消息面上，康方生物宣布，公司自主研发的全球首创PD-1/VEGF双特异性抗体新药依沃西(商品名：依 达方)联合多西他赛，用于治疗经PD-1/L1抑制剂和含铂化疗治疗失败的局部晚期或转移性非小细胞肺癌 的注册性III期临床研究(AK112-305/HARMONi-8A)，已完成首例患者给药。 值得注意的是，这是依沃西在肺癌领域开展的第7项III期研究(其中3项为国际多中心注册临床)。作为全 球首创的PD-1/VEGF双抗，依沃西已在NSCLC领域实现了核心适应症的全面覆盖，完成多线治疗的布 局，有望重塑全球晚期NSCLC的整体治疗格局。同时，依沃西也作为公司"IO+ADC"2.0战略的核心IO 双抗基石药物，已经针对肿瘤免疫核心适应症一线治疗开展了一系列III期临床和II期临床。 康方生物(09926)早盘涨近5%，高见160.4港元，再创历史新高。截至发稿，涨3.86%，报158.7港元，成 交额9.5亿港元。 ...

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]