3SBIO (01530): The anti-VEGF/PD-1 bispecific antibody drug 707 injection has received breakthrough therapy designation from the National Medical Products Administration.

3SBIO (01530) announced that its independently developed anti-VEGF/PD-1 bispecific antibody (research code: 707 injection) was included as a breakthrough therapy by the National Medical Products Administration on April 17, 2025. The indication is for first-line treatment of locally advanced or metastatic non-small cell lung cancer with PD-L1 positivity. The 707 injection is a targeted anti-VEGF/PD-1 bispecific antibody developed by 3SBIO based on the CLF2 patent platform. It is currently undergoing multiple clinical studies in China, with a phase III clinical study approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration for first-line treatment of locally advanced or metastatic non-small cell lung cancer with PD-L1 positivity. In addition, the 707 injection is being studied in multiple phase II trials for first-line treatment of advanced non-small cell lung cancer, metastatic colorectal cancer, advanced gynecologic tumors, among others in China. The new drug clinical trial application for the 707 injection has also been approved by the U.S. Food and Drug Administration. The CDE will provide policy support for drugs included as breakthrough therapies, prioritize resources for communication and exchange, strengthen guidance, and promote drug development. Drugs that meet the relevant conditions may be granted priority review and approval qualifications when submitting applications for market authorization, speeding up the process of drug approval.