AKESO(09926) 华福证券·2024-09-17 04:12Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 81.89 [5]. Core Insights - The company’s drug, Ivosidenib, has shown unprecedented results in the HARMONi-2 study, nearly doubling the median progression-free survival (mPFS) compared to Keytruda, achieving 11.14 months versus 5.82 months [1][9]. - Ivosidenib's single-agent "de-chemotherapy" regimen is expected to become the first-line treatment for lung cancer patients with positive PD-L1 expression, with a New Drug Application (NDA) accepted in August [2]. - The overseas value of Ivosidenib is anticipated to be re-evaluated, with peak sales in the U.S. projected to exceed USD 4.5 billion [3][26]. Summary by Sections HARMONi-2 Study Results - The HARMONi-2 study demonstrated that Ivosidenib significantly outperformed Keytruda in mPFS, with a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death [1][11]. - The study included a diverse patient population, with 42.2% having high PD-L1 expression, and showed consistent results with previous studies, enhancing the credibility of the findings [10][11]. Single-Agent Efficacy - Ivosidenib achieved an mPFS of 11.1 months, outperforming Keytruda combined with chemotherapy in two Phase III studies, indicating its potential as a first-line treatment option [2][13]. - The safety profile of Ivosidenib is favorable, with a discontinuation rate of only 1.5% due to adverse events [16]. Clinical Development and Market Potential - The company is accelerating clinical development for Ivosidenib, with plans for further studies in various cancers, including colorectal and triple-negative breast cancer [3][26]. - Financial projections estimate revenues of CNY 26.5 billion, CNY 40.6 billion, and CNY 64.2 billion for 2024, 2025, and 2026, respectively, with a net profit forecasted to turn positive by 2025 [4][27].