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Shanghai Henlius’ Ph 3 success for Prolia® biosimilar HLX14 (denosumab)

Apr 5, 2024

On 5 April 2024, Shanghai Henlius Biotech (SHB) announced that its phase 3 studies confirmed that HLX14 (denosumab) is equivalent in efficacy, safety, tolerability and immunogenicity to Amgen’s Prolia®.  HLX14 will be indicated for the treatment of osteoporosis in postmenopausal women at high risk of fracture.

SHB announced the successful completion of its phase 1 clinical trials of HLX14 in January 2024.

In June 2022, SHB announced its licence agreement with Organon under which Organon received exclusive global commercialisation rights to HLX14, excluding China, Hong Kong, Macau and Taiwan.