Henlius' HANSIZHUANG gets breakthrough therapy status for gastric cancer

Shanghai Henlius Biotech, Inc. announced its anti-PD-1 monoclonal antibody, HANSIZHUANG (serplulimab injection), combined with chemotherapy for neo-/adjuvant treatment of gastric cancer, has been granted Breakthrough Therapy Designation by China's Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation aims to prioritize the drug's development and accelerate regulatory review.

Breakthrough Therapy Designation is for innovative drugs treating severe, life-threatening diseases with no existing treatment, or where the new therapy significantly benefits patients over available options. This designation highlights HANSIZHUANG's recognized efficacy in this treatment area.

No monoclonal antibody drug targeting PD-1 has been globally approved for neo-/adjuvant treatment for gastric cancer. Worldwide sales of PD-1 targeting monoclonal antibody drugs are projected to reach approximately $45.704 bn in 2024.