Hengrui Medicine Gets NMPA Green Light for Phase Ib/II Study of SHR-A1921 Combo in Advanced Solid Tumors

Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II clinical study for its injectable pipeline candidate SHR-A1921. This investigational treatment is to be used in combination with adebrelimab (SHR-1316) and SHR-8068 for the treatment of advanced solid tumors.

SHR-A1921, an in-house developed antibody-drug conjugate (ADC), targets undisclosed tumor-specific antigens. It is designed to bind to the target antigen on the surface of tumor cells, facilitating the targeted release of small-molecule toxins within the tumor cells. Currently, only one similar product, Gilead’s sacituzumab govitecan, has been approved for marketing in China.

Hengrui’s adebrelimab, a programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb), was approved in China for the treatment of first-line extensive stage small-cell lung cancer (ES-SCLC) in combination with chemotherapy in March last year. SHR-8068 is an in-licensed monoclonal antibody targeting CTLA-4, with only two similar products, ipilimumab and tremelimumab, being commercially available globally. Previously, a combination of adebrelimab with SHR-8068 and SHR-2002, a PVRIG/TIGIT bispecific antibody (BsAb), has been approved for clinical study in solid tumors.- Flcube.com

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