A Bioequivalence Study of Recombinant Human Follicle-Stimulating Hormone Injection Versus Recombinant Human Follitropin For Injection in Healthy Chinese Adult Women

Jigang Zhang; Mingjian Zhang; Wenyuan Xue; Yixin Zha; Shujing Jin; Tianhong Luo; Ying Ding; Weiwei Gao; Xueying Ding; Xiaoyan Zhu

doi:10.1007/s40268-025-00513-w

A Bioequivalence Study of Recombinant Human Follicle-Stimulating Hormone Injection Versus Recombinant Human Follitropin For Injection in Healthy Chinese Adult Women

Drugs R D. 2025 Jul 12. doi: 10.1007/s40268-025-00513-w. Online ahead of print.

Authors

Affiliations

¹ Clinical Research Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No.100 Haining Road, Shanghai, 200080, PR China.
² Changchun GeneScience Pharmaceutical Co., Ltd, Changchun, China.
³ Clinical Research Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No.100 Haining Road, Shanghai, 200080, PR China. dingxueying@126.com.
⁴ Changchun GeneScience Pharmaceutical Co., Ltd, Changchun, China. zhuxiaoyan01@genscigroup.com.

PMID: 40650795
DOI: 10.1007/s40268-025-00513-w

Abstract

Background and objective: This study aimed to evaluate the bioequivalence of a novel prefilled recombinant human follicle-stimulating hormone (rh-FSH) injection (GenSci008) compared with the existing rh-FSH for injection (Jinfollin^®) in healthy Chinese adult women.

Methods: This open-label, randomized, single-center, two-period, two-sequence crossover study involved 24 healthy female volunteers who received single subcutaneous doses of both formulations, separated by a 10-day washout period. Participants underwent pituitary down-regulation using Diphereline^® to minimize endogenous FSH levels. Pharmacokinetic parameters, including peak concentration (C_max), area under the drug-time curve from 0 to t (AUC_0-t), and AUC from 0 to infinity (AUC_0-∞) were measured, and bioequivalence was assessed based on the 90% confidence intervals (CIs) falling within the 80.00-125.00% range. Safety and immunogenicity were also evaluated.

Results: The geometric mean ratios (GMRs) and 90% CIs for baseline-corrected AUC_0-t, AUC_0-∞, and C_max of the test formulation relative to the reference formulation were 99.99% (93.57-106.86), 102.70% (93.31-113.03), and 93.41% (87.77-99.41), respectively; all within the predefined bioequivalence range. Safety profiles were similar between the two formulations, with no suspected unexpected serious adverse reaction (SUSAR) identified.

Conclusion: The novel prefilled rh-FSH injection (GenSci008) is bioequivalent to the reference formulation (Jinfollin^®), offering a user-friendly and precise alternative for subcutaneous administration in the treatment of infertility.