Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to carry out an open, multi-center Phase Ib/II clinical study for its injectable pipeline candidate SHR-A1921 combined with adebrelimab (SHR-1316) in advanced solid tumors. This marks a significant step in the development of new treatment options for patients with advanced solid tumors.
SHR-1316: PD-L1 Monoclonal Antibody
SHR-1316 is a programmed-death ligand 1 (PD-L1) monoclonal antibody (mAb) that has yet to gain market approval but has reached the Phase III stage in extensive small-cell lung cancer (SCLC) among other indications. Globally, PD-L1 products include AstraZeneca’s Tecentriq (atezolizumab), Roche’s Imfinzi (durvalumab), and Merck KGaA/Pfizer’s Bavencio (avelumab). Tecentriq and Imfinzi have been approved in China. Domestic PD-L1s already on the market in China include Alphamab/3D Medicine’s envafolimab and CStone Pharma’s sugemalimab.
SHR-A1921: Antibody-Drug Conjugate (ADC)
SHR-A1921 is an in-house developed antibody-drug conjugate (ADC) targeting undisclosed tumor-specific antigens. The drug is designed to bind to the target antigen on the surface of tumor cells for the targeted release of small-molecule toxins within the tumor cells. This targeted approach aims to improve treatment efficacy and reduce side effects. Currently, only one similar product has been approved for marketing in China.-Fineline Info & Tech