Jiangsu Hengrui Pharmaceuticals(600276.SH): Clinical trials for injection SHR-A2102 in combination with Adalimumab combined with SHR-1802 approved.

Jiangsu Hengrui Pharmaceuticals (600276.SH) announced that its subsidiaries, Suzhou Shengdia 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 the injection SHR-A2102, Adebeli Monoclonal Antibody Injection, and injection SHR-1802. The injection SHR-A2102 is a targeted antibody-drug conjugate (ADC) developed independently by the company with proprietary knowledge against Nectin-4, with a payload of topoisomerase I inhibitor (TOP1i). Various studies have shown a close association between Nectin-4 overexpression in tumors and tumor development and poor prognosis. Currently, there is only one similar product approved for sale globally, Enfortumab vedotin (trade name: Padcev), with estimated global sales of around $1.949 billion in 2024. As of now, the total research and development investment in the SHR-2102 project is approximately 224.84 million yuan. The injection SHR-1802 is a humanized monoclonal antibody developed independently by the company that can activate and promote anti-tumor T cell responses to exert anti-tumor effects. Currently, there are no similar products approved for sale in China. The total research and development investment in the SHR-1802 project is approximately 62.09 million yuan. Adebeli Monoclonal Antibody Injection is a humanized anti-PD-L1 monoclonal antibody independently developed by the company, which can block the PD-1/PD-L1 pathway that leads to tumor immune tolerance through specific binding to the PD-L1 molecule, reactivating the immune system's anti-tumor activity to treat tumors. The company's Adebeli Monoclonal Antibody Injection was approved for sale in February 2023 for first-line treatment in combination with carboplatin and etoposide for extensive-stage small cell lung cancer patients. Similar products Atezolizumab (trade name: Tecentriq), Avelumab (trade name: Bavencio), and Durvalumab (trade name: Imfinzi) have been approved for sale in the United States, with Atezolizumab and Durvalumab also approved in China. Domestically, similar products like Enverolizumab from Corning Jell/Sidley Pharmaceuticals, Shugerli Monoclonal Antibody from cornerstone pharmaceutical, and Bemostub mononkim from Wilmar Grand Tianjing pharmaceutical have been approved for sale. Estimated global sales for Atezolizumab, Avelumab, and Durvalumab amounted to approximately $9.648 billion in 2024. As of now, the total research and development investment in Adebeli Monoclonal Antibody Injection is approximately 93.908 million yuan.