{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T23:13:19Z","timestamp":1790723599213,"version":"4.1.0"},"reference-count":25,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2022,8,22]],"date-time":"2022-08-22T00:00:00Z","timestamp":1661126400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2022,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Current treatment of severe haemophilia A includes prophylaxis with factor VIII (FVIII) replacement. The supply of plasma\u2010derived FVIII is short in China.<\/jats:p><\/jats:sec><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To evaluate the efficacy and safety of a new B\u2010domain deleted (BDD) recombinant FVIII (TQG202) produced by human\u2010derived cells for prophylaxis in severe haemophilia A patients and compare the bioequivalence with Xyntha.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This multicentre, clinical trial consisted of an open\u2010label, randomized, two\u2010period cross\u2010over trial assessing single\u2010dose pharmacokinetics (PK), and a single\u2010arm clinical trial evaluating the efficacy and safety of 24 weeks of TQG202 prophylaxis, and repeated PK were assessed after prophylaxis phase. The single\u2010dose was 50 IU\/kg in PK assessment, and the initial dose was 30 \u00b1 5 IU\/kg for prophylaxis. The primary endpoints of prophylaxis were the annualized bleeding rate (ABR) and the incremental recovery rate of the first administration. Adverse events (AEs) were recorded.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Twenty\u2010six participants were enrolled in the PK assessment and 81 participants in the prophylaxis phase. Mean age was 25.9 \u00b1 10.8 years and all participants were male. The results of PK assessment showed TQG202 is bioequivalent to Xyntha. The total ABR was 2.0 (95% CI: 1.2\u20132.9) in prophylaxis phase. The mean incremental recovery rate of the first administration was .027 (95% CI: .026\u2013.028) (IU\/ml)\/(IU\/kg). AEs occurred in 42 participants, with an incidence of 51.9%. One severe AE not related to TQG202 occurred. No participants developed FVIII inhibitors.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>TQG202 shows bioequivalence with Xyntha. The promising efficacy and tolerability in the severe haemophilia A prophylaxis support the use of TQG202in clinical practice.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hae.14652","type":"journal-article","created":{"date-parts":[[2022,8,23]],"date-time":"2022-08-23T03:30:27Z","timestamp":1661225427000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Efficacy, safety and bioequivalence of the human\u2010derived B\u2010domain\u2010deleted recombinant factor VIII TQG202 for prophylaxis in severe haemophilia A patients"],"prefix":"10.1111","volume":"28","author":[{"given":"Yaming","family":"Xi","sequence":"first","affiliation":[{"name":"Department of Hematology The First Hospital of Lanzhou University  Lanzhou, Gansu Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chenghao","family":"Jin","sequence":"additional","affiliation":[{"name":"Hemophilia Information Management Center of Jiangxi Province Jiangxi Provincial People's Hospital  Nanchang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Liu","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology &amp; Blood Diseases Hospital,Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases Institute of Hematology &amp; Blood Diseases Hospital Chinese Academy of Medical Sciences &amp; Peking Union Medical College  Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hu","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Hematology The Cancer Hospital affiliated to Zhengzhou University  Zhengzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhen","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Hematology Henan Provincial People's Hospital People's Hospital of Zhengzhou University  Zhengzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rongfu","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Hematology Affiliated Drum Tower Hospital Medical School of Nanjing University  Nanjing Jiangsu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shifeng","family":"Lou","sequence":"additional","affiliation":[{"name":"Department of Hematology The Second Affiliated Hospital Chongqing Medical University  Chongqing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xielan","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Hematology Xiangya Hemophilia Diagnosis and Treatment Center Xiangya Hospital Central South University  Changsha Hunan Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fangping","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Hematology Xiangya Hemophilia Diagnosis and Treatment Center Xiangya Hospital Central South University  Changsha Hunan Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peng","family":"Cheng","sequence":"additional","affiliation":[{"name":"Department of Hematology The First Affiliated Hospital of Guangxi Medical University  Nanning Guangxi Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zimin","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Hematology The Affiliated Provincial Hospital of Anhui Medical University  Hefei China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haifei","family":"Jia","sequence":"additional","affiliation":[{"name":"R&amp;D Institute Chia Tai Tianqing Pharmaceutical Group Co. 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