AKESO(09926) 华泰证券·2024-12-19 08:45Investment Rating - The report maintains a "Buy" rating for the company [1] Core Views - Ivonescimab (依沃西单抗) demonstrated significant therapeutic benefits in multiple clinical trials, particularly in the HARMONi-2 study where it outperformed pembrolizumab (帕博利珠单抗), showcasing its potential as a global blockbuster [1] - The overseas expansion of Ivonescimab is expected to enhance its revenue peak and company valuation [1] - The company's mature pipeline, including cadonilimab (卡度尼利单抗) and inusirumab (伊努西单抗), is progressing steadily towards commercialization, with new indications and market potential [4] Clinical Results - In the HARMONi-2 study, Ivonescimab showed a significant PFS advantage over pembrolizumab (11.14 vs 5.82 months, HR=0.51) and demonstrated excellent safety with low rates of TRAE-related discontinuation and mortality (1.5% and 0.5%) [2] - Ivonescimab also showed promising efficacy in NSCLC perioperative treatment, head and neck squamous cell carcinoma, colorectal cancer, and TNBC in Phase II trials [2] Overseas Expansion - Ivonescimab's overseas Phase III trials, HARMONi and HARMONi-3, are progressing, with HARMONi-3 expanding its target population to include both squamous and non-squamous NSCLC [3] - The HARMONi-7 study targeting PD-L1 strong-positive NSCLC patients is set to begin in early 2025, further enhancing Ivonescimab's global potential [3] Other Pipelines - Cadonilimab has seen new indications approved and has been included in the national medical insurance, boosting its commercialization potential [4] - Inusirumab, a PCSK9 monoclonal antibody, was approved in September, and other non-oncology drugs are expected to be launched within the next three years [4] Market Differentiation - The report differs from market consensus by expressing strong confidence in the company's overseas potential, citing the robust data from the HARMONi-2 study and the likelihood of replicating domestic success in international markets [5] Financial Forecasts and Valuation - Revenue forecasts for 2024/2025/2026 have been revised downward to 2.312/3.342/5.409 billion RMB (down 13.0/20.8/14.0% from previous estimates) due to national negotiations and the approval pace of non-oncology drugs [6] - The DCF terminal value has been increased from 36 billion to 65.2 billion RMB, leading to a target market cap of 84.5 billion RMB and a target price of 100.45 HKD [6] Industry Insights - The report highlights the potential of IO (immuno-oncology) combined with anti-angiogenesis therapies, noting that while some combinations have shown promise, others have failed due to toxicity and efficacy issues [27][28] - The LEAP series of studies, which explored the combination of pembrolizumab and lenvatinib, showed mixed results, with some studies achieving positive outcomes while others failed to meet OS endpoints [29][30][31]