{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T03:00:15Z","timestamp":1792724415705,"version":"4.5.0"},"reference-count":7,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T00:00:00Z","timestamp":1762732800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"\n Objective<\/jats:title>\n This study aimed to evaluate the pharmacokinetic (PK) bioequivalence, safety, and immunogenicity of recombinant human follicle-stimulating hormone (rhFSH) for injection (code name: JZB30), developed by Chengdu Jingze Biopharmaceutical Co., Ltd., in comparison with Gonal-f\u00ae developed by Merck Serono in healthy adult Chinese female participants.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n single-center, randomized, open-label, two-period crossover study for bioequivalence assessment enrolled 48 healthy adult female participants, who were equally and randomly assigned to two treatment sequences. Each participant received a single subcutaneous injection of either JZB30 or Gonal-f\u00ae at a dose of 225 IU on Day 1 and again on Day 11 as part of the crossover design. Blood concentrations of FSH were measured using a validated electrochemiluminescence immunoassay, followed by non-compartmental PK analysis. Safety and immunogenicity were systematically monitored throughout the study period, including adverse events and anti-FSH antibody testing.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The geometric mean ratios (GMRs) of the primary PK parameters\u2014Cmax, AUC\n 0-t<\/jats:sub>\n , and\n \n \n \n \n \n A<\/mml:mi>\n U<\/mml:mi>\n C<\/mml:mi>\n <\/mml:mrow>\n \n 0<\/mml:mn>\n \u2212<\/mml:mo>\n \u221e<\/mml:mi>\n <\/mml:mrow>\n <\/mml:msub>\n <\/mml:mrow>\n <\/mml:math>\n <\/jats:inline-formula>\n \u2013after baseline correction were 106.12%, 108.04%, and 115.32%, respectively. The 90% confidence intervals for these parameters (Cmax:101.92%\u2013110.49%; AUC\n 0-t<\/jats:sub>\n :104.13%\u2013112.09%;\n \n \n \n \n \n A<\/mml:mi>\n U<\/mml:mi>\n C<\/mml:mi>\n <\/mml:mrow>\n \n 0<\/mml:mn>\n \u2212<\/mml:mo>\n \u221e<\/mml:mi>\n <\/mml:mrow>\n <\/mml:msub>\n <\/mml:mrow>\n <\/mml:math>\n <\/jats:inline-formula>\n ,: 106.47%\u2013124.90%) all fell within the predefined bioequivalence range of 80%\u2013125%. All adverse events (AEs) were mild (Grade 1) and resolved spontaneously without requiring medical intervention. One participant tested positive for anti-FSH antibodies following administration of the reference formulation; however, the antibody response reverted to negative without any intervention, indicating a low risk of immunogenicity.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n JZB30 was demonstrated to be pharmacokinetically bioequivalent to Gonal-f\u00ae in healthy adult Chinese female participants, with comparable safety profiles and a low risk of immunogenicity. These findings provide evidence to support the clinical application of JZB30 as a biosimilar to Gonal-f\u00ae.<\/jats:p>\n <\/jats:sec>\n \n Clinical Trial Registration<\/jats:title>\n \n The trial was registered on\n ClinicalTrials.gov<\/jats:ext-link>\n under identifier NCT06778304.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.3389\/fphar.2025.1678830","type":"journal-article","created":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T06:29:56Z","timestamp":1762756196000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["A single-center, randomized, open-label, two-period, crossover, fasted bioequivalence study: comparing recombinant human follicle-stimulating hormone for injection (JZB30) with Gonal-f\u00ae in healthy Chinese female participants"],"prefix":"10.3389","volume":"16","author":[{"given":"Zhuo","family":"Chen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qin","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shiyin","family":"Feng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Mo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linrui","family":"Cai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunfeng","family":"Du","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan","family":"Du","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qin","family":"Zou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,11,10]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"238","DOI":"10.1111\/j.1365-2125.2009.03585.x","article-title":"Assessing the bioequivalence of analogues of endogenous substances ('endogenous drugs'): considerations to optimize study design","volume":"69","author":"Dissanayake","year":"2010","journal-title":"Br. J. Clin. Pharmacol."},{"key":"B2","article-title":"Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle-stimulating hormone (rhFSH)","year":"2013"},{"key":"B3","doi-asserted-by":"publisher","first-page":"130","DOI":"10.1186\/s12958-015-0124-y","article-title":"Phase I, two-way, crossover study to demonstrate bioequivalence and to compare safety and tolerability of single-dose XM17 vs Gonal-f\u00ae in healthy women after follicle-stimulating hormone downregulation","volume":"13","author":"Lammerich","year":"2015","journal-title":"Reproductive Biol. Endocrinol."},{"key":"B4","doi-asserted-by":"publisher","first-page":"679","DOI":"10.1016\/s0015-0282(16)56645-x","article-title":"Clinical pharmacology of recombinant human follicle-stimulating hormone. II. Single doses and steady state pharmacokinetics","volume":"61","author":"Le Contonnec","year":"1994","journal-title":"Fertil. Steril."},{"key":"B5","doi-asserted-by":"publisher","first-page":"121","DOI":"10.1185\/030079904x18027","article-title":"Bioequivalence of liquid and freeze-dried recombinant human follicle-stimulating hormone","volume":"21","author":"Lugan","year":"2005","journal-title":"Curr. Med. Res. Opin."},{"key":"B6","unstructured":"Technical guidelines for the development and evaluation of biosimilar medicinal products (trial)\n \n \n 2015"},{"key":"B7","doi-asserted-by":"publisher","first-page":"259","DOI":"10.1007\/s13318-015-0257-6","article-title":"Comparison of pharmacokinetic and safety profiles between bemfola(\u00ae) and Gonal-f(\u00ae) after subcutaneous application","volume":"41","author":"Wolzt","year":"2016","journal-title":"Eur. J. Drug Metab. Pharmacokinet."}],"container-title":["Frontiers in Pharmacology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2025.1678830\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T06:29:57Z","timestamp":1762756197000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2025.1678830\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,10]]},"references-count":7,"alternative-id":["10.3389\/fphar.2025.1678830"],"URL":"https:\/\/doi.org\/10.3389\/fphar.2025.1678830","relation":{},"ISSN":["1663-9812"],"issn-type":[{"value":"1663-9812","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,10]]},"article-number":"1678830"}}