Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (600196.SH) has announced that the drug registration application for its self-developed denosumab biosimilar, HLX14 (recombinant anti-RANKL fully human monoclonal antibody injection), in the 120mg (1.7ml)/vial specification, has been accepted by the National Medical Products Administration (NMPA).

The application was submitted by the company's controlling subsidiary, Shanghai Henlius Biotech, Inc., along with its own subsidiaries. The indication sought in this application covers all indications that have been approved for marketing in China for the reference product, XGEVA® (English trade name).

HLX14 is an independently developed denosumab biosimilar by the company. As of the announcement date, HLX14 (in specifications of 60mg/mL and 120mg/1.7mL) has already received marketing approvals in the United States, the European Union, the United Kingdom, and Canada.

As of August 2026, the company's cumulative research and development investment in HLX14 at this stage amounts to approximately RMB 352 million (unaudited).