FOSUN PHARMA (02196.HK): Registration application for new specification of HLX14 denosumab biosimilar accepted by NMPA

NewTimeSpace News: On 11 September 2026, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (stock code: 02196) announced that the drug registration application for the 120mg (1.7ml) vial specification of HLX14 (a recombinant anti-RANKL fully human monoclonal antibody injection), a denosumab biosimilar independently developed by the company's controlling subsidiary Shanghai Henlius Biotech, Inc. and its subsidiaries, has been accepted by the National Medical Products Administration.

According to the announcement, the indication applied for covers all indications approved in mainland China for its reference product Xgeva. HLX14 is a denosumab biosimilar independently developed by the group; as at the date of the announcement, HLX14 (specifications: 60mg/mL and 120mg/1.7mL) has been approved for marketing in the United States, the European Union, the United Kingdom and Canada, covering all indications approved locally for the relevant originator products; in addition, marketing registration applications for its 60mg (1.0mL) vial and 60mg (1.0mL) pre-filled syringe specifications were accepted by the NMPA in December 2025.

The announcement stated that, as at August 2026, the group's cumulative R&D investment in HLX14 was approximately RMB 352 million (unaudited). According to the latest IQVIA MIDAS data, global sales of denosumab products amounted to approximately USD 8.092 billion in 2025. The company noted that, before commercial production of the accepted specification can commence in mainland China, the manufacturing site must pass GMP compliance inspection and drug registration approval must be obtained, that the acceptance will not have a material impact on the group's results for the current period, and that post-launch sales may be affected by factors including prescribing demand, market competition and sales channels.

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