智通财经网·2025-10-16 11:07Core Viewpoint - The company has received FDA approval for its clinical trial application for JS207, a bispecific antibody targeting PD-1 and VEGF, aimed at treating resectable, AGA-negative non-small cell lung cancer (NSCLC) patients in a Phase II/III study [1][2]. Company Summary - JS207 is a recombinant humanized bispecific antibody designed to target PD-1 and VEGF, developed independently by the company, primarily for the treatment of advanced malignancies [1]. - The antibody has high affinity for both PD-1 and VEGFA, effectively blocking the interaction between PD-1 and its ligands, as well as inhibiting VEGF from binding to its receptors [1]. - JS207 combines the therapeutic effects of immunotherapy and anti-angiogenic therapy, improving the tumor microenvironment and enhancing the infiltration of cytotoxic T lymphocytes, thereby achieving better anti-tumor activity [1][2]. Clinical Research Summary - The clinical trial is an open-label, two-arm, randomized, positive-controlled Phase II/III study comparing the efficacy and safety of JS207 with Nivolumab in NSCLC patients [3]. - This study marks the first confirmatory research for a PD-1/VEGF dual-target drug in a surgical population, led by Professor Wu Yilong from Guangdong Provincial People's Hospital [3]. - The company is also conducting multiple Phase II clinical studies exploring JS207 in various cancers, including NSCLC, colorectal cancer, triple-negative breast cancer, and liver cancer, in combination with chemotherapy and other therapies [2]. Industry Context - Lung cancer remains the leading cause of cancer incidence and mortality globally, with approximately 2.48 million new cases and 1.82 million deaths reported in 2022 [3]. - Non-small cell lung cancer (NSCLC) accounts for about 85% of all lung cancer cases, with 20% to 25% of patients being eligible for surgical resection at diagnosis [3]. - Despite advancements in treatment, there remains an unmet clinical need for improved survival rates and cure rates in resectable NSCLC patients [3].