SHANGHAI, Oct. 16, 2025 — Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a prominent innovation-driven biopharmaceutical company focused on discovering, developing, and commercializing novel therapies, announced that its Investigational New Drug (“IND”) application has received approval from the U.S. Food and Drug Administration (the “FDA”). The application pertains to an open-label, two-arm, randomized, active-controlled, phase 2/3 clinical study. This study aims to compare the company’s recombinant humanized anti-PD-1/VEGF bispecific antibody (code: JS207) against nivolumab for the neoadjuvant treatment of patients with stage II/III, resectable, actionable genomic aberration (AGA)-negative, non-small cell lung cancer (“NSCLC”).
Lung cancer is currently the malignant tumor with the highest global prevalence and mortality rate. According to GLOBOCAN, approximately 2.48 million new lung cancer cases and 1.82 million lung cancer deaths were recorded worldwide in 2022. NSCLC constitutes a major subtype of lung cancer, accounting for about 85% of all cases. Among these, 20%-25% are surgically resectable upon initial diagnosis. However, even after radical surgical intervention, 30%-55% of these patients experience post-surgical recurrence and death. Presently, immune checkpoint inhibitors, specifically anti-PD-1 monoclonal antibodies combined with chemotherapy, are broadly utilized in the perioperative treatment of resectable NSCLC, demonstrating significant improvements in event-free survival (EFS), pathological complete response (pCR), and overall survival (OS). Nevertheless, patients with resectable NSCLC still contend with low survival and cure rates, among other substantial unmet clinical needs.
The ongoing study is an open-label, two-arm, randomized, active-controlled, international multi-center phase 2/3 clinical trial designed to assess the efficacy and safety of JS207 compared to nivolumab for the neoadjuvant treatment of patients with stage II/III, resectable, AGA-negative NSCLC. JS207 now stands as the first PD-1/VEGF dual-target drug to be approved for conducting a confirmatory study in patients eligible for surgery. Professor Yilong WU from Guangdong Provincial People’s Hospital will serve as the principal investigator for this study.
Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, commented, “As a highly promising candidate within Junshi Biosciences’ next-generation immuno-oncology portfolio (I-O 2.0), JS207 has undergone a series of proof-of-concept (POC) studies targeting prevalent cancers both in China and globally. In this ongoing Phase 2/3 clinical trial evaluating neoadjuvant therapy for resectable lung cancer, we have opted to directly challenge first-generation PD-1 monoclonal antibodies with JS207. By leveraging cutting-edge innovative therapies, our goal is to offer more patients superior treatments and a brighter future. The international regulatory authorities have acknowledged our clinical demand-driven R&D approach and scientifically rigorous study design, and their validation is profoundly encouraging. Moving forward, we will intensify our global development efforts to establish JS207 as a cornerstone of the I-O 2.0 portfolio and achieve transformative breakthroughs in immuno-oncology.”
Regarding JS207
JS207, a recombinant humanized anti-PD-1/VEGF bispecific antibody, was developed independently by Junshi Biosciences for the treatment of advanced malignant tumors. Currently, JS207 has received approval to proceed with a phase 2/3 clinical study, and numerous ongoing phase 2 clinical studies are exploring its use in combination with chemotherapy, monoclonal antibodies, antibody-drug conjugates (ADCs), and other drugs across various tumor types, including NSCLC, colorectal cancer, triple-negative breast cancer, and liver cancer.
JS207 possesses the ability to simultaneously bind to PD-1 and VEGFA with high affinity. This effectively blocks the binding of PD-1 to PD-L1 and PD-L2, while also inhibiting the binding of VEGF to its receptor. Consequently, JS207 demonstrates the therapeutic efficacy of both immunotherapeutic and anti-angiogenic drugs. Through the neutralization of VEGF, JS207 suppresses the proliferation of vascular endothelial cells, ameliorates the tumor microenvironment, and enhances the infiltration of cytotoxic T lymphocytes within the tumor microenvironment, thereby achieving superior anti-neoplasm activity.
The design of JS207 is based on toripalimab, a high-affinity, clinically proven, and differentiated anti-PD-1 drug, serving as its backbone. The anti-PD-1 moiety of JS207 incorporates a Fab structure to maintain strong binding affinity to PD-1, thus facilitating better enrichment in the tumor microenvironment. The anti-VEGF moiety exhibits a binding affinity for human vascular endothelial growth factor that is comparable to that of bevacizumab. In non-clinical in vitro cytological tests, a bispecific antibody simultaneously targeting PD-1/PD-L1 and VEGF demonstrated significantly enhanced PD-1 antigen binding and internalization, as well as a synergistic improvement in the NFAT signaling pathway, leading to better activation of immune cells in the tumor microenvironment, compared to the combination of an anti-PD-1/PD-L1 monoclonal antibody and a VEGF monoclonal antibody.
About Junshi Biosciences
Established 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. The company has cultivated a diverse R&D pipeline comprising over 50 drug candidates, with five key therapeutic focus areas spanning cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have secured approvals in both China and international markets, notably toripalimab, which is China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has achieved approval in more than 40 countries and regions, including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively fulfilled its social responsibilities as a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19.
With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences operates under the principle “In China, For Global.” Currently, the company employs approximately 2,500 individuals across its locations in the United States (Maryland) and China (including Shanghai, Suzhou, Beijing, and Guangzhou, among others). For additional information, please visit: http://www.junshipharma.com.
Junshi Biosciences Contact Information
Investor Relations Team:
Junshi Biosciences
+ 86 021-6105 8800
Public Relations Team:
Junshi Biosciences
Zhi Li
+ 86 021-6105 8800
