Hualan Biological investee's denosumab biosimilar application accepted

Hualan Biological Engineering Co., Ltd. announced its investee company, Hualan Genetic Engineering Co., Ltd. (referred to as “Genetic Company”), has received an acceptance notice from the National Medical Products Administration for its domestic production drug registration application for Denosumab Injection. The application, with acceptance number CXSS2500138, falls under Class 3.3 therapeutic biological products.

The Denosumab Injection, at a specification of 120mg (1.7ml) per vial, is intended for the treatment of bone metastases from solid tumors, multiple myeloma, and giant cell tumors of bone. Denosumab, a humanized monoclonal antibody, works by targeting the nuclear factor-κB receptor activator ligand (RANKL), a critical factor in osteoclast formation and function, effectively preventing bone-related events common in malignant bone metastasis.

This biosimilar, developed by Hualan Genetic Engineering, aims to address various skeletal diseases including osteoporosis and osteosarcoma. While the acceptance will not immediately impact Hualan Biological's performance, a successful approval would diversify the Genetic Company's product portfolio. The company emphasizes that the timing and outcome of the registration approval remain uncertain, and investors are advised to exercise caution due to investment risks.