Hualan Biotech (002007.SZ) shares in the company desulumab injection drug registration was accepted

Zhitong Finance App News, Hualan Biotech (002007.SZ) issued an announcement. Recently, Hualan Genetic Engineering Co., Ltd. (hereinafter referred to as “Gene Company”), the company's shareholding company, received the “Notice of Acceptance” (acceptance number: CXSS2500138) for registration and marketing of drugs produced domestically produced with desumab injections issued by the State Drug Administration.

The desumab injection developed by the company is a biosimilar. The original product was developed by Amgen and has been approved and marketed in many countries and regions around the world. It is used to treat various types of skeletal diseases such as osteoporosis and bone giant cell tumor, and its efficacy and safety have been widely clinically proven.

Dysumab is a humanized monoclonal antibody (IgG2 type) that works by specifically targeting nuclear factor kappa B receptor activator ligands (RANKL). RANKL is a key factor necessary for osteoclasts to form, function, and survive. Bone metastases in malignant tumors often cause osteolytic damage, causing bone-related events such as bone pain, pathological fractures, spinal cord compression, and hypercalcemia, which seriously affects patients' quality of life and survival prognosis. By inhibiting RANKL, desumab strongly inhibits osteoclast-mediated bone resorption and bone destruction, thereby effectively preventing and delaying the occurrence of these bone-related events, and is an important clinically important tumor support treatment.

At present, four domestic companies, Jiangsu Taikang Biomedical Co., Ltd., Qilu Pharmaceutical Co., Ltd., Shandong Boan Biotechnology Co., Ltd., and Corning Jerry (Jilin) Biotechnology Co., Ltd. have been approved for listing. If gene companies are approved to go public, they will enrich the Gene Company's product lineup and add new profit growth points for gene companies.