Hengrui Pharma Receives Clinical Trial Approvals for Five Oncology Drugs Including Novel KRAS G12D Inhibitor
核心洞察
Hengrui Pharma and its subsidiaries received NMPA clinical trial approvals for five oncology drugs, including HRS-6093 (搜索), a novel oral KRAS G12D (搜索) inhibitor with no similar approved products globally.
The approved pipeline includes SHR-9839, a dual-pathway blocking humanized antibody, and SHR-1826, a c-Met (搜索) targeting antibody-drug conjugate with cumulative R&D investments totaling over RMB 400 million.
The company's adalimumab injection, already approved for small cell lung cancer treatment in 2023, received additional clinical trial approval alongside SHR-8068, an anti-CTLA-4 (搜索) monoclonal antibody.
Hengrui Pharma and its subsidiaries have received clinical trial approval notifications from China's National Medical Products Administration (NMPA) for five oncology drugs, marking a significant expansion of the company's clinical pipeline. The approvals cover HRS-6093 (搜索) tablets, SHR-9839 subcutaneous injection, SHR-1826 injection, adalimumab injection, and SHR-8068 injection, with clinical trials set to commence in the near future.
Novel KRAS G12D Inhibitor Enters Clinical Development
HRS-6093 (搜索) tablets represent a breakthrough in targeted cancer therapy as a novel, highly potent, and selective oral KRAS G12D (搜索) inhibitor. The drug specifically binds to the KRAS G12D mutant protein to exert anti-tumor activity. According to Hengrui Pharma, no similar product has yet been approved for marketing either domestically or internationally, positioning HRS-6093 as a potential first-in-class therapy. The company has invested approximately RMB 53.3 million in the HRS-6093 tablet program to date.
Dual-Pathway Blocking Antibody Advances
SHR-9839, a humanized antibody drug independently developed by Hengrui, targets advanced solid tumors through a unique mechanism of action. The drug exerts anti-tumor effects by simultaneously blocking two key signaling pathways implicated in tumor initiation and progression. The subcutaneous formulation approved for clinical trials offers potential advantages in administration convenience. Currently, only one other drug targeting the same biomarker has been approved for marketing worldwide. Cumulative R&D investment in SHR-9839-related projects has reached approximately RMB 109.5 million.
Antibody-Drug Conjugate Targets c-Met Pathway
SHR-1826 for injection represents an antibody-drug conjugate approach targeting c-Met (搜索), a receptor tyrosine kinase involved in cancer progression. The drug specifically binds to target antigens on tumor cell surfaces, becomes internalized, and subsequently exerts cytotoxic effects to eliminate cancer cells. The competitive landscape includes ABBV-399 (telisotuzumab vedotin), which received accelerated FDA approval in May 2025. Hengrui has invested approximately RMB 140.9 million in the SHR-1826 program.
Expanding PD-L1 and CTLA-4 Portfolios
The adalimumab injection, a humanized anti-PD-L1 (搜索) monoclonal antibody, received additional clinical trial approval despite already being approved for marketing in 2023. The drug is currently indicated for first-line treatment of patients with extensive-stage small cell lung cancer in combination with carboplatin and etoposide. It works by specifically binding to PD-L1 molecules, blocking the PD-1/PD-L1 signaling pathway that leads to tumor immune tolerance and reactivating immune system antitumor activity.
The global market for similar PD-L1 (搜索) inhibitors demonstrates significant commercial potential. Atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi) generated combined global sales of approximately US$9.648 billion in 2024. Cumulative R&D investment in adalimumab injection projects has reached approximately RMB 117.47 million.
SHR-8068 injection, a fully human anti-CTLA-4 (搜索) monoclonal antibody, completes the immunotherapy portfolio expansion. The drug enhances anti-tumor immune responses through CTLA-4 pathway inhibition. Currently, only two similar products have been approved worldwide: ipilimumab and tremelimumab, which generated combined global sales estimated at approximately US$1.68 billion in 2025. The company has invested approximately RMB 368.1 million in SHR-8068 injection development, representing the largest single program investment among the five approved drugs.
Strategic Investment in Oncology Pipeline
The five clinical trial approvals represent a substantial commitment to oncology drug development, with total cumulative R&D investments across all programs reaching approximately RMB 789.27 million. This diversified approach spans multiple therapeutic mechanisms including targeted therapy, immunotherapy, and antibody-drug conjugates, positioning Hengrui Pharma to address various cancer treatment needs across different patient populations and disease stages.