China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, multi-center Phase Ib/II clinical study of its SHR-1802 combined with SHR-1316 for advanced solid tumors.
Drug Profiles
- SHR-1316: A programmed-death ligand 1 (PD-L1) monoclonal antibody (mAb) currently under investigation for multiple solid tumors. It is awaiting regulatory approval in China for first-line extensive-stage small cell lung cancer in combination with chemotherapy.
- SHR-1802: An in-house developed lymphocyte activation gene 3 protein (LAG-3, aka CD233) with no similar product commercially available globally.
Global PD-L1 Market
Global PD-L1 products include AstraZeneca’s Tecentriq (atezolizumab), Roche’s Imfinzi (durvalumab), and Merck KGaA/Pfizer’s Bavencio (avelumab). Tecentriq and Imfinzi are approved in China, while local PD-L1s on the market include Alphamab/3D Medicine’s envafolimab and CStone Pharma’s sugemalimab. The three global PD-L1 drugs generated combined global sales of USD 6.7 billion in 2021.-Fineline Info & Tech