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Efficacy and safety of denosumab biosimilar CMAB807 versus Prolia in Chinese postmenopausal women with osteoporosis.

作者信息

Jiang Yan, Wang Bingwu, Cheng Qun, Huo Yanan, Hu Maozhong, Wang Qin, Mao Li, Cai Hanqing, Song Lige, Hu Ji, Xiong Xiaojiang, Liu Dongfang, Sheng Zhifeng, Yang Aige, Yan Shigui, Zhang Jun, Hou Sheng, Guo Yajun, Xia Weibo

机构信息

Department of Endocrinology, National Health Commission Key Laboratory of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, PR China.

Department of Orthopedics, Weifang People's Hospital, Weifang, 261044, PR China.

出版信息

Endocrine. 2025 Sep 19. doi: 10.1007/s12020-025-04430-5.

DOI:10.1007/s12020-025-04430-5
PMID:40971122
Abstract
摘要

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Efficacy and safety of denosumab biosimilar CMAB807 versus Prolia in Chinese postmenopausal women with osteoporosis.地舒单抗生物类似药CMAB807与Prolia在中国绝经后骨质疏松症女性中的疗效和安全性比较
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本文引用的文献

1
Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis.候选生物类似药 CT-P41 对比参照药物地舒单抗的疗效和安全性：一项针对绝经后骨质疏松症女性的双盲、随机、阳性对照、3 期临床试验。
Osteoporos Int. 2024 Nov;35(11):1919-1930. doi: 10.1007/s00198-024-07161-x. Epub 2024 Jul 23.
2
Randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis.一项在中国绝经后骨质疏松症女性中评估地舒单抗生物类似药 MW031 的疗效和安全性的随机、双盲、安慰剂对照、多中心研究。
Expert Opin Biol Ther. 2024 Jul;24(7):665-672. doi: 10.1080/14712598.2024.2352587. Epub 2024 May 16.
3
Denosumab biosimilar (LY06006) in Chinese postmenopausal osteoporotic women: A randomized, double-blind, placebo-controlled, multicenter phase III study.地舒单抗生物类似药（LY06006）用于中国绝经后骨质疏松症女性：一项随机、双盲、安慰剂对照、多中心III期研究。
J Orthop Translat. 2022 Oct 29;38:117-125. doi: 10.1016/j.jot.2022.06.007. eCollection 2023 Jan.
4
A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk.一项针对绝经后骨质疏松症和高骨折风险的中国女性患者的地舒单抗生物类似药 QL1206 的 III 期随机、双盲、安慰剂对照临床试验。
Acta Pharmacol Sin. 2023 Feb;44(2):446-453. doi: 10.1038/s41401-022-00954-y. Epub 2022 Jul 27.
5
Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial.在绝经后骨质疏松症中，与参比产品（普罗力®）相比，生物类似药地舒单抗候选药物（Arylia）的疗效和安全性：一项 III 期、随机、双盲、双臂、平行、阳性对照、非劣效性临床试验。
Arthritis Res Ther. 2022 Jun 30;24(1):161. doi: 10.1186/s13075-022-02840-8.
6
Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of CMAB807, a New Denosumab Biosimilar, in Healthy Chinese Subjects.新型地诺单抗生物类似药CMAB807在健康中国受试者中的药代动力学、药效学、安全性及免疫原性
Front Pharmacol. 2022 Jan 24;13:821944. doi: 10.3389/fphar.2022.821944. eCollection 2022.
7
A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China.一项利用真实世界证据支持骨质疏松症产品在中国注册的新病例研究。
Ther Innov Regul Sci. 2022 Jan;56(1):137-144. doi: 10.1007/s43441-021-00342-4. Epub 2021 Oct 11.
8
Denosumab biosimilar in postmenopausal osteoporotic women: A randomized, assessor-blind, active-controlled clinical trial.地舒单抗生物类似药治疗绝经后骨质疏松症女性：一项随机、评估者盲法、阳性药物对照的临床试验。
Indian J Pharmacol. 2021 Jan-Feb;53(1):6-12. doi: 10.4103/ijp.IJP_346_19.
9
An overview and management of osteoporosis.骨质疏松症概述与管理
Eur J Rheumatol. 2017 Mar;4(1):46-56. doi: 10.5152/eurjrheum.2016.048. Epub 2016 Dec 30.
10
Denosumab: Prevention and management of hypocalcemia, osteonecrosis of the jaw and atypical fractures.地诺单抗：低钙血症、颌骨骨坏死及非典型骨折的预防与管理。
Asia Pac J Clin Oncol. 2017 Aug;13(4):266-276. doi: 10.1111/ajco.12517. Epub 2016 Nov 10.