Qilu Reports Initiation of P-III Trial for QL1206 (biosimilar, denosumab) in China

 Qilu Reports Initiation of P-III Trial for QL1206 (biosimilar, denosumab) in China

Qilu Reports Initiation of P-III Trial for QL1206 (biosimilar, denosumab) in China

Shots:

  • The P-III trial involves assessing QL1206 (60 mg, SC) vs PBO (SC) in 216 patients every 6 months for 1 year. Additionally, the candidates will receive 500 mg of calcium and 1,000 IU of vitamin D daily
  • The 1EP of the trial is to evaluate the effect of QL1206 and the 2EP is to evaluate the safety, efficacy, immunogenicity, PK & PD including the objective to evaluate effect of anti-drug antibodies (ADA) and AEs. The trial is expected to complete in July 2021   
  • QL1206 has been currently evaluate in P-I trial assessing its PK, PD, safety in comparison with Xgeva enrolling 168 patients with its expected completion in May 2019

Click here to­ read full press release/ article | Ref: Gabi | Image: Twitter

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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