products Administration (NMPA) for use in treating locally advanced or metastatic NSCLC with negative EGFR mutations and ALK [1]. - The approval is based on positive results from a randomized, double-blind, controlled Phase III clinical trial (AK112–303/HARMONi-2), where the median progression-free survival (PFS) for Iwosimab was 11.14 months compared to 5.82 months for Pembrolizumab, demonstrating a 49% reduction in the risk of disease progression or death (PFS HR=0.51, P<0.0001) [1][2]. - A mid-term analysis of overall survival (OS) at 39% maturity showed that Iwosimab significantly reduced the risk of death by 22.3% compared to Pembrolizumab (OS HR=0.777) [2]. Group 2: Future Plans and Ongoing Research - The company plans to hold a business highlights communication meeting on April 28, 2025, with details to be announced on its official website and public account [2]. - Iwosimab is currently undergoing 12 Phase III clinical studies, including 3 international multicenter trials, and has a total of 18 ongoing clinical trials covering various cancers such as lung cancer, cholangiocarcinoma, head and neck squamous cell carcinoma, triple-negative breast cancer, colorectal cancer, pancreatic cancer, and hepatocellular carcinoma [3].

Core 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]