Junshi Biosciences Announces FDA’s Approval of IND Application for Phase 2/3 Clinical Study of JS207 for the Neoadjuvant Treatment of NSCLC Patients

SHANGHAI, Oct. 16, 2025 (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 investigational new drug (“IND”) application for an open-label, two-arm, randomized, active-controlled, phase 2/3 clinical study comparing the company’s product, recombinant humanized anti-PD-1/VEGF bispecific antibody (code: JS207), to nivolumab for the neoadjuvant treatment of patients with stage Ⅱ/Ⅲ, resectable, actionable genomic aberration (AGA)-negative, non-small cell lung cancer (“NSCLC”) has been approved by the U.S. Food and Drug Administration (the “FDA”).

Lung cancer is currently a malignant tumor with the highest prevalence and mortality rate in the world. According to GLOBOCAN, there were approximately 2.48 million new lung cancer cases and approximately 1.82 million lung cancer deaths worldwide in 2022. NSCLC is a major subtype of lung cancer, accounting for approximately 85% of all cases. Amongst these cases, 20%-25% are surgically resectable at first diagnosis, but even after radical surgical treatment, 30%-55% of these patients suffer from post-surgical recurrence and death. Currently, immune checkpoint inhibitors, represented by anti-PD-1 monoclonal antibodies combined with chemotherapy, have been widely used in the perioperative treatment of resectable NSCLC, and show significant improvements in event-free survival (EFS), pathological complete response (pCR), and overall survival (OS). However, patients with resectable NSCLC still face low survival and cure rates, among other unmet clinical needs.

The study is an open-label, two-arm, randomized, active-controlled, international multi-center phase 2/3 clinical study comparing the efficacy and safety of JS207 to nivolumab for the neoadjuvant treatment of patients with stage Ⅱ/Ⅲ, resectable, AGA-negative NSCLC. JS207 is now the first PD-1/VEGF dual-target drug approved for conducting confirmatory study in patients eligible for surgery. Professor Yilong WU from Guangdong Provincial People’s Hospital will be the principal investigator.

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “As a high-potential candidate in 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 in China and globally. In this ongoing Phase 2/3 clinical trial evaluating neoadjuvant therapy for resectable lung cancer, we have chosen to directly challenge first-generation PD-1 monoclonal antibodies with JS207. By harnessing cutting-edge innovative therapies, we aim to offer more patients better treatments and a better future. The international regulatory authorities have recognized our clinical demand-driven R&D plus scientifically rigorous study design, and their validation is highly encouraging. Moving forward, we will accelerate our global development efforts to make JS207 a cornerstone of the I-O 2.0 porfolio and achieve evolutionary breakthroughs in immuno-oncology.”