天风证券:维持基石药业-B(02616)“买入”评级 三抗在ESMO展示出良好的疗效及安全性信号
智通财经网·2025-10-22 09:00

Core Viewpoint - Tianfeng Securities maintains a "Buy" rating for Basilea Pharmaceutica-B (02616), highlighting the promising efficacy and safety data of CS2009 (PD-1/VEGF/CTLA-4 tri-specific antibody) presented at ESMO, with expectations for its clinical and commercial potential in the future [1] Group 1: Clinical Data and Efficacy - CS2009 showed preliminary efficacy data at the 2025 ESMO conference, with 72.2% of 72 advanced solid tumor patients still undergoing treatment as of October 19, and over 51% of patients having previously received immunotherapy, with a median follow-up of only 1.9 months [1] - All dosage groups exhibited anti-tumor activity with a dose-dependent increase trend; the overall response rate (ORR) was 12.2% (6/49) and the disease control rate (DCR) was 71.4% (35/49) despite a short median follow-up time of approximately 2 months [4] - CS2009 demonstrated a favorable ORR and high DCR (71%) compared to other dual antibodies, even with a significantly shorter follow-up time and a higher rate of previously treated patients [4] Group 2: Safety Profile - CS2009 exhibited a good safety profile, with a grade 3 or higher treatment-related adverse event (TRAE) rate of only 13.9% and a grade 3 or higher immune-related adverse event (irAE) rate of 4.2%, with no grade 4 or 5 TRAEs reported [3] - The incidence of grade 3 or higher TRAEs and those leading to treatment discontinuation was significantly lower than other immuno-oncology dual antibodies and combination therapies, indicating a safety advantage for CS2009 [3] Group 3: Future Development Plans - The global multi-center phase I/II clinical trial for CS2009 has been initiated, with the first patient enrolled in Australia; more data is expected to be presented at the 2026 Q2 ASCO conference [5] - The phase III registration clinical plan is set to include first-line NSCLC (AGA negative, PD-L1 TPS >= 1%), first-line squamous and non-squamous NSCLC (AGA negative, combined with platinum-based chemotherapy), and other first-line solid tumor indications, with an expected launch in 2026 [5]