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

Core Viewpoint - Junshi Biosciences has received FDA approval for its investigational new drug application for JS207, a bispecific antibody targeting PD-1 and VEGF, aimed at treating resectable non-small cell lung cancer (NSCLC) in a phase 2/3 clinical study [1][3][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 [2] - Non-small cell lung cancer (NSCLC) accounts for about 85% of lung cancer cases, with 20%-25% being surgically resectable at diagnosis; however, 30%-55% of these patients experience recurrence post-surgery [2] Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery and commercialization of novel therapies, with over 50 drug candidates in its R&D pipeline [8][9] - The company has five therapeutic focus areas, including cancer, and has received approvals for five products in China and international markets, including toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody [8] Product Details - JS207 is a recombinant humanized anti-PD-1/VEGF bispecific antibody developed by Junshi Biosciences, currently approved for phase 2/3 clinical studies and being explored in various cancers [5][6] - The drug can bind to PD-1 and VEGFA, blocking their interactions and improving the tumor microenvironment, which enhances anti-tumor activity [6][7] Clinical Study Insights - The phase 2/3 clinical study is an open-label, two-arm, randomized, active-controlled trial comparing JS207 to nivolumab for neoadjuvant treatment in patients with stage II/III, resectable, AGA-negative NSCLC [3][4] - Professor Yilong WU from Guangdong Provincial People's Hospital will lead the study as the principal investigator [3]