Biopharmaceutical firm Shanghai Henlius Biotech Inc (Henlius) (2696.HK) and Organon (NYSE: OGN), a provider of medicines and products for women's health, on Monday reported the successful outcome of the phase 3 clinical trial for HLX14, a biosimilar candidate of Prolia and Xgeva (denosumab).

This study, initiated in December 2023 (NCT05352516), aimed to compare HLX14 with EU-sourced reference denosumab in postmenopausal women with osteoporosis at high fracture risk. The primary endpoints, including bone mineral density change and serum type I collagen C-telopeptide percentage change, were met.

Henlius signed an exclusive license and supply deal with Organon in 2022 for the commercialisation rights of two biosimilar candidates, including HLX14, except for China. The company boasts a diverse product pipeline with over 50 molecules and a focus on oncology, autoimmune diseases and ophthalmic conditions.

Organon offers over 60 medicines and products in women's health alongside a growing biosimilars business and established medicine franchise. With headquarters in Jersey City, New Jersey, Organon employs approximately 10,000 individuals and holds a significant presence in fast-growing international markets.