Junshi Biosciences(SH:688180) Globenewswire·2025-10-17 00:23Core Viewpoint - Junshi Biosciences has received FDA approval for the IND application of JS207, a bispecific antibody targeting PD-1 and VEGF, for a phase 2/3 clinical study in patients with resectable NSCLC [1][4]. Industry Overview - Lung cancer is the most prevalent and deadly malignant tumor globally, with approximately 2.48 million new cases and 1.82 million deaths reported in 2022. NSCLC accounts for about 85% of lung cancer cases, with 20%-25% being surgically resectable at diagnosis. Despite surgical treatment, 30%-55% of patients experience recurrence and death [2]. Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery and commercialization of novel therapies. The company has over 50 drug candidates in its R&D pipeline, with five products approved in China and international markets, including toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody [8][9]. Product Details - JS207 is a recombinant humanized anti-PD-1/VEGF bispecific antibody developed by Junshi Biosciences for advanced malignant tumors. It is currently approved for phase 2/3 clinical studies and is being explored in combination with other therapies for various cancers, including NSCLC and triple-negative breast cancer [5][6]. Clinical Study Design - The phase 2/3 clinical study is an open-label, two-arm, randomized, active-controlled trial comparing the efficacy and safety of JS207 to nivolumab for neoadjuvant treatment in stage II/III, resectable, AGA-negative NSCLC. This study is significant as JS207 is the first PD-1/VEGF dual-target drug approved for such a study [3][4]. Mechanism of Action - JS207 binds simultaneously to PD-1 and VEGFA, blocking their interactions and enhancing anti-tumor activity. It combines the effects of immunotherapeutic and anti-angiogenic drugs, improving the tumor microenvironment and increasing cytotoxic T lymphocyte infiltration [6][7].