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Henlius Denosumab Biosimilar Trial Enters Phase III

As Firm’s Shanghai Plant Has Received EU GMP Equivalence

 
• By Chloe Kent

Henlius has administered the first dose in its international Phase III trial into its denosumab biosimilar candidate, HLX14. The firm has also revealed that its new Songjiang plant has been granted GMP equivalence with EU practices.

Osteoporosis
The study will evaluate the impact of Henlius' candidate on bone mineral density. • Source: Shutterstock

The first subject has been dosed in Shanghai Henlius Biotech’s international multicenter Phase III clinical trial for HLX14, its proposed biosimilar to Amgen’s Prolia/Xgeva (denosumab), for the treatment of postmenopausal osteoporosis in women with high fracture risks.

The randomized, double-blind, international multicenter, parallel-controlled Phase III study aims to compare the efficacy, safety, tolerability and immunogenicity of HLX14 with reference denosumab. Patients will be randomized 1:1 to receive either a subcutaneous injection of HLX14 or reference denosumab every six months for two cycles

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