Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company’s innovative anti-HER2 monoclonal antibody (mAb) for the treatment of gastric cancer.
Receiving an Orphan Drug Designation for HLX22 recognizes its potential to treat patients with gastric cancer and marks another milestone for HLX22, following the initiation of its multicenter phase 3 clinical trials in multiple countries and regions worldwide, and signifies a crucial step forward in its global presence.
Until now, gastric cancer still constitutes a major global health problem. According to GLOBOCAN 2022, there were around 1 million new cases and over 660 thousand new deaths of gastric cancer in 2022 globally. Gastric cancer is often diagnosed at an advanced stage, with a poor prognosis and a 5-year relative survival rate of only 6%. Despite significant advancements in targeted therapies, such as anti-HER2 agents, and immune checkpoint inhibitors (anti-PD-1/PD-L1 mAbs) for gastric cancer treatment in recent years, the disease’s high molecular heterogeneity leads to markedly varied responses to chemotherapy, targeted therapy, and immunotherapy across different subtypes.
