Biopharmaceutical company Shanghai Henlius Biotech, Inc. (2696.HK) and healthcare company Organon (NYSE: OGN) announced on Wednesday that the US FDA has accepted the Biologics License Application (BLA) for HLX14, a biosimilar candidate of PROLIA/XGEVA (denosumab).

Denosumab is widely used for treating osteoporosis in postmenopausal women at high fracture risk, among other indications.

In 2022, Henlius granted Organon exclusive commercialisation rights for HLX14 in key markets, including the US, EU and Canada, excluding China. The BLA is supported by comparative analytical and clinical studies demonstrating pharmacokinetic and efficacy similarity to PROLIA in high-risk postmenopausal women.

Henlius, with a focus on affordable biopharmaceuticals in oncology, autoimmune and ophthalmic diseases, has expanded globally with multiple approved products and a pipeline of over 50 molecules.