Jiangsu Hengrui Pharmaceuticals (600276.SH) announced that the company has received a notice from the Food and Drug Administration (FDA) of the United States.
Zhixin Finance and Economics APP News, Jiangsu Hengrui Pharmaceuticals (600276.SH) announced that the company has received a letter of acknowledgment from the Food and Drug Administration (FDA) of the United States, confirming the acceptance of the company's re-submitted Biologics License Application (BLA) for the combination of injection Carilizumab monoclonal antibody and Apatinib mesylate tablets for first-line treatment of unresectable or metastatic hepatocellular carcinoma patients. According to the Prescription Drug User Fee Act (PDUFA), the FDA's target action date for the injection Carilizumab is March 23, 2025.
Injection Carilizumab is a humanized anti-PD-1 monoclonal antibody that can bind to the human PD-1 receptor, block the PD-1/PD-L1 pathway, restore the body's anti-tumor immune response, and form the basis for cancer immunotherapy.
