HENGRUI PHARMA announced that recently, Jiangsu Hengrui Pharmaceuticals Co.,Ltd. and its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Shengdi Pharmaceutical Co., Ltd., and Shanghai Hengrui Pharmaceutical Co., Ltd., have received Drug Clinical Trial Approval Notices from the National Medical Products Administration for HRS-6093 tablets, SHR-9839(sc) for injection, SHR-1826 for injection, adebelisimab injection, and SHR-8068 injection. Clinical trials will be conducted in the near future.
HRS-6093 tablets are a novel, highly effective, and selective oral KRAS G12D inhibitor that can specifically bind to the KRAS G12D mutant protein, exerting an anti-tumor effect. According to inquiries, no similar products have been approved for marketing domestically or internationally. To date, the cumulative R&D investment for the HRS-6093 tablets related project is approximately 53.3 million yuan (unaudited).
SHR-9839 is a self-developed humanized antibody drug intended for the treatment of advanced solid tumors. It exerts anti-tumor effects by simultaneously blocking two key signaling pathways related to tumor development. SHR-9839(sc) for injection is the subcutaneous formulation of SHR-9839. Currently, one drug with the same target has been approved for marketing globally. To date, the cumulative R&D investment for the SHR-9839 related project is approximately 109.5 million yuan (unaudited).
SHR-1826 for injection is an antibody-drug conjugate targeting c-Met. It kills tumor cells by specifically binding to target antigens on the surface of tumor cells and being internalized. According to inquiries, a similar product, ABBV-399 (generic name: telisotuzumab vedotin), received accelerated approval from the U.S. FDA in May 2025. To date, the cumulative R&D investment for the SHR-1826 for injection related project is approximately 140.9 million yuan (unaudited).
Adebelisimab injection is a self-developed humanized anti-PD-L1 monoclonal antibody. It works by specifically binding to the PD-L1 molecule, thereby blocking the PD-1/PD-L1 pathway that leads to tumor immune tolerance, reactivating the immune system's anti-tumor activity to achieve tumor treatment. The company's adebelisimab injection was approved for marketing in 2023, with the approved indication being first-line treatment in combination with carboplatin and etoposide for patients with extensive-stage small cell lung cancer. Internationally, similar products such as Atezolizumab (brand name: Tecentriq), Avelumab (brand name: Bavencio), and Durvalumab (brand name: Imfinzi) have been approved for marketing in the United States, with Atezolizumab and Durvalumab also approved in China. Several similar products have been approved for marketing domestically. According to inquiries, the combined global sales of Atezolizumab, Avelumab, and Durvalumab in 2024 were approximately $9.648 billion. To date, the cumulative R&D investment for the adebelisimab injection related project is approximately 1.1747 billion yuan (unaudited).
SHR-8068 injection is a fully human anti-CTLA-4 monoclonal antibody introduced by the company, which can enhance anti-tumor immune effects. Currently, two similar products are approved for marketing globally: ipilimumab and tremelimumab. According to inquiries, the combined global sales of ipilimumab and tremelimumab in 2025 were approximately $1.68 billion. To date, the cumulative R&D investment for the SHR-8068 injection related project is approximately 368.1 million yuan (unaudited).
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