{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T02:35:54Z","timestamp":1789785354223,"version":"4.0.1"},"reference-count":31,"publisher":"The Endocrine Society","issue":"8","license":[{"start":{"date-parts":[[2024,11,28]],"date-time":"2024-11-28T00:00:00Z","timestamp":1732752000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Xiamen Amoytop Biotech Co, Ltd"},{"name":"Fourteenth Five-Year Plan"},{"name":"National Key Research and Development Projects","award":["2023YFC2706300"],"award-info":[{"award-number":["2023YFC2706300"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,7,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Context<\/jats:title>\n                    <jats:p>Pegpesen is a novel Y-shape pegylated recombinant human growth hormone (rhGH) for once-weekly treatment of children with growth hormone deficiency (GHD).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This work aimed to evaluate the efficacy and safety of Pegpesen in children with GHD vs daily rhGH.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A multicenter, randomized, controlled phase 3 clinical trial was conducted at 23 centers in China with a duration of 52 weeks\u2019 treatment. There were 391 pediatric participants diagnosed with GHD. Participants were randomly assigned 2:1 to a weekly Pegpesen group (140\u2005\u03bcg\/kg\/week) or a daily rhGH group (245\u2005\u03bcg\/kg\/week) for 52 weeks. The primary end point was the growth velocity (GV) at 52 weeks, and the secondary end points mainly involved changes from baseline in height SD scores for chronological age and bone age (\u0394Ht SDS CA and \u0394Ht SDS BA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At 52 weeks, the least squares mean (LS means) of GV was 9.910\u2005cm\/year in the Pegpesen group and 10.037\u2005cm\/year in the daily rhGH group. The LS means difference between groups was \u22120.127 (95% CI, \u22120.4868 to 0.2332), confirming that weekly Pegpesen is noninferior to daily rhGH. The LS means of \u0394Ht SDS CA, \u0394Ht SDS BA, were similar across both groups (all P &amp;gt; .05). Safety profiles and adherence were comparable.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Pegpesen was noninferior to daily rhGH, with similar safety, lower dosage requirements, thus presenting a new therapeutic option for children with GHD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/clinem\/dgae816","type":"journal-article","created":{"date-parts":[[2024,11,27]],"date-time":"2024-11-27T07:55:53Z","timestamp":1732694153000},"page":"e2605-e2613","source":"Crossref","is-referenced-by-count":12,"title":["A Novel Y-Shaped Pegylated Recombinant Human Growth Hormone for Children With Growth Hormone Deficiency"],"prefix":"10.1210","volume":"110","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9009-3284","authenticated-orcid":false,"given":"Yan","family":"Liang","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology , Wuhan 430030 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haiyan","family":"Wei","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Genetics and Metabolism, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital , Zhengzhou 450018 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fan","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, West China Second University Hospital, Sichuan University , Chengdu 610066 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hua","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Sanya Central Hospital , Sanya 572000 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linqi","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Metabolism and Genetic Disorders, Children's Hospital of Soochow University , Suzhou 215003 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Yao","sequence":"additional","affiliation":[{"name":"Department of Genetic Metabolism and Endocrinology, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology , Wuhan 430015 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoming","family":"Luo","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Zhejiang Provincial People's Hospital , Hangzhou 310014 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinran","family":"Cheng","sequence":"additional","affiliation":[{"name":"Department of Pediatric Endocrinology, Genetics, and Metabolism, The Affiliated Women's and Children's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu Women's and Children's Central Hospital , Chengdu 610031 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Genetics and Metabolism, Jiangxi Provincial Children's Hospital , Nanchang 330006 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qun","family":"Lian","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, The First Affiliated Hospital of Xiamen University , Xiamen 361003 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