On 11 September 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has accepted for review the new drug application (NDA) for HLX14 (120 mg/1.7 mL per vial), biosimilar to Amgen’s Xgeva® (denosumab). This follows NMPA acceptance of Henlius’ NDA for a 60 mg/1.0 mL strength of HLX14 in December 2025.
HXL14 was approved in the EU and the US in September 2025, as Bildyos® (referencing Amgen’s Prolia®) and Bilprevda® (referencing Xgeva®), for all reference indications. In March 2026, Henlius and its licensee, Organon, settled BPCIA litigation brought by Amgen in June 2025 in relation to Bildyos® and Bilprevda®. HLX14 has also been approved in Canada, as Bildyos® and Tuzemty® (March 2026).
Shanghai Henlius entered into a licence agreement with Organon in June 2022 under which Organon has exclusive global commercialisation rights to HLX14 for all countries except China, Hong Kong, Macau and Taiwan.
There are a number of denosumab biosimilars approved in China, including Mabwell’s Mailishu® (approved March 2024, referencing Xgeva®) and Maiweijian® (approved May 2026, referencing Prolia®); Boan Biotech’s Boyoubei® (November 2022, referencing Prolia®) and Boluojia® (approved 2024, expanded May 2026, referencing Xgeva®); and Mabpharm’s Puboli® (approved June 2026, referencing Prolia®).