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Fosun Pharmaceutical (600196.SH) subsidiary desulumab biosimilar HLX14 registration application accepted
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Zhitong Finance App News, Fosun Pharmaceutical (600196.SH) issued an announcement. Recently, the company's holding subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd. and its holding subsidiary independently developed desulfamide biosimilar HLX14 (i.e. recombinant anti-RANKL whole human monoclonal antibody injection) drug registration application with a size of 120 mg (1.7 ml) /bottle was accepted by the State Drug Administration. The indications declared this time are all the indications for which the reference drug Agave® (English product name: XGEVA®) has been approved for marketing in China.

According to reports, HLX14 is a desulumab biosimilar drug independently developed by the company. As of the announcement date, HLX14 (specifications: 60 mg/mL, 120 mg/1.7 mL) has been approved for marketing in the US, the European Union, the United Kingdom, and Canada, respectively. As of August 2026, the company's cumulative R&D investment for HLX14 at this stage is approximately 352 million yuan (unaudited).

Disclaimer:Webull uses external vendor Google Translation Service for news translations where we endeavour to ensure these are correct, however, we recommend that you please double-check this information accordingly. Webull is not responsible for translation errors or issues.
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