AKESO(HK:09926) Guotai Junan Securities·2024-09-09 08:41Investment Rating - The report maintains an "Accumulate" rating for 康方生物 (9926) [2][4][5]. Core Views - 康方生物's core product, 依沃西, is entering a harvest period with accelerated revenue growth, leading to an upward revision of revenue forecasts for 2024-2026 to 29.24 billion, 47.69 billion, and 65.95 billion RMB respectively [5]. - The clinical data for 依沃西 against K药 shows record results, with an ITT population HR of 0.51, indicating significant benefits across all subgroups [5]. - The safety profile of 依沃西 in squamous cell carcinoma is superior, breaking through the safety limitations of traditional anti-VEGF therapies [5]. - Multiple clinical trials are advancing, with new plans for first-line NSCLC clinical studies announced by Summit [5]. Summary by Sections Clinical Data - 依沃西's clinical trial results show a median progression-free survival (mPFS) of 11.14 months compared to 5.82 months for K药, with a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death [5]. - The overall response rate (ORR) for 依沃西 is 50.0% versus 38.5% for K药, and the disease control rate (DCR) is 89.9% compared to 70.5% [5]. - Subgroup analyses show strong positive results for various populations, including HRs of 0.46 for PD-L1 TPS≥50% and 0.48 for squamous carcinoma [5]. Safety Profile - The incidence of grade 3 or higher treatment-related adverse events (TRAE) is comparable between 依沃西 and K药 (22.2% vs 18.7%) [5]. - In squamous cell carcinoma patients, the risk of bleeding is not significantly increased, with a grade 3 or higher adverse event rate of 10.2% for 依沃西 compared to 1.0% for K药 [5]. Financial Projections - Revenue forecasts for 康方生物 have been revised upwards, with expected revenues of 2.924 billion RMB in 2024, 4.769 billion RMB in 2025, and 6.595 billion RMB in 2026, reflecting significant growth [9]. - The company reported a net profit of 2.028 billion RMB in 2023, with projections of -334 million RMB in 2024, followed by a return to profitability in 2025 and 2026 [9].