Zhitong Finance App News, Hengrui Pharmaceutical (01276) announced that recently, the company's subsidiaries Suzhou Shengdia Biomedical Co., Ltd., Shanghai Hengrui Pharmaceutical Co., Ltd., and Shanghai Shengdi Pharmaceutical Co., Ltd. received approval from the State Drug Administration (hereinafter referred to as the “State Drug Administration”) to issue the “Drug Clinical Trial Approval Notice” for SHR-7787 injections, SHR-4849 injections, bevacizumab injections, and adbelizumab injections, which will conduct clinical trials in the near future.
According to reports, SHR-7787 injection is a class 1 therapeutic biological product. By inducing the activation of T cells, it exerts a role in targeting and killing tumor cells. Currently, no similar drug has been approved for marketing in China. Up to now, the total R&D investment for SHR-7787 injection-related projects is about 48.93 million yuan.
SHR-4849 injection is an antibody-drug conjugate independently developed by the company that targets DLL3. It can specifically bind to DLL3 antigen on the surface of tumor cells, then be endocytosed into cells and transported to lysosomes. Water releases free toxins and kills tumor cells. It is intended to be used to treat advanced malignant solid tumors. According to inquiries, there are currently no similar drugs approved for marketing at home or abroad. Up to now, the total R&D investment for SHR-4849 injection-related projects is about 69.67 million yuan.
Bevacizumab is a humanized anti-VEGF monoclonal antibody. It was developed by Chinese and foreign pharmaceuticals in collaboration with Genetech, a subsidiary of Roche. It was approved for marketing in the US in 2004. The trade name is Avastin (Avastin), and is currently marketed in China and many countries around the world. The company's bevacizumab injections were approved for marketing in June 2021. Currently, several bevacizumab injections have been approved for marketing in China. According to inquiries, the global sales volume of bevacizumab in 2024 was approximately US$5.655 billion. Up to now, bevacizumab injection-related projects have invested about 348.89 million yuan in R&D
Adbelizumab injection is a humanized anti-PD-L1 monoclonal antibody independently developed by the company. It can block the PD-1/PD-L1 pathway leading to tumor immune tolerance by specifically binding the PD-L1 molecule and reactivate the anti-tumor activity of the immune system, thus achieving the goal of treating tumors. The company's adbelizumab injection was approved for marketing in February 2023. The approved indication is the first-line treatment of patients with extensive small cell lung cancer in combination with carboplatin and etoposide. Similar products abroad, Atezolizumab (trade name: Tecentriq), Avelumab (product name: Bavencio), and Durvalumab (product name: Imfinzi) have been approved for sale in the US. Among them, Atezolizumab and Durvalumab have been approved for sale in China. In China, similar products such as Corning Jerry/Siludi Pharmaceuticals' envolizumab, Cornerstone Pharmaceuticals' sugarimab, and Chia Tai Tianqing Pharmaceuticals' bemosubizumab have been approved for marketing. According to inquiries, total global sales of Atezolizumab, Avelumab, and Durvalumab in 2024 were approximately $9.648 billion. Up to now, the total R&D investment for adbelizumab injection-related projects is about 939.08 million yuan.