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中信建投:予康方生物“买入”评级 创新药疗效优秀、市场空间广阔
Zhi Tong Cai Jing·2025-11-13 08:49

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]