Henlius' HANSZHUANG granted priority review for gastric cancer NDA

Shanghai Henlius Biotech, Inc. announced its new drug application (NDA) for HANSZHUANG (serplulimab injection) has been accepted by China's National Medical Products Administration (NMPA). The NDA, for HANSZHUANG in combination with chemotherapy for neo-/adjuvant treatment of PD-L1 positive, operable gastric cancer patients, has also been granted priority review, which is expected to accelerate its market approval.

The submission is supported by a randomized, double-blind, multi-center phase 3 clinical study. Results indicated that HANSZHUANG combined with chemotherapy significantly extended event-free survival (EFS) and demonstrated better safety and tolerability compared to full-course chemotherapy. This marks a significant development for the company’s lead product.

HANSZHUANG is an anti-PD-1 monoclonal antibody already approved for multiple indications in the Chinese Mainland, including various lung and esophageal cancers, and has received Orphan-drug Designation in several countries. Worldwide sales of PD-1 targeting monoclonal antibody drugs reached approximately $45.7 billion in 2024.