华兰生物(002007.SZ)参股公司地舒单抗注射液药品注册获受理

Core Viewpoint - Hualan Biological (002007.SZ) announced that its subsidiary, Hualan Gene Engineering Co., Ltd., received a notice of acceptance for the production registration application of Dexamethasone Injection from the National Medical Products Administration, marking a significant step towards market entry for this biosimilar drug [1][2] Group 1 - The Dexamethasone Injection developed by the company is a biosimilar, with the original product developed by Amgen and approved in multiple countries for treating various bone diseases, including osteoporosis and giant cell tumors [1] - Dexamethasone is a humanized monoclonal antibody (IgG2 type) that targets RANKL, a key factor necessary for osteoclast formation and function, thereby preventing bone-related events caused by malignant tumor bone metastasis [1] - The drug effectively inhibits osteoclast-mediated bone resorption and destruction, making it an important supportive treatment for cancer patients [1] Group 2 - Currently, four companies in China have received approval for Dexamethasone Injection, including Jiangsu Taikang Biopharmaceutical Co., Ltd., Qilu Pharmaceutical Co., Ltd., Shandong Boan Biotechnology Co., Ltd., and Canaan Jereh (Jilin) Biotechnology Co., Ltd. [2] - If Hualan Gene receives approval, it will enhance the product portfolio of the company and provide a new profit growth point [2]