Core Insights - Akeso, Inc. has initiated a Phase I clinical trial for its personalized mRNA vaccine AK154, targeting pancreatic cancer as both a monotherapy and in combination with bispecific antibodies cadonilimab and ivonescimab [1][2][4] Company Overview - Akeso is a leading biopharmaceutical company founded in 2012, focusing on innovative biological medicines and has developed a comprehensive end-to-end drug development platform [8] - The company has over 50 innovative assets in its pipeline, with 24 candidates currently in clinical trials, including 15 bispecific/multispecific antibodies [8] Product Development - AK154 is Akeso's first mRNA-based therapeutic candidate, designed to address the "cold tumor" phenotype in pancreatic cancer by utilizing sequence-specific mRNA vaccines [2][3] - Preclinical data for AK154 indicates strong immunogenicity and anti-tumor activity, suggesting a favorable safety profile when combined with Akeso's bispecific antibodies [4]

Core Insights - Akeso, Inc. has presented preclinical research data for its novel monoclonal antibody AK135, targeting IL-1RAP, at the 40th Annual Meeting of the Society for Immunotherapy of Cancer [1][2] Group 1: Product Development - AK135 effectively targets IL-1RAP and blocks three key pro-inflammatory signaling pathways—IL-1, IL-33, and IL-36, providing significant pain relief in neuropathy with good tolerability and safety profiles [2][6] - The antibody is currently in Phase I clinical trials for treating chemotherapy-induced peripheral neuropathy (CIPN) [6][11] - Preclinical studies indicate that AK135 shows dose-dependent efficacy in alleviating neuropathic pain and maintains stable body weight in treated models without significant toxicity [8] Group 2: Market Context - CIPN affects 50-90% of chemotherapy-treated patients, with 30-40% progressing to chronic neuropathic pain, highlighting the clinical significance of effective treatment options [5] - Akeso's development of AK135 addresses a critical gap in treatment options for CIPN, as current effective therapies are limited [5][6] Group 3: Company Overview - Akeso is a leading biopharmaceutical company focused on innovative biological medicines, with a robust pipeline of over 50 innovative assets across various disease areas, including cancer and autoimmune diseases [11] - The company has developed a comprehensive end-to-end drug development platform and has 24 candidates in clinical trials, including 15 bispecific/multispecific antibodies [11]

Investment Rating - The report maintains an "Outperform" rating for the company [2][11]. Core Insights - The company reported a revenue of RMB 2.13 billion in 2024, a decrease of 53.1%, primarily due to a reduction in licensing revenue, while commercial sales revenue increased by 24.9% to RMB 2.00 billion [3][16]. - The company has effectively managed costs, with a significant decline in expense ratios, leading to a narrowed operating net loss of RMB 660 million, down 16.7% year-over-year [4][18]. - The clinical pipeline is advancing steadily, with key programs such as Cadonilimab and Ivonescimab making progress in various clinical trials [5][19]. Financial Performance - Revenue projections for 2025-2027 are RMB 3.41 billion, RMB 5.45 billion, and RMB 7.31 billion, reflecting year-over-year growth of 60% and 34% in subsequent years [11][34]. - The company is expected to turn a profit in 2025, achieving a net profit of RMB 50 million [11][34]. - The gross profit margin is projected to remain high, with estimates of 92.3% in 2025 and 92.9% in 2027 [15]. Clinical Pipeline Progress - Cadonilimab is involved in multiple clinical trials, including adjuvant treatment for hepatocellular carcinoma and combination therapies for non-small cell lung cancer [5][19]. - Ivonescimab is also progressing in various trials, including first-line treatments for biliary tract cancer and head and neck squamous cell carcinoma [20][23]. - The company has several NDA/sNDA approvals expected in 2025, which could significantly impact revenue and market position [9][25]. Cost Management - The company has demonstrated excellent cost management, with R&D expenses decreasing by 5.3% due to the transition of certain clinical research services to in-house execution [4][18]. - Selling expenses grew at a lower rate than commercial sales revenue, resulting in a decline in the selling expense ratio by 5.5 percentage points [4][18]. Valuation - The target price has been adjusted to HKD 96.6 per share based on a DCF model, reflecting a WACC of 10.0% and a perpetual growth rate of 3.0% [11][34].