Comparison of Beiyi® and its reference product Enantone® as agonists of luteinizing hormone-releasing hormone against prostate cancer: a multicenter, randomized single-dose study
- Journal
- Frontiers in pharmacology (Q1)
- Published
- 25 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Yuyao Yi, Pengfei Shen, Tongsen Zheng, Ruigang Hou, Lianlian Fan, Yanxia Yu, et al.
- PMID
- 42713047
- DOI
- 10.3389/fphar.2026.1873100
Why clinicians should know about it
- Picked for Urology (top studies of the week, 13 September 2026): Bioequivalence study of leuprolide formulations in prostate cancer
Abstract
BACKGROUND: Leuprolide acetate is a potent agonist of luteinizing hormone-releasing hormone that has been licensed to treat prostate cancer. The microsphere formulation of leuprolide acetate called Beiyi®, developed in China, has shown favorable pharmacokinetics, pharmacodynamics and safety similar to those of the reference drug Enantone® in healthy individuals. The present study examined whether the two formulations are bioequivalent in men with prostate cancer. METHODS: This multicenter, open-label study randomized 120 Chinese men with prostate cancer 1:1 to receive a single subcutaneous injection of Beiyi® or Enantone® (3.75 mg). The two groups were compared in terms of pharmacokinetics and safety. RESULTS: The ratio of the geometric means of the maximum serum concentration (Cmax) of Beiyi® and Enantone® was 98.34% (91.88%-105.25%); the ratio of the geometric means of the concentration-time curve from 7 to 28 days (AUC7-28) was 100.52% (88.17%-114.60%); and the ratio of the geometric means of the concentration-time curve from 0 to 28 days (AUC0-28) was 109.07% (98.54%-120.73%). The three 90% confidence intervals fell within the range of 80.00%-125.00%, indicating similar pharmacokinetics. The two drugs showed similar safety profiles, with no treatment-emergent adverse events leading to withdrawal or death. CONCLUSION: The two formulations of leuprolide acetate microspheres Beiyi® and Enantone® show similar pharmacokinetics and safety in Chinese men with prostate cancer. These results support the further clinical development of Beiyi® as a generic formulation of Enantone®. TRIAL REGISTRATION: CTR20222654 on http://www.chinadrugtrials.org.cn/index.html.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.