摘要：Junshi Biosciences Announces the Completion of First Patient Dosing in the Phase 3 Clinical Trial of JS207 in Combination with JS007 for the First-Line Treatment of Advanced Hepatocellular Carcinoma

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Junshi Biosciences Announces the Completion of First Patient Dosing in the Phase 3 Clinical Trial of JS207 in Combination with JS007 for the First-Line Treatment of Advanced Hepatocellular Carcinoma

SHANGHAI, Oct. 29, 2026 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the first patient dosing has been completed in a multi-center, randomized, controlled, and open-label phase 3 clinical study evaluating the efficacy and safety of the company's product, recombinant humanized anti-PD-1/VEGF bispecific antibody (code: JS207), in combination with recombinant humanized anti-CTLA-4 monoclonal antibody (code: JS007) compared to toripalimab in combination with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma (JS207-017-III-HCC Study, NCT07823348).

Liver cancer is a common malignant tumor of the digestive system worldwide, with hepatocellular carcinoma (HCC) being the main pathological type (accounting for approximately 90%). China bears an exceptionally heavy disease burden of liver cancer. According to statistics of GLOBOCAN 2024, there were approximately 354,100 new liver cancer cases and 303,800 liver cancer deaths in China in 2024, making it the second leading cause of cancer-related death after lung cancer. Due to its insidious onset, over 50% of patients are diagnosed at an intermediate or advanced stage.

Systemic therapy is an important treatment modality for intermediate and advanced liver cancer, which primarily includes molecular targeted drugs, immunotherapy and systemic chemotherapy. However, as the median overall survival of current first-line systemic therapies is less than 2 years, there remain substantial unmet clinical needs for patients with intermediate and advanced liver cancer.

In October 2026, the results of a phase 2 clinical study of JS207 in combination with JS007 for the first-line treatment of advanced HCC were presented at the European Society for Medical Oncology (ESMO) Congress 2026 (Abstract No.: #1693eP). The study results showed that the drug combination therapy exhibited robust anti-tumor activity. A total of 36 patients received treatment of JS207 in combination with JS007 (3 mg/kg Q6W for two cycles, and 1 mg/kg Q6W (i.e. recommended dose) thereafter). Among 34 efficacy-evaluable patients, the objective response rate (ORR) of combined treatment reached 44.1%, the disease control rate (DCR) reached 85.3%, the median progression-free survival (PFS) had not yet been reached, and the six-month PFS rate reached 67%. The drug combination therapy was well tolerated.

JS207-017-III-HCC study is a multi-center, randomized, controlled, open-label phase 3 clinical study. The study aims to evaluate the efficacy and safety of JS207 in combination with JS007 compared to toripalimab in combination with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma. This study plans to enroll 560 subjects, and the primary endpoints are PFS and overall survival (OS).

About JS207

JS207 is a recombinant humanized anti-PD-1/VEGF bispecific antibody self-developed by Junshi Biosciences, mainly used for the treatment of advanced malignant tumors. JS207 can simultaneously bind to PD-1 and VEGFA with high affinity, effectively block the binding of PD-1 to PD-L1 and PD-L2, and inhibit the binding of VEGF to its receptor. JS207 has the efficacy properties of both immunotherapeutic drugs and anti-angiogenic drugs. Through the neutralization of VEGF, JS207 inhibits the proliferation of vascular endothelial cells, improves the tumor microenvironment and increases the infiltration of cytotoxic T lymphocytes in the tumor microenvironment, thereby achieving better anti-tumor activity.

JS207 is designed based on the high-affinity, clinically proven and differentiated anti-PD-1 drug toripalimab as the backbone. The anti-PD-1 moiety of JS207 adopts a Fab structure to maintain binding affinity to PD-1 and thereby attain better enrichment in the tumor microenvironment. The anti-VEGF moiety has a binding affinity for human vascular endothelial growth factor that is comparable to that of bevacizumab. In non-clinical in vitro cytological tests, compared with the combination of an anti-PD-1/PD-L1 monoclonal antibody and a VEGF monoclonal antibody, a bispecific antibody simultaneously targeting PD-1/PD-L1 and VEGF demonstrated significantly enhanced PD-1 antigen binding and internalization, and synergistic enhancement of the NFAT signaling pathway, thereby better activating immune cells in the tumor microenvironment.

About JS007

JS007 is a recombinant humanized anti-CTLA-4 monoclonal antibody injection self-developed by the Company, mainly used for the treatment of advanced malignant tumors. Cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) is an important receptor for T cell surface modulates immune response. Studies have shown that JS007 is able to bind to CTLA-4 specifically and block the interaction between CTLA-4 and its ligand B7 (CD80 or CD86) effectively, thereby activates T-lymphocyte and inhibits the growth of tumor.

About Junshi Biosciences

Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. With our outstanding capacity for innovative drug discovery, strong biotechnology R&D capability, and large-scale production capacity, we have successfully developed a drug candidate portfolio with global competitiveness and a well-structured research pipeline, which covers therapeutic areas including cancer, autoimmune, metabolic, and infectious diseases. Our innovative field spans cutting-edge therapeutic modalities, including mAbs, small-molecule drugs, ADCs, bsAb/msAb, fusion proteins, nucleic acid drugs and vaccines. Five of the company's products have received marketing authorizations in China and international markets, one of which is toripalimab, China's domestically developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 50 countries and regions including China, the US, and Europe.

With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” The company currently employs more than 3,000 people worldwide. Headquartered in Shanghai, China, it has a business presence in multiple countries and regions around the world. For more information, please visit: http://www.junshipharma.com.

Junshi Biosciences Contact Information

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Junshi Biosciences
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PR Team:
Junshi Biosciences
Zhi Li
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+ 86 021-6105 8800