Hengrui Pharmaceutical (01276): SHR-A2009 and adbelizumab injections obtained drug clinical trial approval notices

Zhitong Finance App News, Hengrui Pharmaceutical (01276) issued an announcement. Recently, Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”) subsidiaries Suzhou Shengdia Biomedical 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 a “Drug Clinical Trial Approval Notice” for injectable SHR-A2009 and adbelizumab injections. Clinical trials will be carried out in the near future.

Injectable SHR-A2009 is an antibody-drug conjugate targeting HER3. It can specifically bind to HER3 on the surface of tumor cells, then be engulfed into cells and transported to lysosomes. Water releases free toxins and kills tumor cells. Currently, the marketing license application for this project's single drug for non-small cell lung cancer clinical trials has been accepted, and there are no HER3-targeting ADCs approved to treat NSCLC in the world. Up to now, the total R&D investment for injectable SHR-A2009 related projects is about RMB 319.5 million (unaudited).

Adbelimab 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 has been approved for two indications: first-line treatment of patients with extensive small cell lung cancer in combination with carboplatin and etoposide; combined with platinum-containing chemotherapy as a new adjuvant treatment, and continued to use this product as a single adjuvant treatment after surgery to treat patients with stage II, IIIA, and IIIB that can be surgically resected and have no known EGFR (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangement. 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. A number of similar products have also been approved for sale in China. According to inquiries, total global sales of Atezolizumab, Avelumab, and Durvalumab in 2025 were approximately US$11.054 billion. Up to now, the total R&D investment for adbelimab injection-related projects is about 1251.9 million yuan (unaudited).