博優倍®遵循生物類似藥相關研究指南,通過藥學、非臨床、人體藥代動力學、臨床有效性一系列逐步遞進的研究,科學、嚴謹、完整地確證了博優倍®與原研參照藥的整體相似性,二者的質量、安全性和有效性高度相似,無臨床意義上的差異。博優倍®完成的兩個I期臨床試驗的結果分別已在《Expert Opinion on Investigational Drugs》[1]和《Frontiers in Pharmacology》[2]發表,III期臨床試驗結果已在《Journal of Orthopaedic Translation》[3]發表。
[1] Wang S, Yang X, Huang J, et al. Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a biosimilar of denosumab (LY06006): a randomized, double-blind, single-dose, parallel-controlled clinical study in healthy Chinese subjects [J]. Expert Opin Investig Drugs, 2022,31:1133-1142.
[2] Niu S, Chen M, Yan D, et al. A Randomized Controlled Dose-Escalation Study of LY06006, a Recombinant Humanized Monoclonal Antibody to RANKL, in Chinese Healthy Adults [J]. Frontiers in Pharmacology, 2022,13:893166.
[3] Gu J, Zhang H, Xue Q, et al. Denosumab biosimilar (LY06006) in Chinese postmenopausal osteoporotic women: A randomized, double-blind, placebo-controlled, multicenter phase III study [J]. Journal of Orthopaedic Translation, 2023,38:117-125.
[6] Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists/ American College of Endocrinology Clinical Practice Guidelines for the diagnosis and treatment of postmenopausal osteoporosis-2020 update [J]. Endocr Pract, 2020,26: 1-46.
[7] Shoback D, Rosen CJ, Black DM, et al. Pharmacological management of osteoporosis in postmenopausal women: an endocrine society guideline update [J]. J Clin Endocrinol Metab, 2020, 105: 587-594.
[8] Kanis JA, Cooper C, Rizzoli R, et al. European guidance for the diagnosis and management of osteoporosis in postmenopausal women [J]. Osteoporos Int, 2019, 30: 3-44.
cooseii創辦人葉文宏表示,素有「學生界諾貝爾獎」之稱的霍特獎,每年都圍繞著聯合國的17項永續發展目標SDGs,提出一個全世界最需要解決的問題,廣邀全球年輕學子進行競賽。由台大管理學院學生共組的cooseii,有感全球受到新冠疫情影響甚鉅,特別提出Getting the world back to work「讓世界重回工作崗位」的概念,打造「cooseii」線上平台以藝術計劃協助弱勢創造優勢。
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