Investment Rating - The report maintains an investment rating of "Leading the Market-B" for the biopharmaceutical industry [1][11]. Core Insights - IBI363, a PD-1/IL-2α-bias dual antibody fusion protein developed by Innovent Biologics, shows significant survival benefits in clinical trials for immune-resistant NSCLC, colorectal cancer, and melanoma [3][4]. - The drug demonstrates a controllable safety profile, with the most common grade ≥3 treatment-related adverse events (TRAEs) being joint pain, rash, and anemia [3][4]. - IBI363 has received breakthrough therapy designation in China and fast track designation from the FDA in the United States [4]. Summary by Sections Market Performance - The biopharmaceutical industry has shown strong market performance over the past year, with significant advancements in innovative drug development [1]. Drug Evaluation - IBI363 has shown promising results in various cancers: - In squamous NSCLC, the median overall survival (mOS) reached 15.3 months with a 3 mg/kg dosage, showing a clinical objective response rate (cORR) of 36.7% and a disease control rate (DCR) of 90.0% [4]. - In EGFR wild-type NSCLC adenocarcinoma, mOS was 17.5 months with a 3 mg/kg dosage, achieving a cORR of 24.0% and a DCR of 76.0% [5]. - In colorectal cancer, mOS reached 16.1 months with IBI363 monotherapy, significantly exceeding standard treatment outcomes [6]. - In melanoma, the mPFS was 5.7 months, with a 12-month overall survival rate of 61.5% [7].
生物医药创新药动态更新：IBI363：实现免疫耐药NSCLC、结直肠癌、黑色素瘤临床突破性生存获益