Evidence map›Paper›PMID 40650795›Full record

Trial reportDrugs in R&D2025

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

Abstract readRandomized Controlled TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drugs in R&D, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Jigang ZhangClinical Research Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No.100 Haining Road, Shanghai, 200080, PR China.
Mingjian ZhangClinical Research Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No.100 Haining Road, Shanghai, 200080, PR China.
Wenyuan XueClinical Research Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No.100 Haining Road, Shanghai, 200080, PR China.
Yixin ZhaClinical Research Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No.100 Haining Road, Shanghai, 200080, PR China.
Shujing JinClinical Research Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No.100 Haining Road, Shanghai, 200080, PR China.
Tianhong LuoChangchun GeneScience Pharmaceutical Co., Ltd, Changchun, China.
Ying DingChangchun GeneScience Pharmaceutical Co., Ltd, Changchun, China.
Weiwei GaoChangchun GeneScience Pharmaceutical Co., Ltd, Changchun, China.
Xueying DingClinical Research Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No.100 Haining Road, Shanghai, 200080, PR China. dingxueying@126.com.
Xiaoyan ZhuChangchun GeneScience Pharmaceutical Co., Ltd, Changchun, China. zhuxiaoyan01@genscigroup.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThis 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

methodsThis 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

resultsThe geometric mean ratios (GMRs) and 90% CIs for baseline-corrected AUC

conclusionThe novel prefilled rh-FSH injection (GenSci008) is bioequivalent to the reference formulation (Jinfollin

Indexed as

Follicle Stimulating HormoneFollicle Stimulating Hormone, HumanAdultArea Under CurveChinaCross-Over StudiesEast Asian PeopleFemaleHealthy VolunteersHumansInjections, SubcutaneousRecombinant ProteinsTherapeutic EquivalencyYoung AdultFollicle Stimulating HormoneFollicle Stimulating Hormone, HumanRecombinant Proteins

Identifiers

PMID40650795
PMCPMC12460200

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.