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

IF 2.1 4区医学 Q3 PHARMACOLOGY & PHARMACY

Drugs in Research & Development Pub Date : 2025-07-12 DOI:10.1007/s40268-025-00513-w

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

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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.

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重组人促卵泡激素注射液与重组人促卵泡素注射液在中国健康成年女性体内的生物等效性研究。

背景与目的：本研究旨在评价一种新型预充式重组人促卵泡激素（rh-FSH）注射液（GenSci008）与现有注射用rh-FSH （Jinfollin®）在中国健康成年女性中的生物等效性。方法：这项开放标签、随机、单中心、两期、两序列的交叉研究涉及24名健康女性志愿者，她们接受单次皮下剂量的两种制剂，间隔10天的洗脱期。参与者使用Diphereline®下调垂体水平以降低内源性FSH水平。测定药代动力学参数，包括峰浓度（Cmax）、0-t药时曲线下面积（AUC0-t）和0-∞药时曲线下面积（AUC0-∞），并根据90%置信区间（ci）在80.00-125.00%范围内评价生物等效性。安全性和免疫原性也进行了评价。结果：试验方相对于参比方的基线校正AUC0-t、AUC0-∞和Cmax的几何平均比（gmr）和90% CIs分别为99.99%（93.57 ~ 106.86）、102.70%（93.31 ~ 113.03）和93.41% (87.77 ~ 99.41)；均在预定的生物等效性范围内。两种制剂的安全性相似，未发现可疑的意外严重不良反应（SUSAR）。结论：新型预充型rh-FSH注射液（GenSci008）与参比制剂（Jinfollin®）具有生物等效性，为治疗不孕症提供了一种用户友好且精确的皮下给药选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drugs in Research & Development Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

5.10

自引率

0.00%

发文量

审稿时长

8 weeks

期刊介绍： Drugs in R&D is an international, peer reviewed, open access, online only journal, and provides timely information from all phases of drug research and development that will inform clinical practice. Healthcare decision makers are thus provided with knowledge about the developing place of a drug in therapy. The Journal includes: Clinical research on new and established drugs; Preclinical research of direct relevance to clinical drug development; Short communications and case study reports that meet the above criteria will also be considered; Reviews may also be considered.