Hualan Biological Engineering, Inc. (002007.SZ) related company's registration for the monoclonal antibody injection has been accepted.

Hualan Biological Engineering, Inc. (002007.SZ) announced that its affiliated company, Hualan Genetic Engineering Co., Ltd. (hereinafter referred to as the "Genetic Company"), has received the acceptance notification (acceptance number: CXSS2500138) for the registration and listing application of domestically produced drugs for Denosumab Injection issued by the National Medical Products Administration. The Denosumab Injection developed by the company is a biosimilar drug. The original product was developed by Amgen and has been approved for listing in multiple countries and regions worldwide for the treatment of various bone diseases such as osteoporosis and giant cell tumor. Its efficacy and safety have been widely validated in clinical practice. Denosumab is a humanized monoclonal antibody targeting the receptor activator of nuclear factor B ligand (RANKL). RANKL is a critical factor required for the formation, function, and survival of osteoclasts. Malignant bone metastases often lead to osteolytic destruction, causing bone pain, pathological fractures, spinal cord compression, hypercalcemia, and other bone-related events, severely impacting patients' quality of life and prognosis. Denosumab effectively prevents and delays the occurrence of these bone-related events by inhibiting RANKL, thus serving as an important supportive therapy for cancer patients. At present, four companies in China, Jiangsu Taikang Biomedical Co., Ltd., Qilu Pharmaceutical Co., Ltd., Shandong BOAN BIOTECH Technology Co., Ltd., and Corning Jerry (Jilin) Biotechnology Co., Ltd., have obtained approval for the listing of Denosumab Injections. If the Genetic Company is approved for listing, it will enrich the company's product lineup and add new profit growth points.