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华兰生物参股公司地舒单抗注射液药品注册获受理
Zhi Tong Cai Jing· 2025-12-15 04:32
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: Product Development - The Dexamethasone Injection developed by the company is a biosimilar drug, with the original product developed by Amgen and approved in multiple countries for treating various bone diseases such as 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] Group 2: Market Context - Currently, four companies in China, including Jiangsu Taikang Biopharmaceutical Co., Ltd., Qilu Pharmaceutical Co., Ltd., Shandong Boan Biotechnology Co., Ltd., and Canaan Jereh (Jilin) Biotechnology Co., Ltd., have received approval for their Dexamethasone Injection [2] - If Hualan Gene is approved for market entry, it will enhance the product portfolio of the company and provide a new profit growth point [2]