华兰生物：参股公司帕博利珠单抗注射液药品注册临床试验申请获受理

Core Viewpoint - Hualan Biological (002007.SZ) announced that its subsidiary, Hualan Gene Engineering Co., Ltd., received a clinical trial application acceptance notice from the National Medical Products Administration for the domestic production of the drug Pembrolizumab injection [1] Group 1: Drug Development - The Pembrolizumab injection developed by the company is a biosimilar drug [1] - The original product of Pembrolizumab (brand name: Keytruda) was developed by Merck & Co. and is one of the first PD-1 inhibitors approved globally [1] - Pembrolizumab has been approved for multiple significant cancer indications, including non-small cell lung cancer, melanoma, head and neck squamous cell carcinoma, esophageal cancer, liver cancer, gastric cancer, and colorectal cancer [1] Group 2: Mechanism of Action - Pembrolizumab is a humanized monoclonal antibody targeting the programmed cell death protein 1 (PD-1) [1] - PD-1 is a critical immune checkpoint protein on the surface of immune T cells, which tumor cells can activate to suppress T cell immune activity, leading to immune evasion [1] - Pembrolizumab works by blocking the binding of PD-1 to its ligands PD-L1/PD-L2, restoring T cell tumor-killing function and enhancing the immune system's ability to combat tumors [1] Group 3: Market Impact - As an immune checkpoint inhibitor, Pembrolizumab has become one of the standard treatment options for various advanced malignancies, revolutionizing the landscape of cancer treatment [1]