Hualan Bio's Associate Company Receives NMPA Acceptance for Denosumab Injection Marketing Application

Intelligent Finance APP, Hualan Biological Engineering, Inc. (002007.SZ) announced that recently, its participating company Hualan Genetic Engineering Co., Ltd. (hereinafter referred to as "Hualan Genetic") received the "Notice of Acceptance" (Acceptance No.: CXSS2500138) for the marketing authorization application of Denosumab Injection manufactured in China from the National Medical Products Administration.

The denosumab injection developed by the company is a biosimilar. The original product, developed by Amgen, has been approved for marketing in numerous countries and regions worldwide. It is used to treat various skeletal conditions such as osteoporosis and giant cell tumor of bone, with its efficacy and safety having been extensively validated in clinical settings.

Denosumab is a humanized monoclonal antibody (IgG2 type) that functions by specifically targeting the receptor activator of nuclear factor-κB ligand (RANKL). RANKL is a key factor essential for the formation, function, and survival of osteoclasts. Bone metastases from malignant tumors often lead to osteolytic destruction, causing skeletal-related events such as bone pain, pathological fractures, spinal cord compression, and hypercalcemia, which severely impact patients' quality of life and survival prognosis. By inhibiting RANKL, denosumab effectively suppresses osteoclast-mediated bone resorption and bone destruction, thereby preventing and delaying the occurrence of these skeletal-related events, making it an important supportive treatment drug in clinical oncology.

Currently, four companies in China have received approval for the marketing of Denosumab Injection: Jiangsu Taikang Biopharmaceutical Co., Ltd., Qilu Pharmaceutical Co., Ltd., Shandong Boan Biotechnology Co., Ltd., and Kangning Jerrys (Jilin) Biotechnology Co., Ltd. If Hualan Genetic receives approval, it will enrich Hualan Genetic's product pipeline and create a new profit growth point for the company.