机构：中信建投证券 研究员：贺菊颖/袁清慧/沈毅 核心观点 康方生物于2025 SITC 上发表HARMONi -A 最终OS 结果，中位随访时间32.5 个月时，依沃西治疗组和 对照组的OS HR=0.74（0.58-0.95）（P=0.019），全球首个在EGFR TKI 经治NSCLC PFS与OS 同时取得 具有临床意义和统计学显著性获益的免疫疗法I I I期临床试验。未来可以关注：（1）依沃西单抗国内 HARMONi -2最终OS 结果更新；美国BLA 递交申请；HARMO Ni -3 2026H2 海外鳞癌mPFS 分析； （2）AK104 针对1L 胃癌、2L IO 耐药肝细胞癌及PD-L1 阴性的NSCLC 全球临床试验的开展（ 3 ） AK 1 3 2(Claudin18.2/CD47)、AK137 (CD73/LAG3)进入II 期临床，AK150(ILT2/ILT4/CSF1R)进行IND 申 报。 近日，康方生物发布HARMONi-A 最终OS 结果 2025 年11 月18 日，公司在2025 SITC 重磅发布了HARMONi-A 研究的更新数据：在中位随访时间长达 32.5 个月 ...

Core Viewpoint - CITIC Securities reports that Kangfang Biopharma (09926) has multiple products and indications in its pipeline that are expected to be approved for market entry, indicating a strong long-term sustainable development capability [1] Group 1: Pipeline and Product Development - Kangfang Biopharma's research pipeline is expanding, with a rich reserve of early-stage products [1] - The approval of Iwosimab for market entry contributes to the company's sales growth, while the sales revenue from its products is increasing year by year [1] - The company is rated as "Buy" due to the excellent efficacy of its innovative drug products and the broad market potential [1] Group 2: Clinical Trial Results - At the 2025 SITC, Kangfang Biopharma presented the final overall survival (OS) results of the HARMONi-A trial, showing a median follow-up time of 32.5 months, with an OS hazard ratio (OSHR) of 0.74 (0.58-0.95) (P=0.019) for the Iwosimab treatment group compared to the control group [1] - This trial is noted as the first to achieve clinically meaningful and statistically significant benefits in both progression-free survival (PFS) and OS for an immunotherapy in patients with EGFR TKI-pretreated non-small cell lung cancer (NSCLC) [1] Group 3: Future Focus Areas - Future attention can be directed towards the final OS results update for Iwosimab in the domestic HARMONi-2 trial and the submission of the BLA application in the U.S. [2] - Ongoing global clinical trials for AK104 targeting first-line gastric cancer, second-line IO-resistant hepatocellular carcinoma, and PD-L1 negative NSCLC are also noteworthy [2] - The advancement of AK132 (Claudin18.2/CD47), AK137 (CD73/LAG3) into Phase II clinical trials, and the IND application for AK150 (ILT2/ILT4/CSF1R) are significant developments [2]