Subsidiary SHR-3821 Injection and other drugs of Jiangsu Hengrui Pharmaceuticals (600276.SH) have been approved for clinical trials.

Jiangsu Hengrui Pharmaceuticals (600276.SH) announced recently that its subsidiaries Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Pharmaceuticals Co., Ltd. have received approval from the National Medical Products Administration to conduct clinical trials for SHR-3821 injection, Atezolizumab injection, and Relafupa injection. SHR-3821 injection is a humanized antibody developed by the company for the treatment of advanced solid tumors. It can specifically activate immune cells in tumor tissues to exert a specific anti-tumor effect. Currently, there are no approved drugs with the same target in China. The total research and development investment for the SHR-3821 injection project is approximately 330 million yuan (unaudited). Atezolizumab injection is a humanized anti-PD-L1 monoclonal antibody developed by the company, which can block the PD-1/PD-L1 pathway that causes immune tolerance in tumors by specifically binding to the PD-L1 molecule, reactivating the immune system's anti-tumor activity, and therefore treating tumors. Atezolizumab injection was approved for marketing in 2023 for first-line treatment in combination with carboplatin and etoposide in extensive-stage small cell lung cancer patients. The total research and development investment for the Atezolizumab injection project is approximately 1.175 billion yuan (unaudited). Relafupa alpha injection is a dual-function fusion protein independently developed by the company with intellectual property rights, targeting PD-L1/TGF-RII. It can specifically block the interaction between PD-1/PD-L1 and neutralize TGF- in the tumor microenvironment to exert anti-tumor effects. Relafupa alpha injection was approved for marketing in January 2026 for first-line treatment in combination with fluoropyrimidine-based and platinum-based drugs in locally advanced unresectable, recurrent, or metastatic gastric and gastroesophageal junction adenocarcinoma patients with a validated PD-L1 positive (CPS1). There are currently no similar products approved for marketing domestically or internationally. The total research and development investment for the Relafupa alpha injection project is approximately 727 million yuan (unaudited).