SHR-1501 + BCG

**SHR-1501 + BCG** is a combination therapy under clinical investigation for high-risk non-muscle invasive bladder cancer (NMIBC), consisting of SHR-1501, a pharmacological grade IL-15/IL-15Rα complex fused to an IgG1 Fc (IL-15 superagonist), and BCG (Bacillus Calmette-Guerin), an established intravesical immunotherapy for bladder cancer. SHR-1501 acts by promoting CD8+ T cell and natural killer (NK) cell infiltration, enhancing M1 macrophage activity, and supporting a pro-inflammatory tumor microenvironment. The combination is designed to boost antitumor immune responses and overcome resistance to BCG, which remains a standard of care for NMIBC but shows limitations in BCG-unresponsive cases. Preclinical and early-phase clinical data indicate that SHR-1501 + BCG is well-tolerated and demonstrates favorable efficacy in BCG-naive and BCG-unresponsive NMIBC patients. SHR-1501 is being developed by Jiangsu Hengrui Pharma/Shanghai Hengrui Pharmaceutical; BCG is a broadly used, established product from multiple manufacturers.[1][2][3][4]