华兰生物(002007.SZ)：参股公司收到药品注册临床试验受理通知书

Group 1 - The core point of the article is that 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 Pembrolizumab injection [1] - Pembrolizumab is a biosimilar drug developed by the company, targeting multiple cancers including melanoma, non-small cell lung cancer, esophageal cancer, and head and neck squamous cell carcinoma [1] - The original product of Pembrolizumab, marketed as Keytruda, was developed by Merck and is one of the first PD-1 inhibitors approved globally, recognized for its clinical value across various significant tumor indications [1] Group 2 - Pembrolizumab is a humanized monoclonal antibody targeting the programmed cell death protein 1 (PD-1), which plays a crucial role in immune checkpoint regulation [2] - The drug works by blocking the interaction between PD-1 and its ligands PD-L1/PD-L2, thereby restoring T cell anti-tumor activity and enhancing the immune system's ability to combat tumors [2] - As an immune checkpoint inhibitor, Pembrolizumab has become a standard treatment for various advanced malignancies, revolutionizing the landscape of cancer treatment [2] - Currently, there are no similar drugs approved for marketing in China, aside from the original product [2]