Hualan Bio's Affiliate Submits IND Application for Pembrolizumab Injection, a Biosimilar to Keytruda®

Hualan Biological Engineering, Inc. (002007.SZ) announced recently that its participating company, Hualan Genetic Engineering Co., Ltd. (hereinafter referred to as "Hualan Genetic"), has received the "Acceptance Notice" for the clinical trial application of the domestically produced Pembrolizumab Injection from the National Medical Products Administration.

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

Pembrolizumab 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 suppress the immune activity of T cells by activating the PD-1 pathway, thereby achieving immune escape. Pembrolizumab restores the tumor-killing function of T cells and enhances the ability of the human immune system to fight tumors by blocking the binding of PD-1 to its ligands PD-L1/PD-L2. As an immune checkpoint inhibitor, this drug has become one of the standard treatment options for various advanced malignant tumors, revolutionizing the landscape of cancer treatment.