Adebrelimab (SHR-1316): A Comprehensive Monograph on a Novel PD-L1 Immune Checkpoint Inhibitor

Executive Summary & Drug Profile of Adebrelimab (SHR-1316)

Adebrelimab is a novel, fully humanized immunoglobulin G4 (IgG4) monoclonal antibody that functions as a high-affinity immune checkpoint inhibitor by targeting the programmed death-ligand 1 (PD-L1).[1] Developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd., adebrelimab has achieved a significant clinical milestone with its regulatory approval in China for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) when administered in combination with standard chemotherapy.[4] This approval was predicated on the results of the pivotal Phase 3 CAPSTONE-1 trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival for this patient population, historically characterized by poor prognosis and limited therapeutic advancement.[7]

The molecular design of adebrelimab is distinguished by specific structural modifications engineered to optimize its therapeutic index. These alterations enhance antibody stability and are intended to minimize off-target immune-related toxicities by ablating effector functions, thereby focusing its activity on the blockade of the PD-1/PD-L1 signaling axis.[2] Beyond its established role in ES-SCLC, adebrelimab is the subject of a broad and ambitious clinical development program investigating its efficacy and safety across a range of other solid tumors. These include non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), and gastric cancer, often as a component of innovative combination regimens with chemotherapy, radiotherapy, and other targeted agents.[5] The multiplicity of its development codes and synonyms, such as SHR-1316 and HTI-1088, reflects a typical progression from an internal research compound to a globally recognized therapeutic candidate, with commercial brand name