Jiangsu Hengrui Pharmaceuticals (01276): HRS-7172 tablets, Adebrelimab injection, and other drugs received drug clinical trial approval notices.

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (hereinafter referred to as the "Company") and its subsidiaries received drug clinical trial approval notices approved and issued by the National Medical Products Administration (hereinafter referred to as the "NMPA") for HRS-7172 tablets, Adebrelimab injection, SHR-4610 injection, SHR-8068 injection, SHR-9839 (sc) for injection, SHR-1826 for injection, Bevacizumab injection, HRS-4642 injection, HRS-6093 tablets, and HRS-7058 capsules, and will commence clinical trials in the near future. HRS-7172 tablets are a novel anti-tumor small molecule inhibitor independently developed by the Company. Upon inquiry, there are currently no similar drugs approved for marketing in China. As of now, the cumulative R&D investment in HRS-7172 tablets and related projects is approximately RMB 61.9 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 the PD-L1 molecule, reactivating the anti-tumor activity of the immune system, thereby achieving the purpose of treating tumors. The Company's Adebrelimab injection has been approved for two indications, namely: in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer; in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by continued use of this product as monotherapy adjuvant treatment after surgery, for the treatment of adult patients with resectable stage II, IIIA, and IIIB non-small cell lung cancer (NSCLC) without 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. Upon inquiry, the combined global sales of Atezolizumab, Avelumab, and Durvalumab in 2025 were approximately USD 11.054 billion. As of now, the cumulative R&D investment in Adebrelimab injection and related projects is approximately RMB 1.309 billion (unaudited). SHR-4610 injection is an innovative anti-tumor drug independently developed by the Company, demonstrating good anti-tumor activity in preclinical animal models, and is intended for the treatment of advanced solid tumors. As of now, the cumulative R&D investment in SHR-4610 injection and related projects is approximately RMB 15.5 million (unaudited). SHR-8068 injection is a fully human anti-CTLA-4 monoclonal antibody introduced by the Company, which can enhance the anti-tumor immune effect. The project has advanced to Phase III for multiple combination therapy clinical trials for liver cancer, lung cancer, and others. Currently, two similar products have been approved for marketing globally, namely ipilimumab and tremelimumab. Upon inquiry, the combined global sales of ipilimumab and tremelimumab in 2025 were approximately USD 1.68 billion. As of now, the cumulative R&D investment in SHR-8068 injection and related projects is approximately RMB 510 million (unaudited). SHR-9839 is an EGFR/c-Met bispecific humanized antibody drug independently developed by the Company, intended for the treatment of advanced solid tumors, exerting anti-tumor effects by simultaneously blocking two key signaling pathways related to tumor occurrence and development. SHR-9839 (sc) for injection is a subcutaneous injection formulation of SHR-9839. Currently, one drug with the same target has been approved for marketing globally. As of now, the cumulative R&D investment in SHR-9839 and related projects is approximately RMB 124 million (unaudited). SHR-1826 for injection is an antibody-drug conjugate targeting c-Met, which specifically binds to target antigens on the surface of tumor cells, is internalized into tumor cells, and then kills tumor cells. Currently, the clinical trial of this project for non-small cell lung cancer has advanced to Phase III. Upon inquiry, the similar product ABBV-399 (generic name: telisotuzumab vedotin) received accelerated approval from the U.S. FDA for marketing in May 2025. As of now, the cumulative R&D investment in SHR-1826 for injection and related projects is approximately RMB 170 million (unaudited). Bevacizumab is a humanized anti-VEGF monoclonal antibody, jointly developed by Chugai Pharmaceutical and Genentech, a subsidiary of Roche. It was approved for marketing in the United States in 2004 under the trade name Avastin, and is currently marketed in China and multiple countries worldwide. The Company's Bevacizumab injection is a biosimilar of Avastin and was approved for marketing in 2021. Currently, multiple Bevacizumab injections have been approved for marketing in China. Upon inquiry, the global sales of Bevacizumab in 2025 were approximately USD 5.86 billion. As of now, the cumulative R&D investment in Bevacizumab injection and related projects is approximately RMB 413 million (unaudited). HRS-4642 injection is a KRAS G12D inhibitor independently developed by the Company, in a liposomal formulation. This product can specifically bind to KRAS G12D, inhibit the phosphorylation of MEK and ERK proteins, and exert anti-tumor effects. Upon inquiry, there are currently no similar drugs approved for marketing domestically or internationally. As of now, the cumulative R&D investment in HRS-4642 injection and related projects is approximately RMB 349 million (unaudited). HRS-6093 tablets are a novel, highly potent, selective oral KRAS G12D inhibitor that can specifically bind to the KRAS G12D mutant protein and exert anti-tumor effects. Upon inquiry, there are no similar products approved for marketing domestically or internationally. As of now, the cumulative R&D investment in HRS-6093 tablets and related projects is approximately RMB 60.2 million (unaudited). HRS-7058 is a novel, highly potent, selective small molecule covalent inhibitor, intended for the treatment of KRAS G12C-mutated advanced solid tumors. Globally, similar products Sotorasib and Adagrasib were approved for marketing by the FDA in 2021 and 2022, respectively. In China, four similar products have been approved for marketing, including fulzerasib (approved in 2024), garsorasib (approved in 2024), glecirasib (approved in 2025), and sosimerasib (approved in 2026). Upon inquiry of the EvaluatePharma database, the combined global sales of the above similar products in 2025 were approximately USD 619 million. As of now, the cumulative R&D investment in HRS-7058 and related formulations is approximately RMB 197 million (unaudited).