Hualan Biology (002007.SZ): Participating company Pabolizumab injection drug registration clinical trial application accepted

Zhitong Finance App News, Hualan Biotech (002007.SZ) issued an announcement. Recently, Hualan Genetic Engineering Co., Ltd. (hereinafter referred to as “Gene Company”), the company's shareholding company, received a “Notice of Acceptance” issued by the State Drug Administration for the registration of a clinical trial application for domestically produced drugs of pabolizumab injections.

The pabolizumab injection developed by the company is a biosimilar. The pabolizumab antigen research product (trade name: Coreda®, Keytruda®) was developed by MSD and is one of the world's first PD-1 inhibitors approved for marketing. It has been approved globally for dozens of important tumor indications, including non-small cell lung cancer, melanoma, head and neck squamous cell cancer, esophageal cancer, liver cancer, stomach cancer, colorectal cancer, etc., and its clinical value has been widely recognized.

Pabolizumab is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1). PD-1 is a key immune checkpoint protein on the surface of immune T cells. Tumor cells can inhibit the immune activity of T cells by activating the PD-1 pathway, thereby achieving immune escape. Pabolizumab blocks the binding of PD-1 to its ligands PD-L1/PD-L2, restores the tumor-killing function of T cells and enhances the ability of the human immune system to fight tumors. As an immune checkpoint inhibitor, this drug has become one of the standard treatment options for various advanced malignant tumors, revolutionizing the tumor treatment pattern.