Jiangsu Hengrui Pharmaceuticals (01276) has obtained the drug clinical trial approval letter.

Jiangsu Hengrui Pharmaceuticals (01276) announced that Jiangsu Hengrui Pharmaceuticals Co., Ltd. (hereinafter referred to as the "Company") and its subsidiaries Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Jiangsu Hengrui Pharmaceuticals Co., Ltd., and Shanghai Shengdi Pharmaceuticals Co., Ltd. have received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for injection use of HRS-7058 capsules, HRS-7058 tablets, SHR-9839 (sc), Atezolizumab injection, Bevacizumab injection, and SHR-A2102 injections in the near future. SHR-9839 is a humanized monoclonal antibody drug independently developed by the company, which is intended for the treatment of advanced solid tumors. By simultaneously blocking two key signaling pathways related to tumor development, it plays an anti-tumor role. Injection of SHR-9839 (sc) is a subcutaneous injection preparation of SHR-9839, with one drug targeting the same point already approved for marketing worldwide. As of now, the accumulated research and development investment in the SHR-9839 project is approximately 72.31 million yuan. Atezolizumab injection is a humanized anti-PD-L1 monoclonal antibody independently developed by the company. By specifically binding to the PD-L1 molecule, it blocks the PD-1/PD-L1 pathway that causes tumor immune tolerance, reactivating the immune system's anti-tumor activity to achieve the goal of treating tumors. The company's Atezolizumab injection was approved for marketing in February 2023, with the indication approved for use in combination with carboplatin and etoposide as first-line treatment for extensive-stage small cell lung cancer patients. Several similar products have been approved for marketing internationally. As of now, the accumulated research and development investment in the Atezolizumab injection project is about 969 million yuan. Bevacizumab is a humanized anti-VEGF monoclonal antibody developed in cooperation with Genentech, a subsidiary of Roche. It was approved for marketing in the United States in 2004 under the name Avastin and is currently marketed in China and multiple countries worldwide. The company's Bevacizumab injection was approved for marketing in June 2021 and several Bevacizumab injections have been approved for marketing domestically. According to research, global sales of Bevacizumab in 2024 were approximately 56.55 billion US dollars. The accumulated research and development investment in the Bevacizumab injection project as of now is about 365 million yuan. Injection of SHR-A2102 is a targeted Nectin-4 antibody drug conjugate (ADC) developed independently by the company with intellectual property rights. Its payload is a topoisomerase I inhibitor (TOP1i). Several studies have shown that the high expression of Nectin-4 in tumors is closely related to tumor development and adverse outcomes. There is currently one similar product on the market, Enfortumab Vedotin (trade name: Padcev). According to the EvaluatePharma database, global sales of this product in 2024 were approximately 19.49 billion US dollars. The accumulated research and development investment in the injection of SHR-A2102 project as of now is about 2.48 billion yuan. HRS-7058 is a novel, highly effective, selective small molecule covalent inhibitor intended for the treatment of advanced solid tumors with KRASG12C mutations. Similar products such as Sotorasib and Adagrasib have received FDA accelerated approval for marketing globally, while Fulzurib and Garsorasib have been approved for marketing domestically. According to research, global sales of Sotorasib and Adagrasib in 2024 were approximately 4.85 billion US dollars. As of now, the accumulated research and development investment in HRS7058 related formulations is about 63.91 million yuan.