Jiangsu Hengrui Pharmaceuticals (01276): SHR-2005 Injection, SHR-1501 for Injection, and Adebrelimab Injection Receive Drug Clinical Trial Approval Notices

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, its subsidiaries Suzhou Suncadia Biopharmaceuticals Co., Ltd., Shanghai Shengdi Pharmaceutical Co., Ltd., and Shanghai Hengrui Pharmaceuticals Co., Ltd. received Drug Clinical Trial Approval Notices approved and issued by the National Medical Products Administration (NMPA) for SHR-2005 Injection, SHR-1501 for Injection, and Adebrelimab Injection, and will commence clinical trials in the near future. SHR-2005 Injection is an innovative anti-tumor drug independently developed by the company, intended for the treatment of bladder cancer. Upon inquiry, there are currently no similar drugs approved for marketing either domestically or internationally. To date, the cumulative R&D investment in SHR-2005 Injection-related projects is approximately RMB56.6 million (unaudited). SHR-1501 is an interleukin-15 (IL-15) fusion protein independently developed by the company with intellectual property rights, which can stimulate the proliferation of T cells, B cells, and NK cells in the body to exert anti-tumor effects. Currently, the overseas counterpart product Nogapendekin Alfa Inbakicept (trade name: Anktiva) has been approved for marketing in the United States, while no product targeting the same target has been approved for marketing in China. According to the EvaluatePharma database, the global sales of this product in 2025 totaled approximately US$113 million. To date, the cumulative R&D investment in SHR-1501 for Injection-related projects is approximately RMB130 million (unaudited). Adebrelimab 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 by specifically binding to PD-L1 molecules, thereby reactivating the anti-tumor activity of the immune system to achieve the purpose of tumor treatment. The company's Adebrelimab Injection has been approved for two indications: in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer; and in combination with platinum-containing chemotherapy as neoadjuvant therapy, followed by continued use of this product as monotherapy adjuvant therapy after surgery, for the treatment of 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. Overseas, similar products Atezolizumab (trade name: Tecentriq), Avelumab (trade name: Bavencio), and Durvalumab (trade name: Imfinzi) have been approved for marketing in the United States, among which Atezolizumab and Durvalumab have been approved for marketing in China. Multiple similar products have also been approved for marketing in China. According to inquiries, the global sales of Atezolizumab, Avelumab, and Durvalumab in 2025 totaled approximately US$11.054 billion. To date, the cumulative R&D investment in Adebrelimab Injection-related projects is approximately RMB1.37 billion (unaudited).