Jiangsu Hengrui Pharmaceuticals (01276): SHR-A2009 and Adebelimab injection have received the clinical trial approval notice.

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, its subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Pharmaceutical Co., Ltd. received the approval from the National Medical Products Administration (referred to as "NMPA") for the "Clinical Trial Approval Notice" regarding the injectable SHR-A2009 and Adebali Monoclonal Antibody Injection, which will commence clinical trials soon. Injectable SHR-A2009 is an antibody-drug conjugate targeting HER3, which can specifically bind to HER3 on the surface of tumor cells, be internalized into the cells, and transported to lysosomes, where it releases free toxins through hydrolysis to kill tumor cells. Currently, the application for market approval of SHR-A2009 as a monotherapy for non-small cell lung cancer has been accepted, and there are currently no approved ADCs targeting HER3 for the treatment of NSCLC worldwide. As of now, the total R&D investment in SHR-A2009-related projects has reached approximately 329.5 million yuan (unaudited). Adebali Monoclonal Antibody Injection is a humanized anti-PD-L1 monoclonal antibody independently developed by the company. It can specifically bind to the PD-L1 molecule, thereby blocking the PD-1/PD-L1 pathway that leads to tumor immunotolerance, and reactivating the anti-tumor activity of the immune system to achieve tumor treatment. The Adebali Monoclonal Antibody Injection has been approved for two indications: first-line therapy for extensive-stage small cell lung cancer patients in combination with carboplatin and etoposide; and as neoadjuvant therapy combined with platinum-based chemotherapy, followed by monotherapy with this product as adjuvant therapy for adult patients with resectable stage II, IIIA, and IIIB non-small cell lung cancer (NSCLC) who have no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Similar products such as Atezolizumab (trade name: Tecentriq), Avelumab (trade name: Bavencio), and Durvalumab (trade name: Imfinzi) have been approved for sale in the United States, and Atezolizumab and Durvalumab have been approved for sale in China. Several similar products have also been approved for sale domestically. According to inquiries, the total global sales of Atezolizumab, Avelumab, and Durvalumab are estimated to be approximately 11.054 billion USD in 2025. As of now, the total R&D investment in Adebali Monoclonal Antibody Injection-related projects has reached approximately 1.2519 billion yuan (unaudited).