{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T04:21:53Z","timestamp":1790050913567,"version":"4.0.1"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"11","license":[{"start":{"date-parts":[[2025,9,28]],"date-time":"2025-09-28T00:00:00Z","timestamp":1759017600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2025,9,28]],"date-time":"2025-09-28T00:00:00Z","timestamp":1759017600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"funder":[{"name":"Evive Biotech Co., Ltd."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Drug Investig"],"published-print":{"date-parts":[[2025,11]]},"DOI":"10.1007\/s40261-025-01488-x","type":"journal-article","created":{"date-parts":[[2025,9,28]],"date-time":"2025-09-28T06:09:59Z","timestamp":1759039799000},"page":"855-863","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Efbemalenograstim Alfa (F-627), a Novel Long-Acting rhG-CSF, in Healthy Chinese Participants: An Open-Label, Single-Center Phase I Study"],"prefix":"10.1007","volume":"45","clinical-trial-number":[{"clinical-trial-number":"chictr2400089548","registry":"10.18810\/chictr"}],"author":[{"given":"Zhihai","family":"Cao","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yao","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denny","family":"Hou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shufang","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Yao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gaochong","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianmin","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhengwei","family":"Tang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Song","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xingna","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoxiang","family":"Chu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoyan","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renshu","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4809-7601","authenticated-orcid":false,"given":"Wei","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,9,28]]},"reference":[{"issue":"7 Pt 2","key":"1488_CR1","doi-asserted-by":"publisher","first-page":"96s","DOI":"10.1592\/phco.20.10.96s.35230","volume":"20","author":"VR Adams","year":"2000","unstructured":"Adams VR. Adverse events associated with chemotherapy for common cancers. Pharmacotherapy. 2000;20(7 Pt 2):96s\u2013103s. https:\/\/doi.org\/10.1592\/phco.20.10.96s.35230.","journal-title":"Pharmacotherapy"},{"issue":"2","key":"1488_CR2","doi-asserted-by":"publisher","first-page":"109","DOI":"10.6004\/jnccn.2008.0012","volume":"6","author":"J Crawford","year":"2008","unstructured":"Crawford J, Dale DC, Kuderer NM, Culakova E, Poniewierski MS, Wolff D, et al. Risk and timing of neutropenic events in adult cancer patients receiving chemotherapy: the results of a prospective nationwide study of oncology practice. J Natl Compr Canc Netw. 2008;6(2):109\u201318. https:\/\/doi.org\/10.6004\/jnccn.2008.0012.","journal-title":"J Natl Compr Canc Netw"},{"issue":"6","key":"1488_CR3","doi-asserted-by":"publisher","first-page":"2481","DOI":"10.1007\/s00520-015-3039-4","volume":"24","author":"D Weycker","year":"2016","unstructured":"Weycker D, Li X, Barron R, Li Y, Reiner M, Kartashov A, et al. Risk of chemotherapy-induced febrile neutropenia with early discontinuation of pegfilgrastim prophylaxis in US clinical practice. Support Care Cancer. 2016;24(6):2481\u201390. https:\/\/doi.org\/10.1007\/s00520-015-3039-4.","journal-title":"Support Care Cancer"},{"issue":"12","key":"1488_CR4","doi-asserted-by":"publisher","first-page":"1520","DOI":"10.6004\/jnccn.2017.0175","volume":"15","author":"J Crawford","year":"2017","unstructured":"Crawford J, Becker PS, Armitage JO, Blayney DW, Chavez J, Curtin P, et al. Myeloid growth factors, version 2.2017, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2017;15(12):1520\u201341. https:\/\/doi.org\/10.6004\/jnccn.2017.0175.","journal-title":"J Natl Compr Canc Netw"},{"key":"1488_CR5","doi-asserted-by":"publisher","unstructured":"Guidelines for standardized management of neutropenia induced by chemotherapy and radiotherapy. Zhonghua Zhong Liu Za Zhi. 2017;39(11):868\u201378. https:\/\/doi.org\/10.3760\/cma.j.issn.0253-3766.2017.11.011.","DOI":"10.3760\/cma.j.issn.0253-3766.2017.11.011"},{"issue":"5","key":"1488_CR6","doi-asserted-by":"publisher","first-page":"702","DOI":"10.1177\/1078155215625459","volume":"22","author":"S Mitchell","year":"2016","unstructured":"Mitchell S, Li X, Woods M, Garcia J, Hebard-Massey K, Barron R, et al. Comparative effectiveness of granulocyte colony-stimulating factors to prevent febrile neutropenia and related complications in cancer patients in clinical practice: a systematic review. J Oncol Pharm Pract. 2016;22(5):702\u201316. https:\/\/doi.org\/10.1177\/1078155215625459.","journal-title":"J Oncol Pharm Pract"},{"issue":"6","key":"1488_CR7","doi-asserted-by":"publisher","first-page":"1907","DOI":"10.1006\/bcmd.1996.0102","volume":"88","author":"K Welte","year":"1996","unstructured":"Welte K, Gabrilove J, Bronchud MH, Platzer E, Morstyn G. Filgrastim (r-metHuG-CSF): the first 10 years. Blood. 1996;88(6):1907\u201329. https:\/\/doi.org\/10.1006\/bcmd.1996.0102.","journal-title":"Blood"},{"issue":"3 Suppl 8","key":"1488_CR8","doi-asserted-by":"publisher","first-page":"27","DOI":"10.1053\/j.seminoncol.2004.04.002","volume":"31","author":"L Biganzoli","year":"2004","unstructured":"Biganzoli L, Untch M, Skacel T, Pico JL. Neulasta (pegfilgrastim): a once-per-cycle option for the management of chemotherapy-induced neutropenia. Semin Oncol. 2004;31(3 Suppl 8):27\u201334. https:\/\/doi.org\/10.1053\/j.seminoncol.2004.04.002.","journal-title":"Semin Oncol"},{"issue":"10","key":"1488_CR9","doi-asserted-by":"publisher","first-page":"1009","DOI":"10.1007\/s40261-019-00836-y","volume":"39","author":"ZT Al-Salama","year":"2019","unstructured":"Al-Salama ZT, Keam SJ. Mecapegfilgrastim in chemotherapy-induced neutropenia: a profile of its use in China. Clin Drug Investig. 2019;39(10):1009\u201318. https:\/\/doi.org\/10.1007\/s40261-019-00836-y.","journal-title":"Clin Drug Investig"},{"issue":"1","key":"1488_CR10","doi-asserted-by":"publisher","first-page":"10","DOI":"10.46439\/hematol.2.009","volume":"2","author":"SX-M Li","year":"2023","unstructured":"Li SX-M, Hou Q-S, Wang S-F, Chen J-M, Yao W, Fu Y-Y, et al. Efbemalenograstim alfa, a long-acting granulocyte colony-stimulating factor, a novel dimeric G-CSF Fc fusion protein for reducing the risk of febrile neutropenia following chemotherapy. J Clin Exp Hematol. 2023;2(1):10\u20132. https:\/\/doi.org\/10.46439\/hematol.2.009.","journal-title":"J Clin Exp Hematol"},{"key":"1488_CR11","unstructured":"U.S. Food and Drug Administration. RYZNEUTA\u00ae (efbemalenograstim alfa-vuxw) review information. 2023. Available at: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2023\/761134Orig1s000IntegratedR.pdf."},{"issue":"3","key":"1488_CR12","doi-asserted-by":"publisher","first-page":"727","DOI":"10.1200\/JCO.2002.20.3.72","volume":"20","author":"FA Holmes","year":"2002","unstructured":"Holmes FA, O\u2019Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III\/IV breast cancer. J Clin Oncol. 2002;20(3):727\u201331. https:\/\/doi.org\/10.1200\/JCO.2002.20.3.72.","journal-title":"J Clin Oncol"},{"issue":"2","key":"1488_CR13","doi-asserted-by":"publisher","first-page":"91","DOI":"10.1007\/s00520-023-08260-X","volume":"32","author":"J Glaspy","year":"2024","unstructured":"Glaspy J, Bondarenko I, Krasnozhon D, Rutty D, Chen J, Fu Y, et al. Efbemalenograstim alfa not inferior to pegfilgrastim in providing neutrophil support in women with breast cancer undergoing myelotoxic chemotherapy: results of a phase 2 randomized, multicenter, open-label trial. Support Care Cancer. 2024;32(2):91. https:\/\/doi.org\/10.1007\/s00520-023-08260-X.","journal-title":"Support Care Cancer"},{"issue":"1","key":"1488_CR14","doi-asserted-by":"publisher","first-page":"34","DOI":"10.1007\/s00520-023-08176-6","volume":"32","author":"J Glaspy","year":"2023","unstructured":"Glaspy J, Bondarenko I, Burdaeva O, Chen J, Rutty D, Li R, et al. Efbemalenograstim alfa, an Fc fusion protein, long-acting granulocyte-colony stimulating factor for reducing the risk of febrile neutropenia following chemotherapy: results of a phase III trial. Support Care Cancer. 2023;32(1):34. https:\/\/doi.org\/10.1007\/s00520-023-08176-6.","journal-title":"Support Care Cancer"},{"issue":"5","key":"1488_CR15","doi-asserted-by":"publisher","first-page":"295","DOI":"10.2165\/11586040-000000000-00000","volume":"50","author":"BB Yang","year":"2011","unstructured":"Yang BB, Kido A. Pharmacokinetics and pharmacodynamics of pegfilgrastim. Clin Pharmacokinet. 2011;50(5):295\u2013306. https:\/\/doi.org\/10.2165\/11586040-000000000-00000.","journal-title":"Clin Pharmacokinet"},{"key":"1488_CR16","doi-asserted-by":"publisher","unstructured":"Yan XQ, Hodsman PG, Huang ZH, Sun RY, Sun NC, Huang YL. An open-label, single ascending dose phase I study of F-627, a G-CSF dimer, in healthy male subjects. In: American Society of Hematology; 2010. https:\/\/doi.org\/10.1182\/blood.V116.21.4722.4722.","DOI":"10.1182\/blood.V116.21.4722.4722"},{"issue":"11","key":"1488_CR17","doi-asserted-by":"publisher","first-page":"4889","DOI":"10.1007\/s12325-023-02636-5","volume":"40","author":"H Tang","year":"2023","unstructured":"Tang H, Civoli F, Tatarewicz S, Vandenkoornhuyse N, Finck B. Pharmacokinetic and pharmacodynamic bioequivalence of pegfilgrastim-cbqv delivered via a prefilled autoinjector and prefilled syringe in healthy male participants. Adv Ther. 2023;40(11):4889\u2013906. https:\/\/doi.org\/10.1007\/s12325-023-02636-5.","journal-title":"Adv Ther"},{"issue":"10","key":"1488_CR18","doi-asserted-by":"publisher","first-page":"4291","DOI":"10.1007\/s12325-020-01459-y","volume":"37","author":"B Finck","year":"2020","unstructured":"Finck B, Tang H, Civoli F, Hodge J, O\u2019Kelly H, Vexler V. Pharmacokinetic and pharmacodynamic equivalence of pegfilgrastim-cbqv and pegfilgrastim in healthy subjects. Adv Ther. 2020;37(10):4291\u2013307. https:\/\/doi.org\/10.1007\/s12325-020-01459-y.","journal-title":"Adv Ther"},{"issue":"1","key":"1488_CR19","doi-asserted-by":"publisher","first-page":"75","DOI":"10.1007\/s10637-017-0490-8","volume":"36","author":"H Misra","year":"2018","unstructured":"Misra H, Berryman J, Jubin R, Abuchowski A. A phase I study to determine safety, pharmacokinetics, and pharmacodynamics of ANF-RHO\u2122, a novel PEGylated granulocyte colony-stimulating factor, in healthy volunteers. Invest New Drugs. 2018;36(1):75\u201384. https:\/\/doi.org\/10.1007\/s10637-017-0490-8.","journal-title":"Invest New Drugs"},{"issue":"5","key":"1488_CR20","doi-asserted-by":"publisher","DOI":"10.1002\/prp2.503","volume":"7","author":"K Roth","year":"2019","unstructured":"Roth K, Lehnick D, Wessels H, H\u00f6fler J, Gastl B, Jankowsky R. Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of Pelmeg(\u00ae), a pegfilgrastim biosimilar in healthy subjects. Pharmacol Res Perspect. 2019;7(5):e00503. https:\/\/doi.org\/10.1002\/prp2.503.","journal-title":"Pharmacol Res Perspect"},{"issue":"12","key":"1488_CR21","doi-asserted-by":"publisher","first-page":"2790","DOI":"10.1111\/bcp.13731","volume":"84","author":"R Nakov","year":"2018","unstructured":"Nakov R, Gattu S, Wang J, Velinova M, Schaffar G, Skerjanec A. Proposed biosimilar pegfilgrastim shows similarity in pharmacokinetics and pharmacodynamics to reference pegfilgrastim in healthy subjects. Br J Clin Pharmacol. 2018;84(12):2790\u2013801. https:\/\/doi.org\/10.1111\/bcp.13731.","journal-title":"Br J Clin Pharmacol"}],"container-title":["Clinical Drug Investigation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40261-025-01488-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40261-025-01488-x\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40261-025-01488-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T07:57:30Z","timestamp":1760774250000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40261-025-01488-x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,28]]},"references-count":21,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2025,11]]}},"alternative-id":["1488"],"URL":"https:\/\/doi.org\/10.1007\/s40261-025-01488-x","relation":{},"ISSN":["1173-2563","1179-1918"],"issn-type":[{"value":"1173-2563","type":"print"},{"value":"1179-1918","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,28]]},"assertion":[{"value":"29 April 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 September 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 September 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Denny Hou, Shufang Wang, Wei Yao, Gaochong Zhang, Jianmin Chen, Zhengwei Tang, Linda Song, Xingna Zhao, Xiaoxiang Chu, Xiaoyan Wang, and Renshu Li are employed by the funding body of this study; the remaining authors have no conflicts of interest to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study protocol, informed consent form (ICF), and other relevant documents were reviewed and approved by the Independent Ethics Committee of The Second Affiliated Hospital of Anhui Medical University. The investigator was not involved in the voting of the ethics committee. The sponsor obtained written approval from the Independent Ethics Committee before the commencement of the study (review ID: YW2022-073; approval date: 20 May 2022). The study was conducted in accordance with the Declaration of Helsinki and the Chinese Good Clinical Practice Guidelines. Written informed consent was obtained from all patients before any study-related procedure was performed.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"All data generated or analyzed during this study are included in this published article.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of date and materials"}},{"value":"Wei Hu was the coordinating principal investigator of the study and involved in the development of the study protocol, study execution, and evaluation of the study results. Zhihai Cao and Yao Li were involved in drafting the manuscript and diagrams. Denny Hou, Shufang Wang and Wei Yao were involved in drafting the manuscript. Gaochong Zhang, Xiaoxiang Chu, and Xiaoyan Wang were involved in the study preparation, coordination, and evaluation of the trial. All the authors were involved in the review and approval of the manuscript and contributed to this work.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}