Henlius and Organon Report the P-III Study Results of HLX14 (Biosimilar, Denosumab)

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Henlius and Organon Report the P-III Study Results of HLX14 (Biosimilar, Denosumab)


  • Henlius and Organon revealed results from the P-III trial evaluating the safety, efficacy tolerability and immunogenicity of HLX14 (60mg, SC, Q8M) vs reference candidate denosumab to treat postmenopausal women with osteoporosis at high-risk of fracture
  • The study achieved the 1EPs of percentage change in BMD at the lumbar spine at wk.52 (D365) and percentage change in area under the effect–time curve of serum type I collagen C-telopeptide (s-CTX) at wk.26 (D183) (AUEC0–26W)
  • Henlius collaborated with Organon for exclusive commercialization rights to two biosimilar candidates, incl. HLX14 across the US, the EU and Canada excl. China in 2022

Ref: Henlius | Image: Henlius 

Related News:- Henlius Reports the First Patient Dosing in P-III (HLX14-002-PMOP301) Trial of HLX14 (biosimilar, denosumab) to Treat Osteoporosis in Postmenopausal Women

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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