{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T05:03:12Z","timestamp":1784955792949,"version":"3.55.0"},"reference-count":24,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T00:00:00Z","timestamp":1784505600000},"content-version":"vor","delay-in-days":19,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>We evaluated the pharmacokinetic (PK) bioequivalence and safety of a new formulation of firsekibart (solution for injection) compared with firsekibart lyophilized powder for solution. In this randomized, double\u2010blind, parallel\u2010group study, healthy Chinese adult males received a single subcutaneous dose of 200 mg firsekibart solution for injection (test product, T) or firsekibart powder for solution (reference product, R), followed through Day 141. The primary objective was to evaluate PK bioequivalence between T and R, concluded if least\u2010squares geometric mean ratio (GMR) 90% confidence intervals (CIs) were within 80.00%\u2013125.00%. Safety was also evaluated. A total of 181 participants received T (N = 90) or R (N = 91). PK profiles were comparable between T and R: least\u2010squares GMRs (T\/R; 90% CI) for the maximum serum concentration, area under the concentration\u2013time curve (AUC) from time zero to the last time of quantifiable concentration, and AUC from time 0 to infinity were 104.26% (98.11%, 110.80%), 103.45% (98.15%, 109.04%), and 102.14% (96.75%, 107.83%), respectively. Most treatment\u2010emergent adverse events were mild\/moderate and generally comparable between T and R, with no treatment\u2010related serious adverse events reported. Firsekibart solution for injection was bioequivalent to firsekibart lyophilized powder for solution for injection in healthy Chinese males, with no new safety signals identified.<\/jats:p>","DOI":"10.1002\/cpdd.70077","type":"journal-article","created":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T13:27:35Z","timestamp":1784554055000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Bioequivalence of Two Firsekibart Subcutaneous Formulations: A Randomized, Double\u2010Blind, Single\u2010Dose, Parallel\u2010Group Study in Healthy Chinese Participants"],"prefix":"10.1002","volume":"15","author":[{"given":"Yehua","family":"Xie","sequence":"first","affiliation":[{"name":"Changchun GeneScience Pharmaceutical Co., Ltd. Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiao","family":"Li","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Center Chengdu Xinhua Hospital  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yushi","family":"Chen","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Center Chengdu Xinhua Hospital  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guangli","family":"Ma","sequence":"additional","affiliation":[{"name":"Changchun GeneScience Pharmaceutical Co., Ltd. Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fei","family":"Gu","sequence":"additional","affiliation":[{"name":"Changchun GeneScience Pharmaceutical Co., Ltd. Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuling","family":"Lian","sequence":"additional","affiliation":[{"name":"Changchun GeneScience Pharmaceutical Co., Ltd. Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xu","family":"Zhang","sequence":"additional","affiliation":[{"name":"Changchun GeneScience Pharmaceutical Co., Ltd. Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaolan","family":"Yong","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Center Chengdu Xinhua Hospital  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,20]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm11010166"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2020.04.008"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2665-9913(24)00117-6"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-025-86090-z"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.24180"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2018-026677"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/1756-185x.70375"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2010.09.012"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-023-03098-4"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/nature04516"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kex156"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbspin.2020.05.002"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-209707"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.4103\/0366-6999.216416"},{"key":"e_1_2_10_16_1","volume-title":"ILARIS\u00ae (canakinumab): prescribing information","author":"U.S. Food and Drug Administration (FDA)"},{"key":"e_1_2_10_17_1","volume-title":"Firsekibart approved with 87% reduction in gout recurrence over 6 months","author":"GenSci"},{"issue":"8","key":"e_1_2_10_18_1","article-title":"Firsekibart versus compound betamethasone in acute gout patients unsuitable for standard therapy: a randomized phase 3 trial","volume":"6","author":"Xue Y","year":"2025","journal-title":"Innovation"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr2.70111"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40744-025-00790-6"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-025-03279-4"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.7326\/M16-0570"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2017.12.069"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.3389\/fcvm.2023.1186330"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2021.791983"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70077","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70077","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70077","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T04:41:54Z","timestamp":1784954514000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70077"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7]]},"references-count":24,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2026,7]]}},"alternative-id":["10.1002\/cpdd.70077"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70077","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7]]},"assertion":[{"value":"2026-02-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-05","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-20","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70077"}}