Hengrui’s Trastuzumab Rezetecan and Adebrelimab Granted Breakthrough Therapy Designation by China’s NMPA

China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced on August 11, 2025, that its innovative drugs, trastuzumab rezetecan injection and adebrelimab injection, have been granted breakthrough therapy designation by China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE). The designation covers the combination of trastuzumab rezetecan and adebrelimab for first-line treatment of PD-L1-positive (CPS≥1), locally recurrent, unresectable, or metastatic triple-negative breast cancer. This marks the ninth indication for trastuzumab rezetecan on the breakthrough therapy list.

Drug Mechanisms

• Trastuzumab Rezetecan: This HER2-targeted antibody-drug conjugate (ADC) binds to HER2-expressing tumor cells and releases a cytotoxic payload, inducing cell cycle arrest and apoptosis. It received marketing approval in May 2025 for treating HER2-mutated non-small cell lung cancer (NSCLC) patients in China.
• Adebrelimab: A humanized anti-PD-L1 monoclonal antibody that reactivates the immune system’s anti-tumor activity by blocking the PD-1/PD-L1 pathway. It was launched in March 2023 for extensive-stage small cell lung cancer treatment.-Fineline Info & Tech